Trial Outcomes & Findings for Rezum I Pilot Study for Benign Prostatic Hyperplasia (NCT NCT02943070)

Last Updated: 2021-03-16

Results Overview

International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change (improvement) in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Results posted on

2021-03-16

Participant Flow

This prospective, international, multicenter, non-randomized study recruited subjects who met inclusion/exclusion criteria and consented to participate. Subjects on BPH medication underwent a washout period prior to treatment. Subjects who successfully completed the washout period and still met the inclusion/exclusion criteria were enrolled in the study. Subjects were considered officially enrolled only if treatment with the NxThera Rezūm System was attempted.

Participant milestones

Participant milestones
Measure	Rezum Treatment Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Overall Study STARTED	50
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Rezum Treatment Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Overall Study Physician Decision	1
Overall Study Adverse Event	2
Overall Study Death	2
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	4
Overall Study Retreatment or TURP	13
Overall Study Subjects exited after their 48 month visit per the Sponsor's decision to close the study.	18

Baseline Characteristics

Rezum I Pilot Study for Benign Prostatic Hyperplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Age, Continuous	65.5 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black or African Origin	2 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	45 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	3 Participants n=5 Participants
Region of Enrollment Sweden	27 participants n=5 Participants
Region of Enrollment Czechia	18 participants n=5 Participants
Region of Enrollment Dominican Republic	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Mean change (improvement) in score was calculated for the number of subjects providing data at each follow-up visit.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
International Prostate Symptom Score (IPSS) Change From Baseline IPSS Change at 1 Week	-0.4 score on a scale Standard Deviation 7.8	—	—
International Prostate Symptom Score (IPSS) Change From Baseline IPSS Change at 1 Month	-5.0 score on a scale Standard Deviation 8.3	—	—
International Prostate Symptom Score (IPSS) Change From Baseline IPSS Change at 3 Months	-13.1 score on a scale Standard Deviation 7.2	—	—
International Prostate Symptom Score (IPSS) Change From Baseline IPSS Change at 6 Months	-12.6 score on a scale Standard Deviation 7.9	—	—
International Prostate Symptom Score (IPSS) Change From Baseline IPSS Change at 12 Months	-12.2 score on a scale Standard Deviation 7.7	—	—
International Prostate Symptom Score (IPSS) Change From Baseline IPSS Change at 24 Months	-11.7 score on a scale Standard Deviation 8.4	—	—
International Prostate Symptom Score (IPSS) Change From Baseline IPSS Change at 36 Months	-9.4 score on a scale Standard Deviation 9.0	—	—
International Prostate Symptom Score (IPSS) Change From Baseline IPSS Change at 48 Months	-9.6 score on a scale Standard Deviation 7.5	—	—
International Prostate Symptom Score (IPSS) Change From Baseline IPSS Change at 60 Months	-8.4 score on a scale Standard Deviation 6.7	—	—

PRIMARY outcome

Timeframe: 3 months

Population: Incidence of device-related complications pre-specified under this safety endpoint assessed through 3 months post-implant.

Safety assessed by the frequency of systemic and local serious device related complications and the occurrence of unanticipated device-related adverse effects during treatment and at follow-up, up to 30 days. Due to the nature of the device, any device-related AEs are expected to present themselves during the immediate peri-procedure period (30 days post procedure). The device related complications that will be compared for this safety endpoint are: 1. Severe Urinary Retention (Retention ≥ 24 hours) 2. Fistula between rectum and urethra 3. Perforation of the rectum or GI tract 4. New incidences of retrograde ejaculation

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Major Complications Perforation of the Rectum or GI Tract	0 clinically relevant complications	—	—
Major Complications New incidences of retrograde ejaculation	0 clinically relevant complications	—	—
Major Complications Severe urinary retention (retention >=24 hours	1 clinically relevant complications	—	—
Major Complications Fistula between rectum and urethra	0 clinically relevant complications	—	—

SECONDARY outcome

Timeframe: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Subjects with data at baseline and at the follow-up visit are included in the data summarization.

The proportion of study subjects who were responders were evaluated. A responder is defined as a subject with ≥ 30% improvement in BPH symptoms from baseline as measured by the IPSS.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with>=30% Improvement at 48 Months	18 Participants	—	—
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with>=30% Improvement at 60 Months	4 Participants	—	—
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with>=30% Improvement at 1 Week	12 Participants	—	—
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with>=30% Improvement at 1 Month	20 Participants	—	—
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with>=30% Improvement at 3 Months	39 Participants	—	—
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with>=30% Improvement at 6 Months	40 Participants	—	—
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with>=30% Improvement at 12 Months	36 Participants	—	—
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with>=30% Improvement at 24 Months	28 Participants	—	—
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with>=30% Improvement at 36 Months	19 Participants	—	—

SECONDARY outcome

Timeframe: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Subjects with data at baseline and follow-up visits are included in the data summarization.

