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.
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
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
Parallel
allogeneic mesenchymal stem cells
DrugCell implantation is carried out in the following steps: 1. \- Patient anesthesia 2. \- Identification of the external urinary sphincter and the incompetent area responsible for incontinence through intraurethral cystoscopy. 3. \- Resuspension of the cells by gentle manual shaking of the vials. Once the cells are resuspended, they will be used immediately. 4. \- Injection of the cell suspension with a long, fine needle (those usually used in endoscopic puncture, \<22G) at 2 points of the sphincter that will coincide with the 3 o'clock and 9 o'clock position of the hands of a clock). The injection will be superficial, trying not to go deeper than 2 mm to create a wheal in each injection visible endoscopically. 5. \- Cellular remains, if any, and the vials used will be eliminated following the usual procedures used for the management of hospital surgical waste.
Placebo
DrugPlacebo implantation is carried out in the same way as the drug implantation
Proportion of patients with at least one of the complictations derived from the treatment.
complications derived from treatment will be considered: * Complications during anesthesia. * Complications during treatment administration. * Peri- and postoperative complications. * Adverse effects during follow-up, whether or not associated with the drug
The evaluation of the PAD-test
quantification of the amount of urine lost during the duration of the test (24h),
Flowmetry values
improvement in the flowmetry values. It is expressed in cm3 (or ml) divided by second.and the normal values are between 50 and 80 mL/min
Quality of life SF-12 questionnaire
The score ranges between 0 and 100, where the higher score implies a better health-related quality of life Evaluate the change in the quality of life of the patients with respect to the baseline situation
Quality of life ICQ-SF questionnaire
Evaluate the change in the quality of life of the patients with respect to the baseline situation. Any score greater than zero is considered urinary incontinence.
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