Effect of High Tone Power Therapy on Bladder Disturbance

February 15, 2025 updated by: Mohamed Hamdy Hussien Samy, Cairo University

Effect of High Tone Power Therapy on Bladder Disturbance in Patients with Multiple Sclerosis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Inflammation, demyelination, gliosis, and neuronal loss are all components of multiple sclerosis (MS), is a chronic autoimmune disease that affects the central nervous system (CNS). Myelinated axons in the CNS are the target of MS attacks, which can cause varying degrees of damage to both myelin and axons ). MS affects 2.3 million people worldwide. MS is often diagnosed between the ages of 20 and 50 years, with females experiencing it more often than males. Among the most common MS symptoms are disorders of motor function and gait, spasticity, and sensory challenges including visual problems

. which are causes of disability that are possible to identify by observing from the outside. However, other frequent and disabling symptoms are invisible, including fatigue, cognitive deficits and decline, emotional distress, and pain. Dysfunction of the bladder and bowel are also hidden consequences of MS but rank among the most frequent and troublesome symptoms. it is estimated that 75-90 % of MS will experience bladder problems and up to 50 % of MS will experience bowel problems at some stage in their life. Bladder dysfunction is reported to cause major limitations in one's daily life, and contribute to decreased satisfaction with one's life situation and health Lesions above the pontine micturition center are usually associated with neurogenic detrusor overactivity (NDO), characterized by involuntary detrusor contractions 3 (urgency, frequency, urge incontinence, and no or low post-void residual urine).

Urgency is the sudden desire and intense sensation of needing to pass urine; frequency is the need to urinate many times during the day or at night (nocturia) or both, but in normal or less-than-normal volumes; urge incontinence is an involuntary urine leak while having symptoms of urgency. High-tone power therapy (HTT) is a unique characteristic of electrotherapy. It uses intermediate frequency, metal-compatible alternating current whose frequency oscillates between approximately 4000 Hz and 33000 Hz and intensity is adjusted, unlike traditional electrotherapies such as TENS. Its main effects are introducing energy into the body to activate cells, producing an oscillation or vibration in the cells and tissues to promote metabolism, normalizing the cell metabolism and nerve regeneration.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Faculty of physical therapy, Cairo University
        • Contact:
          • Amira M Eltohamy, professor doctor
          • Phone Number: 0237617691
          • Email: Info@pt.cu.edu.eg
        • Contact:
        • Contact:
          • Eman S Fayiz, Professor of physical therapy
        • Contact:
          • mohamed H Marzouk, lecturer of physical therapy
        • Contact:
          • Salma H Khalil, professor of neurology
        • Contact:
          • Amr M Sayed, ass. professor of neuroloy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. 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

Exclusion Criteria:

  • 1. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group 1
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
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
Other: selected physical therapy program
selected physical therapy protocol for 45 minutes 3 times per week for 3 months in form of pelvic floor exercises and core stability exercise
Active Comparator: Control group 2
twenty patients will receive a selected physical therapy program only 36 sessions 3 times per week for 3 months.
Other: selected physical therapy program
selected physical therapy protocol for 45 minutes 3 times per week for 3 months in form of pelvic floor exercises and core stability exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
over active bladder symptom score (OABSS)
Time Frame: the test will be done 3 days before the beginning of the study and 3 days after completion of the study.
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
Time Frame: the test will be done 3 days before the beginning of the study and 3 days after completion of the 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
Time Frame: the test will be done 3 days before the beginning of the study and 3 days after completion of the study.
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)
Time Frame: the test will be done 3 days before the beginning of the study and 3 days after completion of the study.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 25, 2025

First Submitted That Met QC Criteria

February 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 15, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/012/005399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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