Scandinavian Urethroplasty Study (SUPS)

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.

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

Study Overview

• Status: Completed
• Conditions: Urethral Stricture
• Intervention / Treatment: Procedure: End-to-end; Procedure: Graft

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 Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Hospital
• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital, Dept of Urology
• Sweden
  • Gothenburg, Sweden, 41345
    • Sahlgrenska University Hospital, Dept of Urology
  • Örebro, Sweden, 70185
    • Örebro University Hospital, Dept of Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	Time Frame
Occurrence of failure within the follow up period	One year
Occurrence of complications	From operation to one year

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Helsinki University Central Hospital; Sahlgrenska University Hospital, Sweden; Region Örebro County
• Investigators: Principal Investigator: Alexander Schultz, MD, Consultant

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: operative technique
• Additional Relevant MeSH Terms: Urologic Diseases; Urethral Diseases; Urethral Obstruction; Urethral Stricture
• Other Study ID Numbers: OUS-URO-SUPS