Spinal Cord InjuryNCT07101042
Cold vs. Paraspinal Stimulation for Erectile and Urinary Function in SCI Patients
A study testing Cold Stimulation and Paraspinal Electrical Stimulation in people with Spinal Cord Injury, run by Cairo University.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 55 years, men only
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Cold Stimulation and Paraspinal Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Comparative Study of Cold and Paraspinal Stimulation on Erectile Dysfunction and Urinary Incontinence in Spinal Cord Injury 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.
Read the 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
- Being tested
- Cold Stimulation, Paraspinal Electrical Stimulation
- Keywords
- Spinal Cord Injury, Erectile Dysfunction, Urinary Incontinence, Paraspinal Stimulation, Cold Therapy;
- Medical subject headings
- Spinal Cord Injuries, Erectile Dysfunction, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold StimulationOther
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 StimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Paraspinal Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 4 weeks of intervention
Secondary outcomes (1)
Urinary Incontinence Severity
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.
Measured: Baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Hassan Fayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101042
- Sponsor's protocol ID
- Pending
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, a definitive plan for sharing individual participant data (IPD) has not been established. Data sharing will depend on institutional policies, participant consent provisions, and ethical approval. The research team is considering options for de-identified data sharing in the future, but no repository or framework has been finalized.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Cold and Paraspinal Stimulation on Erectile Dysfunction and Urinary Incontinence in Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT07101042
- Acronym / sponsor ID
- Pending
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Erectile Dysfunction, Urinary Incontinence, Paraspinal Stimulation, Cold Therapy;
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cold Stimulation | Experimental | Other: Cold StimulationParticipants 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. |
| Paraspinal Stimulation | Experimental | Other: Paraspinal Electrical StimulationParticipants 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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold StimulationIce 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 | Cold Stimulation |
| Paraspinal Electrical StimulationSurface 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. | Other | Paraspinal Stimulation |
Primary outcome
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.
1 secondary outcome
Urinary Incontinence Severity
Time frame: Baseline and after 4 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Undecided. At this time, a definitive plan for sharing individual participant data (IPD) has not been established. Data sharing will depend on institutional policies, participant consent provisions, and ethical approval. The research team is considering options for de-identified data sharing in the future, but no repository or framework has been finalized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Stimulation and Paraspinal Electrical Stimulation in people with Spinal Cord Injury, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile Function (time frame: Baseline and after 4 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.