Catheterless Water Vapor Therapy for the Treatment of BPH

NCT04997369 | Suspended DMC FDA Device

• 1 other identifier: 20-02021474
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Water Vapor Therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Changes in urinary symptoms as measured by changes in IPSS.

  Baseline, 36 months

• Changes in urinary symptoms as measured by changes in Qmax at 36 months

  Baseline, 36 months

Study Arms (1)

Catheterless group

EXPERIMENTAL

Device: Rezum

Interventions

Rezum DEVICE

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

Also known as: Water vapor therapy

Catheterless group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Bilal Chughtai, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 9, 2021
• Study Start: October 13, 2021
• Primary Completion: June 21, 2024
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)