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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02321670

Acronym

SUPS

Enrollment

151

Registered

2014-12-22

Start date

2015-09-30

Completion date

2021-02-15

Last updated

2021-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urethral Stricture

Keywords

operative technique

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.

Interventions

PROCEDUREEnd-to-end

Excision of the stricture and end-to-end anastomosis of the urethra.

PROCEDUREGraft

Incision of stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Degree of erectile dysfunction after surgery	up to one year	Measured by changes in IIEF-5
Penile complications	up to one year	Measured by questionnaire made for this study

Secondary

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

Countries

Finland, Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026