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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615454
• Other study ID #: BEMER
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: March 2023
• Source: Imam Abdulrahman Bin Faisal University
• Contact: Abdulaziz A Alzahrani, PhDcandidate
• Phone: +966500324592
• Email: 2210700007[@]iau.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Device:
• bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product).
The experimental group (receive the BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise.
• placebo BEMER
Comparison group (receive placebo BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise.

Locations

Country	Name	City	State
Saudi Arabia	Ali Muteb Alshami	Dammam
Saudi Arabia	Imam Abdulrahman Bin Faisal University	Dammam

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Erection Hardness Scale (EHS)	The EHS is used to rate the hardness of a penile erection. The patient will be asked: How would you rate the hardness of your erection? EHS has a 5-point Likert scale from 0 (penis does not enlarge) to 5 (the penis is completely hard and fully rigid)	Within immediately of completion of the 3-week intervention period.
Primary	International 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.	Change from Baseline Erectile Function at 3 weeks
Secondary	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	Within immediately of completion of the 3-week intervention period.
Secondary	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.	Within immediately of completion of the 3-week intervention period.
Secondary	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)	Within immediately of completion of the 3-week intervention period.