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NCT Number: NCT02321670

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.

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Key information

Conditions

Urethral Stricture Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urethral Diseases Urethral Obstruction Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

End-to-end

Procedure

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

Graft

Procedure

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

Primary outcomes

  1. Degree of erectile dysfunction after surgery

    Time frame: up to one year

    Measured by changes in IIEF-5

  2. Penile complications

    Time frame: up to one year

    Measured by questionnaire made for this study

Secondary outcomes

  1. Occurrence of failure within the follow up period

    Time frame: One year

  2. Occurrence of complications

    Time frame: From operation to one year

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Helsinki University Central Hospital
  • Region Örebro County
  • Sahlgrenska University Hospital

Registry information

Official study 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.

Acronym: SUPS

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2014
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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