Rezum FIM Optimization Study

NCT02940392 | Completed Results

• 1 other identifier: 1633-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).

Conditions

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

Keywords

Rezum

Outcome Measures

Primary Outcomes (1)

• Change in International Prostate Symptom Score

  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 in IPSS was calculated. The IPSS is a validated questionnaire used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH). Scoring ranges from 0 to 35 with overall scores of 0-7 correlated to mildly symptomatic, 8-19 correlated to moderately symptomatic and 20-35 correlated to severely symptomatic. A reduction in score from baseline corresponds to improved outcome post procedure.

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

Other Outcomes (6)

• Intra-procedural and Post-procedural Pain

  Procedure Day, 1 day post procedure, 1 week post procedure, 1 month post procedure, 3 months post procedure ,6 months post procedure

• Number of Subjects Requiring Catheterization Post Procedure

  1 day post procedure, 1 week post procedure, 1 month post procedure

• Post Procedure Catheterization Duration

  1 month post procedure

Study Arms (1)

Rezum Treatment

EXPERIMENTAL

Patients will receive the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia.

Device: Rezum System

Interventions

Rezum System DEVICE

The Rezūm System is designed to treat 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 Principal Investigator.
• Subject must be willing to undergo the procedure without anesthesia.

You may not qualify if:

• History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.
• Presence of a penile implant.
• Any prior minimally invasive intervention (e.g. TUNA,Laser, Microwave) or surgical intervention for the symptoms of BPH.
• Currently enrolled in another clinical trial.
• 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 catheterization specimen).
• Neurogenic bladder or sphincter abnormalities.
• Urethral strictures, bladder neck contracture or muscle spasms.
• Subjects who are interested in maintaining fertility.
• Use of concomitant (or recent) medications to include the following:
• Beta blockers, antihistamines, anticonvulsants, and antispasmodics within 1 week of treatment, unless there is documented evidence of stable dosing for last 6 months (e.g., no dose changes).
• Alpha blockers, antidepressants, anticholinergics, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.
• alpha reductase inhibitor within the last 6 months

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Clinica Canela

La Romana, Dominican Republic

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

teresa.takle-flach@bsci.com

9529306000

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 19, 2016
• First Posted: October 20, 2016
• Study Start: March 19, 2012
• Primary Completion: May 19, 2017
• Study Completion: May 19, 2017
• Last Updated: March 5, 2021
• Results First Posted: March 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)