- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04965025
Multi-stage Urethroplasty With Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage (MAGIC I)
MAGIC I TRIAL - Multi-stage Urethroplasty With Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage: a Randomized Controlled Pilot Study
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicolaas Lumen, MD, PhD
- Phone Number: +32 9 332 22 76
- Email: nicolaas.lumen@uzgent.be
Study Contact Backup
- Name: Wesley Verla
- Phone Number: +32498083423
- Email: wesley.verla@uzgent.be
Study Locations
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-
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Ghent, Belgium, 9000
- Recruiting
- Ghent University Hospital
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Contact:
- Wesley Verla, MD
- Email: Wesley.Verla@uzgent.be
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Principal Investigator:
- Nicolaas Lumen, MD PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Active Comparator: Multi-stage urethroplasty with graft inlay in second stage
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Herein, the graft will be used in the second stage and the first stage will solely consist of opening the urethra longitudinally.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To generate initial data in terms of failure rate after one year for grafting in first stage and for grafting in second stage.
Time Frame: After 1 year of follow-up after second stage
|
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After 1 year of follow-up after second stage
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 1 week after second stage surgery
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The absolute number and percentage of patients requiring additional graft surgery will be recorded.
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1 week after second stage surgery
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To generate initial data in terms of postoperative complications for grafting in first stage and for grafting in second stage.
Time Frame: Within 90 days after first stage and within 90 days after second stage.
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Within 90 days after first stage and within 90 days after second stage.
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To generate initial data in terms of changes in erectile function for grafting in first stage and for grafting in second stage.
Time Frame: Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
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Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
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To generate initial data in terms of changes in ejaculatory function for grafting in first stage and for grafting in second stage.
Time Frame: Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
|
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Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
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To generate initial data in terms of changes in lower urinary tract symptoms for grafting in first stage and for grafting in second stage.
Time Frame: Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
|
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Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
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To generate initial data in terms of changes in urinary continence for grafting in first stage and for grafting in second stage.
Time Frame: Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
|
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Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
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To generate initial data in terms of changes in quality of life for grafting in first stage and for grafting in second stage.
Time Frame: Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
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Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
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To generate initial data in terms of (changes in) patient satisfaction for grafting in first stage and for grafting in second stage.
Time Frame: 3 months after second stage and 1 year after second stage.
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3 months after second stage and 1 year after second stage.
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To generate initial data in terms of change in maximal urinary flow rate (Qmax) for grafting in first stage and for grafting in second stage.
Time Frame: Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
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- Change in Qmax at the aforementioned moments will be presented as median change in score compared to baseline with interquartile range for both treatment arms.
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Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
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To assess feasibility of randomization.
Time Frame: After 12 motnhs of follow-up
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After 12 motnhs of follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicolaas Lumen, University Hospital, Ghent
- Study Director: Wesley Verla, University Hospital, Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-08585
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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