PRP & PDO Threads in Treatment of Stress Incontinence

Al-Azhar University

Status: Enrolling

Conditions: Stress Incontinence, Female

Treatments: Procedure: platelets rich plasma combined with PDO threads

Study type: Interventional

Funder types: Other

Identifiers

NCT06885463

00000501

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

platelets rich plasma combined with PDO threads

Experimental group

Treatment:

Procedure: platelets rich plasma combined with PDO threads