Catheterless Water Vapor Therapy for the Treatment of BPH

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

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.

Study Overview

• Status: Suspended
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: Rezum

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catheterless group	Device: Rezum; The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH).; Other Names: Water vapor therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Bilal Chughtai, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Actual): June 21, 2024
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Water Vapor Therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 20-02021474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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