Urinary Incontinence
Conditions
Keywords
Feminine stress urinary incontinence, Autologous expanded stem cells
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
Interventions
DRUGAdipose-derived expanded stem cells
Intralesional application ASC
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. -Signed informed consen 2. -Good general state of health according to the findings of ythe clinical history and the physical examination 3. -Postmenopausal or over 18 years old women taking highly effective contraceptives following the ICH (M3) EMA guide 4. -Women having rejected de rehabilitation treatment or in which the treatment had failed 5. -Genuine or combined stress urinary incontinence diagnosed with at least 1 year of evolution
Exclusion criteria
1. -Pregnant or lactating women 2. -Active urine infection 3. -Presenting an infravesical obstruction 4. -Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion 5. -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 6. -Cardiopulmonar illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study 7. -Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study 8. -Subjects with congenital or aquired inmunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion 9. -Anesthesic allergy 10. -Major surgery or severe trauma in the previous 6 months 11. -Administration of any drug under experimentation in the present or 3 months before recruitement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the feasability and security of the autologous ASC for the feminine stress urinary incontinence | 16 weeks | compress test (number dthe changes daily) urethrocystoscopy (morphology of urethra) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment using the SF-12 Questionnaire | 1, 4, 16, 24 weeks | SF-12 questionnaire |
| Adverse events | 1, 4, 16, 24 weeks | Data collection |
Countries
Spain
Contacts
Primary ContactMariano García-Arranz, PhD
Backup ContactSergio Alonso Gregorio, MD
Outcome results
None listed