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

NCT05626816 | Recruiting FDA Device

• 3 other identifiers: STUDY00000105CDMRP-SC210121P1CDMRP-SC210121
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bowel; spinal cord injury; electrical stimulation; anorectal manometry; incontinence; tetraplegia; paraplegia; paralysis

Outcome Measures

Primary Outcomes (5)

• ARM outcome - Rectal wall tension

  When an organ relaxes during filling it is called compliance and is characteristic of the rectum and bladder. This allows the organ to hold more material and therefore have a larger void when emptying. After SCI, organs that have had their control systems damaged become spastic and hyperreflexive which leads to smaller volumes and incontinence issues in both bladder and bowel function. By inflating the ARM balloon with air we can slightly distend the rectum and measure the pressure (cmH20) to determine compliance. If the pressure stays the same after inflating the balloon then the rectum has relaxed and it is a measure of compliance. Rectal wall tension will be inferred from this response and abnormal tension will be apparent by reduced compliance (pressure increases when balloon volume increases). This measure will be recorded with and without stimulation.

  Up to three weeks after enrollment

• ARM outcome - Anal sphincter function

  Circumferential sensors on the ARM balloon catheter will detect pressure changes (cmH20) in the anal sphincter during cough, push, squeeze, and rest. Anal sphincter function will be assessed with and without stimulation.

  Up to three weeks after enrollment

• ARM outcome - Rectoanal reflex activity (RAIR)

  Air will be infused into the ARM balloon to distend the rectum. When the rectum is distended the anal sphincter relaxes (rectoanal inhibitory reflex) and the amount of air required to elicit the reflex (cc) will be assessed with and without stimulation.

  Up to three weeks after enrollment

• ARM outcome - Rectal sensation

  Air is infused (50 ml steps) into the ARM balloon until the participant reports: first sensation, urge to defecate, maximum tolerable sensation. The volume of air (cc) is recorded for each sensory event with and without stimulation.

  Up to three weeks after enrollment

• ARM outcome - Presence of hyper reflexive rectal contractions

  After SCI the rectum become hyperreflexive and spastic. A major cause of fecal incontinence after injury is the result of these reflexive contractions and the inability to contract the external sphincter to maintain continence. This combination causes the rectum to expel small amounts of stool rather than storing the material for a larger bowel movement. We will quantify the rectal pressure traces for reflexive contractions and measure their frequency (Hz or count/minute, whichever is most appropriate). Reflexive contractions will be steep increases in rectal pressure while at rest or during distension (sensation and RAIR testing). Measurements will be collected with and without stimulation and compared.

  Up to three weeks after enrollment

Secondary Outcomes (11)

• SCI-QOL Bowel Management Difficulties (SCI-QOL BMD)

  During enrollment, up to one week

• International SCI Bowel Function Basic Dataset Version 2.1 (ISCI BF BDS)

  During enrollment, up to one week

• International Standards of Neurological Classification of SCI (ISNCSCI)

  During enrollment, up to one week

• SCI Common Data Elements - Medical history

  During enrollment, up to one week

• SCI Common Data Elements - History of injury

  During enrollment, up to one week

Study Arms (2)

All interventions, Sham applied first

EXPERIMENTAL

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.

Device: Genital Nerve Stimulation; Diagnostic Test: Clinical exam; Diagnostic Test: Collection of SCI common data elements; Diagnostic Test: Bowel function survey completion; Diagnostic Test: International Standard for Neurological Classification of SCI (ISNCSCI); Diagnostic Test: Response to genital nerve stimulation (GNS); Diagnostic Test: Anorectal Manometry testing (ARM)

All interventions, effective stim applied first

EXPERIMENTAL

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.

Device: Genital Nerve Stimulation; Diagnostic Test: Clinical exam; Diagnostic Test: Collection of SCI common data elements; Diagnostic Test: Bowel function survey completion; Diagnostic Test: International Standard for Neurological Classification of SCI (ISNCSCI); Diagnostic Test: Response to genital nerve stimulation (GNS); Diagnostic Test: Anorectal Manometry testing (ARM)

Interventions

Genital Nerve Stimulation DEVICE

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.

All interventions, Sham applied first; All interventions, effective stim applied first

Clinical exam DIAGNOSTIC_TEST

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

All interventions, Sham applied first; All interventions, effective stim applied first

Collection of SCI common data elements DIAGNOSTIC_TEST

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

All interventions, Sham applied first; All interventions, effective stim applied first

Bowel function survey completion DIAGNOSTIC_TEST

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.

All interventions, Sham applied first; All interventions, effective stim applied first

International Standard for Neurological Classification of SCI (ISNCSCI) DIAGNOSTIC_TEST

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.

All interventions, Sham applied first; All interventions, effective stim applied first

Response to genital nerve stimulation (GNS) DIAGNOSTIC_TEST

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.

All interventions, Sham applied first; All interventions, effective stim applied first

Anorectal Manometry testing (ARM) DIAGNOSTIC_TEST

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,

All interventions, Sham applied first; All interventions, effective stim applied first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Traumatic SCI
• Minimum 6 months post-injury
• Aged 18 years or older
• Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI
• Response to genital nerve stimulation upon screening
• Able to understand and provide informed consent

You may not qualify if:

• Currently enrolled in another functional electrical stimulation (FES) research trial
• Females who are pregnant or 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.
• In the judgement of the PI or Co-Investigators, presence of medical complications that may interfere with the execution of the study.

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• VA of Northeast Ohio Health System: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

MetroHealth Medical System Old Brooklyn Campus

Cleveland, Ohio, 44109, United States

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence; Spinal Cord Injuries; Quadriplegia; Paraplegia; Paralysis

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kim Anderson, PhD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayson Moore

CONTACT

2169573558; MMoore12@metrohealth.org

Rob Hoey, PhD

CONTACT

2169573665; rhoey@metrohealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants will receive the intervention, but randomization will determine the order of presentation of sham and effective stimulation to ensure blinding of the participant.

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 25, 2022
• Study Start: March 21, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 12 months of end of study.
• Access Criteria: Based on the ICPSR guidelines.

Locations

US (1)