Genital Nerve Stimulation for Spinal Cord Injury

Overseen By Megan Hammond Nechols

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: 3

Duration: 4 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether electrical nerve stimulation on the skin in the pelvic area can reduce bowel accidents in people with spinal cord injuries. It aims to determine if this method, known as Genital Nerve Stimulation, can serve as an alternative to current treatments like diet changes, medications, or surgery. Participants will use a TENS device at home for 6-8 hours each day over four weeks. The trial seeks individuals who have had a spinal cord injury for at least six months and experience bowel issues due to the injury. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could lead to new treatment options.

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 is best to discuss this with the research team.

What prior data suggests that this genital nerve stimulation technique is safe for spinal cord injury patients?

Research has shown that stimulating the genital nerves is generally safe. In studies, most individuals with sensation in the area have tolerated the stimulation well, with common settings between 20 to 40 milliamps (mA). This indicates that most people experience minimal discomfort and few side effects.

A review of clinical studies on electrical stimulation therapy for individuals with spinal cord injuries also supports its safety. It shows that these treatments are usually safe for those with neurogenic bowel dysfunction, a condition affecting bowel control due to nerve damage.

While researchers continue to study this specific method of stimulation, it uses a device approved by the FDA, indicating its safety for other uses. Although caution is always advised, current evidence suggests that this treatment is likely safe for most individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about genital nerve stimulation for spinal cord injury because it offers a novel approach to restoring function. Traditional treatments for spinal cord injury often focus on physical rehabilitation and medication to manage symptoms, but this technique targets the nerves directly. The treatment uses specific electrical pulses to stimulate the genital nerve, which may help activate reflexes that assist in regaining control over certain muscles. This direct nerve stimulation is unique and could lead to significant improvements in quality of life for individuals with spinal cord injuries.

What evidence suggests that genital nerve stimulation is effective for spinal cord injury?

Research has shown that stimulating the genital nerves benefits people with spinal cord injuries. In this trial, participants will receive either targeted genital nerve stimulation or sham stimulation. Studies have found that this stimulation can help the bladder hold more urine and reduce sudden bladder contractions, potentially aiding in bowel movement management. Some individuals using this method at home reported fewer leakage incidents, decreasing from about one a day to almost none. A review of clinical studies supports the safety and effectiveness of electrical stimulation for bowel issues after spinal cord injuries. These findings suggest that this approach could be a promising way to manage bowel symptoms in these individuals. ^{2 3 5 6 7}

Who Is on the Research Team?

Kim Anderson, PhD

Principal Investigator

MetroHealth System, Ohio

Are You a Good Fit for This Trial?

This trial is for individuals with spinal cord injuries who experience bowel incontinence. Participants will use a TENS device at home and must be able to commit to daily stimulation sessions, attend three research center visits, and keep a diary of their symptoms.

Inclusion Criteria

I have a spinal cord injury due to trauma.

Score of 14 or higher on the ISCI BF BDS v2.1

Response to genital nerve stimulation able to be elicited upon screening

Exclusion Criteria

Presence of a cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device if, upon clinical evaluation, it may have an interaction with GNS

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

In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Genital Nerve Stimulation

Trial Overview

The study tests if electrical stimulation near the genitals can help manage bowel reflexes causing accidents in spinal cord injury patients. It compares effective stimulation levels against placebo levels using an off-label FDA approved TENS device.

How Is the Trial Designed?

Group I: Target genital nerve stimulation Experimental Treatment 1 Intervention

Stimulation waveforms consist of biphasic, charge-balanced square pulses with a pulse width of 0.2 ms and delivered at 20 Hz. Stimuli will be applied over a range of amplitudes to determine the threshold of stimulation for producing reflex contraction of the anal sphincter (the pudendo-anal reflex). Subsequent stimulation will be applied at threshold for the first week, at 1.5 threshold for the second week, and at twice threshold (or max tolerance) for the third and fourth weeks. The typical stimulation range is 20-40 milliamps (mA) and has been shown to be well tolerated by individuals with sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks.

Group II: Sham genital nerve stimulation Placebo Group 1 Intervention

Sham stimulation will be applied in the same manner as target stimulation, except that the stimulation frequency will be 1 Hz and the stimulation amplitude will be set to a limit that is at the threshold of perception if individuals have sensation, or 10 mA if they do not have sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks.

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28198657/

Genital nerve stimulation increases bladder capacity after SCI

Electrical stimulation of the genital nerves (GNS) acutely inhibits reflex bladder contractions and can increase bladder capacity.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1877065723000702

Beneficial carry-over effects of chronic at-home genital ...

Chronic at-home GNS improved cystometric bladder capacity and reduced urinary incontinence for individuals with incomplete SCI and NDO.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05626816

Acute Genital Nerve Stimulation for Neurogenic Bowel ...

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.

4.

journals.lww.com

journals.lww.com/md-journal/fulltext/2018/10120/a_systematic_review_of_clinical_studies_on.78.aspx

A systematic review of clinical studies on electrical...

In this review, 3 studies revealed the efficacy and safety of transcutaneous electrical stimulation for NBD after SCI. Transcutaneous electrical stimulation ...

5.

tandfonline.com

tandfonline.com/doi/abs/10.1080/10790268.2017.1422881

At-home genital nerve stimulation for individuals with SCI ...

Results: GNS reduced the number of leakage events from 1.0 ± 0.5 to 0.1 ± 0.4 leaks per day in the four subjects who reported incontinence data.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7918133/

Efficacy and Safety of 10 kHz Spinal Cord Stimulation for ...

Findings suggest 10 kHz SCS provides safe and durable pain relief in pragmatic populations of chronic pain patients.

7.

nature.com

nature.com/articles/sc2011159

Acute effect of electrical stimulation of the dorsal genital ...

Acute effect of electrical stimulation of the dorsal genital nerve on rectal capacity in patients with spinal cord injury. J Worsøe,; L ...