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Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage

NCT04965025 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-09-19

No results posted yet for this study

Summary

The principal aim of this pilot study is to directly compare both approaches and analyze the failure rate after one year of follow-up. These data will serve as the basis to design a larger phase II or III trial in the future with failure rate as the primary end-point. Other study objectives are thoroughly described underneath.

Conditions

  • Urethra Stenosis
  • Urethral Stricture

Interventions

PROCEDURE

Multi-stage urethroplasty with graft inlay in first stage

Herein, the graft will be used in the first stage and the second stage will solely consist of retubularizing the urethra.

PROCEDURE

Multi-stage urethroplasty with graft inlay in second stage

Herein, the graft will be used in the second stage and the first stage will solely consist of opening the urethra longitudinally.

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Nicolaas Lumen · University Hospital, Ghent

  • Wesley Verla · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-11
Primary Completion
2025-03-01
Completion
2025-03-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04965025 on ClinicalTrials.gov