Scandinavian Urethroplasty Study (SUPS)

University of Oslo (UIO)

Status: Completed

Conditions: Urethral Stricture

Treatments: Procedure: Graft; Procedure: End-to-end

Study type: Interventional

Funder types: Other

Identifiers

NCT02321670

OUS-URO-SUPS

Details and patient eligibility

About

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

Full 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.

Enrollment: 151 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

151 participants in 2 patient groups

End-to-end

Active Comparator group

Description:

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

Treatment:

Procedure: End-to-end

Graft

Active Comparator group

Description:

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

Treatment:

Procedure: Graft