Genital Nerve Stimulation for Spinal Cord Injury

Overseen By Anvi Kshirsagar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Disqualifiers: Pregnancy, Cardiac pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

52 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What data supports the effectiveness of the treatment Genital Nerve Stimulation for Spinal Cord Injury?

Research shows that genital nerve stimulation can increase sexual arousal in women with spinal cord injuries, suggesting it may help improve sexual function. Additionally, similar techniques like vibratory stimulation have been shown to enhance sexual arousal in women with spinal cord injuries. ^{1 2 3 4 5}

Is genital nerve stimulation safe for humans?

Research on genital nerve stimulation, including studies on women with and without spinal cord injuries, suggests it is generally safe for short-term use. However, more studies are needed to fully understand its long-term safety. ^{1 2 3 4 6}

How is genital nerve stimulation different from other treatments for spinal cord injury?

Genital nerve stimulation is unique because it uses electrical impulses to stimulate nerves in the genital area, which can help improve bladder control and sexual function in people with spinal cord injuries. Unlike other treatments that might focus on medication or physical therapy, this approach directly targets nerve pathways to enhance sensory and functional recovery. ^{1 3 4 6 7}

What is the purpose of this trial?

Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. This study will test the effect of genital nerve stimulation (GNS), with non-invasive electrodes, on the activity of the anus and rectum of persons after SCI. Recording anorectal manometry (ARM) endpoints tells us the function of those tissues and our study design (ARM without stim, ARM with stim, ARM without stim) will allow us to conclude the GNS effect and whether it is likely to reduce fecal incontinence. The study will also collect medical, demographic, and bowel related functional information. The combination of all of these data should help predict who will respond to stimulation, what will happen when stimulation is applied, and if that stimulation is likely to provide an improvement in fecal continence for people living with SCI.

Research Team

Kim Anderson, PhD

Principal Investigator

MetroHealth Medical Center

Eligibility Criteria

This trial is for adults over 18 with traumatic spinal cord injury (SCI) at least 6 months post-injury, having specific reflexes intact. It's not for those in other electrical stimulation studies, pregnant women, or individuals with certain implants or medical complications that could affect the study.

Inclusion Criteria

I understand the study and can give my consent.

It has been at least 6 months since my injury.

Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI

Exclusion Criteria

Currently enrolled in another functional electrical stimulation (FES) research trial

I am not pregnant nor planning to become pregnant during the trial.

Presence of cardiac pacemaker, implanted defibrillator or other implanted FES device if, upon clinical exam, it may have an interaction with GNS

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Manometry Testing

Participants undergo anorectal manometry testing with and without genital nerve stimulation to assess bowel function

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the manometry testing

3 weeks

Treatment Details

Interventions

• Genital Nerve Stimulation

Trial Overview The study tests genital nerve stimulation (GNS) using non-invasive electrodes to improve bowel control in SCI patients. It measures anorectal function before and after GNS to determine its effectiveness against fecal incontinence.

Participant Groups

Group I: All interventions, effective stim applied first Experimental Treatment 7 Interventions

These participants will have all interventions applied, but will be randomly designated to have effective stimulation applied before sham stimulation. This will balance any issue with order of presentation of multiple stimulation sessions.

Group II: All interventions, Sham applied first Experimental Treatment 7 Interventions

These participants will have all interventions applied, but will be randomly designated to have sham stimulation applied before effective stimulation. This will balance any issue with order of presentation of multiple stimulation sessions.

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

VA of Northeast Ohio Health System

Collaborator

Trials

1

Recruited

50+

Findings from Research

A novel sensory substitution device was developed to help men with chronic spinal cord injury (SCI) experience sexual pleasure by mapping hand movements to electrocutaneous sensations on the tongue, showing promising results after 20 training sessions over 8 weeks.

Participants reported increased sexual pleasure and specific sensations below their injury, indicating potential for neuroplasticity in enhancing sexual experiences, although no subjects achieved orgasm, highlighting the need for further research on training frequency and duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a sensory substitution system for the sexual rehabilitation of men with chronic spinal cord injury. Borisoff, JF., Elliott, SL., Hocaloski, S., et al.[2015]

In a study involving 46 women with spinal cord injuries (SCIs) and 11 nondisabled controls, vibratory clitoral stimulation was found to increase vaginal pulse amplitude, indicating genital arousal, but the differences compared to manual stimulation were not statistically significant.

