Spinal Cord InjuryNCT06836739
At-Home Genital Nerve Stimulation for SCI Bowel
A study testing Genital nerve stimulation in people with Spinal Cord Injury, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Genital nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic SCI.
- Minimum of 6 months' post-injury.
- Aged 18 years and older.
- Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI.
- Score of 14 or higher on the ISCI BF BDS v2.1.
- Response to genital nerve stimulation able to be elicited upon screening.
- Able to understand and provide informed consent.
Who cannot join
- Currently enrolled in another functional electrical stimulation (FES) research trial.
- Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report).
- Presence of a cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device if, upon clinical evaluation, it may have an interaction with GNS.
- In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MetroHealth Center for Rehabilitation Research
Cleveland, Ohio, 44109
Mayson Moore, 216-957-3518, mmoore12@metrohealth.org
Megan Hammond Nechols, 216-957-3562, mhammond1@metrohealth.org
About this study
Official title: At-Home Feasibility Trial of Genital Nerve Stimulation to Modulate Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management.
Researchers will:
Read more
- Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label
- Compare a target stimulation level to a placebo stimulation level
Participants will:
- Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home
- Visit the research center 3 times to participate in exams and answer questions
- Keep a daily diary of their bowel symptoms and stimulation times
Read the detailed description
The objective of this proposal is to determine how genital nerve stimulation (GNS) acutely modulates neurogenic bowel dysfunction (NBD) in individuals with different severities of spinal cord injury (SCI) and to determine the key study design and methodology parameters of daily at-home administration of GNS. This study will determine the feasibility of daily application of GNS as an intervention for NBD. Key feasibility measures related to dosage and adherence will be evaluated.
- Conditions
- Spinal Cord Injury
- Being tested
- Genital nerve stimulation
- Keywords
- fecal incontinence, neurogenic bowel, tetraplegia, paraplegia, paralysis, electrical stimulation, neuromodulation, bowel, feasibility, anorectal manometry
- Medical subject headings
- Spinal Cord Injuries, Fecal Incontinence, Neurogenic Bowel, Quadriplegia, Paraplegia, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genital nerve stimulationDevice
Genital nerve stimulation (GNS) will be administered via non-invasive surface skin electrodes. In men, two surface electrodes (1 cm diameter) will be placed on the dorsum of the penile shaft 2 cm apart. In women, one surface electrode will be placed near the clitoris and a second surface electrode will be placed on the labia majora or inner thigh. The electrodes will be connected to an electrical stimulator device.
| Study group | Role | What they receive |
|---|---|---|
| Target genital nerve stimulation | Experimental | Stimulation waveforms consist of biphasic, charge-balanced square pulses with a pulse width of 0.2 ms and delivered at 20 Hz. Stimuli will be applied over a range of amplitudes to determine the threshold of stimulation for producing reflex contraction of the anal sphincter (the pudendo-anal reflex). Subsequent stimulation will be applied at threshold for the first week, at 1.5 threshold for the second week, and at twice threshold (or max tolerance) for the third and fourth weeks. The typical stimulation range is 20-40 milliamps (mA) and has been shown to be well tolerated by individuals with sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks. Receives: Device: Genital nerve stimulation |
| Sham genital nerve stimulation | Sham comparator | Sham stimulation will be applied in the same manner as target stimulation, except that the stimulation frequency will be 1 Hz and the stimulation amplitude will be set to a limit that is at the threshold of perception if individuals have sensation, or 10 mA if they do not have sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks. Receives: Device: Genital nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.
The 1st feasibility measure bench mark will be the proportion of enrolled who complete the full stimulation protocol.
Measured: From baseline to the end of 6 weeks
The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.
The 2nd feasibility measure bench mark will be the number of occurrences of unblinding.
Measured: From baseline to the end of 6 weeks
The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.
The 3rd feasibility measure bench mark will be the retention rate.
Measured: From baseline to the end of 6 weeks
Secondary outcomes (7)
Anorectal Manometry (ARM)
The main secondary endpoint will be anorectal reflex activity as measured by ARM. ARM is the gold standard clinical tool for investigating anorectal function. It is widely available and very well established. Recent efforts have been made to standardize ARM testing protocols so that results can be categorized. The London Classification protocol will be used in ARM testing in this experiment.