The proportion of study subjects who were responders were evaluated. For this measure a responder is defined as a subject with ≥ 50% improvement in BPH symptoms from baseline as measured by the IPSS.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with a ≥ 50% IPSS Improvement at 1 Month	14 Participants	—	—
Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with a ≥ 50% IPSS Improvement at 3 Months	35 Participants	—	—
Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with a ≥ 50% IPSS Improvement at 1 Week	3 Participants	—	—
Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with a ≥ 50% IPSS Improvement at 6 Months	35 Participants	—	—
Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with a ≥ 50% IPSS Improvement at 12 Months	30 Participants	—	—
Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with a ≥ 50% IPSS Improvement at 24 Months	20 Participants	—	—
Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with a ≥ 50% IPSS Improvement at 36 Months	15 Participants	—	—
Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with a ≥ 50% IPSS Improvement at 48 Months	13 Participants	—	—
Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement Proportion of Responders with a ≥ 50% IPSS Improvement at 60 Months	2 Participants	—	—

SECONDARY outcome

Timeframe: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Analysis will be provided for proportion of subjects with improvement ≥ 8 points from baseline at 1 week, 1 month, and 3 months, 6 months, 1 year, annually to 5 years

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS Proportion of Responders With Improvement ≥ 8 Points in IPSS at 1 Week	9 Participants	—	—
Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS Proportion of Responders With Improvement ≥ 8 Points in IPSS at 1 Month	18 Participants	—	—
Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS Proportion of Responders With Improvement ≥ 8 Points in IPSS at 3 Months	37 Participants	—	—
Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS Proportion of Responders With Improvement ≥ 8 Points in IPSS at 6 Months	37 Participants	—	—
Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS Proportion of Responders With Improvement ≥ 8 Points in IPSS at 12 Months	33 Participants	—	—
Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS Proportion of Responders With Improvement ≥ 8 Points in IPSS at 24 Months	24 Participants	—	—
Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS Proportion of Responders With Improvement ≥ 8 Points in IPSS at 36 Months	17 Participants	—	—
Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS Proportion of Responders With Improvement ≥ 8 Points in IPSS at 48 Months	16 Participants	—	—
Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS Proportion of Responders With Improvement ≥ 8 Points in IPSS at 60 Months	4 Participants	—	—

SECONDARY outcome

Timeframe: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Mean change in urinary flow rate was calculated for subjects with data at baseline and follow-up visit.

Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. Average results are based on age and sex. Typical uroflow rates ranges from 10 ml to 21 ml per second. An increase in mL/sec corresponds to improved urinary function.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax) Change from baseline in peak urinary flow rate (Qmax) at 1 Week	-0.2 mL/sec Standard Deviation 4.3	—	—
Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax) Change from baseline in peak urinary flow rate (Qmax) at 1 Month	1.9 mL/sec Standard Deviation 4.8	—	—
Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax) Change from baseline in peak urinary flow rate (Qmax) at 3 Months	5.5 mL/sec Standard Deviation 6.6	—	—
Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax) Change from baseline in peak urinary flow rate (Qmax) at 6 Months	5.2 mL/sec Standard Deviation 5.7	—	—
Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax) Change from baseline in peak urinary flow rate (Qmax) at 12 Months	4.7 mL/sec Standard Deviation 7.0	—	—
Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax) Change from baseline in peak urinary flow rate (Qmax) at 24 Months	4.1 mL/sec Standard Deviation 6.7	—	—
Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax) Change from baseline in peak urinary flow rate (Qmax) at 36 Months	3.5 mL/sec Standard Deviation 6.2	—	—
Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax) Change from baseline in peak urinary flow rate (Qmax) at 48 months	3.0 mL/sec Standard Deviation 4.3	—	—
Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax) Change from baseline in peak urinary flow rate (Qmax) at 60 Months	3.9 mL/sec Standard Deviation 4.3	—	—

SECONDARY outcome

Timeframe: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Measure calculated for subjects with data at baseline and follow-up visit.

Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. This measure reports the number of subjects who experienced a ≥ 30% improvement from baseline at each follow-up interval.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline Qmax improvement of 30% or more over baseline at 3 Months	28 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline Qmax improvement of 30% or more over baseline at 6 Months	32 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline Qmax improvement of 30% or more over baseline at 12 Months	30 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline Qmax improvement of 30% or more over baseline at 24 Months	20 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline Qmax improvement of 30% or more over baseline at 1 Week	14 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline Qmax improvement of 30% or more over baseline at 1 Month	21 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline Qmax improvement of 30% or more over baseline at 36 Months	13 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline Qmax improvement of 30% or more over baseline at 48 months	4 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline Qmax improvement of 30% or more over baseline at 60 Months	4 Participants	—	—

SECONDARY outcome

Timeframe: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Measure calculated for subjects with data at baseline and follow-up visit.

Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. This measure reports the number of subjects who experienced a ≥3 mL/sec improvement from baseline at each follow-up interval.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec Subjects with Qmax Improvement of ≥ 3 ml/sec at 48 months	3 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec Subjects with Qmax Improvement of ≥ 3 ml/sec at 1 Week	11 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec Subjects with Qmax Improvement of ≥ 3 ml/sec at 1 Month	19 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec Subjects with Qmax Improvement of ≥ 3 ml/sec at 3 Months	30 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec Subjects with Qmax Improvement of ≥ 3 ml/sec at 6 Months	30 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec Subjects with Qmax Improvement of ≥ 3 ml/sec at 12 Months	27 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec Subjects with Qmax Improvement of ≥ 3 ml/sec at 24 Months	18 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec Subjects with Qmax Improvement of ≥ 3 ml/sec at 36 Months	12 Participants	—	—
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec Subjects with Qmax Improvement of ≥ 3 ml/sec at 60 Months	3 Participants	—	—

SECONDARY outcome

Timeframe: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Measure calculated for subjects with data at baseline and follow-up visit.

