PRP & PDO Threads in Treatment of Stress Incontinence

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.

Recruiting

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Key information

Conditions

Stress Incontinence, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Egypt

Location status: Recruiting

Location contact

Asem Moussa, Professor

CONTACT

[email protected]

+201001414226

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

platelets rich plasma combined with PDO threads

Procedure

Injections of platelets-rich plasma in the Anterior Vaginal Wall.
PDO thread placement in the paraurethral, lateral urethrovaginal, and suburethral areas

Primary outcomes

evaluation of reported SUI symptoms

Time frame: 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?"

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

The Role of Platelets Rich Plasma Combined With PDO Threads in Treatment of Stress Incontinence in Egyptian Women

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 20, 2025
Registry last updated: Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed