Back to resultsEffect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis
Primary Purpose
Erectile Dysfunction Due to Diseases Classified Elsewhere, Multiple Sclerosis, Relapsing-Remitting
Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product).
placebo BEMER
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction Due to Diseases Classified Elsewhere focused on measuring BEMER, Erectile Dysfunction, Multiple Sclerosis, bio-electromagnetic energy regulation therapy
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.
Sites / Locations
- Ali Muteb AlshamiRecruiting
- Imam Abdulrahman Bin Faisal UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Comparison group
Arm Description
(BEMER activated)
(BEMER deactivated)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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)
Full Information
NCT ID
NCT05615454
First Posted
November 6, 2022
Last Updated
March 7, 2023
Sponsor
Imam Abdulrahman Bin Faisal University
1. Study Identification
Unique Protocol Identification Number
NCT05615454
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction Due to Diseases Classified Elsewhere, Multiple Sclerosis, Relapsing-Remitting
Keywords
BEMER, Erectile Dysfunction, Multiple Sclerosis, bio-electromagnetic energy regulation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The randomization sequence uses an online https://www.randomizer.org// procedure by an independent person not involved in the study. Matching is done using sequentially numbered, concealed opaque envelopes (SNOSE) for equal distribution of subjects between both therapies (Doig & Simpson, 2005). An independent assessor will assess eligibility by following the inclusion and exclusion criteria for treatment allocation. Then he will collect primary demographic data and conduct all outcome measurements pre-and post-treatment. If the participant is eligible, he chooses a sealed envelope placed in a box and goes to the treating therapist. The treating therapist will be blind to outcome measurements. The participants will be blind to the type of treatment, and the independent assessor will be blind to the participants' group.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
(BEMER activated)
Arm Title
Comparison group
Arm Type
Placebo Comparator
Arm Description
(BEMER deactivated)
Intervention Type
Device
Intervention Name(s)
bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product).
Intervention Description
The experimental group (receive the BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise.
Intervention Type
Device
Intervention Name(s)
placebo BEMER
Intervention Description
Comparison group (receive placebo BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise.
Primary Outcome Measure Information:
Title
International Index of Erectile Function - Erectile Function (IIEF-EF)
Description
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
Secondary Outcome Measure Information:
Title
The Arizona Sexual Experience (ASEX) Scale
Description
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.
Title
Modified Fatigue Impact Scale (MFIS)
Description
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.
Title
The Multiple Sclerosis, Intimacy, and Sexuality Questionnaire (MSISQ-19)
Description
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.
Other Pre-specified Outcome Measures:
Title
Erection Hardness Scale (EHS)
Description
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)
Time Frame
Within immediately of completion of the 3-week intervention period.
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Adult men (18-40 years old)
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdulaziz A Alzahrani, PhDcandidate
Phone
+966500324592
Email
2210700007@iau.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Ali M Alshami, Assoc Prof
Phone
+966552225548
Email
alshami@iau.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdulaziz A Alzahrani, PhDcandidate
Organizational Affiliation
imam abdurhman bin faisal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ali Muteb Alshami
City
Dammam
ZIP/Postal Code
31451
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali M Alshami, Assoc Prof
Phone
+966552225548
Email
alshami@iau.edu.sa
First Name & Middle Initial & Last Name & Degree
Turki S Abualait, Assist Prof
Phone
+966545555912
Email
tsabualait@iau.edu.sa
First Name & Middle Initial & Last Name & Degree
Abdulaziz A Alzahrani, PhDcandidate
Facility Name
Imam Abdulrahman Bin Faisal University
City
Dammam
ZIP/Postal Code
31451
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali M Alshami, Assoc Pro
Phone
+966552225548
Email
alshami@iau.edu.sa
First Name & Middle Initial & Last Name & Degree
Turki S Abualait, Assist Prof
Phone
+966545555912
Email
tsabualait@iau.edu.sa
First Name & Middle Initial & Last Name & Degree
Abdulaziz A Alzahrani, PhDCandidate
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis
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