Effect of High Tone Power Therapy on Bladder Disturbance

NCT06837675 | Not Yet Recruiting DMC

• 1 other identifier: REC/012/005399
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to investigate the effect of high-tone power therapy on improving bladder function and quality of life in patients with MS.

Conditions

Multiple Sclerosis

Keywords

overactive bladder

Outcome Measures

Primary Outcomes (4)

• over active bladder symptom score (OABSS)

  Assessment scale for overactive bladder syndrome. It consists of 4 questions about frequency, nocturnal, urgency, and urge incontinence. Total score from 0 to 15

  the test will be done 3 days before the beginning of the study and 3 days after completion of the study.

• Urodynamic study

  The urodynamic study is the golden objective for assessing the bladder's physiological and pathological functions. The test involves an invasive assessments of bladder storage function and bladder emptying function

  the test will be done 3 days before the beginning of the study and 3 days after completion of the study.

• MS bladder check tool

  it is a check tool that aims to improve the management of people with Multiple sclerosis.

  the test will be done 3 days before the beginning of the study and 3 days after completion of the study.

• The international Consultation on Incontinence Questionnaire Short Form (ICIQ-UI)

  The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world.

  the test will be done 3 days before the beginning of the study and 3 days after completion of the study.

Study Arms (2)

Study group 1

EXPERIMENTAL

twenty patients will receive High tone power therapy and selected physical therapy program 36 sessions 3 times per week for 3 months.

Device: high tone power therapy; Other: selected physical therapy program

Control group 2

ACTIVE COMPARATOR

twenty patients will receive a selected physical therapy program only 36 sessions 3 times per week for 3 months.

Other: selected physical therapy program

Interventions

high tone power therapy DEVICE

High tone Power therapy (HiToP191-H) device is a new electrotherapy technology. Its primary impact on the body is to provide energy to the body to activate cells and rebuild it. It can cause an oscillation or vibration that promotes metabolism, nand erve regeneration and relieves pain by dispersing pain and inflammation mediators, nutrients, and waste products

Study group 1

selected physical therapy program OTHER

selected physical therapy protocol for 45 minutes 3 times per week for 3 months in form of pelvic floor exercises and core stability exercise

Control group 2; Study group 1

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Patients diagnosed with MS complaining of bladder disturbance referred by neurologist with a urodynamic study 2. Patients age will be ranged from 20 to 50 years old 3. Body mass index from (18.5 to 24.9) 4. Score of disability 2 to 6 according to EDSS 5. Patients with overactive bladder at least 6 months before the study 6. The severity of overactive bladder OAB will range from 6 to 10 according to overactive bladder symptom score (moderate stage) (OABSS). 7. All the patients will be in the remission period. 8. All the patients will receive the same medical treatment. 9. All the drugs that interfere with bladder function will be stopped. 10. Patients must be medically stable. 11. Patients able to respond to verbal instructions

You may not qualify if:

• \. Unstable cardiac condition (MI, severe cardiac failure) 2. Systemic diseases (DM, RA, AKI) 3. Patients with musculoskeletal deformities 4. Any tumor affects the lumber spine 5. Patients with cognitive problems 16 6. Open wound, burn, and loss of sensation 7. Patients with metal implants 8. Any other diseases that may cause OAB, such as inflammatory or urinary tract infections, Prostatitis in male or Female genital disorders 9. Patients with a history of abdominal or bladder surgeries or diseases 10. MS patients in acute relapse stage 11. Patients with diabetic polyneuropathy

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy, Cairo university

Cairo, Cairo Governorate, 02, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urinary Bladder Diseases; 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

Central Study Contacts

Mohamed H Hussien, masters

CONTACT

02 01068256257; Doctormohamedhamdy@gmail.com

jasmine M Mahmoud, lecturar assistant

CONTACT

02 01011426452; jasminemagdy1993@gmail.com

Study Design

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

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 20, 2025
• Study Start: February 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

EG (1)