Stress urinary incontinence
Conditions
Interventions
The pre therapy evaluation includes: clinical evaluation, general and gynecological physical examination, performance of pad test and urodynamic study, and completion of voiding diary and quality of l
or adipose tissue biopsy of the abdominal wall (20 ml) with general anesthesia in a hospital environment
on a single occasion.
60 women with stress urinary incontinence will be divided into 3 groups and will receive cell therapy through periurethral injection of single-dose of stem cells derived from ad
MDSC: 10 million stem cells derived from skeletal muscle
Group 2- n: 20
BMSC: 10 million stem cells derived from bone marrow
Group 3- n: 20
ADSC: 10 million stem cells derived from adipose tissue
Participants will be evaluated 7-15 days after the biopsy
7-10 days after cell therapy, and then at 3 months, 6 months and 12 months post treatment. A clinical examination, an absorbent test and a quality of life questionnaire will be performed at 3, 6 and 1
Biological/vaccine
Procedure/surgery
Sponsors
Universidade Federal de São Paulo
Hospital Israelita Albert Einstein
Stemcorp
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inclusion criteria. 1. Patients with moderate primary and refractory stress urinary incontinence confirmed by stress cough test; or during urodynamic study; or during the pad test.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Patients with prolapse of anterior or uterine vaginal wall greater than stage 2 POP-Q; Patients submitted to surgical procedures to repair previous SUI; Patients with genital malformations that make it impossible to inject at the site of middle third of the urethra; Patients submitted to previous pelvic radiotherapy; Patients who during clinical evaluation or urodynamics present other diagnoses that not only SUI; Patients who did not agree to participate in the study at any stage or the ones who are not able to read, write and understand the study; Patients <18 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate women after cell therapy using objective parameters for urinary losses: Cough test, pad test and Valsalva leak point pressure through urodynamic study.;The objective of this study is to evaluate the effects of the therapy with periurethral injection of MDSC, BMSC and ADSC in women with stress urinary incontinence. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate after cell therapy using subjective parameters through the application of a specific quality of life questionnaire for SUI (I-Qol). | — |
Countries
Brazil
Contacts
Public ContactMaria Augusta Bortolini
Universidade Federal de São Paulo
Outcome results
None listed