About this trial
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.
Eligibility criteria
Qualifiers
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.
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- allogeneic mesenchymal stem cells
- Placebo