Prostatic Urethral Lift in Subject With Acute Urinary Retention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Urinary Retention
- Sponsor
- NeoTract, Inc.
- Enrollment
- 101
- Locations
- 6
- Primary Endpoint
- Successful Trial Without Catheter Peri-procedurally
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Successful Trial Without Catheter Peri-procedurally
Time Frame: 3 days (± 1 day) from index procedure
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.
Secondary Outcomes
- Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention(Through 3 months)