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

Last updated: February 12, 2025
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Overall Status: Active - Recruiting

Phase

2

Condition

Urinary Incontinence

Genitourinary Prolapse

Enuresis

Treatment

Tamsulosin

Placebo

Clinical Study ID

NCT04597372
IRB00264995
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older

  • willing and able to provide informed consent

  • postoperative urinary retention as defined by a failed RGVT prior to hospitaldischarge

  • Ability to speak and read English

  • Tolerate pill ingestion

Exclusion

Exclusion Criteria:

  • allergy/intolerance to Tamsulosin or sulfa drugs

  • preoperative history of urinary retention as defined by preoperative post voidresidual 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

Study Design

Total Participants: 154
Treatment Group(s): 2
Primary Treatment: Tamsulosin
Phase: 2
Study Start date:
November 03, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.