Platelet Rich Plasma (PRP) and High Intensity Focused Ultrasound (HIFU) in Management of Stress Urinary Incontinence (SUI): Pilot Study

Not Applicable

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT06691334
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

Previous studies Results show (PRP) is safe and effective in treating SUI, other studies show the result of energy base devices (Co2 laser, HIFU) are effective in treating of SUI .

This study add the effect both HIFU and PRP together in treating SUI.

Detailed Description

What is stress urinary incontinence (SUI)? Stress urinary incontinence (SUI) is when urine leaks out with sudden pressure on the bladder and urethra, causing the sphincter muscles to open briefly. With mild SUI, pressure may be from sudden forceful activities, like exercise, sneezing, laughing or coughing. If your SUI is more severe, you may also leak with less forceful activities like standing up, walking or bending over. Urinary "accidents" like this can range from a few drops of urine to enough to soak through the clothes SUI is a very common bladder problem for women. Key SUI statics About half of women age 65 and above find that they sometimes leak urine. How can SUI Affect life? Many people find that SUI gets in the way of daily and social activities. It can affect family and sexual relationships. Some people even begin to feel isolated and hopeless because of it The pelvic floor supports the bladder and urethra. If this area gets stretched, weakened or damaged, then SUI can happen. Pregnancy and childbirth can cause this.

PRP is extremely rich in growth factors and cytokines which regulate tissue reconstruction, PRP is an easily procedure and relatively inexpensive biological material, it is produce directly from patient blood and inject PRP under urethra to restore bulbourethral ligment .

HIFU is an energy-based medical technology with many clinical applications, a device is a non-invasive procedure that provides collagen remodeling and synthesis that may repair and restore pelvic floor and pubourethral ligment, it is non-invasive therapeutic technique, that uses non-ionized ultrasonic waves that provides collagen that tight the endopelvic fascia and adjacent tissues .

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-09-01
• Study Completion: 2023-03-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Study First Posted: 2024-11-15
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

• Patient of previous operation or radiation
• Uncontrolled diabetes Neuromuscular disorder
• Uncontrolled psychiatric diseases
• Pregnancy
• Lactation
• Virgin
• Sepsis
• Active carcinoma
• Cystocele.
• Antiplatelet drug intake less than 7 days before and after procedure. - bleeding disorder.
• Patients cannot deal with Questionnaires.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
After one month of first session, the rate of Improvement of the stress urinary incontinence increased .	One month after first session	Self-reported questionnaires were used to measure pre-Treatment symptom severity and post treatment symptom and severity.

Secondary Outcome Measures

Name	Time	Method
one month after complete three sessions ,the rate of Improvement of the urinary incontinence increased.	One month after complete three sessions	Self-reported questionnaires were used to measure pre-Treatment symptom severity and post treatment symptom and severity.

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt