Overview

This trial is active, not recruiting.

Condition benign prostatic hyperplasia
Treatments urolift system, cystoscopy
Phase phase 3
Sponsor NeoTract, Inc.
Start date February 2011
End date February 2013
Trial size 206 participants
Trial identifier NCT01294150, 1012CP

Summary

The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System when used in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the improvement of International Prostate Symptom Score (IPSS) and safety will be reviewed based on pertinent adverse events.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
The treatment group subjects will undergo the UroLift system procedure. The subject will be blinded as to whether he is in the control or treatment group. Unblinding will occur at 3 months post procedure after the assessments are completed. Subjects treated with the UroLift system may experience return of LUTS. Between 3 and 12 month follow-up assessments, a subject may be retreated with the UroLift system if he meets the retreatment inclusion and exclusion criteria or treated with other approved therapies. Patients that go on for retreatment within the first 12 months will be considered treatment failures. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.
urolift system
The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.
(Sham Comparator)
The control group subjects will undergo a cystoscopy procedure. The subject will be blinded as to whether he is in the control or treatment group. Unblinding will occur at 3 months post procedure after follow-up assessments are completed. Subjects undergoing the cystoscopy procedure may experience return of LUTS. Between 3 and 12 month follow-up assessments, a subject may be treated with the UroLift system if he meets the retreatment inclusion and exclusion criteria. Subjects crossing over will then be followed for 5 years post-treatment. The subject can also be treated by other approved therapies after which follow-up through 12 months is required.
cystoscopy
The Control Group will undergo cystoscopy.

Primary Outcomes

Measure
Comparison of IPSS for Efficacy
time frame: 3 month
Collection of post-treatment catheterization for safety
time frame: > 7 days
IPSS improvement of UroLift patients for efficacy
time frame: 12 months

Secondary Outcomes

Measure
Sexual Function
time frame: 12 Months

Eligibility Criteria

Male participants at least 50 years old.

Inclusion Criteria: - Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH) Exclusion Criteria: - Size, volume,length of prostate

Additional Information

Official title Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms
Principal investigator Claus Roehrborn, MD
Description The randomized portion of the study is a prospective, multicenter, multinational, 2:1 randomized, single-blinded controlled clinical trial comparing the IPSS of the treatment group to the IPSS of the control group at the 3 month follow-up. Subjects in the active treatment group undergo UroLift system treatment. Subjects in the control group undergo a cystoscopy procedure. All subjects will be followed through 12 months, and through 5 years for those that receive the investigational device.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by NeoTract, Inc..