Loading clinical trials...

Urinary Catheter Self-Discontinuation After Urogynecology Surgery | Clinical Trials | Clareo Health

UNKNOWNNA

Urinary Catheter Self-Discontinuation After Urogynecology Surgery

NCT05860634•University of Texas at Austin

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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, sacrospinous ligament 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 of standard care
•5. Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL or more
•6. Are discharged home on the same day of surgery (POD 0)

Exclusion Criteria

•1. Have preoperative voiding dysfunction requiring self-catheterization or indwelling transurethral catheter
•2. Have physical or mental impairment that would impact their ability to remove their catheter themselves.
•3. Undergo urethral bulking injections as part of surgery
•4. Have undergone a planned or unplanned urinary tract procedure requiring prolonged catheterization as standard of care (e.g. cystotomy repair, ureteral reimplantation, vesicovaginal fistula repair, urethral diverticulum repair)

Locations (4)

University of Texas of Austin - Dell Seton Medical Center

Austin, Texas, United States

Seton Medical Center Austin

Austin, Texas, United States

Ascension Seton Hays Hospital

Kyle, Texas, United States

Seton Medical Center Williamson

Round Rock, Texas, United States

Key Dates

Start Date

August 1, 2023

Primary Completion Date

October 1, 2025

Completion Date

November 1, 2025

Last Updated

December 11, 2024

Enrollment

118

ESTIMATED participants

Conditions

Urinary RetentionPelvic Organ ProlapseStress Urinary IncontinenceCatheter Related Complication

Interventions

Catheter self-discontinuation

PROCEDURE

Contacts

Mary M Rieger, MD

CONTACT

512-324-8670 mary.rieger@austin.utexas.edu

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

NCT04597372

Urinary Retention Postoperative

View study

RECRUITINGNA

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

NCT05602246

Pelvic Organ ProlapseCystocele+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Urinary Catheter Self-Discontinuation After Urogynecology Surgery

Inclusion Criteria

Exclusion Criteria

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

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Uroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

Post-operative Urinary Retention (POUR) Following Thoracic Surgery

Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)

Self-discontinuation of Urinary Catheters in a Rural Population