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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02321670
Other study ID # OUS-URO-SUPS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date February 15, 2021

Study information

Verified date October 2021
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 151
Est. completion date February 15, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
End-to-end
Excision of the stricture and end-to-end anastomosis of the urethra.
Graft
Incision of stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided

Locations

Country Name City State
Finland Helsinki University Hospital Helsinki
Norway Oslo University Hospital, Dept of Urology Oslo
Sweden Sahlgrenska University Hospital, Dept of Urology Gothenburg
Sweden Örebro University Hospital, Dept of Urology Örebro

Sponsors (4)

Lead Sponsor Collaborator
Oslo University Hospital Helsinki University Central Hospital, Region Örebro County, Sahlgrenska University Hospital, Sweden

Countries where clinical trial is conducted

Finland,  Norway,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of erectile dysfunction after surgery Measured by changes in IIEF-5 up to one year
Primary Penile complications Measured by questionnaire made for this study up to one year
Secondary Occurrence of failure within the follow up period One year
Secondary Occurrence of complications From operation to one year
See also
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