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?

The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management. Researchers will: * Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label * Compare a target stimulation level to a placebo stimulation level Participants will: * Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home * Visit the research center 3 times to participate in exams and answer questions * Keep a daily diary of their bowel symptoms and stimulation times

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.

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 5}

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 2 3 4 6}

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 4 5 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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. Spain pubmed.ncbi.nlm.nih.gov

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

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. 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]

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

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

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]