Change in post void residual (PVR) urine volume in ml. Post void residual volume was measured by either ultrasound to measure the volume left in the bladder after urination, or by inserting a urinary catheter into the bladder after urination to drain and measure residual urine. Either measurement tool was allowed but the same measurement was to be used pre and post treatment.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval Change from baseline in PVR at 60 Months	-12.6 ml Standard Deviation 52.4	—	—
Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval Change from baseline in PVR at 1 Week	48.8 ml Standard Deviation 135.9	—	—
Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval Change from baseline in PVR at 1 Month	-20.2 ml Standard Deviation 94.7	—	—
Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval Change from baseline in PVR at 3 Months	-30.5 ml Standard Deviation 72.4	—	—
Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval Change from baseline in PVR at 6 Months	-27.1 ml Standard Deviation 81.6	—	—
Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval Change from baseline in PVR at 12 Months	-22.8 ml Standard Deviation 83.7	—	—
Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval Change from baseline in PVR at 24 Months	-11.8 ml Standard Deviation 102.2	—	—
Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval Change from baseline in PVR at 36 Months	11.9 ml Standard Deviation 134.4	—	—
Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval Change from baseline in PVR at 48 months	-14.3 ml Standard Deviation 54.5	—	—

SECONDARY outcome

Timeframe: 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Mean change in total score was calculated for subjects providing data at each follow-up visit.

Change from baseline in sexual function was measured by the International Index of Erectile Function (IIEF) (Scoring on the IIEF ranges from 1 to 30. An increase in score indicates improvement from baseline)

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Change in Sexual Function - Erectile Function IEFF change from baseline at 1 Month	-4.2 score on a scale Standard Deviation 20.7	—	—
Change in Sexual Function - Erectile Function IEFF change from baseline at 3 Months	3.3 score on a scale Standard Deviation 20.0	—	—
Change in Sexual Function - Erectile Function IEFF change from baseline at 6 Months	6.3 score on a scale Standard Deviation 17.6	—	—
Change in Sexual Function - Erectile Function IEFF change from baseline at 12 Months	5.8 score on a scale Standard Deviation 16.4	—	—
Change in Sexual Function - Erectile Function IEFF change from baseline at 24 Months	8.2 score on a scale Standard Deviation 14.8	—	—
Change in Sexual Function - Erectile Function IEFF change from baseline at 36 Months	10.7 score on a scale Standard Deviation 16.9	—	—
Change in Sexual Function - Erectile Function IEFF change from baseline at 48 Months	2.7 score on a scale Standard Deviation 27.4	—	—
Change in Sexual Function - Erectile Function IEFF change from baseline at 60 Months	12.5 score on a scale Standard Deviation 24.1	—	—

SECONDARY outcome

Timeframe: 1 Week post procedure, 1 Month post procedure, 3 Months post procedure

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Rate of Retrograde Ejaculation (when no fluid exits the penis during orgasm (e.g., dry orgasm)

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Change in Sexual Function - Retrograde Ejaculation Incidence of retrograde ejaculation at 1 Week	0 Participants	—	—
Change in Sexual Function - Retrograde Ejaculation Incidence of retrograde ejaculation at 1 Month	0 Participants	—	—
Change in Sexual Function - Retrograde Ejaculation Incidence of retrograde ejaculation at 3 Months	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Measure calculated for subjects providing data at each follow-up visit.

International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval. Improvement in symptoms is shown by a reduction in score.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=37 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) n=13 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume IPSS Change at 6 Months	-11.8 score on a scale Standard Deviation 7.1	-14.9 score on a scale Standard Deviation 9.7	—
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume IPSS Change at 12 Months	-11.6 score on a scale Standard Deviation 7.7	-13.7 score on a scale Standard Deviation 8.0	—
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume IPSS Change at 1 Week	0.3 score on a scale Standard Deviation 7.2	-2.4 score on a scale Standard Deviation 9.3	—
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume IPSS Change at 1 Month	-3.4 score on a scale Standard Deviation 8.0	-9.4 score on a scale Standard Deviation 7.8	—
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume IPSS Change at 3 Months	-12.0 score on a scale Standard Deviation 6.6	-15.9 score on a scale Standard Deviation 8.3	—
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume IPSS Change at 24 Months	-10.2 score on a scale Standard Deviation 8.4	-16.1 score on a scale Standard Deviation 7.4	—
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume IPSS Change at 36 Months	-9.2 score on a scale Standard Deviation 9.3	10.0 score on a scale Standard Deviation 8.8	—
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume IPSS Change at 48 Months	-9.6 score on a scale Standard Deviation 8.4	-9.5 score on a scale Standard Deviation 4.0	—
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume IPSS Change at 60 Months	-6.0 score on a scale Standard Deviation 5.6	-14.5 score on a scale Standard Deviation 6.4	—

