Recruiting

Genital Nerve Stimulation

Sponsor:

MetroHealth Medical Center

Code:

NCT05626816

Conditions

Fecal Incontinence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Genital Nerve Stimulation

Clinical exam

Collection of SCI common data elements

Bowel function survey completion

International Standard for Neurological Classification of SCI (ISNCSCI)

Study Details

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

Study ID

NCT05626816

Start date

Mar 21, 2023

Status verified date

Nov, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: All interventions, Sham applied first

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.

experimental: All interventions, effective stim applied first

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.

Interventions

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.

Clinical exam

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

Collection of SCI common data elements

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

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.

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.

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.

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,

Primary outcome measure

  • ARM outcome - Rectal wall tension [ Time Frame: Up to three weeks after enrollment ]
  • ARM outcome - Anal sphincter function [ Time Frame: Up to three weeks after enrollment ]
  • ARM outcome - Rectoanal reflex activity (RAIR) [ Time Frame: Up to three weeks after enrollment ]
  • ARM outcome - Rectal sensation [ Time Frame: Up to three weeks after enrollment ]
  • ARM outcome - Presence of hyper reflexive rectal contractions [ Time Frame: Up to three weeks after enrollment ]

Central Contacts and Locations

Central contacts

Mayson Moore

2169573558MMoore12@metrohealth.org

Rob Hoey, PhD

2169573665rhoey@metrohealth.org

Locations

MetroHealth Medical System Old Brooklyn Campus

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Mayson Moore

2169573558MMoore12@metrohealth.org

Robert Hoey, PhD

2169573665rhoey@metrohealth.org

Principal Investigator:

Kim Anderson, PhD

More Information

Sponsor

MetroHealth Medical Center

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by MetroHealth Medical Center on 2025-12-02.