Genital Nerve Stimulation for Spinal Cord Injury

Overseen By Mayson Moore

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called genital nerve stimulation (GNS) to help people with spinal cord injuries manage bowel issues, specifically fecal incontinence (accidental bowel movements). Researchers aim to determine if stimulating nerves with non-invasive electrodes can improve the function of the anus and rectum, potentially reducing these accidents. Participants will undergo both real and sham (fake) stimulation sessions to compare effects. The trial seeks individuals who have had a spinal cord injury for at least six months, with the injury located at a specific level (T12 or higher), and who respond to genital nerve stimulation during screening. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve the quality of life for many.

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

Research shows that stimulating certain nerves in the genital area may help people with spinal cord injuries manage bowel problems, such as accidental bowel movements. This method uses non-invasive electrodes to activate specific nerves.

Earlier studies tested this nerve stimulation on individuals with similar issues, like bladder problems caused by nerve damage. These studies found improvements in bladder function and a reduction in urinary issues, suggesting potential safety for bowel problems as well. Importantly, no serious side effects were reported.

The current trial is in an early phase. While past research suggests safety, more information is needed to confirm its safety for bowel issues. Participants should know that the treatment is still under investigation, but it appears well-tolerated so far. ^{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 that directly targets the nervous system to potentially restore function. Unlike traditional treatments that may focus on rehabilitation or medications to manage symptoms, this technique uses electrical stimulation to activate the genital nerves, which could enhance sensory and motor function below the level of injury. This method is non-invasive and could complement existing therapies by directly engaging the neural pathways involved in sensation and movement, offering hope for improved quality of life for individuals with spinal cord injuries.

What evidence suggests that genital nerve stimulation is effective for reducing fecal incontinence in spinal cord injury?

Research has shown that stimulating the nerves in the genital area might help with bowel problems after a spinal cord injury. This method, called genital nerve stimulation (GNS), increases bladder capacity and reduces urine leakage, suggesting it might also aid bowel control. GNS uses electrical signals to activate nerves, potentially improving bladder and bowel function. Early studies on bladder issues are encouraging, demonstrating that GNS is both safe and effective. Although more research is needed specifically for bowel issues, the mechanism of GNS and initial results offer hope for reducing bowel leakage in people with spinal cord injuries. Participants in this trial will experience both sham and effective stimulation to assess GNS's impact on bowel control. ^{1 2 3 6 7}

Who Is on the Research Team?

Kim Anderson, PhD

Principal Investigator

MetroHealth Medical Center

Are You a Good Fit for This Trial?

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

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

Response to genital nerve stimulation upon screening

I understand the study and can give my consent.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6522983/

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

These data inform the design of a long-term clinical trial testing of GNS as an approach to reduce NDO. Keywords: Neurogenic bladder, Electrical ...

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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.

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tandfonline.com

tandfonline.com/doi/abs/10.1080/10790268.2017.1279817

Genital nerve stimulation is tolerable and effective for ...

The objective of this work is to determine if persons with incomplete SCI are able to tolerate acute GNS for bladder inhibition. Methods: Twenty ...

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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...

A systematic review of clinical studies on electrical stimulation therapy for patients with neurogenic bowel dysfunction after spinal cord injury.

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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 ...