Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07101042

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Erectile Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Wounds and Injuries

Age range

25 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold Stimulation

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 Electrical Stimulation

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.

Primary outcomes

  1. Erectile Function

    Time frame: 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 outcomes

  1. Urinary Incontinence Severity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.