Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

Study Overview
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Brief Summary
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This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.

Official Title
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Perioperative Administration of Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

Conditions
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Urinary Retention, Lower Urinary Tract Symptoms, Stress Urinary Incontinence, Pelvic Organ Prolapse

Intervention / Treatment
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* Drug: Placebo oral capsule
* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be 18 years or older as well as willing and able to provide informed consent Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1. Exclusion Criteria: Patient unable or unwilling to provide informed consent Severe allergy to sulfa drugs Known allergy to tamsulosin or another alpha antagonist medication History of urinary retention Planned bladder catheterization greater than 24 hours after surgery Current use of alpha antagonist medication for hypertension End stage renal or liver disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo oral capsule<br>* Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.<br>|
| Experimental: Tamsulosin<br> | Drug: Tamsulosin<br>* Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Urinary Retention | Failed voiding trial upon removal of catheter | Within 72 hours of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score | Total and subscale scores reported. Total score range 0-35, with 0 being less symptomatic and 35 being more symptomatic. Total score is sum of individual questions. Seven subgroups address incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia. Each subgroup is scored 0-5 with 5 being most symptomatic. The last question is independent, rates quality of life from 0 (best) to 6 (worst) | Within 1 week of surgery | 
| Postoperative Urinary Tract Infection | Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection. | Within 6 weeks after surgery | 
| Sent Home With Catheterization | Urinary retention that required homegoing catheterization | within 6 weeks of surgery |