Spinal Cord Injury
Conditions
Keywords
Spinal Cord Injury, Erectile Dysfunction, Urinary Incontinence, Paraspinal Stimulation, Cold Therapy;
Brief summary
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.
Detailed description
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.
Interventions
OTHERCold Stimulation
Ice massage using circular movements over the suprapubic and inner thigh areas to stimulate sensory afferents. Each session lasted 20 minutes, delivered 3 times per week for 4 weeks.
OTHERParaspinal Electrical Stimulation
Surface electrodes applied bilaterally to the T12-L2 region. Parameters: 20 Hz frequency, 200 µs pulse width, intensity set below motor threshold. Sessions were administered 3 times per week for 4 weeks.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants were randomly assigned to one of two parallel groups. The first group received localized cold stimulation, while the second group received paraspinal electrical stimulation. Both interventions were applied independently, with no crossover between groups throughout the study period.
Eligibility
Sex/Gender
MALE
Age
25 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erectile Function | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Incontinence Severity | Baseline and after 4 weeks of intervention | Urinary incontinence will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), a validated patient-reported tool that evaluates frequency, volume of leakage, and its impact on daily life. Scores range from 0 to 21, with higher scores indicating more severe incontinence. |
Outcome results
None listed