Both vibratory and manual clitoral stimulation significantly increased subjective arousal levels in women with SCIs and nondisabled controls, although only nondisabled subjects showed significant differences between the two stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of vibratory stimulation on sexual response in women with spinal cord injury. Sipski, ML., Alexander, CJ., Gomez-Marin, O., et al.[2019]

Pudendal nerve stimulation in patients with complete spinal cord injury (SCI) significantly affects cardiovascular responses, particularly in those with high-level injuries (C6-T6), leading to increased blood pressure and decreased heart rate, indicating the potential for autonomic dysreflexia (AD).

The use of intravenous phentolamine during stimulation effectively mitigates the risk of severe hypertension, allowing for safer application of pudendal nerve stimulation in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autonomic dysreflexia in response to pudendal nerve stimulation. Reitz, A., Schmid, DM., Curt, A., et al.[2013]

Electrical stimulation of the dorsal genital nerve (DGNS) significantly increased subjective sexual arousal in women, including those with female sexual dysfunction (FSD), while tibial nerve stimulation (TNS) showed no effect.

This pilot study, which included healthy women, women with FSD, and women with spinal cord injury, suggests that DGNS may be a promising treatment option for improving sexual arousal in women with FSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute dorsal genital nerve stimulation increases subjective arousal in women with and without spinal cord injury. Bottorff, EC., Gupta, P., Ippolito, GM., et al.[2023]

Individuals with spinal cord injuries often report dissatisfaction with their sexual lives, despite feeling their physical, emotional, and social needs are met, highlighting a significant area of concern that emerges over time.

A case study of a 25-year-old male with a complete spinal cord injury demonstrated the importance of a structured nursing care plan using established nursing classifications (NANDA, NOC, NIC) to address sexual dysfunction, suggesting that targeted sexual education and assessment can improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nursing care in males with spinal cord injury and sexual dysfunction]. Cobo-Cuenca, AI., Martín-Espinosa, NM., Píriz Campos, RM.[2013]

Genital sensation (GS) is crucial for male sexual function, and spinal cord injury (SCI) can lead to genital sensory disturbance (GSD), severely affecting sexual arousal, erection, ejaculation, and overall sexual satisfaction.

The review highlights the need for more research on GSD in SCI patients, discussing the innervation of male GS and current diagnostic and treatment approaches to improve sexual function in these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Male genital sensation after spinal cord injury: a review. Zhang, H., Li, B.[2020]

The study found that increasing the amplitude of dorsal genital nerve stimulation (GNS) significantly improves bladder capacity in individuals with spinal cord injury (SCI) and neurogenic detrusor overactivity, with increases of 34% at 1.5 times the threshold and 77% at 3.2 times the threshold.

There is a linear correlation between GNS amplitude and bladder capacity gain within the tested range (1 to 4 times the threshold), suggesting that optimizing stimulation amplitude could enhance treatment effectiveness for bladder control in SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Genital Nerve Stimulation Amplitude on Bladder Capacity in Spinal Cord Injured Subjects. Yeh, SD., Lin, BS., Chen, SC., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The development of a sensory substitution system for the sexual rehabilitation of men with chronic spinal cord injury. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of vibratory stimulation on sexual response in women with spinal cord injury. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Autonomic dysreflexia in response to pudendal nerve stimulation. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Acute dorsal genital nerve stimulation increases subjective arousal in women with and without spinal cord injury. [2023]

5. Spain pubmed.ncbi.nlm.nih.gov

[Nursing care in males with spinal cord injury and sexual dysfunction]. [2013]

6. China pubmed.ncbi.nlm.nih.gov

Male genital sensation after spinal cord injury: a review. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of Genital Nerve Stimulation Amplitude on Bladder Capacity in Spinal Cord Injured Subjects. [2022]