Trial Outcomes & Findings for Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL) (NCT NCT03605745)

Last Updated: 2021-08-10

Results Overview

The proportion of the intent-to-treat (ITT) analysis population that responds to the Rezum therapy is reported. A responder is defined as a subject who has an improvement in International Prostate Symptom Score (IPSS) \> 30% from baseline to 6 months post-therapy. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.

Recruitment status

TERMINATED

Study phase

Target enrollment

47 participants

Primary outcome timeframe

6 Months

Results posted on

2021-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Overall Study STARTED	47
Overall Study 2 Weeks	47
Overall Study 6 Weeks	47
Overall Study 3 Months	47
Overall Study 6 Months	47
Overall Study 12 Months	40
Overall Study 24 Months	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Overall Study Study was terminated for business reasons	47

Baseline Characteristics

Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=47 Participants Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Age, Continuous	67.8 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized White	40 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: All subjects enrolled were included in the analysis.

Outcome measures

Outcome measures
Measure	Treatment n=47 Participants Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)	39 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: All subjects enrolled were included in the analysis.

Assess the composite rate of post procedure device related serious complications in treated subjects through 6 months follow-up.

Outcome measures

Outcome measures
Measure	Treatment n=47 Participants Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Number of Participants With Post Procedure Device Related Serious Complications	0 Participants

SECONDARY outcome

Timeframe: 6 Month

Population: All subjects enrolled were included in the analysis.

This safety endpoint will be to characterize the rate of post procedure device-related serious retention catheterizations at 6 months.

Outcome measures

Outcome measures
Measure	Treatment n=47 Participants Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Number of Subjects With Device-related Retention Catheterizations	0 Participants

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 3 months, 6 months, 1 year

Population: All subjects with data at both baseline and the follow-up visit were included in the analysis (N=47 at 6 weeks, 3 months, 6 months; N=42 at 12 months).

The change in IPSS from baseline to each follow-up visit was determined. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.

Outcome measures

Outcome measures
Measure	Treatment n=47 Participants Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up Change from baseline to 3 months post-therapy	-10.97 score on a scale Interval -12.68 to -9.27
Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up Change from baseline to 6 months post-therapy	-11.62 score on a scale Interval -13.43 to -9.8
Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up Change from baseline to 12 months post-therapy	-11.80 score on a scale Interval -13.57 to -10.03
Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up Change from baseline to 6 weeks post-therapy	-8.47 score on a scale Interval -10.49 to -6.45

Adverse Events

Treatment

Serious events: 4 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=47 participants at risk Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Infections and infestations Acute Prostatitis	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Hematuria Gross with Clots & Retention	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Nervous system disorders Bells Palsy	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Gastrointestinal disorders Inguinal Hernia	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.

Other adverse events

Other adverse events
Measure	Treatment n=47 participants at risk Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Infections and infestations UTI - Culture Proven	23.4% 11/47 • Number of events 13 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Hematuria - Gross	25.5% 12/47 • Number of events 12 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Urinary Urgency	21.3% 10/47 • Number of events 11 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Bladder Spasms	21.3% 10/47 • Number of events 10 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Dysuria	21.3% 10/47 • Number of events 10 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Acute Urinary Retention	14.9% 7/47 • Number of events 7 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Urinary Incontinence - Urge	10.6% 5/47 • Number of events 6 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
General disorders Pain/Discomfort - Other	8.5% 4/47 • Number of events 5 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Reproductive system and breast disorders Pain/Discomfort - Penile	8.5% 4/47 • Number of events 5 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Poor Stream	10.6% 5/47 • Number of events 5 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Terminal Dribbling	8.5% 4/47 • Number of events 4 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Urinary Incontinence - Not Specified	6.4% 3/47 • Number of events 4 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Gastrointestinal disorders Constipation	6.4% 3/47 • Number of events 3 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Reproductive system and breast disorders Erectile Dysfunction - Worsening	6.4% 3/47 • Number of events 3 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Nocturia	6.4% 3/47 • Number of events 3 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Reproductive system and breast disorders Anejaculation	4.3% 2/47 • Number of events 2 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Reproductive system and breast disorders Decrease in Ejaculatory Volume	4.3% 2/47 • Number of events 2 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Infections and infestations Epididymitis	4.3% 2/47 • Number of events 2 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
General disorders Fever	4.3% 2/47 • Number of events 2 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Reproductive system and breast disorders Hematospermia	4.3% 2/47 • Number of events 2 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Hesitancy	4.3% 2/47 • Number of events 2 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Incomplete Voiding	4.3% 2/47 • Number of events 2 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
General disorders Sloughing	4.3% 2/47 • Number of events 2 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Urinary Frequency	4.3% 2/47 • Number of events 2 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Product Issues Catheter Malfunction	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Reproductive system and breast disorders Erectile Dysfunction - De Novo	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Nervous system disorders Headache	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Hematuria - Intermittent Uncomplicated	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Renal and urinary disorders Hematuria Gross with Clots & Retention	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Gastrointestinal disorders Pain/Discomfort - Abdominal	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Reproductive system and breast disorders Pain/Discomfort - Pelvic	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Reproductive system and breast disorders Pain/Discomfort - Suprapubic	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Reproductive system and breast disorders Retrograde Ejaculation - Confirmed	2.1% 1/47 • Number of events 1 • Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit. For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.

Additional Information

Kaitlyn Rainbow, Clinical Research Associate

Boston Scientific

Phone: 952-930-6627

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60