Back to resultsSafety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction From Autologous Adipose Tissue of URethral Stenosis With Endoscopic Urethrotomy (SURF)
Primary Purpose
Urethral Stenosis
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
lipoaspiration
urethrotomy
autologous ADSVF administration
Sponsored by
About this trial
This is an interventional treatment trial for Urethral Stenosis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Control group
Experimental group
Arm Description
The surgeon trained to lipoaspiration procedure will perform lipoaspiration for the ADSVF cryopreservation under local anesthesia with sedation. The patients of the control group benefices to urethrotomy (standard care) under general anesthesia. The surgical surgical technique necessitates performing three incisions with a cold endoscopic knife in the stenosis to obtain enlargement of urethral lumen on the length of the fibrosis at 3, 9 and 12 o' clock. For patients randomised in the control group, lippoaspiration will be performed for cryopreservation of the autologous ADSVF and potential second administration of ADSVF in case of UrS recurrency. UrS recurrence or primary failure is defined as a recurrence without a period of post procedure improvement). Recurrence incoming before 21 months post experimental treatment will be treated according to the study in order to have a minimum follow-up of 3 months.
The surgeon trained to lipoaspiration procedure will perform lipoaspiration for the ADSVF cryopreservation under local anesthesia with sedation. The patients of the control group benefices to urethrotomy (standard care) under general anesthesia. The surgical surgical technique necessitates performing three incisions with a cold endoscopic knife in the stenosis to obtain enlargement of urethral lumen on the length of the fibrosis at 3, 9 and 12 o' clock. For theses patients -randomised in the experimental group - the experimental cell drug will be customised-made to each patient's lesion and included a dose between 16 and 56 million* viable nucleated cells (VNCs) of fresh or thawed autologous Adipose-derived -Stromal Vascular Fraction, resuspended in saline (0, 9%) - 5% human serum albumin (50 mg/mL) final packaged in 2 to 7 syringes of 1 mL at a concentration of 8 million CNV / mL, individually closed with a tamper-proof Luer Lock cap and labelled to ensure double-blindness.
Outcomes
Primary Outcome Measures
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.
Intensity and duration of urethral pain M6
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
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
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
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
measured at baseline (day of inclusion). This adverse event will be collected during clinical examination from blood sample analysis.
Incidence of urniary infection M1
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
Secondary Outcome Measures
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.
imaging assessment of spongiofibrosis volume with Fat Sat sequences M1
A magnetic-resonance imaging (MRI) will be performed locally at M1 to assess the volume of spongiofibrosis using Sagittal view in T1 Fat Sat after Gadolinium injection.
imaging assessment of spongiofibrosis volume with Fat Sat sequences M9
A magnetic-resonance imaging (MRI) will be performed locally at M9 to assess the volume of spongiofibrosis using Sagittal view in T1 Fat Sat after Gadolinium injection.
Recurrence rate
Recurrence of urethral stenosis (defined as a recurrence without a period of post procedure improvement) will be analyzed at 1, 3, 6,9 18, and 24 months.
Full Information
NCT ID
NCT05857371
First Posted
February 3, 2023
Last Updated
May 4, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT05857371
Brief Title
Safety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction From Autologous Adipose Tissue of URethral Stenosis With Endoscopic Urethrotomy
Acronym
SURF
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
April 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed Description
Urethral stenosis (UrS) is a narrowing of the urethra's caliber. UrS results of ischemic fibrosis of the corpus spongiosum (spongiofibrosis). Fibrosis-induced retraction reduces the size of the urethral lumen. Spongiofibrosis may be due to infections, inflammation, trauma but remains mostly idiopathic.Endo-urethral treatment exposes to a high rate of recurrence (up to 60% depending on the site, length and etiology). The reconstruction treatment is more effective but more complex (use of oral mucosal flap or other substitution tissue, less mastered by the surgical community and more morbid.
The (ADSVF) is an easily accessible source of autologous mesenchymal stem cells. Obtention from lipoaspirates is safe, simple and standardized. Different animal models have demonstrated the pro-healing and anti-fibrotic properties of autologous ADSVF in the urethra corpus cavernous during erectile dysfunction, perineal fistulas during Crohn's disease and systemic sclerosis.
The main objective of this study is to assess the safety and tolerability of ADSVF, as add-on treatment to endoscopic urethrotomy for recurrent bulbar urethral stenosis during the follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
The surgeon trained to lipoaspiration procedure will perform lipoaspiration for the ADSVF cryopreservation under local anesthesia with sedation.
The patients of the control group benefices to urethrotomy (standard care) under general anesthesia. The surgical surgical technique necessitates performing three incisions with a cold endoscopic knife in the stenosis to obtain enlargement of urethral lumen on the length of the fibrosis at 3, 9 and 12 o' clock.
For patients randomised in the control group, lippoaspiration will be performed for cryopreservation of the autologous ADSVF and potential second administration of ADSVF in case of UrS recurrency. UrS recurrence or primary failure is defined as a recurrence without a period of post procedure improvement). Recurrence incoming before 21 months post experimental treatment will be treated according to the study in order to have a minimum follow-up of 3 months.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The surgeon trained to lipoaspiration procedure will perform lipoaspiration for the ADSVF cryopreservation under local anesthesia with sedation.
