The Effect of Tamsulosin on Postoperative Urinary Retention

Phase 4

Terminated

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 with an enhanced recovery after surgery protocol.

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 discharge planned.

Duration of catheterization, postoperative urinary tract infection rates, patient level of satisfaction, Emergency Department (ED) visits and adverse events postoperatively will also be compared between women receiving Tamsulosin versus placebo.

Patients will be offered participation in the study at their postoperative visit if they meet study criteria. Once consent is obtained, patients will be randomized to receive Tamsulosin 0.4 mg orally once daily or matching placebo capsules for a total of 10 days starting 5 days pre-operatively.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.
Tamsulosin	Tamsulosin	Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Postoperative (Day 0) Urinary Retention	Up to 6 weeks postoperatively	Urinary retention can be defined as \>150cc residual volume during an active voiding trial

Secondary Outcome Measures

Name	Time	Method
Urinary Tract Infection Rate	Week 6	Urinary tract infection rate
Incidence of Delayed Urinary Retention	Week 6	Delayed urinary retention will be defined as post-void residual \> 150 cc
Number Emergency Department (ED) Visits	Up to 30 days postoperatively
Total Number of Days of Bladder Catheterization	Week 6
Patient Level of Satisfaction With Voiding Function	Day 0 and 1 week postoperatively	Patient satisfaction questionnaire: Patient Global Impression of Improvement (PGI-I) - Patient level of satisfaction (scale of 1 -7) - very dissatisfied, moderately dissatisfied, slightly dissatisfied, neutral, slightly satisfied, moderately satisfied, very satisfied - the lower the score denotes the more satisfaction)