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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05295420
Enrollment
20
Registered
2022-03-25
Start date
2022-03-01
Completion date
2022-06-30
Last updated
2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence, Urinary Incontinence

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.

Interventions

PROCEDUREplatelet rich plasma

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

Sponsors

Al-Azhar University
CollaboratorOTHER
Egymedicalpedia
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
urinary incontinence severity by PRP treatmentFrom baseline to 3 months after the PRP treatment day.Assessment of urinary incontinence severity by visual analog scale as: from 0 -10,

Secondary

MeasureTime frameDescription
Patients can control voiding on stressFrom baseline to first month and continued to 3 months after the treatment dayAssessment of the patient urine control status as daily pad use, maximum flow rate, and urine residual.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026