Optimal Duration of Foley Catheter After Bulbar Urethroplasty
Optimal Duration of Indwelling Urethral Foley Catheter Following Bulbar Urethroplasty: A Pragmatic Multi-Institutional Randomized Controlled Non-Inferiority Trial
1 other identifier
interventional
320
1 country
4
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2024
CompletedFirst Submitted
Initial submission to the registry
October 22, 2025
CompletedFirst Posted
Study publicly available on registry
October 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
February 27, 2026
December 1, 2025
3 years
October 22, 2025
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants who Experience a Stricture Recurrence
1 year
Number of Participants who Experience a Perioperative Complication
From Foley insertion to Foley removal
Secondary Outcomes (1)
Rate of Retrograde Urethrograms Performed on Day of Foley Removal
Foley Removal
Study Arms (2)
Early Removal
EXPERIMENTALLater Removal
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of pelvic radiation
- Diabetes with Hba1c greater than 8%
- Penile urethral stricture
- Posterior urethroplasty
- Bulbar stricture greater than 7cm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotacollaborator
- Jane Kurtzmanlead
Study Sites (4)
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
Western New York Urology Associates
Buffalo, New York, 14203, United States
Ohio State University
Columbus, Ohio, 43212, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 22, 2025
First Posted
October 27, 2025
Study Start
August 28, 2024
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
February 27, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share