Effect of High Tone Power Therapy on Bladder Disturbance

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT06837675
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study First Submitted: 2025-01-25
• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted QC: 2025-02-15
• Last Update Submitted: 2025-02-15
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Primary Completion: 2026-01
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
over active bladder symptom score (OABSS)	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
Urodynamic study	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
MS bladder check tool	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 international Consultation on Incontinence Questionnaire Short Form (ICIQ-UI)	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.

Trial Locations

Locations (1)

faculty of physical therapy, Cairo university; 🇪🇬 Cairo, Egypt