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New treatment option for Urinary Incontinence Stress
Official title Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
ClinicalTrials.gov ID: NCT06738576
What this study is testing
What is allogeneic mesenchymal stem cells?
allogeneic mesenchymal stem cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for urinary incontinence stress.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate the feasibility and safety, obtaining initial efficacy data, of expanded allogeneic mesenchymal stem cells derived from adipose tissue (HC106) for the treatment of urinary incontinence in women over 50 years of age.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, women only
You may be able to join if
- Women over 50 years old
- Women with a clinical diagnosis of genuine or mixed stress urinary incontinence (SUI) with at least 6 months of evolution. Using the definitions of...
- Women in whom rehabilitative treatment has failed or patients who refuse to undergo rehabilitative or surgical treatment
- Patients without active urinary tract infection (negative urine culture) at the time of recruitment and treatment
- Signing of the informed consent form
You likely can't join if
- Patients with a medical history of previous surgery for incontinence, prolapse or urological/gynecological/colorectal surgery
- Major surgery or serious trauma of the subject in the previous semester
- Women with mixed urinary incontinence, with predominant symptoms of urgency
- History of high-pressure detrusor overactivity
- Present infravesical obstruction, vesico-ureteral reflux or clinical history of urinary fistula (it will be ruled out depending on the case by...
- Present any malignant neoplasm, unless it is basal cell or squamous cell carcinoma of the skin, or present a history of malignant tumors, unless they...
See the full eligibility criteria
- Women over 50 years old
- Women with a clinical diagnosis of genuine or mixed stress urinary incontinence (SUI) with at least 6 months of evolution. Using the definitions of urinary incontinence internationally accepted by the ICS (International...
- Women in whom rehabilitative treatment has failed or patients who refuse to undergo rehabilitative or surgical treatment
- Patients without active urinary tract infection (negative urine culture) at the time of recruitment and treatment
- Signing of the informed consent form
- Patients with a medical history of previous surgery for incontinence, prolapse or urological/gynecological/colorectal surgery
- Major surgery or serious trauma of the subject in the previous semester
- Women with mixed urinary incontinence, with predominant symptoms of urgency
- History of high-pressure detrusor overactivity
- Present infravesical obstruction, vesico-ureteral reflux or clinical history of urinary fistula (it will be ruled out depending on the case by urethrocystoscopy, urethrocystography and flowmetry).
- Present any malignant neoplasm, unless it is basal cell or squamous cell carcinoma of the skin, or present a history of malignant tumors, unless they have been in remission during the previous 5 years.
- Cardiopulmonary disease that, in the opinion of the investigator, is unstable or serious enough to exclude the patient from the study.
- Medical or psychiatric illness of any type that, in the opinion of the researcher, may be a reason for exclusion from the study.
- History of alcohol or other addictive substance abuse in the 6 months prior to inclusion
- Subject's allergy to anesthetics
The study team makes the final eligibility decision.
Where it's taking place
- Coslada, Madrid, Spain
- Madrid, Madrid, Spain
- Móstoles, Madrid, Spain
- Valdemoro, Madrid, Spain
- Villalba, Madrid, Spain
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 female, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Coslada, Madrid, Spain; Madrid, Madrid, Spain; Móstoles, Madrid, Spain; Valdemoro, Madrid, Spain; Villalba, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.