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

Sponsor
Egymedicalpedia (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05295420
Collaborator
Al-Azhar University (Other)
20
1
1
4
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: platelet rich plasma
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Role of Platelet Rich Plasma Injections in Cases of Stress Incontinence
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: platelet-rich plasma

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

Procedure: platelet rich plasma
Injection of Platelet Rich Plasma in the female conditions that suffer from SUI

Outcome Measures

Primary Outcome Measures

  1. urinary incontinence severity by PRP treatment [From baseline to 3 months after the PRP treatment day.]

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

Secondary Outcome Measures

  1. Patients can control voiding on stress [From baseline to first month and continued to 3 months after the treatment day]

    Assessment of the patient urine control status as daily pad use, maximum flow rate, and urine residual.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 SAYED GALAL HOSPITAL, AND AlGalaaTeaching HOSPITAL Cairo Egypt

Sponsors and Collaborators

  • Egymedicalpedia
  • Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Egymedicalpedia
ClinicalTrials.gov Identifier:
NCT05295420
Other Study ID Numbers:
  • 002
First Posted:
Mar 25, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022