Clinical trial NCT02321670: Scandinavian Urethroplasty Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urethral Stricture
Keywords: operative technique
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Region Örebro County
name: Helsinki University Central Hospital
First posted: 2014-12-22
Enrollment: 151
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree of erectile dysfunction after surgery
timeFrame: up to one year
measure: Penile complications
timeFrame: up to one year
Secondary outcomes:
measure: Occurrence of failure within the follow up period
timeFrame: One year
measure: Occurrence of complications
timeFrame: From operation to one year
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital, Dept of Urology
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Dept of Urology
city: Örebro
country: Sweden
facility: Örebro University Hospital, Dept of Urology
Study officials:
affiliation: Consultant
name: Alexander Schultz, MD
role: PRINCIPAL_INVESTIGATOR
References: