Clinical trial NCT05615454: Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis
Official title: Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction Due to Diseases Classified Elsewhere
Multiple Sclerosis, Relapsing-Remitting
Keywords: BEMER
Erectile Dysfunction
Multiple Sclerosis
bio-electromagnetic energy regulation therapy
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention will be provided by a treating therapist who has a clinical experience of more than 13 years. The intervention for both groups will be for three consecutive weeks, five days per week (a total of 15 sessions)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: International Index of Erectile Function - Erectile Function (IIEF-EF)
timeFrame: Change from Baseline Erectile Function at 3 weeks
Secondary outcomes:
measure: The Arizona Sexual Experience (ASEX) Scale
timeFrame: Within immediately of completion of the 3-week intervention period.
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Within immediately of completion of the 3-week intervention period.
measure: The Multiple Sclerosis, Intimacy, and Sexuality Questionnaire (MSISQ-19)
timeFrame: Within immediately of completion of the 3-week intervention period.
Other outcomes:
measure: Erection Hardness Scale (EHS)
timeFrame: Within immediately of completion of the 3-week intervention period.
Locations:
city: Dammam
country: Saudi Arabia
facility: Ali Muteb Alshami
city: Dammam
country: Saudi Arabia
facility: Imam Abdulrahman Bin Faisal University
Study officials:
affiliation: imam abdurhman bin faisal
name: Abdulaziz A Alzahrani, PhDcandidate
role: PRINCIPAL_INVESTIGATOR
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