SURF is a randomised controlled, parallel group, single blind phase II study designed to assess the safety and potential efficacy of an innovative therapeutic strategy for urethral stenosis based on adjuvant injection of autologous Adipose-Derived Stromal Vascular Fraction of Adipose Tissue (ADSVF) during endoscopic urethrotomy (standard care).
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Baseline intensity and duration of urethral pain
Timeframe: 1 day
Intensity and duration of urethral pain D7
Timeframe: 7 days
Intensity and duration of urethral pain M1
Timeframe: 1 month
Intensity and duration of urethral pain M3
Timeframe: 3 months
Intensity and duration of urethral pain M6
Timeframe: 24 months
Intensity and duration of urethral pain M9
Timeframe: 9 months
Intensity and duration of urethral pain M18
Timeframe: 18 months
Intensity and duration of urethral pain M24
Timeframe: 24 months
Incidence of urinary infection
Timeframe: 24 months
Incidence of urniary infection M1
Timeframe: 1 month
Number of patient with urethral bleeding
Timeframe: 1 day
Number of patient with urethral bleeding D7
Timeframe: 7 days
Number of patient with urethral bleeding M1
Timeframe: 1 month
Number of patient with urethral bleeding M3
Timeframe: 3 months
Number of patient with urethral bleeding M6
Timeframe: 6 months
Number of patient with urethral bleeding M9
Timeframe: 9 months
Number of patient with urethral bleeding M18
Timeframe: 18 months
Number of patient with urethral bleeding M24
Timeframe: 24 months
Presence of urethral perforation with fistula or perineal soft tissue infection D7
Timeframe: 7 days
Presence of urethral perforation with fistula or perineal soft tissue infection M1
Timeframe: 1 month
Presence of urethral perforation with fistula or perineal soft tissue infection M3
Timeframe: 3 months
Presence of urethral perforation with fistula or perineal soft tissue infection M6
Timeframe: 6 months
Presence of urethral perforation with fistula or perineal soft tissue infection M9
Timeframe: 9 months
Presence of urethral perforation with fistula or perineal soft tissue infection M18
Timeframe: 18 months
Presence of urethral perforation with fistula or perineal soft tissue infection M24
Timeframe: 24 months