Optimal Duration of Foley Catheter After Bulbar Urethroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early catheter removal, Later catheter removal.
- Who it may be relevant to
- Registry conditions: Urethral Stricture, Bulbar. Basic parameters: 18 years — 70 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimal Duration of Indwelling Urethral Foley Catheter Following Bulbar Urethroplasty: A Pragmatic Multi-Institutional Randomized Controlled Non-Inferiority Trial
Overview
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
Interventions
- Device Early catheter removal
Removal after 7-10 days - Device Later catheter removal
Removal after 18-21 days
Primary outcome measures
- Number of Participants who Experience a Stricture Recurrence [Time frame: 1 year]
- Number of Participants who Experience a Perioperative Complication [Time frame: From Foley insertion to Foley removal]
Secondary outcome measures (1)
- Rate of Retrograde Urethrograms Performed on Day of Foley Removal [Time frame: Foley Removal]
Eligibility criteria
Inclusion criteria
- Cis-male patients
- Age 18-70, inclusive
- Bulbar urethral stricture undergoing a urethroplasty
- Urethral stricture defect less than or equal to 7cm in length
- First time urethroplasty
- Negative urine analysis or urine culture
Exclusion criteria
- History of pelvic radiation
- Diabetes with Hba1c greater than 8%
- Penile urethral stricture
- Posterior urethroplasty
- Bulbar stricture greater than 7cm
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 4 centers
- Lahey Hospital & Medical Center — Burlington
- Western New York Urology Associates — Buffalo
- Ohio State University — Columbus
- University of Utah Hospital — Salt Lake City
Identifiers
NCT: NCT07220980 · 171398