Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Summary

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.

Conditions

• Fecal Incontinence

Interventions

DEVICE

Genital Nerve Stimulation

Electrical stimulation applied to the genital nerve with surface electrodes using an off the shelf TENS unit (Ultima Plus). First, an amplitude threshold for the pudendo-anal reflex responses will be determined. Then, sham (1-2 Hz) and effective stimulation (20 Hz) will be briefly applied to record responses. Then, stimulation will be applied in random presentation order to record any changes in anorectal manometry outcomes due to both sham and effective stimulation.

DIAGNOSTIC_TEST

Clinical exam

Examination by physician determines the presence of pelvic reflexes (pudendo-anal and bulbocavernosus) which are essential for GNS to have an effect.

DIAGNOSTIC_TEST

Collection of SCI common data elements

Data regarding participant demographics, history of injury, and medical history will be collected.

DIAGNOSTIC_TEST

Bowel function survey completion

Two surveys will be conducted to assess the bowel function of the participant. The International SCI Bowel Function Basic Data Set (ISCI BF BDS v2.1) and the SCI Qulaity of Life Bowel Management Difficulties (SCI-QoL BMD) survey scales collect data on overall bowel function and how any difficulties impact the participants quality of life.

DIAGNOSTIC_TEST

International Standard for Neurological Classification of SCI (ISNCSCI)

The physician will conduct the ISNCSCI to determine the level and severity of injury to the spinal cord. This is done by determining the ability to detect light touch and pinprick stimulation. Outcomes will be a Spinal Injury Association Impairment Scale (AIS) grade of A-D.

DIAGNOSTIC_TEST

Response to genital nerve stimulation (GNS)

GNS will be applied to determine if there is a response in the participant. If the participant has no response to the stimulation they will be excluded from the second visit as it is dependent on the ability to respond to GNS.

DIAGNOSTIC_TEST

Anorectal Manometry testing (ARM)

The participant will be instrumented for ARM testing. This requires a special balloon catheter to be inserted into the anus and secured, surface electrode pads being applied to the anal sphincter, and electrode pads being applied to the genital nerve stimulation sites. Once instrumented, the participant will be tested with the London Classification procedure. This procedure asks the participant to perform several actions (squeeze to withhold a bowel movement, push to have a bowel movement, and cough) as well as inflating the balloon on the catheter to determine reflex thresholds (RAIR, retroanal inhibitory reflex which relaxes the anal sphincter in response to rectal distension) and sensory thresholds (first senstation,

Sponsors & Collaborators

• VA of Northeast Ohio Health System

  collaborator UNKNOWN

• Congressionally Directed Medical Research Programs

  collaborator FED

• MetroHealth Medical Center

  lead OTHER

Principal Investigators

• Kim Anderson, PhD · MetroHealth Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-21

Primary Completion

2025-12-31

Completion

2025-12-31

FDA Device

Yes

Countries

• United States

Study Locations