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NCT Number: NCT06837675

Effect of High Tone Power Therapy on Bladder Disturbance

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy, Cairo university

Cairo, Cairo Governorate, 02, Egypt

Location contact

Amira M Eltohamy, professor doctor

CONTACT

[email protected]

0237617691

Amr M Sayed, ass. professor of neuroloy

PRINCIPAL_INVESTIGATOR

Eman S Fayiz, Professor of physical therapy

PRINCIPAL_INVESTIGATOR

Mohamed H Hussien, physical therapy specialist

CONTACT

[email protected]

0201068256257 ext. 0201011426452

Salma H Khalil, professor of neurology

PRINCIPAL_INVESTIGATOR

mohamed H Marzouk, lecturer of physical therapy

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed H Hussien, masters

CONTACT

[email protected]

02 01068256257

jasmine M Mahmoud, lecturar assistant

CONTACT

[email protected]

02 01011426452

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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