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

NCT ID: NCT05295420

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-06-30

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.

Conditions

Stress Urinary Incontinence; Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

platelet-rich plasma

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

Group Type: EXPERIMENTAL

platelet rich plasma

Intervention Type: PROCEDURE

Injection of Platelet Rich Plasma in the female conditions that suffer from SUI

Interventions

platelet rich plasma

Injection of Platelet Rich Plasma in the female conditions that suffer from SUI

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: collaborator

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SAYED GALAL HOSPITAL, AND AlGalaaTeaching HOSPITAL

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Ahmed Tahoon

Identifier Type: -

Identifier Source: org_study_id