Safety and potential effect of innovative treatment by adjuvant injection of stromal vascular Fraction from autologous adipose tissue of URethral stenosis with endoscopic urethrotomy: randomized controlled trial - SURF

Centre Hospitalier Regional De Marseille0 个研究点目标入组 20 人开始时间: 2024年6月26日最近更新: 2024年8月21日

试验速览

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•Signed informed consent, Male, aged from 18 to 85 years, Bulbar urethral stenosis = 3 cm Although there is no concensus on a clear definition of what a significant bulbar UrS is to date, a significant Bulbar UrS will be defined as 3 dimension entity for the study: - A narrowing of urethra that does not accept a standard flexible fibroscope (CH16) to pass through - In a patient with bothersome voiding and/or storage symptoms or any complication (infection, retention) who is asking for a relief - Qmax = 15 ml/s AND USP ICIQ male LUTS voiding dysfunction domain ? 0 (Zero), At least one urethral dilatation or urthrotomy for the bulbar stenosis in the past 24 months before diagnosis of stenosis, Ability to avoid corticoids or immunosuppressive drugs one month after treatment, Good general health status according to clinical history and a physical examination, BMI > 18 to insure adequate access to abdominal or other subcutaneous adipose tissue for adipose tissue harvesting

•Urethral stenosis of other location than bulbar, Contraindication to the anaesthetic or surgical procedure, Corticoids or immunosuppressive drugs > 3 months, Any active viral infection among the following: HIV, HTLV I and II, VHB, VHC and Syphillis, Administrative restricted rights, Urethral stenosis length > 3 cm, Urethral stenosis on reconstructed penis (transgender, post amputation), Prior perineal or pelvic radiotherapy, Concurent urinary tract infection without treatment, Concurent perineal infection, Penile cancer < 5 years, Current or recent history of abnormal, severe, progressive, uncontrolled infectious, hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease, Congenital or acquired immunodeficiencies

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