Back to resultsScandinavian Urethroplasty Study (SUPS)
Primary Purpose
Urethral Stricture
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
End-to-end
Graft
Sponsored by
About this trial
This is an interventional treatment trial for Urethral Stricture focused on measuring operative technique
Eligibility Criteria
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
Sites / Locations
- Helsinki University Hospital
- Oslo University Hospital, Dept of Urology
- Sahlgrenska University Hospital, Dept of Urology
- Örebro University Hospital, Dept of Urology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
End-to-end
Graft
Arm Description
Excision of the stricture and end-to-end anastomosis of the urethra.
Incision of the stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided.
Outcomes
Primary Outcome Measures
Degree of erectile dysfunction after surgery
Measured by changes in IIEF-5
Penile complications
Measured by questionnaire made for this study
Secondary Outcome Measures
Occurrence of failure within the follow up period
Occurrence of complications
Full Information
NCT ID
NCT02321670
First Posted
December 17, 2014
Last Updated
October 26, 2021
Sponsor
Oslo University Hospital
Collaborators
Sahlgrenska University Hospital, Sweden, Region Örebro County, Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02321670
Brief Title
Scandinavian Urethroplasty Study
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Sahlgrenska University Hospital, Sweden, Region Örebro County, Helsinki University Central Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture
Keywords
operative technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
End-to-end
Arm Type
Active Comparator
Arm Description
Excision of the stricture and end-to-end anastomosis of the urethra.
Arm Title
Graft
Arm Type
Active Comparator
Arm Description
Incision of the stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided.
Intervention Type
Procedure
Intervention Name(s)
End-to-end
Intervention Description
Excision of the stricture and end-to-end anastomosis of the urethra.
Intervention Type
Procedure
Intervention Name(s)
Graft
Intervention Description
Incision of stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided
Primary Outcome Measure Information:
Title
Degree of erectile dysfunction after surgery
Description
Measured by changes in IIEF-5
Time Frame
up to one year
Title
Penile complications
Description
Measured by questionnaire made for this study
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
Occurrence of failure within the follow up period
Time Frame
One year
Title
Occurrence of complications
Time Frame
From operation to one year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Schultz, MD
Organizational Affiliation
Consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Oslo University Hospital, Dept of Urology
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Sahlgrenska University Hospital, Dept of Urology
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Örebro University Hospital, Dept of Urology
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
12. IPD Sharing Statement
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Scandinavian Urethroplasty Study
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