Study of Median Lobe Prostatic UroLift Procedure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Median Lobe Prostatic UroLift Procedure

Conditions
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Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Device: UroLift System procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enlarged median lobe (ML) contributing to obstruction of the prostate BPH Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UroLift System procedure<br>All eligible,enrolled subjects will undergo a UroLift procedure | Device: UroLift System procedure<br>* Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH<br>* Other names: Prostatic UroLift (PUL);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%. | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up | 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. | 12 Months | 
| Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up | Present change in Intent to Treat population International Prostate Symptom Score (IPSS) from Baseline to 12 Month Follow-up | 12 Months | 
| Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up | Quality of Life (QOL) score results from a disease-specific (BPH) quality of life question (bother score) scored on a scale from 0 to 6 points (delighted to terrible). | 12 Months | 
| Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up | Quality of Life (QOL) score results from a disease-specific (BPH) quality of life question (bother score) scored on a scale from 0 to 6 points (delighted to terrible). | 12 Months | 
| Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up | BPHII (Benign Prostatic Hyperplasia Impact Index) is used to assess the impact of BPH symptoms on subject health and functioning. The BPHII is a self-administered questionnaire with 4 questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities. Scores for each question range from 0 to 4, with higher score indicating greater impact. Maximum score is 16. | 12 Months | 
| Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up | Present change in Intent to Treat population, Benign Prostatic Hyperplasia Impact Index (BPHII) score from Baseline to 12 Month Follow-up | 12 Months | 
| Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up | Peak or maximum flow rate [ml/sec] was collected using uroflowmetry, a standard diagnostic used to test to assess how well the urinary tract functions. A lower number indicates a reduced flow rate. | 12 Months | 
| Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up | Peak or maximum flow rate [ml/sec] was collected using uroflowmetry, a standard diagnostic used to test to assess how well the urinary tract functions. A lower number indicates a reduced flow rate. | 12 Months | 
| Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up | Post Residual Void (PVR) is the amount of urine left in the bladder after using the restroom. PVR is determined using ultrasound or bladder scanner. | 12 Months | 
| Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up | Post Residual Void (PVR) is the amount of urine left in the bladder after using the restroom. PVR is determined using ultrasound or bladder scanner. | 12 Months |