Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL)

NCT03605745 | Terminated Results FDA Device

• 1 other identifier: 3034-001
• Study Type: interventional
• Target: 47
• Locations: 2 countries
• Sites: 10

Brief Summary

Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes \>80cm3 and ≤150 cm3.

Conditions

BPH With Urinary Obstruction; BPH; BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Keywords

BPH; Minimally Invasive; Water Vapor Therapy; Rezum

Outcome Measures

Primary Outcomes (2)

• Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)

  The proportion of the intent-to-treat (ITT) analysis population that responds to the Rezum therapy is reported. A responder is defined as a subject who has an improvement in International Prostate Symptom Score (IPSS) \> 30% from baseline to 6 months post-therapy. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.

  6 Months

• Number of Participants With Post Procedure Device Related Serious Complications

  Assess the composite rate of post procedure device related serious complications in treated subjects through 6 months follow-up.

  6 Months

Secondary Outcomes (2)

• Number of Subjects With Device-related Retention Catheterizations

  6 Month

• Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up

  Baseline, 6 weeks, 3 months, 6 months, 1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Prostatic Vapor Ablation with Rezum

Device: Prostatic Vapor Ablation

Interventions

Prostatic Vapor Ablation DEVICE

Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.

Also known as: Rezum, Water Vapor Ablation

Treatment

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects ≥ 50 years of age who have symptomatic BPH.
• International Prostate Symptom Score (IPSS) score ≥ 13.
• Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 12 ml/sec with minimum voided volume of ≥ 125 ml.
• Post-void residual (PVR) ≤300 ml.
• Prostate volume \>80 cm3 to ≤150 cm3

You may not qualify if:

• Urology:
• Any prior invasive prostate intervention (e.g., "Radiofrequency" thermotherapy, balloon, microwave thermotherapy, "Prostatic Urethral Lift", "Transurethral Resection", or laser) or other surgical interventions of the prostate.
• Undergone a prostate biopsy within 60 days prior to the scheduled treatment date or has an imminent need for surgery.
• Verified acute bacterial prostatitis within last 12 months documented by culture.
• Active or history of epididymitis within the past 3 months.
• Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the Rezūm device.
• Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months, provided that stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible.
• Subject interested in maintaining fertility.
• Use of the following medications where the dose is not stable (stable dose defined as the same medication and dose in the last three months):
• Beta-blockers;
• Anticonvulsants;
• Antispasmodics;
• Antihistamines;
• Alpha blockers for BPH and anticholinergics or cholinergics;
• Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia));

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (10)

Arizona Urology Specialists

Scottsdale, Arizona, 85258, United States

Location

Pinellas Urology, LLC

St. Petersburg, Florida, 33710, United States

Location

First Urology, PSC

Jeffersonville, Indiana, 47130, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Chesapeake Urology Associates, LLC

Towson, Maryland, 21204, United States

Location

Adult & Pediatric Urology, P.C.

Omaha, Nebraska, 68114, United States

Location

Jersey Urology Group

Somers Point, New Jersey, 08244, United States

Location

Houston Metro Urology

Houston, Texas, 77030, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

Sydney Adventist Hospital/University of Sydney

Wahroonga, New South Wales, 2076, Australia

Location

Limitations and Caveats

The study was terminated by the sponsor for business reasons. As a result there is no patient data presented for the 12 month, 2 year and 3 year follow up visits as they did not occur per termination.

Results Point of Contact

• Title: Kaitlyn Rainbow, Clinical Research Associate
• Organization: Boston Scientific

kat.rainbow@bsci.com

952-930-6627

Study Officials

• Henry Woo, MD

  Sydney Adventist Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Model Details: This study is a prospective, non-randomized clinical trial of subjects with benign prostatic hypertrophy (BPH).

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: July 30, 2018
• Study Start: June 19, 2018
• Primary Completion: June 25, 2020
• Study Completion: August 11, 2020
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); AU (1)