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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
EU CTIS ID: 2024-513306-65-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent
- Male, aged from 18 to 85 years
- Bulbar urethral stenosis ≤ 3 cm Although there is no concensus on a clear definition of what a significant bulbar UrS is to date, a significant Bulbar UrS will be defined as 3 dimension entity for the study: - A narrowing of urethra that does not accept a standard flexible fibroscope (CH16) to pass through - In a patient with bothersome voiding and/or storage symptoms or any complication (infection, retention) who is asking for a relief - Qmax ≤ 15 ml/s AND USP ICIQ male LUTS voiding dysfunction domain ≠ 0 (Zero)
- At least one urethral dilatation or urthrotomy for the bulbar stenosis in the past 24 months before diagnosis of stenosis
- Ability to avoid corticoids or immunosuppressive drugs one month after treatment
- Good general health status according to clinical history and a physical examination
You likely can't join if
- Urethral stenosis of other location than bulbar
- 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
- Urethral stenosis length > 3 cm
See the full eligibility criteria
- Signed informed consent
- Male, aged from 18 to 85 years
- Bulbar urethral stenosis ≤ 3 cm Although there is no concensus on a clear definition of what a significant bulbar UrS is to date, a significant Bulbar UrS will be defined as 3 dimension entity for the study: - A narrowing of urethra that does not accept a standard flexible fibroscope (CH16) to pass through - In a patient with bothersome voiding and/or storage symptoms or any complication (infection, retention) who is asking for a relief - Qmax ≤ 15 ml/s AND USP ICIQ male LUTS voiding dysfunction domain ≠ 0 (Zero)
- At least one urethral dilatation or urthrotomy for the bulbar stenosis in the past 24 months before diagnosis of stenosis
- Ability to avoid corticoids or immunosuppressive drugs one month after treatment
- 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
- Urethral stenosis of other location than bulbar
- 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
- Urethral stenosis length > 3 cm
- Urethral stenosis on reconstructed penis (transgender, post amputation)
- Prior perineal or pelvic radiotherapy
- Concurent urinary tract infection without treatment
- Concurent 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.