The Effect of Tamsulosin on Postoperative Urinary Retention

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Urinary Retention

In brief

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.

Key facts

Study ID

NCT04682366

Run by

Wake Forest University Health Sciences

People needed

4

Starts

2021-10-19

Expected to finish

2022-11-10

Last updated by the study team

2024-01-31

Who can join

Age: 21 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Wake Forest Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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