Optimal Duration of Foley Catheter After Bulbar Urethroplasty

Part of paid clinical trials in Burlington, Massachusetts.

Sponsor
Jane Kurtzman
Study ID
NCT07220980
Status
Enrolling By Invitation

Conditions

  • Urethral Stricture, Bulbar

Eligibility Criteria

Sex
MALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Early catheter removal — DEVICE
    Removal after 7-10 days
  • Later catheter removal — DEVICE
    Removal after 18-21 days

Study Details

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

Key Dates

Start date
Aug 28, 2024
Status verified
Dec 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Early Removal
  • Experimental: Later Removal

Primary Outcome Measure

Number of Participants who Experience a Stricture Recurrence [ Time Frame: 1 year ]

Locations (4)

FacilityCityStateZIPSite coordinators
Lahey Hospital & Medical CenterBurlingtonMassachusetts01805-
Western New York Urology AssociatesBuffaloNew York14203-
Ohio State UniversityColumbusOhio43212-
University of Utah HospitalSalt Lake CityUtah84132-

Find similar trials in Burlington, MA