Catheterless Water Vapor Therapy for the Treatment of BPH
Primary Purpose
Benign Prostatic Hyperplasia
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rezum
Sponsored by
About this trial
This is an interventional device feasibility trial for Benign Prostatic Hyperplasia focused on measuring Water Vapor Therapy
Eligibility Criteria
Inclusion Criteria:
- Male subject of 40 - 80 years of age
- Has provided informed consent
- Has a diagnosis of bladder outlet obstruction due to benign prostatic enlargement
- Able to complete self-administered questionnaires
- Is a surgical candidate for Rezum
- Has medical record documentation of Qmax < 15 ml/s
- Has medical record documentation of prostate volume from 30-80 ml by transrectal ultrasound (TRUS)
- Has a bladder contractility index score ≥ 100, calculated by detrusor pressure at Qmax (pDet@qmax) + (5xQmax).
- Willing to undergo pressure-flow studies to calculate BCI prior to surgical intervention.
- Has serum creatinine within the normal range.
- Able to perform intermittent catheterization.
Exclusion Criteria:
- Has a life expectancy < 2 years
- Is currently enrolled in or plans to enroll in any concurrent drug or device study
- Has an active infection (e.g., urinary tract infection or prostatitis)
- Has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
- Has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days
- Has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years
- Has a diagnosis of lichen sclerosis
- Has a diagnosis of neurogenic bladder or other neurologic disorder that affects bladder function
- Has a diagnosis of polyneuropathy (e.g., diabetic)
- Has a history of lower urinary tract surgery
- Has a diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
- Has an inability to perform intermittent self-catheterization
- Has been catheterized or has a post-void residual (PVR) of > 400 ml in the 14 days prior to the surgical procedure
- Has a current diagnosis of bladder stones
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Catheterless group
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS).
The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity.
Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax).
The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction.
Secondary Outcome Measures
Changes in urinary symptoms as measured by changes in IPSS.
The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity.
Changes in urinary symptoms as measured by changes in Qmax at 36 months
The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction.
Full Information
NCT ID
NCT04997369
First Posted
July 29, 2021
Last Updated
October 12, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04997369
Brief Title
Catheterless Water Vapor Therapy for the Treatment of BPH
Official Title
Feasibility and Multicenter Assessment of Catheter-less Water Vapor Therapy (Rezum) for the Treatment of Benign Prostatic Hyperplasia (BPH)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
Principal Investigator changing locations.
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH). One of the limitations of the technology is the need for post-operative catheterization up to 5 days. The aim of this study is to assess the feasibility of employing Catheterless Rezum post-operatively in patients with normal or strong bladder contractility. Upon a positive outcome of interim analysis, the effectiveness of Catheterless Rezum will be assessed at five sites for the multicenter phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Water Vapor Therapy
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Catheterless group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Rezum
Other Intervention Name(s)
Water vapor therapy
Intervention Description
The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH).
Primary Outcome Measure Information:
Title
Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS).
Description
The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity.
Time Frame
Baseline, 36 months
Title
Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax).
Description
The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction.
Time Frame
Baseline, 36 months
Secondary Outcome Measure Information:
Title
Changes in urinary symptoms as measured by changes in IPSS.
Description
The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity.
Time Frame
Baseline, 36 months
Title
Changes in urinary symptoms as measured by changes in Qmax at 36 months
Description
The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction.
Time Frame
Baseline, 36 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male subject of 40 - 80 years of age
Has provided informed consent
Has a diagnosis of bladder outlet obstruction due to benign prostatic enlargement
Able to complete self-administered questionnaires
Is a surgical candidate for Rezum
Has medical record documentation of Qmax < 15 ml/s
Has medical record documentation of prostate volume from 30-80 ml by transrectal ultrasound (TRUS)
Has a bladder contractility index score ≥ 100, calculated by detrusor pressure at Qmax (pDet@qmax) + (5xQmax).
Willing to undergo pressure-flow studies to calculate BCI prior to surgical intervention.
Has serum creatinine within the normal range.
Able to perform intermittent catheterization.
Exclusion Criteria:
Has a life expectancy < 2 years
Is currently enrolled in or plans to enroll in any concurrent drug or device study
Has an active infection (e.g., urinary tract infection or prostatitis)
Has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
Has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days
Has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years
Has a diagnosis of lichen sclerosis
Has a diagnosis of neurogenic bladder or other neurologic disorder that affects bladder function
Has a diagnosis of polyneuropathy (e.g., diabetic)
Has a history of lower urinary tract surgery
Has a diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
Has an inability to perform intermittent self-catheterization
Has been catheterized or has a post-void residual (PVR) of > 400 ml in the 14 days prior to the surgical procedure
Has a current diagnosis of bladder stones
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bilal Chughtai, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Catheterless Water Vapor Therapy for the Treatment of BPH
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