SECONDARY outcome

Timeframe: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=37 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) n=13 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe IPSS Change at 1 Week	0.4 score on a scale Standard Deviation 7.6	-2.5 score on a scale Standard Deviation 8.2	—
International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe IPSS Change at 1 Month	-4.1 score on a scale Standard Deviation 7.0	-7.4 score on a scale Standard Deviation 11.2	—
International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe IPSS Change at 3 Months	-11.9 score on a scale Standard Deviation 6.7	-17.0 score on a scale Standard Deviation 7.8	—
International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe IPSS Change at 6 Months	-12.2 score on a scale Standard Deviation 7.5	-14.3 score on a scale Standard Deviation 9.2	—
International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe IPSS Change at 12 Months	-11.9 score on a scale Standard Deviation 7.5	-13.1 score on a scale Standard Deviation 8.7	—
International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe IPSS Change at 24 Months	11.7 score on a scale Standard Deviation 7.7	-11.8 score on a scale Standard Deviation 10.9	—
International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe IPSS Change at 36 Months	-9.4 score on a scale Standard Deviation 8.9	-9.2 score on a scale Standard Deviation 10.2	—
International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe IPSS Change at 48 Months	-10.5 score on a scale Standard Deviation 7.4	-5.6 score on a scale Standard Deviation 7.5	—
International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe IPSS Change at 60 Months	-8.2 score on a scale Standard Deviation 7.3	-10.0 score on a scale Standard Deviation 0.0	—

SECONDARY outcome

Timeframe: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval and grouped by Baseline IPSS. Improvement in symptoms is shown by a reduction in score.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=23 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) n=20 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 n=7 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS IPSS Change at 60 Months	-7.7 score on a scale Standard Deviation 4.7	-3.5 score on a scale Standard Deviation 7.8	-14.5 score on a scale Standard Deviation 6.4
International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS IPSS Change at 1 Week	1.8 score on a scale Standard Deviation 4.9	-2.9 score on a scale Standard Deviation 9.1	-0.1 score on a scale Standard Deviation 10.2
International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS IPSS Change at 1 Month	-3.3 score on a scale Standard Deviation 7.0	-5.4 score on a scale Standard Deviation 8.7	-9.0 score on a scale Standard Deviation 10.6
International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS IPSS Change at 3 Months	-9.7 score on a scale Standard Deviation 5.4	-13.9 score on a scale Standard Deviation 7.1	-21.4 score on a scale Standard Deviation 5.5
International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS IPSS Change at 6 Months	-9.2 score on a scale Standard Deviation 5.8	-14.1 score on a scale Standard Deviation 7.7	-19.7 score on a scale Standard Deviation 8.9
International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS IPSS Change at 12 Months	-8.2 score on a scale Standard Deviation 5.0	-14.6 score on a scale Standard Deviation 7.6	-19.2 score on a scale Standard Deviation 9.2
International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS IPSS Change at 24 Months	-7.9 score on a scale Standard Deviation 5.2	-12.9 score on a scale Standard Deviation 8.9	-20.6 score on a scale Standard Deviation 9.2
International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS IPSS Change at 36 Months	-6.9 score on a scale Standard Deviation 5.2	-9.0 score on a scale Standard Deviation 10.9	-20.7 score on a scale Standard Deviation 4.0
International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS IPSS Change at 48 Months	-7.2 score on a scale Standard Deviation 5.2	-9.8 score on a scale Standard Deviation 8.3	-17.7 score on a scale Standard Deviation 8.0

SECONDARY outcome

Timeframe: Day of treatment, 1 Day post procedure, 1 Week post procedure, 1 Month post procedure, 3 Months post procedure

Population: Subjects with data at the scheduled visits are included in the data summarization.

Pain scores were obtained for all subjects using the Iowa Pain Thermometer. Maximum intraprocedural pain scores were analyzed, together with the pain scores reported at follow-up intervals through 3 months. The treatment pain scores were reported by subjects post-procedure and was based on their recollections. Scale is 0-12 with higher scores corresponding to higher pain reported.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Procedural Pain Score Pain Score on day of Treatment	4.0 score on a scale Standard Deviation 3.3	—	—
Procedural Pain Score Pain Score 1 Day Post-Treatment	1.9 score on a scale Standard Deviation 2.3	—	—
Procedural Pain Score Pain Score 1 Week Post-Treatment	1.9 score on a scale Standard Deviation 2.6	—	—
Procedural Pain Score Pain Score 1 Month Post-Treatment	1.2 score on a scale Standard Deviation 2.1	—	—
Procedural Pain Score Pain Score 3 Months Post-Treatment	0.5 score on a scale Standard Deviation 1.6	—	—

SECONDARY outcome

Timeframe: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Change in Quality of Life was measured using a QoL question in the IPSS. QoL data were collected at each follow up visit. One question in the IPSS asked subjects to rate their "quality of life due to urinary symptoms" on a scale of 0 = Delighted to 6 = Terrible. A reduction in score from baseline equates to improved outcome.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS) Change from Baseline in IPSS QoL Score at 1 Week	-0.3 score on a scale Standard Deviation 1.4	—	—
Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS) Change from Baseline in IPSS QoL Score at 1 Month	-1.1 score on a scale Standard Deviation 1.8	—	—
Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS) Change from Baseline in IPSS QoL Score at 3 Months	-2.7 score on a scale Standard Deviation 1.6	—	—
Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS) Change from Baseline in IPSS QoL Score at 6 Months	-2.7 score on a scale Standard Deviation 1.7	—	—
Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS) Change from Baseline in IPSS QoL Score at 12 Months	-2.7 score on a scale Standard Deviation 1.5	—	—
Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS) Change in IPSS QoL Change from Baseline in IPSS QoL Score at 24 Months	-2.6 score on a scale Standard Deviation 1.7	—	—
Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS) Change from Baseline in IPSS QoL Score at 36 Months	-2.4 score on a scale Standard Deviation 2.1	—	—
Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS) Change from Baseline in IPSS QoL Score at 48 Months	-2.5 score on a scale Standard Deviation 1.6	—	—
Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS) Change from Baseline in IPSS QoL Score at 60 Months	-1.6 score on a scale Standard Deviation 1.8	—	—

