Study of Median Lobe Prostatic UroLift Procedure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NeoTract, Inc.
- Enrollment
- 45
- Primary Endpoint
- At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%.
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of using UroLift in subjects with a prostatic median lobe enlargement due to benign prostatic hyperplasia (BPH).
Detailed Description
Study Objectives: Evaluate the safety and effectiveness of the UroLift® System when used in symptomatic benign prostatic hyperplasia (BPH) subjects with an enlarged median lobe.
Study Design: Prospective, multicenter, non-blinded, single arm (non-randomized) study.
Sample Size: A total of no more than 48 subjects will be enrolled. Subject Population: Males age of 50 years or older diagnosed with lower urinary tract symptoms (LUTS) with enlarged median lobe.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Enlarged median lobe (ML) contributing to obstruction of the prostate
Exclusion Criteria
- Not provided
Arms & Interventions
UroLift System procedure
All eligible,enrolled subjects will undergo a UroLift procedure
Intervention: UroLift System procedure (Device)
Outcomes
Primary Outcomes
At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%.
Time Frame: 6 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). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic.
Secondary Outcomes
- Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up(12 Months)
- Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up(12 Months)
- Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up(12 Months)
- Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up(12 Months)
- Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up(12 Months)
- Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up(12 Months)
- Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up(12 Months)
- Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up(12 Months)
- Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up(12 Months)
- Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up(12 Months)