Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

Last updated: October 8, 2021
Sponsor: University Hospitals Cleveland Medical Center
Overall Status: Completed

Phase

2/3

Condition

Urinary Incontinence

Genitourinary Prolapse

Enuresis

Treatment

N/A

Clinical Study ID

NCT03524339
Tamsulosin for POUR
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must be 18 years or older as well as willing and able to provide informedconsent
  • Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinaryincontinence
  • Standard postoperative plan must include admission to the hospital with foleycatheterization overnight the night after surgery, and planned removal of foleycatheter and active voiding trial on postoperative day 1.

Exclusion

Exclusion Criteria:

  • Patient unable or unwilling to provide informed consent
  • Severe allergy to sulfa drugs
  • Known allergy to tamsulosin or another alpha antagonist medication
  • History of urinary retention
  • Planned bladder catheterization greater than 24 hours after surgery
  • Current use of alpha antagonist medication for hypertension
  • End stage renal or liver disease

Study Design

Total Participants: 132
Study Start date:
August 01, 2018
Estimated Completion Date:
June 09, 2020

Connect with a study center

  • University Hospitals

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

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