Clinical trial NCT05860634: Urinary Catheter Self-Discontinuation After Urogynecology Surgery
Official title: Urinary Catheter Self-Discontinuation After Urogynecology Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: 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)

Primary outcomes:
measure: Number of Participants With Postoperative Urinary Retention
timeFrame: Post-operative day 1
Secondary outcomes:
measure: Rates of postoperative urinary tract infection (UTI)
timeFrame: within 6 weeks of surgery
measure: Incidence of recurrent POUR
timeFrame: within 6 weeks of surgery
measure: Number of postoperative patient encounters
timeFrame: within 6 weeks of surgery
measure: Patient satisfaction assessment via the Acceptability of Intervention Measure (AIM) Questionnaire
timeFrame: Post-operative day 1
measure: Patient satisfaction assessment via the the Surgical Satisfaction Questionnaire - 8 (SSQ-8).
timeFrame: Post-operative day 1
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas of Austin - Dell Seton Medical Center
state: Texas
city: Austin
country: United States
facility: Seton Medical Center Austin
state: Texas
city: Kyle
country: United States
facility: Ascension Seton Hays Hospital
state: Texas
city: Round Rock
country: United States
facility: Seton Medical Center Williamson
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Mary M Rieger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Austin
name: Collin M McKenzie, MD
role: PRINCIPAL_INVESTIGATOR
References: