A Comparative Study of Cold and Paraspinal Stimulation on Erectile Dysfunction and Urinary Incontinence in Spinal Cord Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Erectile Function
研究概览
简要总结
This study is being conducted to compare the effects of two simple treatments-cold therapy and electrical stimulation applied to the lower back-on sexual function and urinary control in men with spinal cord injury (SCI). Many individuals with SCI experience difficulties with erection and urinary leakage, which can negatively affect their quality of life.
In this study, participants will be assigned to receive either cold stimulation (using ice massage) or electrical stimulation over the spine. Each treatment will be applied three times a week for four weeks. The study will measure improvements in erectile function using a questionnaire called SHIM (Sexual Health Inventory for Men), and urinary control using a short-form urinary incontinence questionnaire.
The goal is to identify which treatment provides better results, is more comfortable for patients, and can be safely used as part of rehabilitation in clinical settings.
详细描述
Erectile dysfunction and urinary incontinence are among the most challenging secondary complications faced by men with spinal cord injury (SCI). These dysfunctions result primarily from disruption of spinal autonomic pathways and contribute significantly to reduced quality of life, social participation, and psychological well-being. Despite their clinical significance, non-invasive therapeutic approaches targeting autonomic recovery are under-researched.
This randomized controlled trial investigates the comparative effects of two non-invasive stimulation techniques-localized cold stimulation and paraspinal electrical stimulation-on erectile function and urinary incontinence in adult males with chronic SCI. Cold therapy activates superficial sensory afferents and spinal reflex arcs, while paraspinal stimulation is hypothesized to engage deeper segmental pathways within the thoracolumbar cord that contribute to pelvic organ regulation.
The study is designed to assess changes in erectile function using the SHIM questionnaire and changes in urinary incontinence using the ICIQ-UI SF. Both interventions will be applied over four weeks, with standardized protocols and session frequency. Findings from this trial may offer insight into accessible, low-risk options for addressing autonomic dysfunction in SCI and guide future rehabilitation protocols focused on quality-of-life outcomes.
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
- Single (Outcomes Assessor)
盲法说明
Only the outcomes assessor was blinded to group allocation. Participants and care providers were aware of the intervention being delivered due to the physical nature of the treatments (cold vs. electrical stimulation). The blinded assessor was responsible for administering and scoring all post-treatment outcome measures.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participants aged 25 to 55 years
- •Confirmed diagnosis of thoracic or lumbar spinal cord injury (≥ 6 months post-injury)
- •Presence of erectile dysfunction, indicated by a SHIM score ≤ 21
- •Self-reported urinary incontinence
- •Medically stable and able to participate in the study sessions
排除标准
- •Cognitive impairment or psychiatric conditions interfering with study compliance
- •Active urinary tract infection
- •History of urological surgery within the past 12 months
- •Presence of implanted electrical devices (e.g., pacemakers)
- •Skin conditions (e.g., ulcers, dermatitis) at stimulation or ice application sites
- •Use of medications affecting sexual or urinary function within the past 3 months
结局指标
主要结局
Erectile Function
时间窗: Baseline and after 4 weeks of intervention
Erectile function will be assessed using the Sexual Health Inventory for Men (SHIM), a validated 5-item questionnaire measuring severity of erectile dysfunction. Scores range from 1 to 25, with higher scores indicating better function.
次要结局
- Urinary Incontinence Severity(Baseline and after 4 weeks of intervention)
研究者
Islam Hassan Fayed
Physiotherapist
Cairo University