Optimal Duration of Foley Catheter After Bulbar Urethroplasty
Part of paid clinical trials in Burlington, Massachusetts.
- Sponsor
- Jane Kurtzman
- Study ID
- NCT07220980
- Status
- Enrolling By Invitation
Conditions
- Urethral Stricture, Bulbar
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Early catheter removal — DEVICERemoval after 7-10 days
- Later catheter removal — DEVICERemoval after 18-21 days
Study Details
The goal of this clinical trial is to learn when is the best time to remove a Foley catheter (tube used to drain urine from the bladder) after surgery in adult men who have a specific type of urethral stricture disease (narrowing of the tube that carries urine from the body). The main question it aims to answer is: \- Is there a difference between removing the catheter at 7-10 days versus 18-21 days? Researchers will compare Foley removal at 7-10 days to removal at 18-21 days to see if there is a difference in problems after surgery or if the narrowing returns. Participants will: * Complete a survey before surgery, when the catheter is removed, and within 12 months after surgery * Complete follow-up visits after surgery based on your specific medical needs and standard of care
Key Dates
- Start date
- Aug 28, 2024
- Status verified
- Dec 2025
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 320 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Early Removal
- Experimental: Later Removal
Primary Outcome Measure
Number of Participants who Experience a Stricture Recurrence [ Time Frame: 1 year ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | - |
| Western New York Urology Associates | Buffalo | New York | 14203 | - |
| Ohio State University | Columbus | Ohio | 43212 | - |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | - |