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Not yet recruiting NCT07101042

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

No phase Interventional Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cold Stimulation, Paraspinal Electrical Stimulation.
Who it may be relevant to
Registry conditions: Spinal Cord Injury. Basic parameters: 25 years — 55 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Comparative Study of Cold and Paraspinal Stimulation on Erectile Dysfunction and Urinary Incontinence in Spinal Cord Injury Patients

Overview

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

  • Other 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.
  • 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.

Primary outcome measures

  • Erectile Function [Time frame: Baseline and after 4 weeks of intervention]
Secondary outcome measures (1)
  • Urinary Incontinence Severity [Time frame: Baseline and after 4 weeks of intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07101042 · Pending

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