Cold vs. Paraspinal Stimulation for Erectile and Urinary Function in SCI Patients

Cairo University (CU)

Status: Not yet enrolling

Conditions: Spinal Cord Injury

Treatments: Other: Paraspinal Electrical Stimulation; Other: Cold Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07101042

Pending

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Cold Stimulation

Experimental group

Description:

Participants in this group received localized cold therapy using ice massage applied to the suprapubic and inner thigh regions for 20 minutes per session, three times per week for four weeks.

Treatment:

Other: Cold Stimulation

Paraspinal Stimulation

Experimental group

Description:

Participants in this group received surface electrical stimulation over the T12-L2 paraspinal region. Sessions were 30 minutes each, delivered three times per week for four weeks.

Treatment:

Other: Paraspinal Electrical Stimulation