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The Role of Platelet Rich Plasma Injections in Cases of Stress Incontinence

Primary Purpose

Stress Urinary Incontinence, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
platelet rich plasma
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

35 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female patient with mild to moderate SUI

Exclusion Criteria:

  • Under anti-platelet agent treatment
  • Platelet dysfunction syndrome
  • Critical thrombocytopenia
  • Acute and chronic infections
  • Anti-coagulation therapy
  • History of malignancy

Sites / Locations

  • SAYED GALAL HOSPITAL, AND AlGalaaTeaching HOSPITAL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

platelet-rich plasma

Arm Description

to assess the role of platelet-rich plasma in the treatment of SUI as a non-invasive method

Outcomes

Primary Outcome Measures

urinary incontinence severity by PRP treatment
Assessment of urinary incontinence severity by visual analog scale as: from 0 -10,

Secondary Outcome Measures

Patients can control voiding on stress
Assessment of the patient urine control status as daily pad use, maximum flow rate, and urine residual.

Full Information

First Posted
February 27, 2022
Last Updated
July 6, 2023
Sponsor
Egymedicalpedia
Collaborators
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05295420
Brief Title
The Role of Platelet Rich Plasma Injections in Cases of Stress Incontinence
Official Title
The Role of Platelet Rich Plasma Injections in Cases of Stress Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia
Collaborators
Al-Azhar University

4. Oversight

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

5. Study Description

Brief Summary
Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). It is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall. Current SUI treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure.
Detailed Description
Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation. Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). It is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall. Current SUI treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure. The mid-urethral sling (MUS) has become the preferred procedure, as it is less invasive than the Burch colposuspension. However, the MUS procedure has a 5-20% failure rate and carries risks such as infection, voiding dysfunction, hemorrhage, pain, bladder or urethral injury, and mesh erosion. Hence, there is a need for alternative efficacious, outpatient SUI treatments. Platelet-derived therapies are a growing trend across multiple medical and surgical specialties. Evidence suggests that platelets play an important role in tissue repair, vascular remodeling and inflammatory and immune responses through secretion of growth factors, cytokines, and chemokines. These biologically active proteins include transforming growth factor-β, platelet-derived growth factor, platelet-derived epithelial growth factor, insulin-like growth factor, vascular endothelial growth factor. These growth factors are implicated in many aspects of natural wound healing, including chemotaxis, cell proliferation, cell differentiation. The key role of platelets in these processes makes them an attractive candidate for therapies aimed at accelerating natural healing. One of the most well-described platelet-based therapies is autologous platelet-rich plasma (PRP). PRP is derived from the centrifugation of whole blood with a separator gel to remove the red and white blood cells. The resulting supernatant has a greater than four-fold increase in platelets and other plasma proteins. This concentrate is then administered via injection.

6. Conditions and Keywords

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

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 (Actual)

8. Arms, Groups, and Interventions

Arm Title
platelet-rich plasma
Arm Type
Experimental
Arm Description
to assess the role of platelet-rich plasma in the treatment of SUI as a non-invasive method
Intervention Type
Procedure
Intervention Name(s)
platelet rich plasma
Intervention Description
Injection of Platelet Rich Plasma in the female conditions that suffer from SUI
Primary Outcome Measure Information:
Title
urinary incontinence severity by PRP treatment
Description
Assessment of urinary incontinence severity by visual analog scale as: from 0 -10,
Time Frame
From baseline to 3 months after the PRP treatment day.
Secondary Outcome Measure Information:
Title
Patients can control voiding on stress
Description
Assessment of the patient urine control status as daily pad use, maximum flow rate, and urine residual.
Time Frame
From baseline to first month and continued to 3 months after the treatment day

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female patient with mild to moderate SUI Exclusion Criteria: Under anti-platelet agent treatment Platelet dysfunction syndrome Critical thrombocytopenia Acute and chronic infections Anti-coagulation therapy History of malignancy
Facility Information:
Facility Name
SAYED GALAL HOSPITAL, AND AlGalaaTeaching HOSPITAL
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Role of Platelet Rich Plasma Injections in Cases of Stress Incontinence

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