Prostatic Urethral Lift in Subject With Acute Urinary Retention

Study Overview
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Brief Summary
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Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (BPH).

Detailed Description
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The study is a multi-centre, prospective evaluation of PUL and retrospective review of invasive surgery as potential comparator. The study is intended to be conducted at up to 5 different centres in the United Kingdom to enrol up to 50 subjects. Subject follow-up visits are at post-procedure, 6 weeks, 3 months, 6 months and 12 months.

Official Title
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Prostatic Urethral Lift in Subject With Acute Urinary Retention

Conditions
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Acute Urinary Retention, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: UroLift System Procedure


Participation Criteria
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Eligibility Criteria
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UroLift System Procedure Arm Inclusion Criteria: Male gender Diagnosis of symptomatic BPH Age ≥ 50 years Prostate volume ≤ 100 cc per ultrasound (US) Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker Exclusion Criteria: An obstructive or protruding median lobe of the prostate Previous BPH surgical procedure Previous pelvic surgery Urethral conditions that prevents insertion and delivery of device system into bladder Retention volume of >1500 mL Has not had prostate cancer excluded History of prostate or bladder cancer Biopsy of the prostate within the 6 weeks prior to Index Procedure History of neurogenic or atonic bladder Acute or chronic renal failure Known coagulopathies or subject on anticoagulants within 3 days of index procedure (excluding up to 100mg ASA) Known bladder stones within the prior 3 months or treatment within 12 months Prostatitis requiring treatment (antibiotics) within the last year Other co-morbidities that could impact the study results severe cardiac arrhythmias uncontrolled by medications or pacemaker congestive heart failure New York Heart Association (NYHA) III or IV history of uncontrolled diabetes mellitus significant respiratory disease in which hospitalisation may be required known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy) Life expectancy estimated to be less than 5 years Desire to maintain fertility post procedure Unable or unwilling to complete all required questionnaires and follow up assessments Unable or unwilling to sign informed consent form Currently enroled in any other clinical research trial that has not completed the primary endpoint

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UroLift System procedure<br>All eligible,enroled subjects will undergo a UroLift procedure. | Device: UroLift System Procedure<br>* Minimally invasive procedure in patients with acute urinary retention secondary to BPH.<br>* Other names: Prostatic UroLift (PUL);|
| No Intervention: Retrospective Arm<br>Chart review will be performed on all invasive BPH surgeries (TURP, Holmium Laser Enucleation of the prostate (HoLEP), etc) performed by the site from June 1, 2015 to December 31, 2015 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Trial Without Catheter Peri-procedurally | Success is defined as a spontaneous voided volume of ≥100 mL associated with a post void residual volume by ultrasound <300 mL 3 days (± 1 day) after the index procedure catheter placement without the need for re-catheterisation. | 3 days (± 1 day) from index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention | Number of patients who experienced adjudicated Serious Adverse Events related to Benign prostatic hyperplasia (BPH) Intervention Procedure or Device | Through 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign prostatic hyperplasia, BPH, Urinary retention, prostate, hypertrophy