Scandinavian Urethroplasty Study

Urethral Stricture Clinical Trial

— SUPS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321670
• Other study ID #: OUS-URO-SUPS
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: February 15, 2021

Study information

• Verified date: October 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: February 15, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Urethral Stricture

Intervention

Procedure:
• End-to-end
Excision of the stricture and end-to-end anastomosis of the urethra.
• Graft
Incision of stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Norway	Oslo University Hospital, Dept of Urology	Oslo
Sweden	Sahlgrenska University Hospital, Dept of Urology	Gothenburg
Sweden	Örebro University Hospital, Dept of Urology	Örebro

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Helsinki University Central Hospital, Region Örebro County, Sahlgrenska University Hospital, Sweden

Countries where clinical trial is conducted

Finland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of erectile dysfunction after surgery	Measured by changes in IIEF-5	up to one year
Primary	Penile complications	Measured by questionnaire made for this study	up to one year
Secondary	Occurrence of failure within the follow up period		One year
Secondary	Occurrence of complications		From operation to one year