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

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · May 4, 2023

Keywords

ClinConnect Summary

This clinical trial, called SURF, is exploring an innovative treatment for a condition known as urethral stenosis, which is a narrowing of the urethra that can lead to difficulties with urination. The study is testing a new approach where doctors will inject a special type of tissue taken from the patient’s own fat into the area during a standard surgical procedure called endoscopic urethrotomy. This trial aims to determine if this injection can improve the safety and effectiveness of the treatment.

To participate in this study, you need to be a male between the ages of 18 and 85 who has a specific type of urethral stenosis that is 3 centimeters or shorter in length. You should have undergone at least one prior treatment for this condition in the last two years and be in generally good health. Participants will be closely monitored throughout the trial to assess how well the treatment works and if there are any side effects. If you’re considering joining the study, it’s important to discuss this with your doctor to see if you meet the eligibility criteria and to understand the potential benefits and risks involved.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Ability to avoid corticoids or immunosuppressive drugs one month after treatment. For any patients with either corticoid or immunosuppressive treatment the physician in charge of this treatment will be contacted and asked to give a written approval for one month cessation of the therapy
• • 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
• Exclusion Criteria:
• • 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
• • Concurrent urinary tract infection without treatment
• • Concurrent 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
• • 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
• • Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician
• • Diagnosis of untreated and unresolved BPH benign prostatic hyperplasia or BNC bladder neck contracture
• • Diagnosis of carcinoma of the urethra, bladder or prostate within the last two (2) years