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

Not Applicable

Completed

• Conditions: Urinary Incontinence; Stress Urinary Incontinence
• Interventions: Procedure: platelet rich plasma

• Registration Number: NCT05295420
• Lead Sponsor: Egymedicalpedia

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.

Study Timeline

• Study First Submitted: 2022-02-27
• Study Start: 2022-03-01
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-25
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

SAYED GALAL HOSPITAL, AND AlGalaaTeaching HOSPITAL; 🇪🇬 Cairo, Egypt