An interventional study of Genital Nerve Stimulation and Clinical exam in Fecal Incontinence, sponsored by MetroHealth Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by MetroHealth Medical Center · Not applicable, Interventional, and Treatment
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.
Time commitment: A person who participates in this study will have the option of coming in for one or two visits (for a total of about 7.5 hours). Descriptions below will separate the research activities into two visits for clarity.
Minimizing barriers to participation:
Visit 1 (screening): When a person decides to participate in the study they will be scheduled to come in for a screening visit. During this visit they will: provide informed consent to participate, participate in the initial screening exams, and have genital nerve stimulation (GNS) applied briefly to determine if the nerve responds to electrical stimulation.
If a person completes the screening procedures and qualifies for the study they will be invited back to complete the manometry visit.
Visit 2 (manometry):
Overall design: GNS and the London classification system will be used to assess bowel function in two different states, with stimulation and without stimulation. This will be applied in the order of no stimulation (condition A), stimulation (condition B), no stimulation (condition A repeated).
283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.
This study's planned enrollment of 52 is close to the median of 50 across 203 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →MetroHealth Medical Center is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
Examination by physician determines the presence of pelvic reflexes (pudendo-anal and bulbocavernosus) which are essential for GNS to have an effect.
Data regarding participant demographics, history of injury, and medical history will be collected.
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.
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.
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.
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,
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to three weeks after enrollment
SCI-QOL Bowel Management Difficulties (SCI-QOL BMD)
A survey on bowel management difficulties and the effect of those complications on the participants quality of life will be conducted and data collected by study staff. Answers are chosen from a 5-point Likert scale from 1 (never/not at all) to 5 (always/very much) and higher scores represent greater difficulty managing bowel complications.
Time frame: During enrollment, up to one week
International SCI Bowel Function Basic Dataset Version 2.1 (ISCI BF BDS)
A survey on bowel function after SCI will be conducted and data collected by study staff. The instrument is on a scale from 0-45 with higher scores indicating greater dysfunction.
Time frame: During enrollment, up to one week
International Standards of Neurological Classification of SCI (ISNCSCI)
This is a standard assessment tool to determine level and severity of injury by the American Spinal Injury Association. The test uses pin prick and light touch to determine motor and sensory capability along the body. At the end of the test the participant will have information on their level (i.e. T8) and severity (grade A-D, with A being motor and sensory complete injury). These endpoints overlap with the clinical exam outcomes and will only be conducted once. Therefore, the ISNCSCI is being conducted in the context of the clinical exam endpoints below.
Time frame: During enrollment, up to one week
SCI Common Data Elements - Medical history
Data will be collected regarding body system categories (constitutional symptoms, eyes, ears/nose/mouth/throat, cardiovascular, respiratory, gastrointestinal, genitourinary, musculoskeletal, integumentary, neurological, psychiatric, endocrine, hematologic/lymphatic, and allergic/immunologic) including start date, end date, and ongoing status.
Time frame: During enrollment, up to one week
SCI Common Data Elements - History of injury
Data regarding the injury etiology and time frame will be collected from the participant.
Time frame: During enrollment, up to one week
SCI Common Data Elements - Demographics
Data regarding the participants' gender, birth date, race, ethnicity, marital status, number of members in household, area of residence, number of years of education, and primary occupation.
Time frame: During enrollment, up to one week
Clinical exam - abdominal exam
An SCI-specialized clinician will assess the participant in regard to abdominal health. This data will be incorporated into a clinical characterization of bowel dysfunction.
Time frame: During enrollment, up to one week
Clinical exam - Evaluation of sacral reflexes
An SCI-specialized clinician will assess the participant in regard to the integrity of the sacral reflexes. These include the pudendo-anal reflex (PA) and bulbocavernosus (BC) reflexes that are critical for responding to the genital nerve stimulation.
Time frame: During enrollment, up to one week
Clinical exam - Anal sphincter tone
An SCI-specialized clinician will assess the participant in regard to anal sphincter tone. After injury the external anal sphincter is either spastic (tightly closed and difficult to relax) or flaccid (completely lax and does not contract) based on the level of injury. If the damage to the spinal cord is at the level of the sacrum (just above the tailbone area) it will cause a flaccid phenotype and indicates damage to the reflex pathways necessary for the experiment.
Time frame: During enrollment, up to one week
Clinical exam - Sensation
An SCI-specialized clinician will assess the participant in regard to areas of the body that have sensation. This data is incorporated in the ISNCSCI test and will not be duplicated.
Time frame: During enrollment, up to one week
Clinical exam - Voluntary contraction
An SCI-specialized clinician will assess the participant in regard to the lowest area of the body that the participant is able to contract voluntarily. This data is incorporated in the ISNCSCI test and will not be duplicated.
Time frame: During enrollment, up to one week
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — A deidentified set will be transferred to the Inter-University Consortium for Political and Social Research (ICPSR) for data sharing and long-term preservation.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Within 12 months of end of study.
Access criteria: Based on the ICPSR guidelines.
Started Mar 2023 (actual). Primary completion is estimated for Dec 2026, 45 months after the start.
Of 70 non-industry interventional studies with no phase under Fecal Incontinence, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's planned 45 months is above that.
Counting every sponsor, half of 86 studies reached it within 36 months; a quarter within 20 and three quarters within 57.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 1, 2026: primary completion Dec 2025 → Dec 2026 and completion Dec 2025 → Dec 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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