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

March 7, 2023 updated by: Abdulaziz Alzahrani, Imam Abdulrahman Bin Faisal University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Saudi Arabia
      • Dammam, Saudi Arabia, 31451
        • Recruiting
        • Ali Muteb Alshami
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abdulaziz A Alzahrani, PhDCandidate
      • Dammam, Saudi Arabia, 31451
        • Recruiting
        • Imam Abdulrahman Bin Faisal University
        • Contact:
        • Principal Investigator:
          • Abdulaziz A Alzahrani, PhDCandidate
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
(BEMER activated)
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 Comparator: Comparison group
(BEMER deactivated)
Device: placebo BEMER
Comparison group (receive placebo BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Index of Erectile Function - Erectile Function (IIEF-EF)
Time Frame: 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.
Change from Baseline Erectile Function at 3 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erection Hardness Scale (EHS)
Time Frame: Within immediately of completion of the 3-week intervention period.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imam Abdulrahman Bin Faisal University

Investigators

  • Principal Investigator: Abdulaziz A Alzahrani, PhDcandidate, imam abdurhman bin faisal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

March 30, 2024

Study Registration Dates

First Submitted

November 6, 2022

First Submitted That Met QC Criteria

November 11, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEMER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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