Urinary Catheter Self-Discontinuation After Urogynecology Surgery

NCT05860634 | Unknown DMC

• 1 other identifier: STUDY00004321
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Urinary Retention; Pelvic Organ Prolapse; Stress Urinary Incontinence; Catheter Related Complication

Keywords

Post-operative urinary retention; Pelvic organ prolapse; Stress urinary incontinence; Cather self-discontinuation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative Urinary Retention

  Non-inferiority comparison of the rates of persistent POUR on POD1 between catheter self-discontinuation and standard office catheter. Persistent POUR is defined as PVR greater than 100 mL by bladder scan on POD1.

  Post-operative day 1

Secondary Outcomes (5)

• Rates of postoperative urinary tract infection (UTI)

  within 6 weeks of surgery

• Incidence of recurrent POUR

  within 6 weeks of surgery

• Number of postoperative patient encounters

  within 6 weeks of surgery

• Patient satisfaction assessment via the Acceptability of Intervention Measure (AIM) Questionnaire

  Post-operative day 1

• Patient satisfaction assessment via the the Surgical Satisfaction Questionnaire - 8 (SSQ-8).

  Post-operative day 1

Study Arms (2)

Catheter office-discontinuation group

NO INTERVENTION

The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 1. At this visit, the patients will undergo a backfill voiding trial.

Catheter self-discontinuation group

EXPERIMENTAL

The patients randomized to the catheter self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 1.

Procedure: Catheter self-discontinuation

Interventions

Catheter self-discontinuation PROCEDURE

Self-discontinuation of a transurethral catheter

Catheter self-discontinuation group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are at least 18 years of age
• Are fluent and able to read in English or Spanish
• 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
• Have transurethral catheter in place at the conclusion of surgery as part of standard care
• Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL or more
• Are discharged home on the same day of surgery (POD 0)

You may not qualify if:

• Have preoperative voiding dysfunction requiring self-catheterization or indwelling transurethral catheter
• Have physical or mental impairment that would impact their ability to remove their catheter themselves.
• Undergo urethral bulking injections as part of surgery
• 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)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (4)

University of Texas of Austin - Dell Seton Medical Center

Austin, Texas, 78701, United States

RECRUITING

Seton Medical Center Austin

Austin, Texas, 78705, United States

RECRUITING

Ascension Seton Hays Hospital

Kyle, Texas, 78640, United States

RECRUITING

Seton Medical Center Williamson

Round Rock, Texas, 78665, United States

RECRUITING

MeSH Terms

Conditions

Urinary Retention; Pelvic Organ Prolapse; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Mary M Rieger, MD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Collin M McKenzie, MD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary M Rieger, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 16, 2023
• Study Start: August 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)