Safety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction From Autologous Adipose Tissue of URethral Stenosis With Endoscopic Urethrotomy

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 groups