The Effect of Tamsulosin on Postoperative Urinary Retention (NCT04682366) | Clinical Trial Compass
TerminatedPhase 4
The Effect of Tamsulosin on Postoperative Urinary Retention
Stopped: Challenges in enrollment led to decission for termination
United States4 participantsStarted 2021-10-19
Plain-language summary
This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing same-day discharge with an enhanced recovery after surgery protocol.
Who can participate
Age range21 Years – 99 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Stage II or greater pelvic organ prolapse in \> 1 vaginal compartment
* Plan for multicompartment native tissue vaginal repair (which would include any combination of uterosacral ligament suspension, sacrospinous ligament suspension, cystocele and/or rectocele repair, with or without hysterectomy and with or without concomitant mid-urethral sling) or vaginal closure with female pelvic medicine and reconstructive surgery (FPMRS) - trained surgeons at Wake Forest Baptist Health
* Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-day hospital discharge
* Willing to remain compliant with Investigation Product (IP)
Exclusion Criteria:
* Intraoperative complication necessitating prolonged bladder drainage or placement of a vaginal pack x 24 hours (patients would exit study after randomization and will be excluded from the per-protocol analysis)
* Patients whose surgical plan would necessitate a voiding trial on postop day \>0
* Less than 21 years of age
* Unable to understand English
* Patients who are scheduled to undergo combined colorectal procedures such as rectopexy, sphincteroplasty
* Patient with known allergy to Tamsulosin or sulfa drugs
* Patients with upcoming cataract surgery
* Patient with orthostatic hypotension
* History of postvoid residual (PVR\>150) prior to surgery with prolapse reduction
* Patients with hypertension on alpha-blockers
* Single compartment prolapse repair (anterior or posterior repair only)
* Use …
What they're measuring
1
Number of Participants With Postoperative (Day 0) Urinary Retention