Rezum I Pilot Study for Benign Prostatic Hyperplasia

NCT02943070 | Completed Results

• 1 other identifier: 1189-001
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 3

Brief Summary

Evaluate the safety and efficacy of the Rezum System for the treatment of BPH

Conditions

Prostatic Hyperplasia; Benign Prostatic Hyperplasia; Adenoma, Prostatic; Prostatic Adenoma; Prostatic Hyperplasia, Benign; Prostatic Hypertrophy; Prostatic Hypertrophy, Benign; Rezum

Keywords

Rezum; Water Vapor Ablation

Outcome Measures

Primary Outcomes (2)

• International Prostate Symptom Score (IPSS) Change From Baseline

  International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change (improvement) in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.

  Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

• Major Complications

  Safety assessed by the frequency of systemic and local serious device related complications and the occurrence of unanticipated device-related adverse effects during treatment and at follow-up, up to 30 days. Due to the nature of the device, any device-related AEs are expected to present themselves during the immediate peri-procedure period (30 days post procedure). The device related complications that will be compared for this safety endpoint are: 1. Severe Urinary Retention (Retention ≥ 24 hours) 2. Fistula between rectum and urethra 3. Perforation of the rectum or GI tract 4. New incidences of retrograde ejaculation

  3 months

Secondary Outcomes (23)

• Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement

  Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

• Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement

  Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

• Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS

  Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

• Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)

  Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

• Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline

  Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Study Arms (1)

Rezum Treatment

EXPERIMENTAL

Patients received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.

Device: Rezum System

Interventions

Rezum System DEVICE

The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.

Also known as: Rezum Procedure, Rezum, Water Vapor Ablation, Rezum Delivery Device, Rezum Generator

Rezum Treatment

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects \> 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention.
• IPSS score of ≥ 15.
• Qmax: Peak flow rate ≤ 15 ml/sec.
• Post-void residual (PVR) \< 300 ml.
• Prostate transverse diameter \> 30 mm.
• Prostate volume between 20 to 120 gm.
• Voided volume ≥ 125 mL
• Subject able to complete the study protocol in the opinion of the investigator.
• Life expectancy of at least one year.

You may not qualify if:

• History of any illness or surgery that may confound the results of the study or have risk to subject.
• Presence of a penile implant.
• Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH.
• Currently enrolled or has been enrolled in another trial in the past 30 days.
• Confirmed or suspected malignancy of prostate or bladder
• Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
• Previous pelvic irradiation or radical pelvic surgery.
• Documented active urinary tract infection by culture or bacterial prostatitis within last year documented by culture (UTI is defined as \>100,000 colonies per ml urine from midstream clean catch or catherization specimen)
• Neurogenic bladder or sphincter abnormalities.
• Urethral strictures, bladder neck contracture or muscle spasms.
• Subjects interested in maintaining fertility.
• Use of concomitant medications to include the following:
• Use of, antihistamines, and antispasmodics within 1 week of treatment unless there is documented evidence stable dosing for last 6 months (no dose changes).
• Use of alpha blockers, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.
• Use of 5-alpha reductase inhibitor within the last 6 months

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

University Hospital

Brno, Czechia

Location

Clinica Canela

La Romana, Dominican Republic

Location

Urologcentrum

Stockholm, Sweden

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This was a pilot study conducted on a new therapy at a limited number of sites (3 total).

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Boston Scientific Corporation

teresa.takle-flach@bsci.com

952-930-6000

Study Officials

• Kevin M Hagelin

  Program Manager, Clinical Affairs, Boston Scientific

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 24, 2016
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2018
• Last Updated: March 16, 2021
• Results First Posted: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1); SE (1); CZ (1)