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).
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
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
Parallel
lipoaspiration
Procedure/SurgeryThe surgeon will perform lipoaspiration under local anesthesia for the ADSVF production.
urethrotomy
Procedure/SurgeryThe urologist will perform an endoscopic urethrotomy (standard care).
autologous ADSVF administration
DrugADSVF will be administrated in fibrotic lesion during urethrotomy by the urologist.
Baseline intensity and duration of urethral pain
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
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
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
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.
USP score
Change from baseline Urinary Symptom Profile (USP) scores at 1, 3, 6, 9, 18 and 24 months. USP scores include 3 different scales : * low stream score. Minimum score = 0 ; Maximum score (worse outcome) = 9 * overactivity score. Minimum score = 0 ; Maximum score (worse outcome) = 21 * stress incontinence. Minimum score = 0 ; Maximum score (worse outcome) = 9
International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)
Change from baseline ICIQ-MLUTS at 1, 3, 6, 9, 18 and 24 months. Minimum score = 0 ; Maximum score (worse outcome) = 21
Uroflowmetry
Uroflowmetry is a noninvasive test of the voiding phase. It consists in a device which assess urine flow (Q max normal \>12ml/s, shape of the curve) and the urinated volume. To be interpreted Uroflowmetry needs to be coupled with a post micturition residual volume mesasure via an automated bladder sonography device. Urinated volume + residual volume known as bladder pre-charge and needs to be higher than 150ml to make the uroflowmetry nterpretable and meaningful. Urinary change from baseline will be measured at 1, 3, 6, 9, 18 and 24 months.
Baseline imaging assessment of spongiofibrosis volume with Fat Sat sequences
A magnetic-resonance imaging (MRI) will be performed locally at Screening (baseline), to assess the volume of spongiofibrosis using Sagittal view in T1 Fat Sat after Gadolinium injection.
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