Urinary Catheter Self-Discontinuation After Urogynecology Surgery (CATH)

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse; Stress Urinary Incontinence; Urinary Retention; Catheter Related Complication
• Intervention / Treatment: Procedure: Catheter self-discontinuation

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.

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary M Rieger, MD; Phone Number: 512-324-8670; Email: mary.rieger@austin.utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Seton Medical Center Austin
      • Contact: Collin M McKenzie, MD; Phone Number: 512-324-8670; Email: collin.mckenzie@austin.utexas.edu
    • Austin, Texas, United States, 78701
      • Recruiting
      • University of Texas of Austin - Dell Seton Medical Center
      • Contact: Collin M McKenzie, MD; Phone Number: 512-324-8670; Email: collin.mckenzie@austin.utexas.edu
    • Kyle, Texas, United States, 78640
      • Recruiting
      • Ascension Seton Hays Hospital
      • Contact: Collin M McKenzie, MD; Phone Number: 512-324-8670; Email: collin.mckenzie@austin.utexas.edu
    • Round Rock, Texas, United States, 78665
      • Recruiting
      • Seton Medical Center Williamson
      • Contact: Collin M McKenzie, MD; Phone Number: 512-324-8670; Email: collin.mckenzie@austin.utexas.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Catheter office-discontinuation group; 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.
Experimental: Catheter self-discontinuation group; 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; Self-discontinuation of a transurethral catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of postoperative urinary tract infection (UTI)	Rates of postoperative UTI within 6 weeks of surgery - UTI will be defined as treatment with antibiotics for symptoms of UTI.	within 6 weeks of surgery
Incidence of recurrent POUR	Recurrent POUR will be defined as any participant with successful POD1 voiding trial who later requires replacement of catheter due to recurrent POUR within 6 weeks of surgery. Recurrent POUR is defined as PVR greater than 100 mL by bladder scan after passing initial POD1 voiding trial.	within 6 weeks of surgery
Number of postoperative patient encounters	Number of postoperative patient encounters, including any patient call to the office, electronic medical record message to office from patient, office visit, or emergency department visit.	within 6 weeks of surgery
Patient satisfaction assessment via the Acceptability of Intervention Measure (AIM) Questionnaire	Patient satisfaction with catheter removal method as assessed via the Acceptability of Intervention Measure (AIM) Questionnaire. The AIM Questionnaire is a 4-item questionnaire on a 5-point Likert scale. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree Scoring Instructions: Scale is created by averaging responses. Scale values range from 1 to 5. The higher the score is, the higher the degree the patient finds the intervention acceptable.	Post-operative day 1
Patient satisfaction assessment via the the Surgical Satisfaction Questionnaire - 8 (SSQ-8).	Patient satisfaction with catheter removal method as assessed via the Surgical Satisfaction Questionnaire - 8 (SSQ-8). The SSQ-8 is an 8-item questionnaire, with responses recorded on a 5-point Likert scale with responses from 0 "Very Unsatisfied" to 4 "Very Satisfied." Scoring uses the mean average of the 8 scores being multiplied by 25 (the questionnaire is considered incomplete if more than 2 items are not answered), yielding a potential range of scores from 0 to 100. The higher the score is, the greater the degree of surgical satisfaction.	Post-operative day 1

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Mary M Rieger, MD, University of Texas at Austin; Principal Investigator: Collin M McKenzie, MD, University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Stress urinary incontinence; Pelvic organ prolapse; Post-operative urinary retention; Cather self-discontinuation
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Prolapse; Pelvic Organ Prolapse; Urinary Retention
• Other Study ID Numbers: STUDY00004321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No