Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- International Index of Erectile Function - Erectile Function (IIEF-EF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
International Index of Erectile Function - Erectile Function (IIEF-EF)
时间窗: 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.
次要结局
- 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.)
研究者
Abdulaziz Alzahrani
PhD Candidate
Imam Abdulrahman Bin Faisal University