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

Phase 1

• Conditions: Urinary Incontinence
• Interventions: Drug: Adipose-derived expanded stem cells

• Registration Number: NCT01804153
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-04
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-01
• Last Update Submitted: 2013-03-01
• Study First Posted: 2013-03-05
• Last Update Posted: 2013-03-05
• Primary Completion: 2013-10
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous expanded stem cells	Adipose-derived expanded stem cells	Adipose-derived expanded stem cells

Primary Outcome Measures

Name	Time	Method
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 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 collection

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain