Scandinavian Urethroplasty Study

NCT ID: NCT02321670

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2021-02-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Urethral Stricture

Keywords

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operative technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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End-to-end

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

Group Type ACTIVE_COMPARATOR

End-to-end

Intervention Type PROCEDURE

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

Graft

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

Group Type ACTIVE_COMPARATOR

Graft

Intervention Type PROCEDURE

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

Interventions

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End-to-end

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

Intervention Type PROCEDURE

Graft

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Region Örebro County

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ole Jacob Nilsen

Consultant, Head of section

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Schultz, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant

Locations

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Helsinki University Hospital

Helsinki, , Finland

Site Status

Oslo University Hospital, Dept of Urology

Oslo, , Norway

Site Status

Sahlgrenska University Hospital, Dept of Urology

Gothenburg, , Sweden

Site Status

Örebro University Hospital, Dept of Urology

Örebro, , Sweden

Site Status

Countries

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Finland Norway Sweden

Other Identifiers

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OUS-URO-SUPS

Identifier Type: -

Identifier Source: org_study_id