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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: PRP injection; Device: Hifu procedure and PRP injection

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Ain Shams University Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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).
Active Comparator: 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	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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Director: Dina Srour, MS, Ain Shams Maternity Hospital Egypt Ain Shams University Maternity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: urinary incontinence

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No