Innovative Injection Treatment for Urethral Stenosis
Safety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction From Autologous Adipose Tissue of URethral Stenosis With Endoscopic Urethrotomy
Recruiting
Phase 2Interventional Study
Urethral Stenosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Assistance Publique Hopitaux De Marseille · Other
Who this trial is looking for
This trial is looking for men aged 18 to 85 who have urethral stenosis. Participants will receive a new treatment involving an injection during a standard procedure to help improve their condition.
Are You a Good Fit for This Trial?
Must not be takingCorticoidsImmunosuppressive drugs
You may be able to join if
I am male and between 18 and 85 years old.
I have bulbar urethral stenosis that is 3 cm or less.
I have had at least one treatment for my stenosis in the past 24 months.
I am in good general health.
I can avoid taking corticoids or immunosuppressive drugs for one month after treatment.
My BMI is over 18.
You may not be able to join if
I have urethral stenosis in a location other than bulbar.
My urethral stenosis is longer than 3 cm.
I have had prior pelvic radiotherapy.
I currently have a urinary tract infection without treatment.
I have a recent history of severe uncontrolled disease.
I have any active viral infections like HIV or hepatitis.
I have untreated benign prostatic hyperplasia.
I have been diagnosed with cancer of the urethra, bladder, or prostate in the last two years.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.