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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NxThera Inc
ClinicalTrials.gov Identifier:
NCT01912339
First received: July 26, 2013
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptom
Device: Rezum System
Procedure: Rigid Cystoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Minimally Invasive Prostatic Vapor Ablation - Multicenter, Controlled Study for the Treatment of BPH (Rezūm II)

Resource links provided by NLM:


Further study details as provided by NxThera Inc:

Primary Outcome Measures:
  • Efficacy: International Prostate Symptom Score (IPSS) [ Time Frame: 3 Month Follow-up Visit ] [ Designated as safety issue: No ]
    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. The eighth question is designed to assess the degree of "bother" associated with the subject's urinary symptoms.

  • Safety: Device Related Serious Complications [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Percent Responders at 3 Months [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  • Percent Responders at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Percent Responders at 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 195
Study Start Date: July 2013
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Treatment: Rezūm System
Device: Rezum System

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.

Control
Control: Rigid Cystoscopy
Procedure: Rigid Cystoscopy
Endoscopy of the urinary bladder via the urethra.
Other Name: Cystoscopy

Detailed Description:

This study is a prospective, controlled, randomized single blind clinical trial of subjects with benign prostatic hyperplasia, which will allow for an interim analysis for sample size adjustment. Subjects first will be randomized in a 2:1 proportion in favor of the Treatment arm. Subjects in the Control arm will be allowed to crossover to have the Rezūm treatment after the 3-month follow-up examination.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male subjects > 50 years of age who have symptomatic BPH.
  2. International Prostate Symptom Score (IPSS) score ≥ 13.
  3. Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml.
  4. Post-void residual (PVR) ≤250 ml.
  5. Prostate volume > 30 and ≤ 80 gm.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912339

Locations
United States, Arizona
Arizona Institute of Urology
Tucson, Arizona, United States, 85704
United States, Colorado
Urology Associates of Denver
Denver, Colorado, United States, 80113
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
United States, Illinois
Southern Illinois University
Springfield, Illinois, United States, 62794
United States, Maryland
Chesapeake Urology
Townson, Maryland, United States, 21204
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Metro Urology
Woodbury, Minnesota, United States, 55125
United States, New York
Manhattan Medical Research
New York, New York, United States, 10016
United States, Ohio
The Urology Group
Cincinnati, Ohio, United States, 45212
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Texas Urology
Carrolton, Texas, United States, 75010
UT Southwestern
Dallas, Texas, United States, 75390
Urology of San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
NxThera Inc
Investigators
Principal Investigator: Claus Roehrborn, MD UT Southwestern
Principal Investigator: Kevin McVary, MD Southern Illinois University
  More Information

No publications provided

Responsible Party: NxThera Inc
ClinicalTrials.gov Identifier: NCT01912339     History of Changes
Other Study ID Numbers: 2105-001
Study First Received: July 26, 2013
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NxThera Inc:
Hyperlasia
Retention
Prostate

Additional relevant MeSH terms:
Hyperplasia
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Signs and Symptoms
Urological Manifestations

ClinicalTrials.gov processed this record on October 21, 2014