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

Primary Purpose

Stress Incontinence, Female

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRP injection
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Incontinence, Female

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: stress incontinence patients Exclusion Criteria: prolapse patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Stress incontinence patients

    Arm Description

    PRP injection

    Outcomes

    Primary Outcome Measures

    Stress incontinence change
    Visual Assessment System assessment

    Secondary Outcome Measures

    Full Information

    First Posted
    August 14, 2023
    Last Updated
    August 19, 2023
    Sponsor
    Kasr El Aini Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06012370
    Brief Title
    Injecting Plasma-rich Platelets & Hyaluronic Acid for Patients With Stress Urinary Incontinence
    Official Title
    A Pilot Study of Injecting Plasma-rich Platelets and Hyaluronic Acid for Patients With Stress INCONTINENCE; A NON-RANDOMIZED CLINICAL TRIAL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2023 (Anticipated)
    Study Completion Date
    October 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kasr El Aini Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Injection of PRP and hyaluronic acid in stress incontinence patients
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Incontinence, Female

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stress incontinence patients
    Arm Type
    Other
    Arm Description
    PRP injection
    Intervention Type
    Procedure
    Intervention Name(s)
    PRP injection
    Intervention Description
    Injection of PRP and hyaluronic acid
    Primary Outcome Measure Information:
    Title
    Stress incontinence change
    Description
    Visual Assessment System assessment
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: stress incontinence patients Exclusion Criteria: prolapse patients

    12. IPD Sharing Statement

    Learn more about this trial

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

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