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

NCT ID: NCT06691334

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-03-01

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 .

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A: 10 cases will be group which is PRP injection 2 ml below urethra in one month interval.

Procedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under urethra.

Group Type: ACTIVE_COMPARATOR

PRP injection

Intervention Type: DEVICE

Active comparator: PRP 3 cycles of platelet-rich plasma injection treatment in 4 weeks intervals. Procedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under the urethra. Cycle patient will examined and asked to fill daily micturition plan International consolation on incontinence questionnaire-urinary incontinence short form (ICIQ UI SF), urogenital distress inventory (UDI-6), incontinence impact questionnaire (11Q-7) and over active bladder symptoms scores (OABSS).

Group B: 10 cases will be group B which is PRP combined together with vaginal HIFU.

Procedure: 3 cycles of vaginal HIFU together with 3 cycles of platelet-rich plasma injection treatment in 4 weeks intervals

Group Type: ACTIVE_COMPARATOR

Hifu procedure and PRP injection

Intervention Type: DEVICE

Procedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under urethra.And intravaginal Hifu in4 weeks intervals. Cycle patient will examined and asked to fill daily micturition plan International consolation on incontinence questionnaire-urinary incontinence short form (ICIQ UI SF), urogenital distress inventory (UDI-6), incontinence impact questionnaire (11Q-7) and over active bladder symptoms scores (OABSS).

Interventions

PRP injection

Active comparator: PRP 3 cycles of platelet-rich plasma injection treatment in 4 weeks intervals. Procedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under the urethra. Cycle patient will examined and asked to fill daily micturition plan International consolation on incontinence questionnaire-urinary incontinence short form (ICIQ UI SF), urogenital distress inventory (UDI-6), incontinence impact questionnaire (11Q-7) and over active bladder symptoms scores (OABSS).

Intervention Type: DEVICE

Hifu procedure and PRP injection

Procedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under urethra.And intravaginal Hifu in4 weeks intervals. Cycle patient will examined and asked to fill daily micturition plan International consolation on incontinence questionnaire-urinary incontinence short form (ICIQ UI SF), urogenital distress inventory (UDI-6), incontinence impact questionnaire (11Q-7) and over active bladder symptoms scores (OABSS).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Women complain of SUI is the symptom of urinary leakage due to increased abdominal pressure, which can be caused by activities such as sneezing, coughing, exercise, lifting, and position change (American Urological Association 2017).
• Positive cough test when filled urinary bladder.
• Women chose non-invasive management rather than surgical management. • • Among the 20 patients enrolled, the average age was 30-60 years old.
• Urodynamic study proven the diagnosis.

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dina Mohamed Ahmed Srour

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina Srour, MS

Role: STUDY_DIRECTOR

Ain Shams Maternity Hospital Egypt Ain Shams University Maternity Hospital

Locations

Ain Shams University Maternity Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Urinary incontinence

Identifier Type: -

Identifier Source: org_study_id