Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery

Study Overview
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Brief Summary
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The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.

Detailed Description
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The primary objective is to determine the impact of Tamsulosin on duration of urinary retention following pelvic reconstructive surgery in women. Duration of catheterization via indwelling foley or clean intermittent self-catheterization (CISC), measured in days, will be compared between women receiving Tamsulosin versus placebo after diagnosis of postoperative urinary retention via standardized voiding trial. It is hypothesized that women receiving Tamsulosin will have a shorter duration of urinary retention, fewer urinary tract infections, and improved quality of life as compared with placebo. The Euroqol-5D (EQ-5D) will be used to compare physical, emotional, functional, and social/family well-being between women receiving Tamsulosin and placebo. Upon diagnosis of POUR, women will be offered participation in the study. Once consent is obtained, women will be randomized to tamsulosin 0.4 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course, whichever occurs first.

Official Title
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The Impact of Tamsulosin on Duration of Post-Operative Urinary Retention in Women Undergoing Pelvic Reconstructive Surgery- A Double Blind, Randomized, Placebo-Controlled Study

Conditions
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Urinary Retention Postoperative

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older willing and able to provide informed consent postoperative urinary retention as defined by a failed RGVT prior to hospital discharge Ability to speak and read English Tolerate pill ingestion Exclusion Criteria: allergy/intolerance to Tamsulosin or sulfa drugs preoperative history of urinary retention as defined by preoperative post void residual of >150mL current use of alpha antagonist medication for hypertension severe dementia end stage renal or liver disease history of severe heart failure or major cardiovascular event in the last 6 months

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin<br>10 capsules will be distributed to subjects to be taken daily. Each capsule contains 0.4mg of Tamsulosin. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy. | Drug: Tamsulosin<br>* Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.<br>|
| Placebo Comparator: Placebo<br>10 capsules will be distributed to subjects to be taken daily. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy. | Drug: Placebo<br>* Placebo will be prepared by the IDS pharmacist (or contracted pharmacy) and encapsulated in identical appearing wraps. Subjects will be provided with 10 capsules to be taken daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the impact of Tamsulosin on duration of urinary retention | The primary outcome is duration of postoperative urinary retention measured in days following failed retrograde voiding trial. | Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the impact of Tamsulosin on rates of urinary tract infection (UTI). | The electronic medical record (EMR) will be reviewed to determine if subjects were treated for a urinary tract infection (UTI). UTIs will be diagnosed by a urine culture confirming bacteriuria of at least 10 ^5 CFU/mL. UTIs treated presumptively and without culture will also be included as positive cultures. | Date of failed the retrograde voiding trial and up to 6 weeks. | 
| To quantify the effect of Tamsulosin on patient quality of life. | Patients will be asked to complete the Euroqol-5D (EQ-5D) questionnaire to assess quality of life. The EQ-5D is scored with a 5-digit code of index values which reflect how good or bad a health state is (Level 1 indicates no problem where is Level 5 indicates extreme problems). | Prior to discharge and again at 2 weeks follow up |