The Effect of Periurethral Injection of Platelet Rich Plasma Versus Mid-urethral Sling in Treatment of Stress Urinary Incontinence : a Randomized Clinical Trial

April 18, 2026 updated by: Ain Shams University
this study used to compare efficacy between platelet rich plasma periurethral injection versus mid urethral sling ( trans obturator tape ) in treatment of stress urinary incontinence

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

stress urinary incontinence classified in urodynamic study according to Valsalva leak point pressure to intrinsic sphincteric muscle weakness best treated by PRP periurethral injection and VLPP is less than or equal 60cmH2O and MUCP less than 20cmH2O(21 ) patients enrolled in this group , while hypermobile urethra identified by VLPP is high more than 90cmh2O best treated by trans obturator tape(21) patients recruited in this group , mode of preparation of PRP is by withdrawing 15 ml blood and placed in falcon tube with ACD ( acid citrate dextrose) added centrifuged first at 800 RPM and then the supernatant removed and re-centrifuged again at 3500 RPM and then injected periurethral by 5cc syringe with 30G needle after applying 2% lidocaine ,patient assessed at one and three month objectively by cough stress test and subjectively by ICIQ questionnaire and presence of any adverse effect

Study Type

Interventional

Enrollment (Estimated)

42

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 Contact

Study Contact Backup

  • Name: mahmoud mohamed Ghaleb, Doctor of medicine
  • Phone Number: 02 01007212975

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:

  • stress urinary incontinence identified by urodynamic study
  • patient agreement to undergo surgical treatment

Exclusion Criteria:

  • previous GUS operation
  • evidence of detrusor overactivity urinary system
  • presence of pelvic organ prolapse
  • malignancies of genitourinary system
  • history of hemorrhagic disorders , on anti platelet treatment , uncontrolled diabetes mellitus .

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: patients complaining of stress urinary incontinence based on urodynamic study
GROUP 1: 21 patients allocated who have SUI ISD will receive PRP GROUP 2: 21 patient who have hypermobile urethra will receive TOT
Procedure: Platelet Rich Plasma
GROUP 1 : 21patient will have platelet rich plasma injected periurethral in intrinsic muscle weakness in stress urinary incontinence
Procedure: Mid urethral sling ( trans obturator tape)
GROUP 2 : (21) patient having SUI due to hypermobile urethra will have TOT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
objective assessment of SUI through cough stress test
Time Frame: after one and three months
after one and three months

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: mohamed Abdelhamid nasr El Din, Doctor of medicine, urogynecology unit ainshams 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 (Estimated)

April 15, 2026

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

April 18, 2026

First Submitted That Met QC Criteria

April 18, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD285/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

in informed consent all participants information will be only known by the research and investigator committee and their personal information will be kept with confidentiality

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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