PRP & PDO Threads in Treatment of Stress Incontinence

March 18, 2025 updated by: Asem Anwar Moussa, Al-Azhar University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: platelets rich plasma combined with PDO threads
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?"
After 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00000501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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