SECONDARY outcome

Timeframe: Baseline to 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Change in Quality of Life will be measured with the Benign Prostatic Hyperplasia Impact Index (BPHII). Data were collected at specified follow up visits. BPHII scores range from 0 (no/mild symptoms) to 35 (severe symptoms). A reduction in score from baseline equates to an improvement in symptoms.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII) Change from Baseline in BPHII Score at 1 Month	-1.0 score on a scale Standard Deviation 3.7	—	—
Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII) Change from Baseline in BPHII Score at 3 Months	-4.4 score on a scale Standard Deviation 2.9	—	—
Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII) Change from Baseline in BPHII Score at 6 Months	-4.5 score on a scale Standard Deviation 3.1	—	—
Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII) Change from Baseline in BPHII Score at 12 Months	-4.3 score on a scale Standard Deviation 2.8	—	—
Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII) Change from Baseline in BPHII Score at 24 Months	-4.4 score on a scale Standard Deviation 3.2	—	—
Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII) Change from Baseline in BPHII Score at 36 Months	-3.5 score on a scale Standard Deviation 4.0	—	—
Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII) Change from Baseline in BPHII Score at 48 Months	-4.0 score on a scale Standard Deviation 3.5	—	—
Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII) Change from Baseline in BPHII Score at 60 Months	-2.1 score on a scale Standard Deviation 4.2	—	—

SECONDARY outcome

Timeframe: 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Quality of Life was measured using EQ-5D-3L questionnaire. QoL data were collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. EQ-5D-3L index ranges from -0.109 to 1.000, with 1.000 corresponding to the best health state and -0.109 corresponding to the worst health. Mean change in overall score from baseline is reported.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Change from Baseline in EQ-5D-3L Overall Score at 48 Month	-0.0 score on a scale Standard Deviation 0.2	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Change from Baseline in EQ-5D-3L Overall Score at 1 Month	-0.0 score on a scale Standard Deviation 0.2	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Change from Baseline in EQ-5D-3L Overall Score at 3 Month	0.0 score on a scale Standard Deviation 0.2	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Change from Baseline in EQ-5D-3L Overall Score at 6 Month	0.1 score on a scale Standard Deviation 0.1	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Change from Baseline in EQ-5D-3L Overall Score at 12 Month	0.0 score on a scale Standard Deviation 0.1	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Change from Baseline in EQ-5D-3L Overall Score at 24 Month	0.0 score on a scale Standard Deviation 0.1	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Change from Baseline in EQ-5D-3L Overall Score at 36 Month	0.0 score on a scale Standard Deviation 0.1	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Change from Baseline in EQ-5D-3L Overall Score at 60 Month	-0.1 score on a scale Standard Deviation 0.1	—	—

SECONDARY outcome

Timeframe: 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Quality of Life was measured using EQ-5D-3L questionnaire and collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. The EQ-5D-3L includes a visual analog scale (VAS) which is a vertical scale with numbers ranging from 0 to 100. Subjects were asked to draw a line to the place on the scale that best represented how good or bad his health was on that day. The worst state a subject can imagine is marked zero, and the best state the subject can imagine is marked 100. Mean change in VAS score from baseline is reported. An increase in score is considered a better outcome.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS) Change from Baseline in EQ-5D-3L VAS Score at 1 Month	2.8 score on a scale Standard Deviation 18.0	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS) Change from Baseline in EQ-5D-3L VAS Score at 3 Month	8.3 score on a scale Standard Deviation 18.3	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS) Change from Baseline in EQ-5D-3L VAS Score at 6 Month	9.1 score on a scale Standard Deviation 14.5	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS) Change from Baseline in EQ-5D-3L VAS Score at 12 Month	7.4 score on a scale Standard Deviation 19.7	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS) Change from Baseline in EQ-5D-3L VAS Score at 24 Month	5.8 score on a scale Standard Deviation 18.3	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS) Change from Baseline in EQ-5D-3L VAS Score at 36 Month	9.2 score on a scale Standard Deviation 20.9	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS) -0.1Change from Baseline in EQ-5D-3L VAS Score at 48 Month	6.5 score on a scale Standard Deviation 17.9	—	—
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS) Change from Baseline in EQ-5D-3L VAS Score at 60 Month	-0.1 score on a scale Standard Deviation 11.9	—	—

