Comparison Between Two Techniques in Treatment of Female Stress Urinary Incontinence

January 16, 2026 updated by: Marwa Reda Mohamed Gebril, Kafrelsheikh University

Comparison Between the Effect of Periurethral Injection of Platelet-rich Plasma VS Platelet Rich Fibrin in Treatment of Female Stress Urinary Incontinence

compare the therapeutic effect of periurethral injection of autologous platelet-rich plasma (PRP) and injectable platelet rich fibrin (i-PRF) in treatment of female stress urinary incontinence and comparing the need for re-injection in the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

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
      • Kafr ash Shaykh, Egypt
        • Kafr Elsheikh University Hospital

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients with primary symptoms of SUI confirmed by patient's medical history and clinical examination, including a focused incontinence evaluation

    • Age range of 30-75 years
    • Females unfit for surgery
    • Females with SUI recurrence after previous surgical procedure by suburethal sling
    • Females refusing surgical interventions

Exclusion Criteria:

  • Residual urine volume exceeding 100 cc after excretion
  • Evidence of detrusor over-activity on the urodynamic test
  • Active urinary tract or vaginal infection
  • Malignancies of the genitourinary system
  • Patients with genitourinary fistula or urethral diverticulum

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group one who had received PRP injections
Biological: Platelet Rich Plasma
Approximately 5 mL of PRP will be injected at three points (on both sides of the urethra and urethrovaginal space) under local anesthesia. Injections will be performed by gynecologist in the outpatient clinic.
Active Comparator: group two who had received i-PRF injections
Biological: Platelet rich fibrin
Approximately 5 mL of i-PRF will be injected at three points (on both sides of the urethra and urethrovaginal space) under local anesthesia. Injections will be performed by gynecologist in the outpatient clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in the severity of SUI measured by Incontinence Impact Questionnaire (IIQ7)
Time Frame: baseline and three and six months follow up
baseline and three and six months follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in the severity of SUI using 10 point visual analogue scale
Time Frame: baseline and three and six months follow up
baseline and three and six months follow up

Collaborators and Investigators

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

Sponsor

Kafrelsheikh 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)

July 10, 2024

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

January 2, 2026

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KFSIRB200-320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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