Status:
TERMINATED
The Effect of Tamsulosin on Postoperative Urinary Retention
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Urinary Retention
Eligibility:
FEMALE
21-99 years
Phase:
PHASE4
Brief 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...
Detailed Description
The primary objective is to determine the effect of Tamsulosin on same-day active voiding trial in women undergoing female pelvic reconstructive surgery with vaginal native tissue repair with same-day...
Eligibility Criteria
Inclusion
- 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
- 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 of mesh for prolapse repair
- High tone pelvic floor dysfunction
Key Trial Info
Start Date :
October 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04682366
Start Date
October 19 2021
End Date
November 10 2022
Last Update
January 31 2024
Active Locations (1)
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1
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157