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

  • STATUS
    Recruiting
  • End date
    Mar 25, 2024
  • participants needed
    30
  • sponsor
    University Hospital, Ghent
Updated on 25 July 2021

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.

Description

Urethral stricture disease can occur throughout the entire length of the male urethra and has a wide variety of potential etiologies1. The standard treatment for this condition is urethroplasty, an open reconstructive procedure aiming to restore urethral patency1.

Urethroplasty covers a wide variety of surgical techniques and can be performed in a single stage or in multiple stages1. The latter option is generally reserved for patients with a very challenging disease1 (often including very dense fibrosis and poor local tissue conditions) and is most commonly performed for urethral strictures in the penile urethra2.

In case of a multi-stage urethroplasty, the first stage generally involves opening the urethra longitudinally over its diseased segment and suturing the urethral edges to the edges of the skin1. After that, a period of urethral rest of at least 3 months is foreseen after which the second stage procedure is performed by tubularizing the urethral plate around a transurethral catheter and closing the dartos layer and skin over the reconstructed urethra1. When the urethral plate is too narrow or of too poor quality to allow retubularization, the urethral plate is incised on the midline and a graft is sutured into the defect in order to augment the urethra enough to allow for retubularization after all1.

This dorsal inlay procedure can be performed during the first or second stage1. To the best of our knowledge, there are no studies that directly compare the outcomes of both approaches and consequently, there is no clear guidance for surgeons as to whether the graft should be administered during the first or second stage of the procedure. Also, there are absolutely no data available to use in a power analysis for a randomized controlled trial investigating this matter.

Against this background, 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 trial in the future with failure rate as the primary end-point. Other study objectives are thoroughly described underneath.

Details
Condition stricture urethral, Urethral Stricture, Urethral Strictures
Treatment Multi-stage urethroplasty with graft inlay in first stage, Multi-stage urethroplasty with graft inlay in second stage
Clinical Study IdentifierNCT04965025
SponsorUniversity Hospital, Ghent
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations
Age 18 years
Male patient
Fit for operation, upon surgeon's discretion
Isolated penile stricture that requires a multi-stage urethroplasty with dorsal inlay of a graft (upon surgeon's discretion)
Use of oral mucosa as graft material
Patient is able and willing to comply with protocol
Prior urethral surgery (dilation, urethrotomy of urethroplasty) is allowed

Exclusion Criteria

Absence of signed written informed consent
Age < 18 years
Female patients
Transgender patients
Patients unfit for operation
Stricture disease extending beyond the penile urethra or concomitant stricture at a different urethral segment
Use of graft other than oral 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
Unwilling or unable to comply with study protocol
Patients deciding not to undergo the second stage will be excluded post-hoc
When the surgeon intra-operatively decides to carry out a single-stage procedure after all, the patient will also be excluded post-hoc
If the surgeon decides that no graft is needed to retubularize the urethra, the patient will also be excluded post-hoc
If the surgeon decides that a two-stage Bracka repair is needed, where the urethral plate is entirely cut away during the first stage and grafted, the patient will also be excluded post-hoc
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