N/A
N=101
Prostatic Urethral Lift in Subject With Acute Urinary Retention
Acute Urinary Retention · Benign Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT03194737 ↗Enrolled (actual)
101
Serious AEs
8.9%
Results posted
Jul 2021
Primary outcome: Primary: Successful Trial Without Catheter Peri-procedurally — 29; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UroLift System Procedure (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- NeoTract, Inc.
- Primary completion
- Jan 2019
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 | — |
Summary
Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (BPH).
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.