Stem Cells Treatment for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery (HULPURO)

Phase 2

Completed

• Conditions: Urinary Incontinence
• Interventions: Drug: Inject of Autologous Adipose-derived stem cells

• Registration Number: NCT01799694
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Status Verified: 2012-09
• Study First Submitted: 2012-09-04
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted QC: 2013-02-24
• Study First Posted: 2013-02-27
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Expanded Stem Cells	Inject of Autologous Adipose-derived stem cells	Inject of Autologous Adipose-derived expanded stem cells

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain