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

Conditions

URethral stenosis

Brief summary

Safety endpoints will include the frequency and intensity of classic adverse events of urethrotomy: urethral bleeding, urinary infection, urethral pain (intensity and duration), and urethral perforation with fistula or perineal soft tissue infection.

Detailed description

Symptoms and quality of life using validated scale and questionnaires: ICIQ male LUTS (International Consultation on incontinence Questionnaire), USP (Urinary Symptom Profile) questionnaires and a PGII (Personnal Global impression of Improvement) scale, US examination: Uroflowmetry (Qmax in ml/s, voided volume in ml) and post voiding residual volume using ultrasound bladder scan., Recurrence occurring between 3 months and 24 months after the ADSVF injection and defined as a urinary retention or a decrease in uroflowmetry and quality of life equal to baseline situation ± 20% in a patient asking for a relief after an initial period of improvement (compare to baseline values), Volume of spongiofibrosis using MRI in Sagittal view in T1 Fat Sat after Gadolinium injection (reconstruction to evaluate total volume in mm3 of spongiofibrosis).

Related papers

No related papers found yet.

Interventions

DRUGSVF 8 inj prep

DRUGthawed SVF 8 inj prep

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety endpoints will include the frequency and intensity of classic adverse events of urethrotomy: urethral bleeding, urinary infection, urethral pain (intensity and duration), and urethral perforation with fistula or perineal soft tissue infection.	—

Secondary

Measure	Time frame
Symptoms and quality of life using validated scale and questionnaires: ICIQ male LUTS (International Consultation on incontinence Questionnaire), USP (Urinary Symptom Profile) questionnaires and a PGII (Personnal Global impression of Improvement) scale, US examination: Uroflowmetry (Qmax in ml/s, voided volume in ml) and post voiding residual volume using ultrasound bladder scan., Recurrence occurring between 3 months and 24 months after the ADSVF injection and defined as a urinary retention or a decrease in uroflowmetry and quality of life equal to baseline situation ± 20% in a patient asking for a relief after an initial period of improvement (compare to baseline values), Volume of spongiofibrosis using MRI in Sagittal view in T1 Fat Sat after Gadolinium injection (reconstruction to evaluate total volume in mm3 of spongiofibrosis).	—

Measure

Time frame

Symptoms and quality of life using validated scale and questionnaires: ICIQ male LUTS (International Consultation on incontinence Questionnaire), USP (Urinary Symptom Profile) questionnaires and a PGII (Personnal Global impression of Improvement) scale, US examination: Uroflowmetry (Qmax in ml/s, voided volume in ml) and post voiding residual volume using ultrasound bladder scan., Recurrence occurring between 3 months and 24 months after the ADSVF injection and defined as a urinary retention or a decrease in uroflowmetry and quality of life equal to baseline situation ± 20% in a patient asking for a relief after an initial period of improvement (compare to baseline values), Volume of spongiofibrosis using MRI in Sagittal view in T1 Fat Sat after Gadolinium injection (reconstruction to evaluate total volume in mm3 of spongiofibrosis).

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Countries

France

Outcome results

None listed