PRP & PDO Threads in Treatment of Stress Incontinence

NCT06885463 | Recruiting

• 1 other identifier: 00000501
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• evaluation of reported SUI symptoms

  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?"

  After 4 months

Study Arms (1)

platelets rich plasma combined with PDO threads

EXPERIMENTAL

Procedure: platelets rich plasma combined with PDO threads

Interventions

platelets rich plasma combined with PDO threads PROCEDURE

1. Injections of platelets-rich plasma in the Anterior Vaginal Wall. 2. PDO thread placement in the paraurethral, lateral urethrovaginal, and suburethral areas

platelets rich plasma combined with PDO threads

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

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

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 20, 2025
• Study Start: March 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

EG (1)