Urinary Catheter Self-Discontinuation After Urogynecology Surgery

Last updated: December 5, 2024
Sponsor: University of Texas at Austin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Incontinence

Genitourinary Prolapse

Enuresis

Treatment

Catheter self-discontinuation

Clinical Study ID

NCT05860634
STUDY00004321
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery.

Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Are at least 18 years of age

  2. Are fluent and able to read in English or Spanish

  3. Undergo POP and/or SUI surgery (uterosacral ligament suspension, sacrospinousligament fixation, sacral colpopexy, anterior colporrhaphy, posterior colporrhaphy,and/or mid-urethral sling) that occurs on Monday - Thursday

  4. Have transurethral catheter in place at the conclusion of surgery as part ofstandard care

  5. Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL ormore

  6. Are discharged home on the same day of surgery (POD 0)

Exclusion

Exclusion Criteria:

  1. Have preoperative voiding dysfunction requiring self-catheterization or indwellingtransurethral catheter

  2. Have physical or mental impairment that would impact their ability to remove theircatheter themselves.

  3. Undergo urethral bulking injections as part of surgery

  4. Have undergone a planned or unplanned urinary tract procedure requiring prolongedcatheterization as standard of care (e.g. cystotomy repair, ureteral reimplantation,vesicovaginal fistula repair, urethral diverticulum repair)

Study Design

Total Participants: 118
Treatment Group(s): 1
Primary Treatment: Catheter self-discontinuation
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
November 01, 2025

Study Description

This is a prospective, randomized, two-parallel arm, non-inferiority trial to evaluate two methods of catheter discontinuation in women with post-operative urinary retention (POUR) after surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI). This study will evaluate whether self-discontinuation of transurethral catheter by patients is non-inferior to standard office discontinuation based on rates of persistent POUR on post-operative day (POD) 1.

Connect with a study center

  • Seton Medical Center Austin

    Austin, Texas 78705
    United States

    Active - Recruiting

  • University of Texas of Austin - Dell Seton Medical Center

    Austin, Texas 78701
    United States

    Active - Recruiting

  • Ascension Seton Hays Hospital

    Kyle, Texas 78640
    United States

    Active - Recruiting

  • Seton Medical Center Williamson

    Round Rock, Texas 78665
    United States

    Active - Recruiting

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