Scandinavian Urethroplasty Study

• Register: ClinicalTrials.gov
• Last refreshed on: 8 November 2021
• Main ID: NCT02321670
• Date of registration: 17/12/2014
• Prospective Registration: Yes
• Primary sponsor: Oslo University Hospital
• Public title: Scandinavian Urethroplasty Study SUPS
• Scientific 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.
• Date of first enrolment: September 2015
• Target sample size: 151
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02321670
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Finland, Norway, Sweden

Contacts

• Name: Alexander Schultz, MD
• Affiliation: Consultant

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Urethral Stricture

Intervention(s)

Procedure: End-to-end

Procedure: Graft

Primary Outcome(s)

Degree of erectile dysfunction after surgery [Time Frame: up to one year]

Penile complications [Time Frame: up to one year]

Secondary Outcome(s)

Occurrence of complications [Time Frame: From operation to one year]

Occurrence of failure within the follow up period [Time Frame: One year]

Secondary ID(s)

OUS-URO-SUPS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Helsinki University Central Hospital

Region Örebro County

Sahlgrenska University Hospital, Sweden