Optimal Duration of Foley Catheter After Bulbar Urethroplasty

Jane Kurtzman

Status: Invitation-only

Conditions: Urethral Stricture, Bulbar

Treatments: Device: Early catheter removal; Device: Later catheter removal

Study type: Interventional

Funder types: Other

Identifiers

NCT07220980

171398

Details and patient eligibility

About

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

Enrollment: 320 estimated patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Early Removal

Experimental group

Treatment:

Device: Early catheter removal

Later Removal

Experimental group

Treatment:

Device: Later catheter removal