CompletedNot Applicable

Prostatic Urethral Lift in Subject With Acute Urinary Retention

United Kingdom101 participantsStarted 2018-03-24

Plain-language summary

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

Who can participate

Age range50 Years

SexMALE

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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

What they're measuring

Successful Trial Without Catheter Peri-procedurally

Timeframe: 3 days (± 1 day) from index procedure

Trial details

NCT IDNCT03194737

SponsorNeoTract, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-21

Results submitted2021-05-06

View on ClinicalTrials.gov More Acute Urinary Retention trials