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.
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.
Absence of signed written informed consent.
Age < 18 years.
Female patients.
Transgender patients.
Parallel
Multi-stage urethroplasty with graft inlay in first stage
Procedure/SurgeryHerein, 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
Procedure/SurgeryHerein, the graft will be used in the second stage and the first stage will solely consist of opening the urethra longitudinally.
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