Measured: From baseline to the end of 6 weeks
Clinical exam
This is conducted by a clinician and involves a gastrointestinal system clinical exam of bowel dysfunction.
Measured: From baseline to the end of 6 weeks
Bowel diary
A bowel diary is a means for participants to record daily bowel activities. It will be time-stamped. Parameters that are targeted to be recorded include stool type (using the Bristol Stool Scale), amount, planned emptying episodes (including time), incontinence episodes, sense of urgency, straining, medications, and complications such as nausea or hemorrhoids. These data will characterize each participant's bowel management routine, daily habits, and gastrointestinal (GI) symptoms.
Measured: From baseline to the end of 6 weeks.
Stimulation diary
A record of hours of daily stimulation use will also be captured in a stimulation diary.
Measured: From baseline to the end of 6 weeks.
International SCI (ISCI) Bowel Function (BF) Basic Dataset (BDS) version 2.1
The ISCI BF BDS v2.1 incorporates the Neurogenic Bowel Dysfunction Score as well as information about GI or anal sphincter dysfunction unrelated to SCI, surgical procedures on the GI tract, defecation methods and bowel care procedures, the need to wear external continence products, and presence of abdominal pain or discomfort. The NBDS was developed specifically for SCI and measures the degree of neurogenic bowel dysfunction symptomology and the impact on quality of life (QoL). There are 10 items, and they are symptom-based and weighted by the impact on QoL. The score ranges from 0-45 with a higher score meaning a worse outcome.
Measured: From baseline to the end of 6 weeks.
SCI-QoL Bowel Management Difficulties (SCI-QoL BMD)
The SCI-QoL BMD measures difficulties people living with SCI have with bowel management, including feelings of distress associated with bowel problems they experience in daily life. The items focus on issues related to fecal incontinence and the psychosocial consequences of fecal incontinence, which is different that the ISCI BF BDS v2.1 and why it was selected as an additional secondary outcome measure. The full scale is composed of 26 items, but a computer assisted technology version and 9-item short form version have also been created. The short form version will be used in this trial and is available for download from Assessment Center. Each item has a response option based on a 5-point Likert scale ranging from 1 'never/not at all' to 5 always/very much'. Raw scores range from 9-45 with higher scores representing greater difficulty managing bowel problems.
Measured: From baseline to the end of 6 weeks.
SCI Common Data Elements (CDEs)
SCI CDEs to be collected include 1) Medical History for body system categories including start date, end date, and ongoing status, 2) History of Injury (injury time frame, injury etiology), 3) Demographics (gender, birth date, race, ethnicity, marital status, number of members in household, area of residence, number of years of education, primary occupation), and 4) International Standards for Neurological Classification of SCI for injury classification (upper extremity motor score, lower extremity motor score, total motor score, light touch sensory score, pinprick sensory score, deep anal pressure, voluntary anal contraction, zone of partial preservation, and impairment grade data)
Measured: At baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Mar 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Kimberly Anderson, PhD, MetroHealth Medical Center
- Investigators
- Kim Anderson, PhD, Principal investigator, MetroHealth System, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836739
- Sponsor's protocol ID
- STUDY00000717
- Other IDs
- W81XWH2210778 - SC210121, W81XWH2210781 - SC210121P1
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A deidentified dataset will be transferred to the Inter-University Consortium for Political and Social Research (ICPSR) for data sharing and long-term preservation.
Publications
Hoey R, Binko A, Bourbeau D, Fass R, Gunzler D, Korty L, Kshirsagar A, Moore M, Moynahan M, Nechols MH, Petrie B, Stitts E, Wilson J, Anderson KD. At-home feasibility trial of genital nerve stimulation to modulate neurogenic bowel dysfunction in individuals living with spinal cord injury: a protocol. Front Neurol. 2026 Aug 21;17:1922192. doi: 10.3389/fneur.2026.1922192. eCollection 2026.
PubMed 42698424
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-Home Feasibility Trial of Genital Nerve Stimulation to Modulate Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06836739
- Acronym / sponsor ID
- STUDY00000717
- Conditions
- Spinal Cord Injury
- Keywords
- fecal incontinence, neurogenic bowel, tetraplegia, paraplegia, paralysis, electrical stimulation, neuromodulation, bowel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management.
