stress urinary incontinence
Conditions
Interventions
Sponsors
Abe Hirokazu
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Stress urinary incontinence 2. Female whose consent acquisition date is more than 20 years and less than 85 years 3. Patients who can appropriately evaluate pain from start of screening to the end of observation 4. Patients who have received sufficient explanation using ICF and understand the contents, and who have obtained written consent to participate in the study group based on their free will 5. Patients who can follow the scedule established until the end of the examination period
Exclusion criteria
Exclusion criteria: 1. Patients who have a skin disease or infection at the administration site on the day of screening test or autologous platelet-rich plasma (PRP) administration, and who are at risk of infection due to injection 2. Patients with a history or complication of malignancy within 5 years before obtaining consent 3. Patients with more than 150 ml of residual urine 4. Patients with platelet abnormalities 5. Patients taking anticoagulants 6. Patients with thrombosis 7. Patients with hypofibrinogenemia 8. Patients with hemodynamic instability 9. Patients with sepsis 10. Patient with anemia 11. Patients with acute or chronic infections 12. Patients with infectious diseases (HBV, HCV, HIV), other serious diseases 13. Patients with chronic liver dysfunction 14. Patients who have a history or complication of drug dependence or alcoholism 15. Patients with mental illness such as depression, dementia, schizophenia and anxiety 16. Presence of a metal implant or any other contraindication to magnetic resonance imaging (MRI) 17. Patients iudged inappropriate by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy of autologous platelet-rich plasma (PRP) in treatment of female stress urinary incontinence Safety adverse drug reaction and adverse event such as infection, bleeding, and anaphylaxis laboratory evidence Efficacy GRA (Global Response Assessment) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of autologous platelet-rich plasma (PRP) in treatment of female stress urinary incontinence Efficacy VAS (Visual analogue scale) score The following evaluation will be performed on the amount of urinary incontinence Urinary incontinence amount Rate of decrease in urinary incontinence Number of urinary incontinence per day Number of urine pads per day Rate of decrease in the number of urinary incontinence | — |
Countries
Japan
Contacts
Public ContactRyoko Kohata
Kameda Medical Center
Outcome results
None listed