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NCT Number: NCT05857371

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

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).

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Key information

Conditions

Urethral Stenosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urethral Diseases Urethral Obstruction Urethral Stricture Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, France

Location status: Recruiting

Location contact

GILLES KARSENTY

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lipoaspiration

Procedure

The surgeon will perform lipoaspiration under local anesthesia for the ADSVF production.

urethrotomy

Procedure

The urologist will perform an endoscopic urethrotomy (standard care).

autologous ADSVF administration

Drug

ADSVF will be administrated in fibrotic lesion during urethrotomy by the urologist.

Primary outcomes

  1. Baseline intensity and duration of urethral pain

    Time frame: 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.

  2. Intensity and duration of urethral pain D7

    Time frame: 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.

  3. Intensity and duration of urethral pain M1

    Time frame: 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.

  4. Intensity and duration of urethral pain M3

    Time frame: 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.

  5. Intensity and duration of urethral pain M6

    Time frame: 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.

  6. Intensity and duration of urethral pain M9

    Time frame: 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.

  7. Intensity and duration of urethral pain M18

    Time frame: 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.

  8. Intensity and duration of urethral pain M24

    Time frame: 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.

  9. Incidence of urinary infection

    Time frame: 24 months

    measured at baseline (day of inclusion). This adverse event will be collected during clinical examination from blood sample analysis.

  10. Incidence of urniary infection M1

    Time frame: 1 month

    measured 1 month after therapeutic administration. This adverse event will be collected during clinical examination from blood sample analysis.

  11. Number of patient with urethral bleeding

    Time frame: 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.

  12. Number of patient with urethral bleeding D7

    Time frame: 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.

  13. Number of patient with urethral bleeding M1

    Time frame: 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.

  14. Number of patient with urethral bleeding M3

    Time frame: 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.

  15. Number of patient with urethral bleeding M6

    Time frame: 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.

  16. Number of patient with urethral bleeding M9

    Time frame: 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.

  17. Number of patient with urethral bleeding M18

    Time frame: 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.

  18. Number of patient with urethral bleeding M24

    Time frame: 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.

  19. Presence of urethral perforation with fistula or perineal soft tissue infection D7

    Time frame: 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.

  20. Presence of urethral perforation with fistula or perineal soft tissue infection M1

    Time frame: 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.

  21. Presence of urethral perforation with fistula or perineal soft tissue infection M3

    Time frame: 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.

  22. Presence of urethral perforation with fistula or perineal soft tissue infection M6

    Time frame: 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.

  23. Presence of urethral perforation with fistula or perineal soft tissue infection M9

    Time frame: 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.

  24. Presence of urethral perforation with fistula or perineal soft tissue infection M18

    Time frame: 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.

  25. Presence of urethral perforation with fistula or perineal soft tissue infection M24

    Time frame: 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.

Secondary outcomes

  1. USP score

    Time frame: 24 months

    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

  2. International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)

    Time frame: 24 months

    Change from baseline ICIQ-MLUTS at 1, 3, 6, 9, 18 and 24 months. Minimum score = 0 ; Maximum score (worse outcome) = 21

  3. Uroflowmetry

    Time frame: 24 months

    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.

  4. Baseline imaging assessment of spongiofibrosis volume with Fat Sat sequences

    Time frame: 24 months

    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.

  5. imaging assessment of spongiofibrosis volume with Fat Sat sequences M1

    Time frame: 24 months

    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.

  6. imaging assessment of spongiofibrosis volume with Fat Sat sequences M9

    Time frame: 24 months

    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.

  7. Recurrence rate

    Time frame: 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra GIULIANI

CONTACT

[email protected]

0491382870

Gilles Karsenty, Pr.

CONTACT

[email protected]

0491435170

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study 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

Acronym: SURF

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 12, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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