SECONDARY outcome

Timeframe: 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Quality of Life was measured using EQ-5D-3L questionnaire. QoL data were collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. Each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Presented below are the scoring counts for each of the dimensions for baseline and follow up interval.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Anxiety Dimension Score · Level 1 (No Problems)	32 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Anxiety Dimension Score · Level 2 (Some Problems)	16 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Anxiety Dimension Score · Level 3 (Extreme Problems)	2 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Anxiety Dimension Score · Level 2 (Some Problems)	8 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Anxiety Dimension Score · Level 3 (Extreme Problems)	2 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Anxiety Dimension Score · Level 1 (No Problems)	41 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Anxiety Dimension Score · Level 2 (Some Problems)	6 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Anxiety Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Anxiety Dimension Score · Level 2 (Some Problems)	6 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Anxiety Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Anxiety Dimension Score · Level 1 (No Problems)	35 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Anxiety Dimension Score · Level 2 (Some Problems)	10 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Anxiety Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Anxiety Dimension Score · Level 1 (No Problems)	26 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Anxiety Dimension Score · Level 2 (Some Problems)	8 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Anxiety Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Anxiety Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Anxiety Dimension Score · Level 1 (No Problems)	5 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Mobility Dimension Score · Level 1 (No Problems)	43 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Mobility Dimension Score · Level 2 (Some Problems)	7 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Mobility Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Mobility Dimension Score · Level 1 (No Problems)	40 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Mobility Dimension Score · Level 2 (Some Problems)	6 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Mobility Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Mobility Dimension Score · Level 1 (No Problems)	37 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Mobility Dimension Score · Level 2 (Some Problems)	8 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Mobility Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Mobility Dimension Score · Level 1 (No Problems)	27 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Mobility Dimension Score · Level 2 (Some Problems)	7 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Mobility Dimension Score · Level 1 (No Problems)	17 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Mobility Dimension Score · Level 2 (Some Problems)	10 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Mobility Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Pain Dimension Score · Level 1 (No Problems)	22 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Pain Dimension Score · Level 3 (Extreme Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Pain Dimension Score · Level 1 (No Problems)	24 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Pain Dimension Score · Level 2 (Some Problems)	20 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Pain Dimension Score · Level 3 (Extreme Problems)	2 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Pain Dimension Score · Level 1 (No Problems)	32 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Pain Dimension Score · Level 2 (Some Problems)	15 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Pain Dimension Score · Level 2 (Some Problems)	16 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Pain Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Pain Dimension Score · Level 1 (No Problems)	20 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Pain Dimension Score · Level 2 (Some Problems)	9 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Pain Dimension Score · Level 1 (No Problems)	12 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Pain Dimension Score · Level 3 (Extreme Problems)	2 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Pain Dimension Score · Level 1 (No Problems)	4 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Self-care Dimension Score · Level 2 (Some Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Self-care Dimension Score · Level 1 (No Problems)	48 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Self-care Dimension Score · Level 2 (Some Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Self-care Dimension Score · Level 2 (Some Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Self-care Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Self-care Dimension Score · Level 1 (No Problems)	46 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Self-care Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Self-care Dimension Score · Level 2 (Some Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Self-care Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Self-care Dimension Score · Level 1 (No Problems)	33 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Self-care Dimension Score · Level 2 (Some Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Self-care Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Self-care Dimension Score · Level 1 (No Problems)	26 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Self-care Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Self-care Dimension Score · Level 1 (No Problems)	24 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Self-care Dimension Score · Level 2 (Some Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Self-care Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Self-care Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Usual Activity Dimension Score · Level 1 (No Problems)	40 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Usual Activity Dimension Score · Level 2 (Some Problems)	7 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Usual Activity Dimension Score · Level 1 (No Problems)	45 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Usual Activity Dimension Score · Level 2 (Some Problems)	3 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Usual Activity Dimension Score · Level 2 (Some Problems)	4 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Usual Activity Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Usual Activity Dimension Score · Level 1 (No Problems)	31 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Usual Activity Dimension Score · Level 2 (Some Problems)	3 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Usual Activity Dimension Score · Level 2 (Some Problems)	2 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Usual Activity Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Anxiety Dimension Score · Level 1 (No Problems)	39 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Anxiety Dimension Score · Level 1 (No Problems)	40 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Anxiety Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Anxiety Dimension Score · Level 1 (No Problems)	22 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Anxiety Dimension Score · Level 2 (Some Problems)	5 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Anxiety Dimension Score · Level 1 (No Problems)	19 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Anxiety Dimension Score · Level 2 (Some Problems)	7 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Anxiety Dimension Score · Level 2 (Some Problems)	2 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Anxiety Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Mobility Dimension Score · Level 1 (No Problems)	43 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Mobility Dimension Score · Level 2 (Some Problems)	6 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Mobility Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Mobility Dimension Score · Level 1 (No Problems)	43 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Mobility Dimension Score · Level 2 (Some Problems)	5 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Mobility Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Mobility Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Mobility Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Mobility Dimension Score · Level 1 (No Problems)	15 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Mobility Dimension Score · Level 2 (Some Problems)	10 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Mobility Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Mobility Dimension Score · Level 1 (No Problems)	3 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Mobility Dimension Score · Level 2 (Some Problems)	4 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Usual Activity Dimension Score · Level 3 (Extreme Problems)	2 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Usual Activity Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Usual Activity Dimension Score · Level 1 (No Problems)	46 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Usual Activity Dimension Score · Level 2 (Some Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Usual Activity Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Usual Activity Dimension Score · Level 1 (No Problems)	41 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Usual Activity Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Usual Activity Dimension Score · Level 1 (No Problems)	25 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Usual Activity Dimension Score · Level 1 (No Problems)	20 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Usual Activity Dimension Score · Level 2 (Some Problems)	4 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Usual Activity Dimension Score · Level 3 (Extreme Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Usual Activity Dimension Score · Level 1 (No Problems)	6 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Usual Activity Dimension Score · Level 2 (Some Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Usual Activity Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Pain Dimension Score · Level 2 (Some Problems)	25 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Pain Dimension Score · Level 3 (Extreme Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Pain Dimension Score · Level 1 (No Problems)	30 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Pain Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Pain Dimension Score · Level 1 (No Problems)	28 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Pain Dimension Score · Level 2 (Some Problems)	16 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Pain Dimension Score · Level 2 (Some Problems)	12 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 24 Month_Pain Dimension Score · Level 3 (Extreme Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Pain Dimension Score · Level 1 (No Problems)	17 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Pain Dimension Score · Level 3 (Extreme Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 48 Month_Pain Dimension Score · Level 2 (Some Problems)	12 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Pain Dimension Score · Level 2 (Some Problems)	2 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Pain Dimension Score · Level 3 (Extreme Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Self-care Dimension Score · Level 1 (No Problems)	50 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Self-care Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 1 Month_Self-care Dimension Score · Level 3 (Extreme Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 3 Month_Self-care Dimension Score · Level 1 (No Problems)	47 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 6 Month_Self-care Dimension Score · Level 2 (Some Problems)	0 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 12 Month_Self-care Dimension Score · Level 1 (No Problems)	45 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 36 Month_Self-care Dimension Score · Level 2 (Some Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Self-care Dimension Score · Level 1 (No Problems)	6 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L 60 Month_Self-care Dimension Score · Level 2 (Some Problems)	1 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Usual Activity Dimension Score · Level 1 (No Problems)	47 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Usual Activity Dimension Score · Level 2 (Some Problems)	3 Participants	—	—
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L Baseline_Usual Activity Dimension Score · Level 3 (Extreme Problems)	0 Participants	—	—

