At-Home Genital Nerve Stimulation for SCI Bowel
ConditionSpinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMetroHealth Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Genital nerve stimulation
DeviceGenital 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.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Target genital nerve stimulationExperimental treatment 1 intervention
Group B: Sham genital nerve stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeks3
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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.4
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.Other outcomes
1
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.2
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
MetroHealth Medical Center
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov