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

NCT ID: NCT04965025

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-11
• Study Completion Date: 2025-03-01

Brief 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.

Detailed 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.

Conditions

Urethra Stenosis; Urethral Stricture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multi-stage urethroplasty with graft inlay in first stage

Group Type: EXPERIMENTAL

Multi-stage urethroplasty with graft inlay in first stage

Intervention Type: PROCEDURE

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

Multi-stage urethroplasty with graft inlay in second stage

Group Type: ACTIVE_COMPARATOR

Multi-stage urethroplasty with graft inlay in second stage

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolaas Lumen

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Wesley Verla

Role: STUDY_DIRECTOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Nicolaas Lumen, MD, PhD

Role: CONTACT

nicolaas.lumen@uzgent.be

+32 9 332 22 76

Wesley Verla

Role: CONTACT

wesley.verla@uzgent.be

+32498083423

Facility Contacts

Wesley Verla, MD

Role: primary

Wesley.Verla@uzgent.be

Nicolaas Lumen, MD PhD

Role: backup

Other Identifiers

BC-08585

Identifier Type: -

Identifier Source: org_study_id