SECONDARY outcome

Timeframe: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. These will be measured as: • Proportion of subjects that are satisfied with the procedure overall Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 1 Week · Satisfied	23 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 1 Week · Neither Satisfied or Dissatisfied (Neutral)	6 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 1 Week · Dissatisfied	2 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 1 Week · Very Dissatisfied	1 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 1 Month · Very Satisfied	18 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 1 Month · Satisfied	19 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 1 Month · Neither Satisfied or Dissatisfied (Neutral)	8 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 3 Months · Satisfied	22 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 3 Months · Very Dissatisfied	0 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 6 Months · Dissatisfied	2 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 12 Months · Very Satisfied	19 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 12 Months · Satisfied	19 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 12 Months · Very Dissatisfied	0 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 24 Months · Dissatisfied	0 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 24 Months · Very Dissatisfied	0 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 36 Months · Very Dissatisfied	0 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 48 Months · Very Satisfied	10 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 48 Months · Very Dissatisfied	0 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 1 Week · Very Satisfied	16 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 1 Month · Dissatisfied	2 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 1 Month · Very Dissatisfied	0 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 3 Months · Very Satisfied	21 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 3 Months · Neither Satisfied or Dissatisfied (Neutral)	3 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 3 Months · Dissatisfied	1 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 6 Months · Very Satisfied	18 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 6 Months · Satisfied	20 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 6 Months · Neither Satisfied or Dissatisfied (Neutral)	7 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 6 Months · Very Dissatisfied	0 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 12 Months · Neither Satisfied or Dissatisfied (Neutral)	6 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 12 Months · Dissatisfied	1 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 24 Months · Very Satisfied	12 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 24 Months · Satisfied	12 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 24 Months · Neither Satisfied or Dissatisfied (Neutral)	3 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 36 Months · Very Satisfied	11 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 36 Months · Satisfied	8 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 36 Months · Neither Satisfied or Dissatisfied (Neutral)	4 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 36 Months · Dissatisfied	0 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 48 Months · Satisfied	11 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 48 Months · Neither Satisfied or Dissatisfied (Neutral)	3 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 48 Months · Dissatisfied	2 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 60 Months · Very Satisfied	1 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 60 Months · Satisfied	4 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 60 Months · Neither Satisfied or Dissatisfied (Neutral)	2 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 60 Months · Dissatisfied	0 Participants	—	—
Subject Satisfaction - Satisfied With Overall Procedure Proportion of subjects satisfied with the procedure at 60 Months · Very Dissatisfied	0 Participants	—	—

SECONDARY outcome

Timeframe: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. Outcome measured as: • Proportion of subjects that would recommend this treatment to friends and families Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 1 Week · Probably Will	14 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 1 Week · Probably Will Not	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 1 Month · Definitely Will	24 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 1 Month · Definitely Will not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 6 Months · Definitely Will	29 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 6 Months · Probably Will	12 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 24 Months · Definitely Will	18 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 36 Months · Not Sure	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 60 Months · Probably Will Not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 60 Months · Definitely Will not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 1 Week · Definitely Will	26 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 1 Week · Not Sure	7 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 1 Week · Definitely Will not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 1 Month · Probably Will	16 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 1 Month · Not Sure	6 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 1 Month · Probably Will Not	2 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 3 Months · Definitely Will	33 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 3 Months · Probably Will	10 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 3 Months · Not Sure	4 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 3 Months · Probably Will Not	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 3 Months · Definitely Will not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 6 Months · Not Sure	5 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 6 Months · Probably Will Not	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 6 Months · Definitely Will not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 12 Months · Definitely Will	30 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 12 Months · Probably Will	12 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 12 Months · Not Sure	3 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 12 Months · Probably Will Not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 12 Months · Definitely Will not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 24 Months · Probably Will	8 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 24 Months · Not Sure	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 24 Months · Probably Will Not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 24 Months · Definitely Will not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 36 Months · Definitely Will	17 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 36 Months · Probably Will	5 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 36 Months · Probably Will Not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 36 Months · Definitely Will not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 48 Months · Definitely Will	17 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 48 Months · Probably Will	8 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 48 Months · Not Sure	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 48 Months · Probably Will Not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 48 Months · Definitely Will not	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 60 Months · Definitely Will	4 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 60 Months · Probably Will	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family Proportion of subjects who would recommend procedure to friends/family at 60 Months · Not Sure	2 Participants	—	—

