The purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months, following dilation or internal urethrotomy (cutting open), results in a higher rate of urethral patency during the first year of follow-up when compared to the control group that does not receive a stent.
Patients with bulbar urethral stricture are 2:1 randomised for either urethral dilation or internal urethrotomy with (treatment group) or without (control group) subsequent stenting. All patients are followed for up to one year at 4-6 weeks, 3, 6, 9 and 12 months with visual assessment (urethroscopy) of urethral patency at the treated segment of the urethra. The stent is removed at one year. In case of premature stent removal the patient is also followed for up to one year unless further intervention is decided. Control patients are offered the stent treatment option if the stricture recurs within the observation period but this group is separately analysed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Urethral Stenting
Jack McAninch
San Francisco, California, United States
Mississippi Urology
Jackson, Mississippi, United States
Cleveland Clinic
Cleveland, Ohio, United States
Bryn Mawr Urology
Bryn Mawr, Pennsylvania, United States
Stent/control effectiveness - urethral patency
Time frame: 1 year
Peak urinary flow rate
Time frame: Immediate
Re-intervention
Time frame: Short term
Standard survey instruments (QOL, IPSS etc.)
Time frame: 15 mos
Stent placement success
Time frame: immediate
Stent removal success
Time frame: immediate
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University Urological Associates
Providence, Rhode Island, United States
Devine-Tidewater Urology
Norfolk, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States