The Effect of Tamsulosin on Postoperative Urinary Retention

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Tamsulosin

Criteria

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 of mesh for prolapse repair

• High tone pelvic floor dysfunction