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

NCT04965025 | Recruiting DMC

• 1 other identifier: BC-08585
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Urethra Stenosis; Urethral Stricture

Outcome Measures

Primary Outcomes (1)

• To generate initial data in terms of failure rate after one year for grafting in first stage and for grafting in second stage.

  * Failure will be defined as the inability to pass a 16 Fr flexible cystoscope through the reconstructed area without damaging the urethral mucosa. * A point-estimate with 95% confidence intervals will be made for the one year failure rate of grafting in first stage and grafting in second stage. These data will serve as the basis to design a larger trial in the future.

  After 1 year of follow-up after second stage

Secondary Outcomes (10)

• To genarate initial data in terms of need for additional graft surgery for grafting in first stage. End-point time-frame: time period between first and second stage procedure.

  1 week after second stage surgery

• To generate initial data in terms of postoperative complications for grafting in first stage and for grafting in second stage.

  Within 90 days after first stage and within 90 days after second stage.

• To generate initial data in terms of changes in erectile function for grafting in first stage and for grafting in second stage.

  Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.

• To generate initial data in terms of changes in ejaculatory function for grafting in first stage and for grafting in second stage.

  Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.

• To generate initial data in terms of changes in lower urinary tract symptoms for grafting in first stage and for grafting in second stage.

  Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.

Study Arms (2)

Multi-stage urethroplasty with graft inlay in first stage

EXPERIMENTAL

Procedure: Multi-stage urethroplasty with graft inlay in first stage

Multi-stage urethroplasty with graft inlay in second stage

ACTIVE COMPARATOR

Procedure: Multi-stage urethroplasty with graft inlay in second stage

Interventions

Multi-stage urethroplasty with graft inlay in first stage 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 first stage

Multi-stage urethroplasty with graft inlay in second stage PROCEDURE

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

Multi-stage urethroplasty with graft inlay in second stage

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nicolaas Lumen

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Wesley Verla

  University Hospital, Ghent

  STUDY DIRECTOR

Central Study Contacts

Nicolaas Lumen, MD, PhD

CONTACT

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

Wesley Verla

CONTACT

+32498083423; wesley.verla@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants cannot be blinded because of the nature of the surgery. Treating surgeon cannot be blinded. Blinding of outcome assessors, data analysts and authors of the manuscript was considered, but lifted due to practical considerations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT with two arms.

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: July 16, 2021
• Study Start: November 11, 2020
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon request only

Locations

BE (1)