PRP & PDO Threads in Treatment of Stress Incontinence

NCT ID: NCT06885463

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-06-30

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.

Conditions

Stress Incontinence, Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

platelets rich plasma combined with PDO threads

Group Type: EXPERIMENTAL

platelets rich plasma combined with PDO threads

Intervention Type: PROCEDURE

1. Injections of platelets-rich plasma in the Anterior Vaginal Wall.

2. PDO thread placement in the paraurethral, lateral urethrovaginal, and suburethral areas

Interventions

platelets rich plasma combined with PDO threads

1. Injections of platelets-rich plasma in the Anterior Vaginal Wall.

2. PDO thread placement in the paraurethral, lateral urethrovaginal, and suburethral areas

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Asem Anwar Moussa

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University.

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Asem Moussa, Professor

Role: primary

dramoussa77@hotmail.com

+201001414226

Other Identifiers

00000501

Identifier Type: -

Identifier Source: org_study_id