Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis
NCT ID: NCT05615454
Last Updated: 2023-03-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-02-28
Study Completion Date
2024-03-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Erectile Dysfunction Due to Diseases Classified Elsewhere
Multiple Sclerosis, Relapsing-Remitting
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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)
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
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.
Study Groups
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Experimental group
(BEMER activated)
Group Type
EXPERIMENTAL
bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product).
Intervention Type
DEVICE
The experimental group (receive the BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise.
Comparison group
(BEMER deactivated)
Group Type
PLACEBO_COMPARATOR
placebo BEMER
Intervention Type
DEVICE
Comparison group (receive placebo BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise.
Interventions
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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.
Intervention Type
DEVICE
placebo BEMER
Comparison group (receive placebo BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise.
Intervention Type
DEVICE
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
40 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Imam Abdulrahman Bin Faisal University
OTHER
Sponsor Role
lead
Responsible Party
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Abdulaziz Alzahrani
PhD Candidate
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Abdulaziz A Alzahrani, PhDcandidate
Role: PRINCIPAL_INVESTIGATOR
imam abdurhman bin faisal
Locations
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Ali Muteb Alshami
Dammam, , Saudi Arabia
Site Status
RECRUITING
Imam Abdulrahman Bin Faisal University
Dammam, , Saudi Arabia
Site Status
RECRUITING
Countries
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Saudi Arabia
Central Contacts
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Facility Contacts
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References
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Abdulla FA, Albagmi FM, Al-Khamis FA. Factors that influence quality of life in patients with multiple sclerosis in Saudi Arabia. Disabil Rehabil. 2022 Aug;44(17):4775-4783. doi: 10.1080/09638288.2021.1919929. Epub 2021 May 9.
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BACKGROUND
Alawami AS, Abdulla FA. Psychometric properties of an Arabic translation of the modified fatigue impact scale in patients with multiple sclerosis. Disabil Rehabil. 2021 Nov;43(22):3251-3259. doi: 10.1080/09638288.2020.1731853. Epub 2020 Feb 28.
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BACKGROUND
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Ben-Zacharia AB. Therapeutics for multiple sclerosis symptoms. Mt Sinai J Med. 2011 Mar-Apr;78(2):176-91. doi: 10.1002/msj.20245.
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Dastoorpoor M, Zamanian M, Moradzadeh R, Nabavi SM, Kousari R. Prevalence of sexual dysfunction in men with multiple sclerosis: a systematic review and meta-analysis. Syst Rev. 2021 Jan 6;10(1):10. doi: 10.1186/s13643-020-01560-x.
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Dorey G, Speakman M, Feneley R, Swinkels A, Dunn C, Ewings P. Randomised controlled trial of pelvic floor muscle exercises and manometric biofeedback for erectile dysfunction. Br J Gen Pract. 2004 Nov;54(508):819-25.
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Dorey G, Speakman MJ, Feneley RC, Swinkels A, Dunn CD. Pelvic floor exercises for erectile dysfunction. BJU Int. 2005 Sep;96(4):595-7. doi: 10.1111/j.1464-410X.2005.05690.x.
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Gandhi F, Jhaveri S, Avanthika C, Singh A, Jain N, Gulraiz A, Shah P, Nasir F. Impact of Vitamin D Supplementation on Multiple Sclerosis. Cureus. 2021 Oct 5;13(10):e18487. doi: 10.7759/cureus.18487. eCollection 2021 Oct.
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BACKGROUND
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BACKGROUND
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BACKGROUND
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Li V, Haslam C, Pakzad M, Brownlee WJ, Panicker JN. A practical approach to assessing and managing sexual dysfunction in multiple sclerosis. Pract Neurol. 2020 Apr;20(2):122-131. doi: 10.1136/practneurol-2019-002321. Epub 2019 Nov 21.
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Palm P, Zwisler AO, Svendsen JH, Thygesen LC, Giraldi A, Jensen KG, Lindschou J, Winkel P, Gluud C, Steinke E, Berg SK. Sexual rehabilitation for cardiac patients with erectile dysfunction: a randomised clinical trial. Heart. 2019 May;105(10):775-782. doi: 10.1136/heartjnl-2018-313778. Epub 2018 Oct 31.
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Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, Lublin FD, Metz LM, McFarland HF, O'Connor PW, Sandberg-Wollheim M, Thompson AJ, Weinshenker BG, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria". Ann Neurol. 2005 Dec;58(6):840-6. doi: 10.1002/ana.20703.
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Rennie D. CONSORT revised--improving the reporting of randomized trials. JAMA. 2001 Apr 18;285(15):2006-7. doi: 10.1001/jama.285.15.2006. No abstract available.
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Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002 Aug;14(4):226-44. doi: 10.1038/sj.ijir.3900857.
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Rosenbaum TY. Pelvic floor involvement in male and female sexual dysfunction and the role of pelvic floor rehabilitation in treatment: a literature review. J Sex Med. 2007 Jan;4(1):4-13. doi: 10.1111/j.1743-6109.2006.00393.x.
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Shafik A, el-Sibai O, Shafik AA. Magnetic stimulation of the cavernous nerve for the treatment of erectile dysfunction in humans. Int J Impot Res. 2000 Jun;12(3):137-41; discussion 141-2. doi: 10.1038/sj.ijir.3900521.
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Shamloul R, Ghanem H, Abou-zeid A. Validity of the Arabic version of the sexual health inventory for men among Egyptians. Int J Impot Res. 2004 Oct;16(5):452-5. doi: 10.1038/sj.ijir.3901248.
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Thomas C, Konstantinidis C. Neurogenic Erectile Dysfunction. Where Do We Stand? Medicines (Basel). 2021 Jan 7;8(1):3. doi: 10.3390/medicines8010003.
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Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
Reference Type
BACKGROUND
Other Identifiers
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BEMER
Identifier Type: -
Identifier Source: org_study_id
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