N/A
Completed N=101
Prostatic Urethral Lift in Subject With Acute Urinary Retention
Acute Urinary Retention · Benign Prostatic Hyperplasia
Source: ClinicalTrials.gov NCT03194737 ↗
Enrolled (actual)
101
Serious AEs
8.9%
Results posted
Jul 2021
Primary outcomePrimary: Successful Trial Without Catheter Peri-procedurally — 29; 0 Participants
Summary
Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (BPH).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Trial Without Catheter Peri-procedurally |
29; 0 | — |
| SECONDARY Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention |
4; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03194737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.