Trial Outcomes & Findings for Rezum FIM Optimization Study (NCT NCT02940392)

Last Updated: 2021-03-05

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 in IPSS was calculated. The IPSS is a validated questionnaire used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH). Scoring ranges from 0 to 35 with overall scores of 0-7 correlated to mildly symptomatic, 8-19 correlated to moderately symptomatic and 20-35 correlated to severely symptomatic. A reduction in score from baseline corresponds to improved outcome post procedure.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

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

Results posted on

2021-03-05

Participant Flow

This single arm, single center interventional 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 Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat 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	15
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Rezum Treatment Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat 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 Lost to Follow-up	3
Overall Study Retreatment	3
Overall Study Death	2

Baseline Characteristics

Rezum FIM Optimization Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rezum Treatment n=15 Participants Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat 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	69.9 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic/Latino	14 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	1 Participants n=5 Participants
Region of Enrollment Dominican Republic	15 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 in score was calculated for the number of subjects providing data at each follow-up visit.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=15 Participants Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat 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 International Prostate Symptom Score IPSS Change at 1 Week	-6.1 score on a scale Standard Deviation 13.8
Change in International Prostate Symptom Score IPSS Change at 1 Month	-12.9 score on a scale Standard Deviation 12.8
Change in International Prostate Symptom Score IPSS change at 3 months	-14.6 score on a scale Standard Deviation 9.1
Change in International Prostate Symptom Score IPSS change at 6 months	-14.8 score on a scale Standard Deviation 11.0
Change in International Prostate Symptom Score IPSS change at 12 months	-13.6 score on a scale Standard Deviation 7.5
Change in International Prostate Symptom Score IPSS change at 24 months	-13.9 score on a scale Standard Deviation 5.1
Change in International Prostate Symptom Score IPSS change at 36 months	-7.6 score on a scale Standard Deviation 6.4
Change in International Prostate Symptom Score IPSS change at 48 months	-13.0 score on a scale Standard Deviation 7.4
Change in International Prostate Symptom Score IPSS change at 60 months	-7.6 score on a scale Standard Deviation 6.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Procedure Day, 1 day post procedure, 1 week post procedure, 1 month post procedure, 3 months post procedure ,6 months post procedure

Population: Pain score was not collected for 1 subject at each of the following visits: 1 day, 3 month, and 6 month

Intra-procedural and post-procedural pain for each subject was assessed using the Wong Baker Pain Rating scale (0-10 with 0 indicating no pain and 10 indicating worst pain imaginable). Each subject selected the response on the pain scale that he felt best represented his pain level. Unless otherwise noted, the subjects were not given pain medications or anesthesia. All subjects were given an anti-anxiety medication plus a Non-Steroidal Anti-Inflammatory Drug (NSAID) pre-procedure.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=15 Participants Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat 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.
Intra-procedural and Post-procedural Pain average pain score post-procedure (day of procedure)	3.5 score on a scale Standard Deviation 2.7
Intra-procedural and Post-procedural Pain average pain 1 day post-procedure	0.1 score on a scale Standard Deviation 0.3
Intra-procedural and Post-procedural Pain average pain 1 week post-procedure	0.2 score on a scale Standard Deviation 0.6
Intra-procedural and Post-procedural Pain average pain 1 month post-procedure	0.5 score on a scale Standard Deviation 2.1
Intra-procedural and Post-procedural Pain average pain 3 months post-procedure	0.0 score on a scale Standard Deviation 0.0
Intra-procedural and Post-procedural Pain average pain 6 months post-procedure	0.0 score on a scale Standard Deviation 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day post procedure, 1 week post procedure, 1 month post procedure

Population: Number of subjects requiring post-procedure catheterization. Two (2) subjects were catheterized prior to the Rezūm study enrollment and treatment. The decision was made to move forward with treating both subjects. All subjects were observed for 24 hours in the clinic post-procedure. Post-procedure catheterization was allowed if determined that the subject had symptoms of retention (defined as failure to void within 8 hours post procedure) or required catheterization for other safety reasons.

All subjects were kept at the clinic for observation for 24 hours post-procedure. The number of subjects requiring post-procedure catheterization were recorded.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=15 Participants Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat 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.
Number of Subjects Requiring Catheterization Post Procedure Subjects catheterized at 1 day post procedure	9 participants
Number of Subjects Requiring Catheterization Post Procedure Subjects catheterized at 1 week post procedure	8 participants
Number of Subjects Requiring Catheterization Post Procedure Subjects catheterized at 1 month post procedure	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month post procedure

Population: Data provided for subjects who underwent the Rezūm ablation procedure.

