NCT02321670

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

November 3, 2021

Status Verified

October 1, 2021

Enrollment Period

5.4 years

First QC Date

December 17, 2014

Last Update Submit

October 26, 2021

Conditions

Urethral Stricture

Keywords

operative technique

Outcome Measures

Primary Outcomes (2)

  • Degree of erectile dysfunction after surgery

    Measured by changes in IIEF-5

    up to one year

  • Penile complications

    Measured by questionnaire made for this study

    up to one year

Secondary Outcomes (2)

  • Occurrence of failure within the follow up period

    One year

  • Occurrence of complications

    From operation to one year

Study Arms (2)

End-to-end

ACTIVE COMPARATOR

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

Procedure: End-to-end

Graft

ACTIVE COMPARATOR

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

Procedure: Graft

Interventions

End-to-endPROCEDURE

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

End-to-end
GraftPROCEDURE

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

Graft

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Oslo University Hospital, Dept of Urology

Oslo, 0424, Norway

Location

Sahlgrenska University Hospital, Dept of Urology

Gothenburg, 41345, Sweden

Location

Örebro University Hospital, Dept of Urology

Örebro, 70185, Sweden

Location

MeSH Terms

Conditions

Urethral Stricture

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Alexander Schultz, MD

    Consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Head of section

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 22, 2014

Study Start

September 1, 2015

Primary Completion

January 31, 2021

Study Completion

February 15, 2021

Last Updated

November 3, 2021

Record last verified: 2021-10

Locations

FI(1)SE(2)NO(1)