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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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07220980
Enrollment
320
Registered
2025-10-27
Start date
2024-08-28
Completion date
2027-09-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urethral Stricture, Bulbar

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

Interventions

Removal after 7-10 days

DEVICELater catheter removal

Removal after 18-21 days

Sponsors

Jane Kurtzman
Lead SponsorOTHER
University of Minnesota
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of Participants who Experience a Stricture Recurrence1 year
Number of Participants who Experience a Perioperative ComplicationFrom Foley insertion to Foley removal

Secondary

MeasureTime frame
Rate of Retrograde Urethrograms Performed on Day of Foley RemovalFoley Removal

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026