Measures the duration (days) of catheterization for subjects who required catheterization post procedure. Post-procedure catheterization was allowed if the Principal Investigator determined that the subject had symptoms of retention (defined as failure to void within 8 hours post procedure) or required catheterization for other safety reasons.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=15 Participants Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat 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.
Post Procedure Catheterization Duration Overall catheterization duration (days) per subject	7.6 days Standard Deviation 10.9
Post Procedure Catheterization Duration Overall catheterization duration (days) per episode (13 episodes in 10 subjects)	5.8 days Standard Deviation 6.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week , 1 month, 3 months, 6 months post procedure

Population: One subject (each) did not have MRI available at the 3 month and 6 month follow-up visit.

Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in lesion volume was calculated.

Outcome measures

Outcome measures
Measure	Rezum Treatment n=15 Participants Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat 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.
Lesion Characteristics Via MRI (Changes in Lesion Volume) Mean percent change from 1 week to 1 month	-53.7 percentage of change in lesion volume Standard Deviation 17.8
Lesion Characteristics Via MRI (Changes in Lesion Volume) Mean percent change from 1 week to 3 months	-88.9 percentage of change in lesion volume Standard Deviation 8.1
Lesion Characteristics Via MRI (Changes in Lesion Volume) Mean percent change from 1 week to 6 months	-95.8 percentage of change in lesion volume Standard Deviation 4.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week, 1 month, 3 months, 6 months post-procedure

Population: One subject (each) did not have MRI data available at the 3 month and 6 month visit

Outcome measures

Outcome measures
Measure	Rezum Treatment n=15 Participants Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat 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.
Lesion Characteristics Via MRI (Changes in Prostate Volume) Mean percent change from 1 week to 1 month	-14.7 percentage of change in prostate volume Standard Deviation 13.2
Lesion Characteristics Via MRI (Changes in Prostate Volume) Mean percent change from 1 week to 3 months	-25.6 percentage of change in prostate volume Standard Deviation 11.4
Lesion Characteristics Via MRI (Changes in Prostate Volume) Mean percent change from 1 week to 6 months	-32.3 percentage of change in prostate volume Standard Deviation 10.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week, 1 month, 3 months, 6 months post-procedure

Population: One subject (each) did not have MRI available at the 3 month and 6 month visit

Outcome measures

Outcome measures
Measure	Rezum Treatment n=15 Participants Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat 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.
Lesion Characteristics Via MRI (Changes in Transition Zone Volume) Mean percent change from 1 week to 1 month	-18.6 percentage of change in TZ volume Standard Deviation 15.0
Lesion Characteristics Via MRI (Changes in Transition Zone Volume) Mean percent change from 1 week to 3 months	-30.4 percentage of change in TZ volume Standard Deviation 13.6
Lesion Characteristics Via MRI (Changes in Transition Zone Volume) Mean percent change from 1 week to 6 months	-37.7 percentage of change in TZ volume Standard Deviation 14.6

Adverse Events

Rezum Treatment

Serious events: 3 serious events

Other events: 14 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Rezum Treatment n=15 participants at risk Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat 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 Subject was surgically treated for a pre-existing hernia.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Adenocarcinoma	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Urinary Retention	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.

Other adverse events

Other adverse events
Measure	Rezum Treatment n=15 participants at risk Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat 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 Tract Infection (UTI) - Suspected	46.7% 7/15 • Number of events 9 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Urinary Retention	40.0% 6/15 • Number of events 6 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Dysuria	26.7% 4/15 • Number of events 5 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Hematuria	33.3% 5/15 • Number of events 5 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
General disorders Fever	20.0% 3/15 • Number of events 4 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Poor Stream	20.0% 3/15 • Number of events 4 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Urinary Urgency	13.3% 2/15 • Number of events 3 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Infections and infestations Infection (non UTI)	13.3% 2/15 • Number of events 2 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
General disorders Other	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Terminal Dribbling	13.3% 2/15 • Number of events 2 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Urinary Frequency	13.3% 2/15 • Number of events 2 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Hematuria with Clots and Retention	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Prostatic Urethral Injury	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders UTI - Prophylaxis	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Ureteral Calculi	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Renal and urinary disorders Urinary Incontinence - Urge	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of index procedure through the 60 month follow-up assessment. AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.

Additional Information

Director, Clinical Operations

Boston Scientific

Phone: 9529306000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place