Status:
COMPLETED
Stem Cells Treatment for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery (HULPURO)
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Conditions:
Urinary Incontinence
Eligibility:
MALE
18+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- Signed informed consent
- Men over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
- Prostate cancer diagnosed subjects via a biopsy and having had a radical surgery with a healing purpose in the previous 18 months
- Having urinary incontinence after the surgery
- Failure in any previous conservative treatment
Exclusion
- Having had an adjuvant treatment
- Having a PSA ≥ 0,2 after surgery
- Having any sign or symptom that suggest the investigator the non-healing of the adenocarcinoma
- Active urine infection
- Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
- Cardiopulmonary 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 acquired immunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
- Anesthetic allergy
- Major surgery or severe trauma in the previous 6 months
- Administration of any drug under experimentation in the present or in the previous 3 months before recruitment
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01799694
Start Date
July 1 2011
End Date
February 1 2013
Last Update
March 8 2013
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046