Recruiting

Observational Study

Sponsor:

University of Texas at Austin

Code:

NCT05860634

Conditions

Urinary Retention

Pelvic Organ Prolapse

Stress Urinary Incontinence

Catheter Related Complication

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Catheter self-discontinuation

Study Details

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

Study ID

NCT05860634

Start date

Aug 1, 2023

Status verified date

Jan, 2024

Completion date

Nov 1, 2025

Anticipated

Primary completion date

Oct 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Catheter self-discontinuation

Self-discontinuation of a transurethral catheter

Primary outcome measure

  • Number of Participants With Postoperative Urinary Retention [ Time Frame: Post-operative day 1 ]

Central Contacts and Locations

Central contacts

Locations

University of Texas of Austin - Dell Seton Medical Center

Recruiting

Austin, Texas, United States, 78701

Contacts

Seton Medical Center Austin

Recruiting

Austin, Texas, United States, 78705

Contacts

Ascension Seton Hays Hospital

Recruiting

Kyle, Texas, United States, 78640

Contacts

Seton Medical Center Williamson

Recruiting

Round Rock, Texas, United States, 78665

Contacts

More Information

Sponsor

University of Texas at Austin

Last update posted

Dec 11, 2024

Last verified

Jan, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2024-12-11.