Assessment of Platelet Rich Plasma Injection in Managing Female Patients Complaining of Mixed Urinary Incontinence (PRP) (PRP)

January 5, 2025 updated by: Zagazig University

Assessment of Role of Platelet Rich Plasma in Managing Women with Mixed Urinary Incontinence

The goal of this clinical trial is to assess the efficacy of platelet-rich plasma (PRP) for the treatment of mixed urinary incontinence determine .The main question it aims to answer whether PRP is it safe and effective in managing mixed urinary incontinence? Researchers will assess efficacy of PRP in both stress and urgency incontinence treatment

Participants will:

  • Undergo PRP injection in to mid urethra , and installation into bladder every 1 month for 3 month
  • Visit the clinic once every 1 month for checkups and urodynamic study after 3 month, and 4 month after last installation

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients will be subjected to:

  • An informed consent will be taken from every patient.

  • Complete history taking:

    • Personal history
    • Any complaint.
    • Past medical and past surgical history.
    • Family history.

    • Severity of incontinence by International consultation on incontinence questionnaire- short form (ICIQ-SF), OAB symptom score ,Cough stress test

      *Complete physical examination.

    • General examination: Vital signs (Blood pressure, Temperature, Heart rate, Respiratory rate).
    • neurological examination: gait, perineal sensation, bulbocavernous reflex, cognitive status
    • abdominal examination : distended bladder, masses , hernia, DRE
    • Pelvic examination: vaginal atrophy, skin excoriation, vault examination, organ prolapse, pelvic floor muscle strength , cough test, Q tip test, Marshall test

    • urodynamics done for documentation of detrusor overactivity before and after PRP installation after 3rd instillation and 4 m after last instillation

      • patient is placed in the dorsal lithotomy position
      • PRP is obtained from a sample of patients' blood drawn at the time of treatment
      • A 30 cc venous blood draw will yield 3-5 cc of PRP
      • The blood draw occurs with the addition of an anticoagulant, such as citrate dextrose A( .5 ml)to prevent platelet activation prior to its use
      • in room temp 21-24 to avoid activation of platelet
      • a specialized 'table top cold centrifuge' device to centrifugate the sample
      • After centrifugation, each vial was confirmed to contain three layers from top to bottom, namely, the platelet pellet, gel, and red blood cells. The platelet pellet was remixed with the supernatant by inverting the tubes gently 5-10 times.
      • A-PRP was injected into the anterior vaginal mucosa around the mid-urethral area, which was approximately 1 cm below the urethral meatus and had a depth of about 1.5 cm; 2 mL were injected underneath the mid-urethral area and 1.5 mL was injected on either side of the urethra
      • 10ml PRP used to instill intravesical for urgency urinary incontinence by urethral catheter
      • patient received four injections of PRP at monthly intervals
      • follow up done after 3rd instillation and 4 months after finishing injections
      • follow up done by subjective symptoms as previous scoring system and objective by Urodynamics

Study Type

Interventional

Enrollment (Estimated)

24

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
      • Egypt, Egypt
        • Zagazig University
      • Zagazig, Egypt
        • Zagazig university hospital , Egypt

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:

  • Women with MUI ( mild and moderate degree of stress incontinence)
  • Age between 20 to 60 years -

Exclusion Criteria:

  • intrinsic sphincteric deficiency (ISD)
  • Pregnancy
  • Sepsis
  • Acute and chronic infections
  • Chronic liver disease
  • Anti-coagulation therapy
  • History of malignancy
  • Under anti-platelet agent treatment

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: PRP injection at midurethra with PRP instillation into urinary bladder

A-PRP was injected into the anterior vaginal mucosa around the mid-urethral area, which was approximately 1 cm below the urethral meatus and had a depth of about 1.5 cm; 2 mL were injected underneath the mid-urethral area and 1.5 mL was injected on either side of the urethra

*10ml PRP used to instill intravesical for urgency urinary incontinence by urethral catheter
Biological: Platelet Rich Plasma
PRP injection into the midurethra and its instillation into urinary bladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of females with treatment-related improvement of mixed urinary incontinence after receiving platelet-rich plasma (PRP) injection and instillation.
Time Frame: From enrollment to the end of intervention at 6 month "

Treatment -related improvement of urinary incontinence is assessed using:

  • International consultation on incontinence questionnaire- short form (ICIQ-SF).
  • OAB symptom score.
  • Cough stress test.

  • Urodynamics.

    1. ICIQ-Sf questionnaire before and after treatment: Scoring scale: 0-21, minimum 0, maximum 21. A higher score indicates greater impairment from incontinence.
    2. OAB symptom score: has a maximum score of 15 with more weight assigned to urgency and urgency incontinence than on frequency. Higher score indicates greater impairment from incontinence.
    3. Urodynamics: for assessment of of detrusor over-activity before and after treatment.
From enrollment to the end of intervention at 6 month "

Collaborators and Investigators

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

Sponsor

Zagazig 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)

December 28, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 29, 2024

First Submitted That Met QC Criteria

January 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 5, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 782/29-oct-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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