Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- International Index of Erectile Function - Erectile Function (IIEF-EF)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes 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.
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Experimental group
(BEMER activated)
Intervention: bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product). (Device)
Comparison group
(BEMER deactivated)
Intervention: placebo BEMER (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- The Arizona Sexual Experience (ASEX) Scale(Within immediately of completion of the 3-week intervention period.)
- Modified Fatigue Impact Scale (MFIS)(Within immediately of completion of the 3-week intervention period.)
- The Multiple Sclerosis, Intimacy, and Sexuality Questionnaire (MSISQ-19)(Within immediately of completion of the 3-week intervention period.)
Investigators
Abdulaziz Alzahrani
PhD Candidate
Imam Abdulrahman Bin Faisal University