Self-removal of urinary catheters after urogynecology surgery
Urinary Catheter Self-Discontinuation After Urogynecology Surgery
This study is testing if women can safely remove their own urinary catheters at home after surgery for pelvic issues, instead of having them taken out in a doctor's office.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Texas at Austin Academic / other |
| Locations | 4 sites (Austin, Texas and 3 other locations) |
| Trial ID | NCT05860634 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the safety of self-removal of transurethral urinary catheters by patients at home versus standard removal in the office after urogynecologic surgery. Participants will be randomly assigned to one of two groups: those who will remove their catheters at home and those who will have them removed in a clinical setting. The study focuses on women experiencing post-operative urinary retention following surgeries for pelvic organ prolapse or stress urinary incontinence. The primary outcome will assess the rates of persistent urinary retention one day after surgery.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who are undergoing specific urogynecologic surgeries and are diagnosed with post-operative urinary retention.
Not a fit: Patients with pre-existing voiding dysfunction or those requiring prolonged catheterization will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could empower patients to manage their recovery more independently and potentially reduce the need for follow-up office visits.
How similar studies have performed: While similar approaches have been explored, this specific method of self-discontinuation post-surgery is relatively novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Austin, Texas and 3 other locations
- University of Texas of Austin - Dell Seton Medical Center — Austin, Texas, United States (Recruiting)
- Seton Medical Center Austin — Austin, Texas, United States (Recruiting)
- Ascension Seton Hays Hospital — Kyle, Texas, United States (Recruiting)
- Seton Medical Center Williamson — Round Rock, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Mary M Rieger, MD — University of Texas at Austin
- Study coordinator: Mary M Rieger, MD
- Email: mary.rieger@austin.utexas.edu
- Phone: 512-324-8670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.