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

Urinary Retention Postoperative Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04597372
Study type Interventional
Source Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Contact Lindsay Turner
Phone (412)-330-6151
Email lindsay.turner@AHN.ORG
Status Recruiting
Phase Phase 2
Start date November 3, 2021
Completion date December 2025
View Details
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