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

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis, Relapsing-Remitting; Erectile Dysfunction Due to Diseases Classified Elsewhere
• Interventions: Device: placebo BEMER

• Registration Number: NCT05615454
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

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.

Study Timeline

• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2022-11-11
• Study First Posted: 2022-11-14
• Study Start: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09
• Primary Completion: 2023-12-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison group	placebo BEMER	(BEMER deactivated)

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Function - Erectile Function (IIEF-EF)	Change from Baseline Erectile Function at 3 weeks	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.

Secondary Outcome Measures

Name	Time	Method
The Arizona Sexual Experience (ASEX) Scale	Within immediately of completion of the 3-week intervention period.	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
Modified Fatigue Impact Scale (MFIS)	Within immediately of completion of the 3-week intervention period.	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.
The Multiple Sclerosis, Intimacy, and Sexuality Questionnaire (MSISQ-19)	Within immediately of completion of the 3-week intervention period.	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)

Trial Locations

Locations (2)

Ali Muteb Alshami; 🇸🇦 Dammam, Saudi Arabia

Imam Abdulrahman Bin Faisal University; 🇸🇦 Dammam, Saudi Arabia