Injecting Plasma-rich Platelets & Hyaluronic Acid for Patients With Stress Urinary Incontinence

August 19, 2023 updated by: suzy abdelaziz Abdelhamid, Kasr El Aini Hospital

A Pilot Study of Injecting Plasma-rich Platelets and Hyaluronic Acid for Patients With Stress INCONTINENCE; A NON-RANDOMIZED CLINICAL TRIAL

Injection of PRP and hyaluronic acid in stress incontinence patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Operative details Dissection of the ant vag wall from the urethra and lower part of the bladder Identify the bladder neck using Foly s catheter injection of 1.5 to 2 ml PRP combined with Hyaluronic acid suburethra almost at the level of mid urethra (avoiding the bl neck) then closure of the vag wall ( after removal of the excess vag tissue.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

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:

  • stress incontinence patients

Exclusion Criteria:

  • prolapse patients

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
Other: Stress incontinence patients
PRP injection
Procedure: PRP injection
Injection of PRP and hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress incontinence change
Time Frame: 6 months
Visual Assessment System assessment
6 months

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

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)

September 1, 2023

Primary Completion (Estimated)

October 31, 2023

Study Completion (Estimated)

October 31, 2023

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 19, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 19, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBH-1572023

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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