Early removal of urinary catheters after urogynecologic surgery
Early Patient Removal of Urinary Catheters After Urogynecologic Surgery
This study is testing if women can safely remove their urinary catheters at home the day after surgery instead of waiting a few days, to see if it affects their recovery and comfort.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Raleigh, North Carolina) |
| Trial ID | NCT06344884 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of allowing patients to remove their urinary catheters at home on the first postoperative day (POD1) compared to the standard removal on postoperative days three or four (POD3-4). It is a randomized, controlled, non-inferiority trial focusing on the risk of urinary retention, healthcare resource utilization, patient experience, and incidence of postoperative urinary tract infections (UTIs). Women undergoing prolapse or anti-incontinence surgery who fail their voiding trials will be included in the study. Participants will be instructed on how to remove their catheters at home after surgery.
Who should consider this trial
Good fit: Ideal candidates are women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge.
Not a fit: Patients who are non-English speaking, pregnant, or have specific pre-existing conditions related to urinary retention may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced hospital stays and improved patient comfort by allowing earlier catheter removal.
How similar studies have performed: Previous studies have shown that early catheter removal at home is non-inferior to standard removal, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge. Exclusion Criteria: * Non-English speaking (due to limited resources to consent non-English speaking patients) * Pregnant * Postvoid residual (PVR) \>150 mL or dependent upon catheterization to void pre-operatively * Urethral bulking injection surgery * Intra-operative complication requiring prolonged catheterization
Where this trial is running
Raleigh, North Carolina
- UNC Health Rex — Raleigh, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Lauren Tholemeier, MD — University of North Carollina at Chapel Hill
- Study coordinator: Lauren Tholemeier, MD
- Email: lthol@email.unc.edu
- Phone: 984-974-0496
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.