Safety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction From Autologous Adipose Tissue of URethral Stenosis With Endoscopic Urethrotomy
lipoaspiration: The surgeon will perform lipoaspiration under local anesthesia for the ADSVF production.
urethrotomy: The urologist will perform an endoscopic urethrotomy (standard care).
autologous ADSVF administration: ADSVF will be administrated in fibrotic lesion during urethrotomy by the urologist.
Study summary
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
Sex
MALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Baseline intensity and duration of urethral pain — 1 day A degree of pain can be expected at the tissue sampling site. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator. The events intensity will be graded according to the version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE) classification (grade 1 to 5 toxicity) of National Cancer Institute.
Intensity and duration of urethral pain D7 — 7 days measured 7 days after therapeutic administration. A degree of pain can be expected at the tissue sampling site. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator. The events intensity will be graded according to the version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE) classification (grade 1 to 5 toxicity) of National Cancer Institute.
Intensity and duration of urethral pain M1 — 1 month measured 1 month after therapeutic administration. A degree of pain can be expected at the tissue sampling site. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator. The events intensity will be graded according to the version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE) classification (grade 1 to 5 toxicity) of National Cancer Institute.
Intensity and duration of urethral pain M3 — 3 months measured 3 months after therapeutic administration. A degree of pain can be expected at the tissue sampling site. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator. The events intensity will be graded according to the version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE) classification (grade 1 to 5 toxicity) of National Cancer Institute.
Intensity and duration of urethral pain M6 — 24 months measured 6 months after therapeutic administration. A degree of pain can be expected at the tissue sampling site. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator. The events intensity will be graded according to the version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE) classification (grade 1 to 5 toxicity) of National Cancer Institute.
Intensity and duration of urethral pain M9 — 9 months measured 9 months after therapeutic administration. A degree of pain can be expected at the tissue sampling site. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator. The events intensity will be graded according to the version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE) classification (grade 1 to 5 toxicity) of National Cancer Institute.
Intensity and duration of urethral pain M18 — 18 months measured 18 months after therapeutic administration. A degree of pain can be expected at the tissue sampling site. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator. The events intensity will be graded according to the version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE) classification (grade 1 to 5 toxicity) of National Cancer Institute.
Intensity and duration of urethral pain M24 — 24 months measured 24 months after therapeutic administration. A degree of pain can be expected at the tissue sampling site. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator. The events intensity will be graded according to the version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE) classification (grade 1 to 5 toxicity) of National Cancer Institute.
Incidence of urinary infection — 24 months measured at baseline (day of inclusion). This adverse event will be collected during clinical examination from blood sample analysis.
Incidence of urniary infection M1 — 1 month measured 1 month after therapeutic administration. This adverse event will be collected during clinical examination from blood sample analysis.
Number of patient with urethral bleeding — 1 day measured at baseline (day of inclusion). This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator.
Number of patient with urethral bleeding D7 — 7 days measured 7 days after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator.
Number of patient with urethral bleeding M1 — 1 month measured 1 month after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator.
Number of patient with urethral bleeding M3 — 3 months measured 3 months after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator.
Number of patient with urethral bleeding M6 — 6 months measured 6 months after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator.
Number of patient with urethral bleeding M9 — 9 months measured 9 months after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator.
Number of patient with urethral bleeding M18 — 18 months measured 18 months after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator.
Number of patient with urethral bleeding M24 — 24 months measured 24 months after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator. The events intensity will be graded according to the version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE) classification (grade 1 to 5 toxicity) of National Cancer Institut.
Presence of urethral perforation with fistula or perineal soft tissue infection D7 — 7 days measured 7 days after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator. The events intensity will be graded according to the version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE) classification (grade 1 to 5 toxicity) of National Cancer Institut.
Presence of urethral perforation with fistula or perineal soft tissue infection M1 — 1 month measured 1 month after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator.
Presence of urethral perforation with fistula or perineal soft tissue infection M3 — 3 months measured 3 months after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator.
Presence of urethral perforation with fistula or perineal soft tissue infection M6 — 6 months measured 6 months after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator.
Presence of urethral perforation with fistula or perineal soft tissue infection M9 — 9 months measured 9 months after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator. The events intensity will be graded according to the version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE) classification (grade 1 to 5 toxicity) of National Cancer Institut.
Presence of urethral perforation with fistula or perineal soft tissue infection M18 — 18 months measured 18 months after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator.
Presence of urethral perforation with fistula or perineal soft tissue infection M24 — 24 months measured 24 months after therapeutic administration. This adverse event will be collected during clinical examination from the investigator questioning the patient; or from the patient's unsolicited reporting, as encouraged to do towards the investigator.
Trial sites (1)
Facility
City
Region
Status
Assistance Publique Hopitaux de Marseille
Marseille
France
Recruiting
More Assistance Publique Hopitaux De Marseille trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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