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

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

Recruiting
18 years and older
Female
Phase 2

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Overview

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.

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.

Eligibility

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

Study details
    Urinary Retention Postoperative

NCT04597372

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

29 January 2024

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