We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03605745
Recruitment Status : Terminated (Sponsor decided to terminate the study due to business reasons)
First Posted : July 30, 2018
Results First Posted : August 10, 2021
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions BPH With Urinary Obstruction
BPH
BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Intervention Device: Prostatic Vapor Ablation
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 47
2 Weeks 47
6 Weeks 47
3 Months 47
6 Months 47
12 Months 40
24 Months 1
Completed 0
Not Completed 47
Reason Not Completed
Study was terminated for business reasons             47
Arm/Group Title Treatment
Hide Arm/Group Description

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 Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants
67.8  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
0
   0.0%
Male
47
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Hispanic or Latino
4
   8.5%
Not Hispanic or Latino
43
  91.5%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Black or African American
3
   6.4%
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
White
40
  85.1%
Hispanic or Latino
4
   8.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants
47
1.Primary Outcome
Title Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)
Hide Description 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.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects enrolled were included in the analysis.
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 47
Measure Type: Count of Participants
Unit of Measure: Participants
39
  83.0%
2.Primary Outcome
Title Number of Participants With Post Procedure Device Related Serious Complications
Hide Description Assess the composite rate of post procedure device related serious complications in treated subjects through 6 months follow-up.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects enrolled were included in the analysis.
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 47
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Number of Subjects With Device-related Retention Catheterizations
Hide Description This safety endpoint will be to characterize the rate of post procedure device-related serious retention catheterizations at 6 months.
Time Frame 6 Month
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects enrolled were included in the analysis.
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 47
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up
Hide Description 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.
Time Frame Baseline, 6 weeks, 3 months, 6 months, 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 47
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Change from baseline to 6 weeks post-therapy Number Analyzed 47 participants
-8.47
(-10.49 to -6.45)
Change from baseline to 3 months post-therapy Number Analyzed 47 participants
-10.97
(-12.68 to -9.27)
Change from baseline to 6 months post-therapy Number Analyzed 47 participants
-11.62
(-13.43 to -9.80)
Change from baseline to 12 months post-therapy Number Analyzed 42 participants
-11.80
(-13.57 to -10.03)
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title Treatment
Hide Arm/Group Description

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.

All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   0/47 (0.00%)    
Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   4/47 (8.51%)    
Gastrointestinal disorders   
Inguinal Hernia  [1]  1/47 (2.13%)  1
Infections and infestations   
Acute Prostatitis  [2]  1/47 (2.13%)  1
Nervous system disorders   
Bells Palsy   1/47 (2.13%)  1
Renal and urinary disorders   
Hematuria Gross with Clots & Retention   1/47 (2.13%)  1
Indicates events were collected by systematic assessment
[1]
Worsening of Right Inguinal Hernia
[2]
Acute Prostatitis
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment
Affected / at Risk (%) # Events
Total   41/47 (87.23%)    
Gastrointestinal disorders   
Constipation   3/47 (6.38%)  3
Pain/Discomfort - Abdominal   1/47 (2.13%)  1
General disorders   
Pain/Discomfort - Other   4/47 (8.51%)  5
Fever   2/47 (4.26%)  2
Sloughing   2/47 (4.26%)  2
Infections and infestations   
UTI - Culture Proven   11/47 (23.40%)  13
Epididymitis   2/47 (4.26%)  2
Nervous system disorders   
Headache   1/47 (2.13%)  1
Product Issues   
Catheter Malfunction   1/47 (2.13%)  1
Renal and urinary disorders   
Hematuria - Gross   12/47 (25.53%)  12
Urinary Urgency   10/47 (21.28%)  11
Bladder Spasms   10/47 (21.28%)  10
Dysuria   10/47 (21.28%)  10
Acute Urinary Retention   7/47 (14.89%)  7
Urinary Incontinence - Urge   5/47 (10.64%)  6
Poor Stream   5/47 (10.64%)  5
Terminal Dribbling   4/47 (8.51%)  4
Urinary Incontinence - Not Specified   3/47 (6.38%)  4
Nocturia   3/47 (6.38%)  3
Hesitancy   2/47 (4.26%)  2
Incomplete Voiding   2/47 (4.26%)  2
Urinary Frequency   2/47 (4.26%)  2
Hematuria - Intermittent Uncomplicated   1/47 (2.13%)  1
Hematuria Gross with Clots & Retention   1/47 (2.13%)  1
Reproductive system and breast disorders   
Pain/Discomfort - Penile   4/47 (8.51%)  5
Erectile Dysfunction - Worsening   3/47 (6.38%)  3
Anejaculation   2/47 (4.26%)  2
Decrease in Ejaculatory Volume   2/47 (4.26%)  2
Hematospermia   2/47 (4.26%)  2
Erectile Dysfunction - De Novo   1/47 (2.13%)  1
Pain/Discomfort - Pelvic   1/47 (2.13%)  1
Pain/Discomfort - Suprapubic   1/47 (2.13%)  1
Retrograde Ejaculation - Confirmed   1/47 (2.13%)  1
Indicates events were collected by systematic assessment
The study was terminated by the sponsor for business reasons. As a result there is no patient data presented for the 12 month, 2 year and 3 year follow up visits as they did not occur per termination.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kaitlyn Rainbow, Clinical Research Associate
Organization: Boston Scientific
Phone: 952-930-6627
EMail: kat.rainbow@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03605745    
Other Study ID Numbers: 3034-001
First Submitted: July 23, 2018
First Posted: July 30, 2018
Results First Submitted: June 4, 2021
Results First Posted: August 10, 2021
Last Update Posted: August 10, 2021