SECONDARY outcome

Timeframe: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. Outcome measured as: • Proportion of subjects who would undergo the same treatment if their symptoms were to recur after 5 years Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur · Very Unlikely	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Likely	27 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Unlikely	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Unlikely	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Unlikely	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Likely	3 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur · Very Likely	23 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur · Likely	17 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur · Not Sure	6 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur · Unlikely	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur · Very Likely	17 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur · Likely	21 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur · Not Sure	8 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur · Unlikely	2 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur · Very Unlikely	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Likely	15 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Not Sure	5 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Unlikely	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Unlikely	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Likely	25 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Likely	13 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Not Sure	8 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Unlikely	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Likely	29 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Likely	10 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Not Sure	5 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Unlikely	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Likely	12 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Likely	12 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Not Sure	2 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Unlikely	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Unlikely	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Likely	10 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Likely	8 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Not Sure	2 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Unlikely	3 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Unlikely	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Likely	12 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Likely	8 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Not Sure	5 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Unlikely	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Likely	1 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Not Sure	3 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Unlikely	0 Participants	—	—
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur · Very Unlikely	0 Participants	—	—

SECONDARY outcome

Timeframe: Day of Procedure

Population: Subjects with procedure data are included in the summarization.

Procedure time: Time from delivery device insertion to final delivery device withdrawal

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Procedural Parameters - Procedure Time	6.7 minutes Standard Deviation 5.8	—	—

SECONDARY outcome

Timeframe: Day of Procedure

Population: Subjects with procedure data are included in the summarization.

Treatment time: time from first vapor delivery to last vapor delivery

Outcome measures

Outcome measures
Measure	Rezum Treatment n=50 Participants Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Rezum Treatment - Smaller Prostates (<35g) Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects With Baseline IPSS 26-35 Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Procedural Parameters - Treatment Time	4.5 minutes Standard Deviation 4.9	—	—

Adverse Events

Rezum Treatment

Serious events: 8 serious events

Other events: 38 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Rezum Treatment n=50 participants at risk Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Cardiac disorders Cardiac Event	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Musculoskeletal and connective tissue disorders Pain/Discomfort - Pelvic	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Urinary Retention	6.0% 3/50 • Number of events 5 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Urinary Frequency	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Gastrointestinal disorders Weakness or Fatigue	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Gastrointestinal disorders Diarrhea	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Cancer -Other	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Urinary Tract Infection-Proven	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Poor Stream	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
General disorders Other	4.0% 2/50 • Number of events 5 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Infections and infestations Infection Other than UTI	2.0% 1/50 • Number of events 2 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.

Other adverse events

Other adverse events
Measure	Rezum Treatment n=50 participants at risk Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Renal and urinary disorders Urinary Retention	30.0% 15/50 • Number of events 18 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Urinary Urgency	30.0% 15/50 • Number of events 16 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Dysuria	20.0% 10/50 • Number of events 10 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
General disorders Other	8.0% 4/50 • Number of events 5 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Poor Stream	16.0% 8/50 • Number of events 9 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders UTI - Suspected	18.0% 9/50 • Number of events 10 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Nocturia	12.0% 6/50 • Number of events 7 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
General disorders Pain/Discomfort	14.0% 7/50 • Number of events 7 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Hematuria - Gross	8.0% 4/50 • Number of events 6 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Urinary Incontinence - Urge	6.0% 3/50 • Number of events 5 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Urinary Frequency	4.0% 2/50 • Number of events 3 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Hesitancy	6.0% 3/50 • Number of events 3 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
General disorders Pain/Discomfort - Pelvic	2.0% 1/50 • Number of events 2 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Urethral Secretion w/o Hematuria or Stones	6.0% 3/50 • Number of events 3 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Pain/Discomfort with Scrotum	4.0% 2/50 • Number of events 2 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Gastrointestinal disorders Abdominal Bloating with Gas	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Bladder Spasms	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Cancer - Prostate	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Gastrointestinal disorders Constipation	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Gastrointestinal disorders Diverticulitis	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
General disorders Dizziness	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Skin and subcutaneous tissue disorders Epididymitis	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
General disorders Injury - Other	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
General disorders Pain/Discomfort - Back	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
General disorders Pain/Discomfort - Perineum	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Prostatic Cyst De Novo	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Musculoskeletal and connective tissue disorders Spinal Stenosis	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Terminal Dribbling	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Renal and urinary disorders Urinary Incontinence - Not Specified	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.

Additional Information

Director, Clinical Operations

Boston Scientific Corporation

Phone: 952-930-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place