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

NCT06691334 | Completed

• 1 other identifier: Urinary incontinence
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• one month after complete three sessions ,the rate of Improvement of the urinary incontinence increased.

  One month after complete three sessions

Study Arms (2)

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

ACTIVE COMPARATOR

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

Device: PRP injection

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

ACTIVE COMPARATOR

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

Interventions

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

Hifu procedure and PRP injection 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).

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

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dina Srour, MS

  Ain Shams Maternity Hospital Egypt Ain Shams University Maternity Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 15, 2024
• Study Start: March 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

EG (1)