Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders

Study Overview
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Brief Summary
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Our hypothesis is that patients receiving preoperative Tamsulosin will have decrease rates of postoperative urinary retention (POUR) after surgery in females for pelvic floor disorders.

Detailed Description
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This study is a prospective randomized control trial. Patients undergoing pelvic surgery will randomized into two groups. The study group will receive one oral dose of .4mg of Tamsulosin preoperatively.The control group will receive one placebo pill preoperatively. Success or failure of initial voiding trial in postoperative period will be measured. Patients who fail the voiding trial will be discharged home with Foley catheter as is standard protocol at our institution.

Official Title
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Preoperative Tamsulosin to Prevent Postoperative Urinary Retention in Females After Surgery For Pelvic Floor Disorders

Conditions
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Urinary Retention

Intervention / Treatment
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* Drug: Tamsulosin 0.4Mg Capsule
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i. Patient undergoing surgery for prolapse with or without mid-urethral sling procedure. ii. Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings Exclusion Criteria: i. Diagnosis of urinary retention preoperatively (post void residual >150ml) ii. Malignancy iii. History of neurological disease iv. History of spinal cord injuries v. Allergy to Tamsulosin vi. Perioperative complications requiring prolonged postoperative bladder drainage vii. Incontinence procedures other than mid-urethral slings
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative Tamsulosin<br>The study group will receive one oral dose .4mg of Tamsulosin prior to surgery. | Drug: Tamsulosin 0.4Mg Capsule<br>* Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased<br>|
| Placebo Comparator: Preoperative Placebo<br>The control group will receive one oral dose of placebo pill prior to surgery. | Drug: Placebo oral tablet<br>* Placebo pill given preoperatively<br>* Other names: Preoperative Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tamsulosin Effect | Assess the effect of Tamsulosin in preventing POUR, defined by failure of initial voiding trial postoperatively. | Up to 4 hours after surgery while patient is in post-anesthesia care unit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Narcotic Use | Amount of postoperative narcotic use will be tracked to assess if increased narcotic use has an effect on postoperative voiding trial (The amount of narctoic use will be measured in milligrams) | Up to 4 hours after surgery while patient is in post-anesthesia care unit. | 
| Effect of Tamsulosin on postoperative blood pressure | A side effect of Tamsulosin in hypotension, therefore, postoperative blood pressure will be evaluated to see if Tamsulosin had a significant impact on blood pressure | Up to 4 hours after surgery while patient is in post-anesthesia care unit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female Pelvic Floor Disorders, Postoperative Urinary Retention, Tamsulosin