Study on the safety and efficacy of autologous platelet-rich plasma (PRP) in treatment of female stress urinary incontinence

Not Applicable

Recruiting

• Conditions: stress urinary incontinence

• Registration Number: JPRN-jRCTc030230394
• Lead Sponsor: Abe Hirokazu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-16
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified