Urethra StenosisMAGIC INCT04965025
Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage
A study testing Multi-stage urethroplasty with graft inlay in first stage and Multi-stage urethroplasty with graft inlay in second stage in people with Urethra Stenosis and Urethral Stricture, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethra Stenosis, Urethral Stricture
- What is being tested?
- Multi-stage urethroplasty with graft inlay in first stage and Multi-stage urethroplasty with graft inlay in second stage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Nov 2020to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Wesley Verla, MD, Wesley.Verla@uzgent.be
Nicolaas Lumen, MD PhD
About this study
Official title: 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
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.
Read the 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
- Being tested
- Multi-stage urethroplasty with graft inlay in first stage, Multi-stage urethroplasty with graft inlay in second stage
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-stage urethroplasty with graft inlay in first stageProcedure or surgery
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 stageProcedure or surgery
Herein, the graft will be used in the second stage and the first stage will solely consist of opening the urethra longitudinally.
| Study group | Role | What they receive |
|---|---|---|
| Multi-stage urethroplasty with graft inlay in first stage | Experimental | Not described Receives: Procedure: Multi-stage urethroplasty with graft inlay in first stage |
| Multi-stage urethroplasty with graft inlay in second stage | Active comparator | Not described Receives: Procedure: Multi-stage urethroplasty with graft inlay in second stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The absolute number and percentage of patients requiring additional graft surgery will be recorded.
- Reasons for additional graft surgery will be recorded qualitatively.
- Total number of grafts required will be recorded as well and will be presented as median with interquartile range for both treatment arms.
Measured: 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.
- Complications will be classified according to Clavien-Dindo4 and presented as absolute numbers with percentages for both treatment arms.
- Types of complication will also be specified.
Measured: 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.
- International Index of Erectile Function (IIEF-5) questionnaire will be used (this is standard of care).
- The IIEF-5 questionnaire provides a summative score between 5 and 25 and should be interpreted as follows: 22-25 = no erectile dysfunction; 17-21 = mild erectile dysfunction; 12-16 = mild to moderate erectile dysfunction; 8-11 = moderate erectile dysfunction; 5-7 = severe erectile dysfunction.
- Change in erectile function at the aforementioned moments will be presented as median change in score compared to baseline with interquartile range for both treatment arms.
Measured: 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.
- Male Sexual Health Questionnaire - Ejaculatory Dysfunction short form (MSHQ-EjD) questionnaire will be used (this is standard of care).
- The MSHQ-EjD short form questionnaire, consisting of 4 questions, provides a summative score between 1 and 15 (question 1 - 3) and a bother/satisfaction score between 0 and 5 (question 4).
- Change in ejaculatory function at the aforementioned moments will be presented as median change in score compared to baseline with interquartile range for both treatment arms.
Measured: 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.
- International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms module (ICIQ-MLUTS) questionnaire and Peeling's voiding picture will be used (this is standard of care).
- The ICIQ-MLUTS module, consisting of 7 questions, provides a summative score between 0 (asymptomatic) and 24 (most symptomatic) (question 1 - 6) and a bother score between 0 (not bothersome) and 3 (very bothersome) (question 7). Peeling's voiding picture provides a score between 1 and 4.
- Change in lower urinary tract symptoms at the aforementioned moments will be presented as median change in score compared to baseline with interquartile range for both treatment arms.
Measured: 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 urinary continence for grafting in first stage and for grafting in second stage.
- International Consultation on Incontinence Questionnaire - Urinary Incontinence short form (ICIQ-UI) questionnaire will be used (this is standard of care).
- The ICIQ-UI short form questionnaire, consisting of 3 scoring questions and 1 self-diagnostic question, provides a summative score between 0 (asymptomatic) and 21 (most symptomatic).
- Change in urinary continence at the aforementioned moments will be presented as median change in score compared to baseline with interquartile range for both treatment arms.
Measured: 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 quality of life for grafting in first stage and for grafting in second stage.
- The 3-level version of the EQ-5D (EQ-5D-3L) questionnaire and the EQ Visual Analogue Scale (EQ-VAS) will be used (this is standard of care).
- The EQ-5D-3L questionnaire, consisting of 5 questions, provides a 5-digit score in which every digit varies between 1, 2 and 3. The EQ-VAS provides a scale between 0 and 100.
- Change in quality of life at the aforementioned moments will be presented as median change in score compared to baseline with interquartile range for both treatment arms.
Measured: 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) patient satisfaction for grafting in first stage and for grafting in second stage.
- Two specific questions about patient satisfaction will be used (this is standard of care).
- The results of these two questions will be presented as absolute numbers with percentages for each possible answer for both treatment arms.
Measured: 3 months after second stage and 1 year after second stage.
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.
- 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.
Measured: Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
To assess feasibility of randomization.
- The proportion of patients randomized over all patients undergoing multi-stage urethroplasty with dorsal inlay of a graft that were screened for the trial will be used to assess feasibility.
- A proportion of 0.70 or higher will be considered as 'feasible'.
Measured: After 12 motnhs of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start11 Nov 2020
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethra StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT with two arms.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolaas Lumen, Principal investigator, University Hospital, GhentWesley Verla, Study director, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965025
- Sponsor's protocol ID
- BC-08585
- Acronym
- MAGIC I
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04965025
- Acronym / sponsor ID
- MAGIC I / BC-08585
- Conditions
- Urethra Stenosis, Urethral Stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT with two arms.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (13 listed)
- Absence of signed written informed consent.
- Age < 18 years.
- Female patients.
- Transgender patients.
- Patients unfit for operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-stage urethroplasty with graft inlay in first stageHerein, the graft will be used in the first stage and the second stage will solely consist of retubularizing the urethra. | Procedure or surgery | Multi-stage urethroplasty with graft inlay in first stage |
| Multi-stage urethroplasty with graft inlay in second stageHerein, the graft will be used in the second stage and the first stage will solely consist of opening the urethra longitudinally. | Procedure or surgery | Multi-stage urethroplasty with graft inlay in second stage |
Primary outcome
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
* 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.
10 secondary outcomes
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
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.
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.
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.
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.
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.
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.
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.
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.
To assess feasibility of randomization.
Time frame: After 12 motnhs of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. Upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolaas Lumen principal investigator
University Hospital, Ghent
Wesley Verla study director
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-stage urethroplasty with graft inlay in first stage and Multi-stage urethroplasty with graft inlay in second stage in people with Urethra Stenosis and Urethral Stricture, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolaas Lumen, MD, PhD (+32 9 332 22 76, nicolaas.lumen@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.