Scandinavian Urethroplasty Study. A Multicentre, Prospective, Randomized Study Comparing Bulbar Urethroplasty With Excision and Primary Anastomosis or With an Onlay Grafting Procedure Using Buccal Mucosa.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 151
- Locations
- 8
- Primary Endpoint
- Penile complications
Study Overview
Brief Summary
A multicentre, prospective, randomized study comparing bulbar urethroplasty with excision and primary anastomosis or with an onlay grafting procedure using buccal mucosa.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with bulbar urethral stricture, length estimated by urethrography or endoscopy ≤ 2 cm
- •Patient is able and willing to sign informed consent
- •Patient is able and willing to complete all study requirements
Exclusion Criteria
- •Previous open urethroplasty
- •Previous hypospadia surgery
- •Previous surgery for congenital curvature or Mb Peyronie
- •Previous pelvic irradiation therapy
- •Known grave psychiatric disorder
- •Haemophilia or other clotting disorders that cause bleeding diathesis
- •Use of medication to increase erectile function, such as PDE5-inhibitors and intracavernous injections, during the study
- •Any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study
Outcomes
Primary Outcomes
Penile complications
Time Frame: up to one year
Measured by questionnaire made for this study
Degree of erectile dysfunction after surgery
Time Frame: up to one year
Measured by changes in IIEF-5
Secondary Outcomes
- Occurrence of complications(From operation to one year)
- Occurrence of failure within the follow up period(One year)
Investigators
Ole Jacob Nilsen
Consultant, Head of section
Oslo University Hospital