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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04965025
Other study ID # BC-08585
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 11, 2020
Est. completion date March 1, 2025

Study information

Verified date April 2024
Source University Hospital, Ghent
Contact Nicolaas Lumen, MD, PhD
Phone +32 9 332 22 76
Email nicolaas.lumen@uzgent.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Other study objectives are thoroughly described underneath.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.
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.

Locations

Country Name City State
Belgium Ghent University Hospital Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
1 week after second stage surgery
Secondary 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.
Within 90 days after first stage and within 90 days after second stage.
Secondary 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.
Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
Secondary 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.
Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
Secondary 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.
Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
Secondary 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.
Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
Secondary 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.
Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
Secondary 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.
3 months after second stage and 1 year after second stage.
Secondary 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. Preoperative, 3 months after first stage (before second stage), 3 months after second stage and 1 year after second stage.
Secondary 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'.
After 12 motnhs of follow-up
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