PRP & PDO Threads in Treatment of Stress Incontinence

Not Applicable

Recruiting

• Conditions: Stress Incontinence, Female

• Registration Number: NCT06885463
• Lead Sponsor: Al-Azhar University

Brief Summary

The study will include 10 women with pure or predominant SUI symptoms, with severe urodynamic stress incontinence on urodynamics defined as loss of urine with sudden increases in abdominal pressure: eg, coughing, sneezing, or laughing). This will be conducted at the Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University. The purpose of study is to evaluate the efficacy and safety of platelets rich plasma combined with PDO threads in the treatment of stress incontinence in Egyptian women.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-01
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

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

Inclusion Criteria

• Nonpregnant Women with SUI
• Age between 20 to 45 years
• Patients had a history of failed conservative treatment
• Patients were on the waiting list for surgical treatment of SUI

Exclusion Criteria

• Under anti-platelet agent treatment
• Under NSAIDs
• Platelet dysfunction syndrome
• Critical thrombocytopenia
• Hypofibrionogenaemia
• Sepsis
• Acute and chronic infections
• Chronic liver disease
• Anti-coagulation therapy
• History of malignancy
• Pregnancy
• history of active malignant pathology
• mental disorders making them unable to give consent
• genitourinary fistula
• pelvic organs prolapse stage >2 according to the Pelvic Organ Prolapse Quantification system, and detrusor overactivity on urodynamics.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
evaluation of reported SUI symptoms	After 4 months	subjective evaluation of reported SUI symptoms, indicated by the patient's response to question of the ICIQ-FLUTS questionnaire: "Does urine leak when you are physically active, exert yourself, cough or sneeze?"

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University.; 🇪🇬 Cairo, Egypt