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

  • STATUS
    Recruiting
  • End date
    May 16, 2023
  • participants needed
    154
  • sponsor
    Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Updated on 16 December 2021
Accepts healthy volunteers

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.

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.

Details
Condition Urinary Retention Postoperative
Treatment Placebo, Tamsulosin
Clinical Study IdentifierNCT04597372
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Last Modified on16 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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