An interventional study of Genital nerve stimulation in Spinal Cord Injury, 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 2026-11-03.
Sponsored by MetroHealth Medical Center · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 12 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries 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.
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.
Device: Genital nerve stimulation
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.
Device: Genital nerve stimulation
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to the end of 6 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: At baseline.
Treatment questionnaire
It is important to be able to collect participant feedback on the ease or difficulty of using the TENS unit and applying GNS at home. This is important feasibility information that should be collected, and we will generate a form to enable more standardized collection of this data from each participant. This will include prompts such as any difficulty placing electrodes, any difficulty keeping electrodes in place, any need for further training on the device once home, any device malfunctions, any need for replacement components or electrodes, etc.
Time frame: At the end of 6 weeks.
Study exit questionnaire
A study exit questionnaire will be used to determine whether participants remained blinded throughout the study and any perspectives on their experience while in the study.
Time frame: At the end of 6 weeks.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Within 12 months of the end of study.
Access criteria: Based on ICPSR guidelines.
Started Mar 2025 (actual). Primary completion is estimated for Sep 2027, 30 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 30 months is below that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: primary completion Sep 2026 → Sep 2027 and completion Sep 2026 → Sep 2027.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.