Phase 3
N=132
Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
Urinary Retention · Lower Urinary Tract Symptoms · Stress Urinary Incontinence · Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT03524339 ↗Enrolled (actual)
132
Serious AEs
2.5%
Results posted
Nov 2021
Primary outcome: Primary: Postoperative Urinary Retention — 16; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo oral capsule (Drug); Tamsulosin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Urinary Retention |
16; 5 | — |
| SECONDARY International Prostate Symptom Score |
6; 7 | — |
| SECONDARY Postoperative Urinary Tract Infection |
6; 4 | — |
| SECONDARY Sent Home With Catheterization |
7; 5 | — |
Summary
This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.
Eligibility Criteria
Inclusion Criteria
- Patients must be 18 years or older as well as willing and able to provide informed consent
- Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence
- Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1.
Exclusion Criteria
- Patient unable or unwilling to provide informed consent
- Severe allergy to sulfa drugs
- Known allergy to tamsulosin or another alpha antagonist medication
- History of urinary retention
- Planned bladder catheterization greater than 24 hours after surgery
- Current use of alpha antagonist medication for hypertension
- End stage renal or liver disease
Data sourced from ClinicalTrials.gov (NCT03524339). 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.