Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis

Imam Abdulrahman Bin Faisal University

Status: Enrolling

Conditions: Multiple Sclerosis, Relapsing-Remitting; Erectile Dysfunction Due to Diseases Classified Elsewhere

Treatments: Device: bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product).; Device: placebo BEMER

Study type: Interventional

Funder types: Other

Identifiers

NCT05615454

BEMER

Details and patient eligibility

About

Multiple sclerosis (MS) is an inflammatory disease that affects the brain and spinal cord. There are potential impacts on neurological functions, including sensory and autonomic functions. The Primary observed in males with MS is erectile dysfunction (ED), which substantially impacts the quality of life. There is increasing literature on electromagnetic fields' biological and clinical effects, particularly on ED.

Full description

The study aims to examine the bio-electromagnetic energy regulation therapy (BEMER) on erectile dysfunction with MS. We will recruit participants with MS having ED in a Triple-blind randomized clinical trial study. All participants will be randomly assigned to either an experimental group (receive the BEMER therapy) or a comparison group (receive placebo BEMER therapy) for five days/week for three weeks. Participants will also receive pelvic floor exercises in both groups.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of MS according to the McDonald Revised criteria.
• Score 6-25 on the International Index of Erectile Function 15 (IIEF-15) will be recruited.
• Had sexual activity in the past month.
• Have Relapsing-remitting MS (RRMS) type and one month of clinical relapse, at least before the experimental study date.

Exclusion criteria

• If they have cognitive impairment that causes problems in answering the questionnaire.
• History of major chronic illness or other neurological disorders.
• Received any treatment for ED in the past seven days
• Previous therapy with a pulsed electromagnetic field, epilepsy, pacemaker, and acute bacterial infection with fever.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

(BEMER activated)

Treatment:

Device: bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product).

Comparison group

Placebo Comparator group

Description:

(BEMER deactivated)

Treatment:

Device: placebo BEMER