Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate)

NCT01912339 | Completed Results DMC

• 1 other identifier: 2105-001
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 15

Brief Summary

To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptom

Keywords

Hyperplasia; Retention; Prostate

Outcome Measures

Primary Outcomes (2)

• Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up

  Comparison of the change in BPH symptoms as measured by IPSS change between the Treatment and Control arm at 3 months post-treatment. The IPSS is a well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH Symptoms. The first seven questions of the IPSS Questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency each on a scale of 0 to 5. The total score, summed across the seven items measured, ranges from 0 (no symptoms) to 35 (most severe symptoms).

  3 Month Follow-up Visit

• Safety: Device Related Serious Complications

  This safety endpoint will be to demonstrate that the composite observed rate of post-procedure device related serious complications in the Treatment Arm are is less than or equal to 12% at 3 months. Composite device related serious complications for this endpoint are 1) De Novo (new) severe urinary retention lasting more than 21 consecutive days post treatment, 2) Device related formation of fistula between the rectum and urethra, and 3) device perforation of the rectum or GI tract. Twelve percent was a pre-specified performance goal for the safety endpoint.

  3 Months

Secondary Outcomes (3)

• Responders at 3 Months

  3 Months

• Responders at 6 Months

  6 Months

• Responders at 12 Months

  12 Months

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment: Rezūm System

Device: Rezum System

Control

OTHER

Control: Rigid Cystoscopy

Procedure: Rigid Cystoscopy

Interventions

Rezum System DEVICE

The Rezūm System uses sterile water vapor (steam) to treat BPH by delivering targeted, controlled doses of stored thermal energy directly to the transition zone of the prostate gland. A narrow sheath, similar in shape and size to a cystoscope, is inserted transurethrally and positioned within the prostatic urethra between the bladder neck and the verumontanum. A thin needle is deployed through the urethra into the transition zone, and a very short (8-10 second) treatment of water vapor is delivered directly into the hyperplastic tissue and immediately disperses through the tissue interstices. Upon contact with the tissue, the vapor condenses, or phase shifts, into its liquid state, releasing the stored thermal energy contained within the vapor. This thermal energy is released directly against the walls of the tissue cells within the treatment zone, gently and immediately denaturing the cell membranes, thereby causing instantaneous cell death.

Treatment

Rigid Cystoscopy PROCEDURE

Endoscopy of the urinary bladder via the urethra.

Also known as: Cystoscopy

Control

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• 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 ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml.
• Post-void residual (PVR) ≤250 ml.
• Prostate volume \> 30 and ≤ 80 gm.

You may not qualify if:

• History of clinically significant congestive heart failure (i.e. NYHA Class III and IV).
• History of diabetes not controlled by a stable dose of medication over the past three months. Patients with a Hemoglobin A1c that is \<8.0% are allowed.
• History of significant respiratory disease where hospitalization for the disease is required.
• History of immunosuppressive conditions (e.g., AIDS, post-transplant).
• Cardiac arrhythmias that are not controlled by medication or medical device.
• An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.
• Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study.
• Presence of a penile implant or stent(s) in the urethra or prostate.
• Any prior invasive prostate intervention (e.g., radio frequency (RF) ablation, balloon, microwave, or laser) or other surgical interventions of the prostate.
• Currently enrolled in any other pre-approval investigational study in the USA (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)).
• History of confirmed malignancy or cancer of prostate or bladder, however, high grade PIN is acceptable.
• History of cancer in non-genitourinary system that is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of randomization.
• Previous pelvic irradiation or radical pelvic surgery.
• Diagnosed with active Lyme Disease (borreliosis).
• PSA \> 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is \> 2.5 ng/ml and ≤ 10 ng/ml with free PSA \<25%, prostate cancer for the subject must be/had been ruled out through a negative biopsy prior to enrollment.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (15)

Arizona Institute of Urology

Tucson, Arizona, 85704, United States

Location

Urology Associates of Denver

Denver, Colorado, 80113, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Southern Illinois University

Springfield, Illinois, 62794, United States

Location

Chesapeake Urology

Towson, Maryland, 21204, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Metro Urology

Woodbury, Minnesota, 55125, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

The Urology Group

Cincinnati, Ohio, 45212, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Texas Urology

Carrollton, Texas, 75010, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Urology of San Antonio

San Antonio, Texas, 78229, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Hyperplasia

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Limitations and Caveats

All adverse events reported, including those not related to the Rezum procedure. Events related to the procedure are summarized in McVary 2016 (see "Publications automatically indexed to this study").

Results Point of Contact

• Title: Kevin Hagelin, Clinical Program Manager
• Organization: Boston Scientific Corporation

kevin.hagelin@bsci.com

(800) 328-3881

Study Officials

• Claus Roehrborn, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

• Kevin McVary, MD

  Southern Illinois University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: July 31, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: October 17, 2016
• Last Updated: April 13, 2020
• Results First Posted: May 15, 2017

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)