Catheterless Water Vapor Therapy for the Treatment of BPH

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Feasibility and Multicenter Assessment of Catheter-less Water Vapor Therapy (Rezum) for the Treatment of Benign Prostatic Hyperplasia (BPH)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04997369
• Other study ID #: 20-02021474
• Status: Suspended
• Phase: N/A
• Start date: October 13, 2021
• Est. completion date: July 2027

Study information

• Verified date: October 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: July 2027
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• Rezum
The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH).

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 36 months
Primary	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.	Baseline, 36 months
Secondary	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.	Baseline, 36 months
Secondary	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.	Baseline, 36 months