NCT02321670

Scandinavian Urethroplasty Study

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urethral Stricture

Interventions

Type	Name	Description
PROCEDURE	End-to-end	Excision of the stricture and end-to-end anastomosis of the urethra.
PROCEDURE	Graft	Incision of stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided

Timeline

• Start date: 2015-09-01
• Primary completion: 2021-01-31
• Completion: 2021-02-15
• First posted: 2014-12-22
• Last updated: 2021-11-03

Locations

4 sites across 3 countries: Finland, Norway, Sweden