SUPS: Scandinavian Urethroplasty Study

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02321670

Collaborator

Sahlgrenska University Hospital, Sweden (Other), Region Örebro County (Other), Helsinki University Central Hospital (Other)

151

Enrollment

Locations

Arms

65.5

Actual Duration (Months)

37.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urethral Stricture	Procedure: End-to-end Procedure: Graft	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

151 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Jan 31, 2021

Actual Study Completion Date :

Feb 15, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Occurrence of failure within the follow up period [One year]
Occurrence of complications [From operation to one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Helsinki University Hospital	Helsinki	Finland	00029
2	Oslo University Hospital, Dept of Urology	Oslo	Norway	0424
3	Sahlgrenska University Hospital, Dept of Urology	Gothenburg	Sweden	41345
4	Örebro University Hospital, Dept of Urology	Örebro	Sweden	70185

Sponsors and Collaborators

Oslo University Hospital
Sahlgrenska University Hospital, Sweden
Region Örebro County
Helsinki University Central Hospital

Investigators

Principal Investigator: Alexander Schultz, MD, Consultant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ole Jacob Nilsen, Consultant, Head of section, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT02321670

Other Study ID Numbers:

OUS-URO-SUPS

First Posted:

Dec 22, 2014

Last Update Posted:

Nov 3, 2021

Last Verified:

Oct 1, 2021

Keywords provided by Ole Jacob Nilsen, Consultant, Head of section, Oslo University Hospital

operative technique

Additional relevant MeSH terms:

Urethral Stricture

Study Results

No Results Posted as of Nov 3, 2021