ConditionUrethral Stenosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-85
SponsorAssistance Publique Hopitaux De Marseille
About this trial
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).
Eligibility criteria
Qualifiers
Signed informed consent
Male, aged from 18 to 85 years
Bulbar urethral stenosis ≤ 3 cm.
At least one urethral dilatation or urethrotomy for the bulbar stenosis in the past 24 months before diagnosis of stenosis
Disqualifiers
Urethral stenosis of other location than bulbar
Urethral stenosis length > 3 cm
Urethral stenosis on reconstructed penis (transgender, post amputation)
Prior perineal or pelvic radiotherapy
Trial design
Treatments tested in this trial
- lipoaspiration
- urethrotomy
- autologous ADSVF administration
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov