Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- NeoTract, Inc.
- Enrollment
- 206
- Locations
- 19
- Primary Endpoint
- Collection of Post-treatment Catheterization for Safety
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)
Exclusion Criteria
- •Size, volume,length of prostate
Outcomes
Primary Outcomes
Collection of Post-treatment Catheterization for Safety
Time Frame: Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days
The primary safety endpoint is an assessment of the rate of extended post-operative urinary catheterization in the subjects randomized to the UroLift group of the study in the ITT group. The extended post-operative urinary catheterization rate is defined as including those subjects who required catheterization within the first 3 days as part of post-operative management for inability to void, and required the catheter for more than 7 days. 2/140 met this endpoint.
Comparison of IPSS for Efficacy
Time Frame: 3 month
The UroLift system will be considered superior to the Control if the mean International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 months demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for cystoscopy alone. The IPSS is an 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). SCORING: 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic
Mean UroLift Improvement in IPSS at 12 Months
Time Frame: 12 months
The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. To meet co-primary effectiveness endpoint, the lower bound of a one-sided 97.5% confidence interval of IPSS mean percent change from baseline at Month 12 in the UroLift group must be greater than or equal to 30%.
Secondary Outcomes
- Sexual Function(12 Months)