Urinary Catheter Self-Discontinuation After Urogynecology Surgery

Pelvic Organ Prolapse Clinical Trial

— CATH  

Official title:

Urinary Catheter Self-Discontinuation After Urogynecology Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860634
• Other study ID #: STUDY00004321
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: University of Texas at Austin
• Contact: Mary M Rieger, MD
• Phone: 512-324-8670
• Email: mary.rieger[@]austin.utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Catheter Related Complication
• Enuresis
• Pelvic Organ Prolapse
• Prolapse
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Retention

Intervention

Procedure:
• Catheter self-discontinuation
Self-discontinuation of a transurethral catheter

Locations

Country	Name	City	State
United States	Seton Medical Center Austin	Austin	Texas
United States	University of Texas of Austin - Dell Seton Medical Center	Austin	Texas
United States	Ascension Seton Hays Hospital	Kyle	Texas
United States	Seton Medical Center Williamson	Round Rock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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