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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
The experimental group (receive the BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise.
Comparison group (receive placebo BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise.
Ali Muteb Alshami
Dammam, Saudi Arabia
RECRUITINGImam Abdulrahman Bin Faisal University
Dammam, Saudi Arabia
RECRUITINGInternational Index of Erectile Function - Erectile Function (IIEF-EF)
International Index of Erectile Function Erectile Function domain (IIEF-EF domain score) this means only questions 1, 2, 3, 4, 5, and 15 of IIEF-15.
Time frame: Change from Baseline Erectile Function at 3 weeks
The Arizona Sexual Experience (ASEX) Scale
The ASEX was designed to assess five significant aspects of sexual dysfunction: drive, arousal, penile erection/vaginal lubrication, capability to achieve orgasm, and orgasmic satisfaction. Items are measured on a 6-point scale (1-6), with higher scores reflecting impaired sexual function. This scale allows for quick detection of sexual dysfunction. Sexual dysfunction was defined as one ASEX total score of ≥19, 2, any one item with a score of 5 or 3, or any three items with a score of ≥4
Time frame: Within immediately of completion of the 3-week intervention period.
Modified Fatigue Impact Scale (MFIS)
The MFIS is a 21-item, multidimensional questionnaire that collects information about the effects of physical (9-item), psychosocial (2-item), and cognition (10-item) fatigue over the past four weeks. Participants ranked the 21 items on a 5-point Likert scale with anchors of never (0) and always (4). The optimal cutoff scores of the overall MFIS-A, physical/social, and cognitive subscales indicative of fatigue are 35.5, 18.5, and 15.5, respectively. Changes of 14.68 points or more may indicate a clinically significant change in fatigue in multiple sclerosis patients.
Time frame: Within immediately of completion of the 3-week intervention period.
The Multiple Sclerosis, Intimacy, and Sexuality Questionnaire (MSISQ-19)
The MSISQ-19 is the most accurate and widely used tool for exploring the impact of MS on sexual function, assessing all aspects of sexual life and all three levels of sexual dysfunction (Domingo et al., 2018). It is a 19-item self-report questionnaire assessing the effect of MS symptoms on sexual activity and general sexual satisfaction during the previous six months (Carotenuto et al., 2021). Each item is scored on a Likert scale (1=never, 2=rarely, 3=sometimes, 4=often, and 5=always). In addition to the overall score, the MSISQ-19 provides scores on three different subscales: primary sexual dysfunction (calculated by items 12, 16, 17, 18, and 19) , Secondary sexual dysfunction (calculated by items 1, 2, 3, 4, 5, 6, 8, 10, and 11) and tertiary sexual dysfunction (described by items 7, 9, 13, 14, and 15) (Carotenuto et al., 2021)
Time frame: Within immediately of completion of the 3-week intervention period.
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