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

A

Ain Shams Maternity Hospital

Status

Completed

Conditions

Urinary Incontinence

Treatments

Device: Hifu procedure and PRP injection
Device: PRP injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06691334
Urinary incontinence

Details and patient eligibility

About

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.

Full 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 .

Enrollment

20 patients

Sex

Female

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Group A: 10 cases will be group which is PRP injection 2 ml below urethra in one month interval.
Active Comparator group
Description:
Procedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under urethra.
Treatment:
Device: PRP injection
Group B: 10 cases will be group B which is PRP combined together with vaginal HIFU.
Active Comparator group
Description:
Procedure: 3 cycles of vaginal HIFU together with 3 cycles of platelet-rich plasma injection treatment in 4 weeks intervals
Treatment:
Device: Hifu procedure and PRP injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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