Urinary Incontinence
Conditions
Keywords
Urinary incontinence, Autologous expanded stem cells, Radical prostate cancer surgery
Brief summary
The purpose of this study is to evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery
Interventions
DRUGInject of Autologous Adipose-derived stem cells
Inject in muscle of autologous adipose derived stem cells
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent 2. Men over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination 3. Prostate cancer diagnosed subjects via a biopsy and having had a radical surgery with a healing purpose in the previous 18 months 4. Having urinary incontinence after the surgery 5. Failure in any previous conservative treatment
Exclusion criteria
1. Having had an adjuvant treatment 2. Having a PSA ≥ 0,2 after surgery 3. Having any sign or symptom that suggest the investigator the non-healing of the adenocarcinoma 4. Active urine infection 5. Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion 6. Cardiopulmonary 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 acquired immunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion 9. Anesthetic allergy 10. Major surgery or severe trauma in the previous 6 months 11. Administration of any drug under experimentation in the present or in the previous 3 months before recruitment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery | 16 weeks | Possibility of inject ASc by cystoscope |
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 collected |
Countries
Spain
Outcome results
None listed