The patients of the control group benefices to urethrotomy (standard care) under general anesthesia. The surgical surgical technique necessitates performing three incisions with a cold endoscopic knife in the stenosis to obtain enlargement of urethral lumen on the length of the fibrosis at 3, 9 and 12 o' clock.
For theses patients -randomised in the experimental group - the experimental cell drug will be customised-made to each patient's lesion and included a dose between 16 and 56 million* viable nucleated cells (VNCs) of fresh or thawed autologous Adipose-derived -Stromal Vascular Fraction, resuspended in saline (0, 9%) - 5% human serum albumin (50 mg/mL) final packaged in 2 to 7 syringes of 1 mL at a concentration of 8 million CNV / mL, individually closed with a tamper-proof Luer Lock cap and labelled to ensure double-blindness.
Intervention Type
Procedure
Intervention Name(s)
lipoaspiration
Intervention Description
The surgeon will perform lipoaspiration under local anesthesia for the ADSVF production.
Intervention Type
Procedure
Intervention Name(s)
urethrotomy
Intervention Description
The urologist will perform an endoscopic urethrotomy (standard care).
Intervention Type
Drug
Intervention Name(s)
autologous ADSVF administration
Intervention Description
ADSVF will be administrated in fibrotic lesion during urethrotomy by the urologist.
Primary Outcome Measure Information:
Title
Baseline intensity and duration of urethral pain
Description
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.
Time Frame
1 day
Title
Intensity and duration of urethral pain D7
Description
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.
Time Frame
7 days
Title
Intensity and duration of urethral pain M1
Description
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.
Time Frame
1 month
Title
Intensity and duration of urethral pain M3
Description
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.
Time Frame
3 months
Title
Intensity and duration of urethral pain M6
Description
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.
Time Frame
24 months
Title
Intensity and duration of urethral pain M9
Description
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.
Time Frame
9 months
Title
Intensity and duration of urethral pain M18
Description
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.
Time Frame
18 months
Title
Intensity and duration of urethral pain M24
Description
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.
Time Frame
24 months
Title
Incidence of urinary infection
Description
measured at baseline (day of inclusion). This adverse event will be collected during clinical examination from blood sample analysis.
Time Frame
24 months
Title
Incidence of urniary infection M1
Description
measured 1 month after therapeutic administration. This adverse event will be collected during clinical examination from blood sample analysis.
Time Frame
1 month
Title
Number of patient with urethral bleeding
Description
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.
Time Frame
1 day
Title
Number of patient with urethral bleeding D7
Description
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.
Time Frame
7 days
Title
Number of patient with urethral bleeding M1
Description
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.
Time Frame
1 month
Title
Number of patient with urethral bleeding M3
Description
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.
Time Frame
3 months
Title
Number of patient with urethral bleeding M6
Description
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.
Time Frame
6 months
Title
Number of patient with urethral bleeding M9
Description
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.
Time Frame
9 months
Title
Number of patient with urethral bleeding M18
Description
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.
Time Frame
18 months
Title
Number of patient with urethral bleeding M24
Description
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.
Time Frame
24 months
Title
Presence of urethral perforation with fistula or perineal soft tissue infection D7
Description
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.
Time Frame
7 days
Title
Presence of urethral perforation with fistula or perineal soft tissue infection M1
Description
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.
Time Frame
1 month
Title
Presence of urethral perforation with fistula or perineal soft tissue infection M3
Description
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.
Time Frame
3 months
Title
Presence of urethral perforation with fistula or perineal soft tissue infection M6
Description
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.
Time Frame
6 months
Title
Presence of urethral perforation with fistula or perineal soft tissue infection M9
Description
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.
Time Frame
9 months
Title
Presence of urethral perforation with fistula or perineal soft tissue infection M18
Description
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.
Time Frame
18 months
Title
Presence of urethral perforation with fistula or perineal soft tissue infection M24
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
USP score
Description
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
Time Frame
24 months
Title
International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)
Description
Change from baseline ICIQ-MLUTS at 1, 3, 6, 9, 18 and 24 months. Minimum score = 0 ; Maximum score (worse outcome) = 21
Time Frame
24 months
Title
Uroflowmetry
Description
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.
Time Frame
24 months
Title
Baseline imaging assessment of spongiofibrosis volume with Fat Sat sequences
Description
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.
Time Frame
24 months
Title
imaging assessment of spongiofibrosis volume with Fat Sat sequences M1
Description
A magnetic-resonance imaging (MRI) will be performed locally at M1 to assess the volume of spongiofibrosis using Sagittal view in T1 Fat Sat after Gadolinium injection.
Time Frame
24 months
Title
imaging assessment of spongiofibrosis volume with Fat Sat sequences M9
Description
A magnetic-resonance imaging (MRI) will be performed locally at M9 to assess the volume of spongiofibrosis using Sagittal view in T1 Fat Sat after Gadolinium injection.
Time Frame
24 months
Title
Recurrence rate
Description
Recurrence of urethral stenosis (defined as a recurrence without a period of post procedure improvement) will be analyzed at 1, 3, 6,9 18, and 24 months.
Time Frame
24 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
gender identtity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilles Karsenty, Pr.
Phone
0491435170
Email
Gilles.KARSENTY@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra GIULIANI
Phone
0491382870
Email
alexandra.giuliani@ap-hm.fr
12. IPD Sharing Statement
Learn more about this trial
Safety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction From Autologous Adipose Tissue of URethral Stenosis With Endoscopic Urethrotomy
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