Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dy
Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product).
Placebo
- placebo BEMER
What it measured
Main measures
International Index of Erectile Function - Erectile Function (IIEF-EF)
Change from Baseline Erectile Function at 3 weeks
Bladder, bowel and sexual function
Other measures (3)
The Arizona Sexual Experience (ASEX) Scale
Within immediately of completion of the 3-week intervention period.
Bladder, bowel and sexual functionQuality of life (reported by participants)Modified Fatigue Impact Scale (MFIS)
Within immediately of completion of the 3-week intervention period.
Thinking and memoryFatigueThe Multiple Sclerosis, Intimacy, and Sexuality Questionnaire (MSISQ-19)
Within immediately of completion of the 3-week intervention period.
Bladder, bowel and sexual functionQuality of life (reported by participants)
Who could take part
Relapsing MS · 18 to 40
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
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.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.Background
AlJumah M, Bunyan R, Al Otaibi H, Al Towaijri G, Karim A, Al Malik Y, Kalakatawi M, Alrajeh S, Al Mejally M, Algahtani H, Almubarak A, Cupler E, Alawi S, Qureshi S, Nahrir S, Almalki A, Alhazzani A, Althubaiti I, Alzahrani N, Mohamednour E, Saeedi J, Ishak S, Almudaiheem H, El-Metwally A, Al-Jedai A. Rising prevalence of multiple sclerosis in Saudi Arabia, a descriptive study. BMC Neurol. 2020 FebBackground
Ben-Zacharia AB. Therapeutics for multiple sclerosis symptoms. Mt Sinai J Med. 2011 Mar-Apr;78(2):176-91. doi: 10.1002/msj.20245.Background
Carotenuto A, De Giglio L, Chiodi A, Petracca M, Rosa L, Bianchi M, Ferrante I, Lauro F, Moccia M, Ianniello A, Pozzilli C, Brescia Morra V, Lanzillo R. Validation of the Italian version of the Multiple Sclerosis Intimacy and Sexuality Questionnaire-19. Neurol Sci. 2021 Jul;42(7):2903-2910. doi: 10.1007/s10072-020-04873-w. Epub 2020 Nov 21.Background
Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.Background
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.Background
Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.Background
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.Background
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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History
Started
Feb 2023
Main results due
Dec 2023
Finished
Mar 2024