NCT04551417

Brief Summary

For bulbar urethral strictures, it remains unclear whether ventral onlay graft urethroplasty is non-inferior to dorsal onlay graft urethroplasty in terms of patency rates.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 4, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

5.8 years

First QC Date

June 29, 2020

Last Update Submit

January 30, 2024

Conditions

Urethra Stenosis

Outcome Measures

Primary Outcomes (1)

  • Failure-free survival after 24 months

    Failure is defined as the inability to pass a flexible 16 Fr cystoscope through the reconstructed area without damaging the urethral mucosa.

    24 months

Secondary Outcomes (10)

  • Change in postoperative erectile function

    Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.

  • Change in ejaculatory function

    Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.

  • Change in LUTS

    Baseline question, followed by question at 3, 12 and 24 months of follow-up.

  • Change in LUTS

    Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.

  • Change in urinary continence

    Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.

  • +5 more secondary outcomes

Study Arms (2)

Dorsal onlay graft urethroplasty

ACTIVE COMPARATOR
Procedure: Free graft urethroplasty

Ventral onlay graft urethroplasty

EXPERIMENTAL
Procedure: Free graft urethroplasty

Interventions

Free graft urethroplastyPROCEDURE

Free graft urethroplasty will be performed either with ventral or dorsal onlay of the graft.

Dorsal onlay graft urethroplastyVentral onlay graft urethroplasty

Eligibility Criteria

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

You may qualify if:

  • Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations (Appendix B).
  • Age ≥ 18 years.
  • Male patient.
  • Fit for operation, based on the surgeon's expert opinion.
  • Isolated bulbar urethral stricture confirmed by imaging.
  • Preputium, penile shaft skin, buccal mucosa and lingual mucosa are allowed as free graft material in the executed dorsal onlay or ventral onlay FGU.
  • Patient is able and willing to attend the follow-up consultations.

You may not qualify if:

  • Absence of signed written informed consent (Appendix B).
  • Age \< 18 years.
  • Female patients.
  • Transgender patients.
  • Patients unfit for operation.
  • Concomitant urethral strictures at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck).
  • A unique urethral stricture at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck).
  • Prior bulbar urethroplasty.
  • Lichen Sclerosus related strictures.
  • Strictures after failed hypospadias repair.
  • Patients with neurogenic bladder.
  • History of pelvic radiation therapy.
  • Utilization of free graft material other than preputium, penile shaft skin, buccal mucosa or lingual mucosa.
  • 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.
  • Patient declares that it will be impossible for him to attend the follow-up consultations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nicolaas Lumen

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

  • Wesley Verla

    University Hospital, Ghent

    STUDY DIRECTOR

Central Study Contacts

Nicolaas Lumen

CONTACT

+32 9 332 22 76nicolaas.lumen@uzgent.be

Wesley Verla

CONTACT

+32 9 332 22 76nicolaas.lumen@uzgent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

September 16, 2020

Study Start

March 4, 2020

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)