NCT05857371

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
23mo left

Started Mar 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Mar 2024Apr 2028

First Submitted

Initial submission to the registry

February 3, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

March 13, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3.6 years

First QC Date

February 3, 2023

Last Update Submit

February 3, 2026

Conditions

Urethral Stenosis

Outcome Measures

Primary Outcomes (25)

  • 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.

    1 day

  • 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.

    7 days

  • 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.

    1 month

  • 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.

    3 months

  • 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.

    24 months

  • 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.

    9 months

  • 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.

    18 months

  • 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.

    24 months

  • Incidence of urinary infection

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

    24 months

  • Incidence of urniary infection M1

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

    1 month

  • 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.

    1 day

  • 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.

    7 days

  • 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.

    1 month

  • 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.

    3 months

  • 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.

    6 months

  • 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.

    9 months

  • 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.

    18 months

  • 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.

    24 months

  • 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.

    7 days

  • 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.

    1 month

  • 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.

    3 months

  • 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.

    6 months

  • 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.

    9 months

  • 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.

    18 months

  • 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.

    24 months

Secondary Outcomes (7)

  • USP score

    24 months

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

    24 months

  • Uroflowmetry

    24 months

  • Baseline imaging assessment of spongiofibrosis volume with Fat Sat sequences

    24 months

  • imaging assessment of spongiofibrosis volume with Fat Sat sequences M1

    24 months

  • +2 more secondary outcomes

Study Arms (2)

Control group

SHAM COMPARATOR

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.

Procedure: lipoaspirationProcedure: urethrotomy

Experimental group

EXPERIMENTAL

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.

Procedure: lipoaspirationProcedure: urethrotomyDrug: autologous ADSVF administration

Interventions

lipoaspirationPROCEDURE

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

Control groupExperimental group
urethrotomyPROCEDURE

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

Control groupExperimental group
autologous ADSVF administrationDRUG

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

Experimental group

Eligibility Criteria

Age18 Years - 85 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsgender identtity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

RECRUITING

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • FRANCOIX CREMIEUX

    ASSISITANCE PUBLIQUE HOPITAUX DE MARSEILLE

    STUDY DIRECTOR

Central Study Contacts

Gilles Karsenty, Pr.

CONTACT

0491435170Gilles.KARSENTY@ap-hm.fr

Alexandra GIULIANI

CONTACT

0491382870alexandra.giuliani@ap-hm.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2023

First Posted

May 12, 2023

Study Start

March 13, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

FR(1)