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

NCT ID: NCT07101042

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2025-10-10

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cold Stimulation

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.

Group Type: EXPERIMENTAL

Cold Stimulation

Intervention Type: OTHER

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.

Paraspinal Stimulation

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.

Group Type: EXPERIMENTAL

Paraspinal Electrical Stimulation

Intervention Type: OTHER

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.

Interventions

Cold 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.

Intervention Type: OTHER

Paraspinal 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Islam Hassan Fayed

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Pending

Identifier Type: -

Identifier Source: org_study_id