Scandinavian Urethroplasty Study

Study Overview
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Brief Summary
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A multicentre, prospective, randomized study comparing bulbar urethroplasty with excision and primary anastomosis or with an onlay grafting procedure using buccal mucosa.

Detailed Description
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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.

Official Title
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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.

Conditions
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Urethral Stricture

Intervention / Treatment
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* Procedure: End-to-end
* Procedure: Graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: End-to-end<br>Excision of the stricture and end-to-end anastomosis of the urethra. | Procedure: End-to-end<br>* Excision of the stricture and end-to-end anastomosis of the urethra.<br>|
| Active Comparator: Graft<br>Incision of the stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided. | Procedure: Graft<br>* Incision of stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of erectile dysfunction after surgery | Measured by changes in IIEF-5 | up to one year | 
| Penile complications | Measured by questionnaire made for this study | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of failure within the follow up period |  | One year | 
| Occurrence of complications |  | From operation to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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operative technique