Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Uri… (NCT06738576) | Clinical Trial Compass
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Spain60 participantsStarted 2024-12-16
Plain-language summary
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.
Who can participate
Age range50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 Continence Society): to. SUI: any involuntary loss of urine, immediately preceded by exertion. b. Mixed UI: any involuntary loss of urine, immediately preceded by exertion or an uncontrollable desire to urinate.
The predominance of effort will be assessed when more than 50% of the patient's daily losses occur preceded by effort.
* 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
Exclusion Criteria:
* 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 …
What they're measuring
1
Proportion of patients with at least one of the complictations derived from the treatment.