Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)

Study Overview
=================
Brief Summary
-----------------
Evaluate the feasability and security of the autologous ASC for the femenine stress urinary incontinence

Detailed Description
-----------------
Evaluate safety of adipose derived stem cells to femenine urinary incontinence with local application

Official Title
-----------------
Phase II Clinical Trial to Study the Feasibility and Safety of the Expanded Autologous Mesenchymal Stem Cells Use Derived From Adipose Tissue (ASC) for the Local Feminine Stress Urinary Incontinence

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: Adipose-derived expanded stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Signed informed consen -Good general state of health according to the findings of ythe clinical history and the physical examination -Postmenopausal or over 18 years old women taking highly effective contraceptives following the ICH (M3) EMA guide -Women having rejected de rehabilitation treatment or in which the treatment had failed -Genuine or combined stress urinary incontinence diagnosed with at least 1 year of evolution Exclusion Criteria: -Pregnant or lactating women -Active urine infection -Presenting an infravesical obstruction -Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion -Presenting any other malignant neoplasia unless it is a basocellar or a skin epidermoide carcinoma or presents antecedents of malignant tumours, unless they are in a remission phase for the previous 5 years -Cardiopulmonar illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study -Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study -Subjects with congenital or aquired inmunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion -Anesthesic allergy -Major surgery or severe trauma in the previous 6 months -Administration of any drug under experimentation in the present or 3 months before recruitement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous expanded stem cells<br>Adipose-derived expanded stem cells | Drug: Adipose-derived expanded stem cells<br>* Intralesional application ASC<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the feasability and security of the autologous ASC for the feminine stress urinary incontinence | compress test (number dthe changes daily) urethrocystoscopy (morphology of urethra) | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment using the SF-12 Questionnaire | SF-12 questionnaire | 1, 4, 16, 24 weeks | 
| Adverse events | Data collection | 1, 4, 16, 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Feminine stress urinary incontinence, Autologous expanded stem cells