The Effect of Tamsulosin on Postoperative Urinary Retention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Effect of Tamsulosin on Postoperative Urinary Retention in Women Undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A Randomized Trial

Conditions
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Urinary Retention

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin<br>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. | Drug: Tamsulosin<br>* Oral drug: 10 days of 0.4 mg of oral Tamsulosin<br>|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* Oral drug: 10 days of identical-appearing placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of postoperative urinary retention (POUR) | Urinary retention can be defined as >150cc residual volume during an active voiding trial | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary tract infection rate |  | Week 6 | 
| Incidence of delayed urinary retention | Delayed urinary retention will be defined as post-void residual > 150 cc | Week 6 | 
| 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 | 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) | Day 0 and 1 week postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative care, Urinary tract infection, Female pelvic reconstructive surgery, Enhanced recovery after surgery, Tamsulosin, Flomax