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

NCT07101042 | Not Yet Recruiting

• 1 other identifier: Pending
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; Erectile Dysfunction; Urinary Incontinence; Paraspinal Stimulation; Cold Therapy;

Outcome Measures

Primary Outcomes (1)

• Erectile Function

  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.

  Baseline and after 4 weeks of intervention

Secondary Outcomes (1)

• Urinary Incontinence Severity

  Baseline and after 4 weeks of intervention

Study Arms (2)

Cold Stimulation

EXPERIMENTAL

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.

Other: Cold Stimulation

Paraspinal Stimulation

EXPERIMENTAL

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.

Other: Paraspinal Electrical Stimulation

Interventions

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.

Cold Stimulation

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.

Paraspinal Stimulation

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Spinal Cord Injuries; Erectile Dysfunction; Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: September 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 10, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07