A multicentre, prospective, randomized study comparing bulbar urethroplasty with excision and primary anastomosis or with an onlay grafting procedure using buccal mucosa.
The study is a prospective, randomized study to compare two common techniques of urethroplasty used to treat bulbar urethral strictures. One technique is excision of the stricture and end-to-end anastomosis of the urethra. The other technique is an onlay grafting procedure with buccal mucosa where the corpus spongiosum is not divided. The study is designed to compare complications of sexual and penile function, and is not powered to compare the success rates of the two techniques. The primary endpoint will be degree of erectile dysfunction and penile complications. The secondary endpoint will be restricturing leading to reoperation, and other complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
151
Excision of the stricture and end-to-end anastomosis of the urethra.
Incision of stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided
Helsinki University Hospital
Helsinki, Finland
Oslo University Hospital, Dept of Urology
Oslo, Norway
Sahlgrenska University Hospital, Dept of Urology
Gothenburg, Sweden
Örebro University Hospital, Dept of Urology
Örebro, Sweden
Degree of erectile dysfunction after surgery
Measured by changes in IIEF-5
Time frame: up to one year
Penile complications
Measured by questionnaire made for this study
Time frame: up to one year
Occurrence of failure within the follow up period
Time frame: One year
Occurrence of complications
Time frame: From operation to one year
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