Researchers will:
- Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label
- Compare a target stimulation level to a placebo stimulation level
Participants will:
- Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home
- Visit the research center 3 times to participate in exams and answer questions
- Keep a daily diary of their bowel symptoms and stimulation times
Detailed description
The objective of this proposal is to determine how genital nerve stimulation (GNS) acutely modulates neurogenic bowel dysfunction (NBD) in individuals with different severities of spinal cord injury (SCI) and to determine the key study design and methodology parameters of daily at-home administration of GNS. This study will determine the feasibility of daily application of GNS as an intervention for NBD. Key feasibility measures related to dosage and adherence will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Target genital nerve stimulation | Experimental | Device: Genital nerve stimulationStimulation waveforms consist of biphasic, charge-balanced square pulses with a pulse width of 0.2 ms and delivered at 20 Hz. Stimuli will be applied over a range of amplitudes to determine the threshold of stimulation for producing reflex contraction of the anal sphincter (the pudendo-anal reflex). Subsequent stimulation will be applied at threshold for the first week, at 1.5 threshold for the second week, and at twice threshold (or max tolerance) for the third and fourth weeks. The typical stimulation range is 20-40 milliamps (mA) and has been shown to be well tolerated by individuals with sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks. |
| Sham genital nerve stimulation | Sham comparator | Device: Genital nerve stimulationSham stimulation will be applied in the same manner as target stimulation, except that the stimulation frequency will be 1 Hz and the stimulation amplitude will be set to a limit that is at the threshold of perception if individuals have sensation, or 10 mA if they do not have sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Traumatic SCI.
- Minimum of 6 months' post-injury.
- Aged 18 years and older.
- Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI.
- Score of 14 or higher on the ISCI BF BDS v2.1.
Key exclusion criteria (4 listed)
- Currently enrolled in another functional electrical stimulation (FES) research trial.
- Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report).
- Presence of a cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device if, upon clinical evaluation, it may have an interaction with GNS.
- In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genital nerve stimulationGenital nerve stimulation (GNS) will be administered via non-invasive surface skin electrodes. In men, two surface electrodes (1 cm diameter) will be placed on the dorsum of the penile shaft 2 cm apart. In women, one surface electrode will be placed near the clitoris and a second surface electrode will be placed on the labia majora or inner thigh. The electrodes will be connected to an electrical stimulator device. | Device | Sham genital nerve stimulation, Target genital nerve stimulation |
Primary outcome
The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.
Time frame: From baseline to the end of 6 weeks
The 1st feasibility measure bench mark will be the proportion of enrolled who complete the full stimulation protocol.
The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.
Time frame: From baseline to the end of 6 weeks
The 2nd feasibility measure bench mark will be the number of occurrences of unblinding.
The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.
Time frame: From baseline to the end of 6 weeks
The 3rd feasibility measure bench mark will be the retention rate.
7 secondary outcomes
Anorectal Manometry (ARM)
Time frame: From baseline to the end of 6 weeks
Clinical exam
Time frame: From baseline to the end of 6 weeks
Bowel diary
Time frame: From baseline to the end of 6 weeks.
Stimulation diary
Time frame: From baseline to the end of 6 weeks.
International SCI (ISCI) Bowel Function (BF) Basic Dataset (BDS) version 2.1
Time frame: From baseline to the end of 6 weeks.
SCI-QoL Bowel Management Difficulties (SCI-QoL BMD)
Time frame: From baseline to the end of 6 weeks.
SCI Common Data Elements (CDEs)
Time frame: At baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Derived from this study: PubMed 42698424Hoey R, Binko A, Bourbeau D, Fass R, Gunzler D, Korty L, Kshirsagar A, Moore M, Moynahan M, Nechols MH, Petrie B, Stitts E, Wilson J, Anderson KD. At-home feasibility trial of genital nerve stimulation to modulate neurogenic bowel dysfunction in individuals living with spinal cord injury: a protocol. Front Neurol. 2026 Aug 21;17:1922192. doi: 10.3389/fneur.2026.1922192. eCollection 2026.
- Individual participant dataSharing planned: Yes. A deidentified dataset will be transferred to the Inter-University Consortium for Political and Social Research (ICPSR) for data sharing and long-term preservation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kim Anderson, PhD principal investigator
MetroHealth System, Ohio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genital nerve stimulation in people with Spinal Cord Injury, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mayson Moore (216-957-3518, mmoore12@metrohealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD. (time frame: From baseline to the end of 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06836739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.