Optimal Duration of Foley Catheter After Bulbar Urethroplasty

NCT ID: NCT07220980

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-28

Study Completion Date

2027-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Urethral Stricture, Bulbar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Early Removal

Group Type EXPERIMENTAL

Early catheter removal

Intervention Type DEVICE

Removal after 7-10 days

Later Removal

Group Type EXPERIMENTAL

Later catheter removal

Intervention Type DEVICE

Removal after 18-21 days

Interventions

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Early catheter removal

Removal after 7-10 days

Intervention Type DEVICE

Later catheter removal

Removal after 18-21 days

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role collaborator

Jane Kurtzman

OTHER

Sponsor Role lead

Responsible Party

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Jane Kurtzman

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Utah Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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171398

Identifier Type: -

Identifier Source: org_study_id

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