Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Study Overview
Status
Conditions
Intervention / Treatment
- 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)
Detailed Description
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:
- - If you live in the region (Cuyahoga, Lorain, Medina, Lake, or Geauga counties of Ohio) and need assistance with transportation to get to and from the research site for a visit, the study team will make these arrangements at no cost to you. If you live outside of the region, the study team will reimburse your transportation expenses up to a maximum of $556 per visit.
- - If you live a distance away from the research site for which it would be easier for you to spend the night closer for a research visit, accessible lodging is available at the Zubizarreta House. This house is right next door to the MetroHealth Rehabilitation Institute and is designed for people with spinal cord injuries. The overnight stay will be provided at no cost to you, but if you need a caregiver to stay with you that is your responsibility.
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):
- - Preparation: the participant will be asked to complete their typical bowel program the night before their manometry visit is scheduled. There are no restrictions on medications, eating, or drinking prior to the visit.
- - Instrumentation: the participant will have the study instrumentation applied.
- - Testing procedures with ARM and GNS: The London classification protocol will be used to assess ano-rectal function. This procedure uses a short (~12 minutes) procedure of actions to determine how the anus and rectum are functioning.
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rob Hoey, PhD
- Phone Number: 2169573665
- Email: rhoey@metrohealth.org
Study Contact Backup
- Name: Mayson Moore
- Phone Number: 2169573558
- Email: MMoore12@metrohealth.org
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44109
- Recruiting
- MetroHealth Medical System Old Brooklyn Campus
-
Contact:
- Robert Hoey, PhD
- Phone Number: 2169573665
- Email: rhoey@metrohealth.org
-
Principal Investigator:
- Kim Anderson, PhD
-
Principal Investigator:
- Rob Hoey, PhD
-
Sub-Investigator:
- Dennis Bourbeau, PhD
-
Sub-Investigator:
- James Wilson, DO
-
Sub-Investigator:
- Ronnie Fass, MD
-
Sub-Investigator:
- Doug Gunzler, PhD
-
Contact:
- Mayson Moore
- Phone Number: 2169573558
- Email: MMoore12@metrohealth.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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, |
|
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.
|
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, |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ARM outcome - Rectal wall tension
Time Frame: Up to three weeks after enrollment
|
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. |
Up to three weeks after enrollment
|
|
ARM outcome - Anal sphincter function
Time Frame: Up to three weeks after enrollment
|
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.
|
Up to three weeks after enrollment
|
|
ARM outcome - Rectoanal reflex activity (RAIR)
Time Frame: Up to three weeks after enrollment
|
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.
|
Up to three weeks after enrollment
|
|
ARM outcome - Rectal sensation
Time Frame: Up to three weeks after enrollment
|
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.
|
Up to three weeks after enrollment
|
|
ARM outcome - Presence of hyper reflexive rectal contractions
Time Frame: Up to three weeks after enrollment
|
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. |
Up to three weeks after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SCI-QOL Bowel Management Difficulties (SCI-QOL BMD)
Time Frame: During enrollment, up to one week
|
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.
|
During enrollment, up to one week
|
|
International SCI Bowel Function Basic Dataset Version 2.1 (ISCI BF BDS)
Time Frame: During enrollment, up to one week
|
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.
|
During enrollment, up to one week
|
|
International Standards of Neurological Classification of SCI (ISNCSCI)
Time Frame: During enrollment, up to one week
|
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.
|
During enrollment, up to one week
|
|
SCI Common Data Elements - Medical history
Time Frame: During enrollment, up to one week
|
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.
|
During enrollment, up to one week
|
|
SCI Common Data Elements - History of injury
Time Frame: During enrollment, up to one week
|
Data regarding the injury etiology and time frame will be collected from the participant.
|
During enrollment, up to one week
|
|
SCI Common Data Elements - Demographics
Time Frame: During enrollment, up to one week
|
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.
|
During enrollment, up to one week
|
|
Clinical exam - abdominal exam
Time Frame: During enrollment, up to one week
|
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.
|
During enrollment, up to one week
|
|
Clinical exam - Evaluation of sacral reflexes
Time Frame: During enrollment, up to one week
|
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.
|
During enrollment, up to one week
|
|
Clinical exam - Anal sphincter tone
Time Frame: During enrollment, up to one week
|
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.
|
During enrollment, up to one week
|
|
Clinical exam - Sensation
Time Frame: During enrollment, up to one week
|
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.
|
During enrollment, up to one week
|
|
Clinical exam - Voluntary contraction
Time Frame: During enrollment, up to one week
|
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.
|
During enrollment, up to one week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kim Anderson, PhD, MetroHealth Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Rectal Diseases
- Trauma, Nervous System
- Spinal Cord Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Spinal Cord Injuries
- Paralysis
- Quadriplegia
- Paraplegia
- Fecal Incontinence
Other Study ID Numbers
- STUDY00000105
- CDMRP-SC210121P1 (Other Grant/Funding Number: Department of Defense CDMRP SCIRP)
- CDMRP-SC210121 (Other Grant/Funding Number: Department of Defense CDMRP SCIRP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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