Clinical trial NCT05626816: Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Official title: Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fecal Incontinence
Keywords: bowel
spinal cord injury
electrical stimulation
anorectal manometry
incontinence
tetraplegia
paraplegia
paralysis
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: VA of Northeast Ohio Health System
First posted: 2022-11-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will receive the intervention, but randomization will determine the order of presentation of sham and effective stimulation to ensure blinding of the participant.
Primary purpose: TREATMENT

Brief summary: 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.

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:

1. - 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.
2. - 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):

1. - 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.
2. - Instrumentation: the participant will have the study instrumentation applied.
3. - 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).

Eligibility criteria: 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.

Primary outcomes:
measure: ARM outcome - Rectal wall tension
timeFrame: Up to three weeks after enrollment
measure: ARM outcome - Anal sphincter function
timeFrame: Up to three weeks after enrollment
measure: ARM outcome - Rectoanal reflex activity (RAIR)
timeFrame: Up to three weeks after enrollment
measure: ARM outcome - Rectal sensation
timeFrame: Up to three weeks after enrollment
measure: ARM outcome - Presence of hyper reflexive rectal contractions
timeFrame: Up to three weeks after enrollment
Secondary outcomes:
measure: SCI-QOL Bowel Management Difficulties (SCI-QOL BMD)
timeFrame: During enrollment, up to one week
measure: International SCI Bowel Function Basic Dataset Version 2.1 (ISCI BF BDS)
timeFrame: During enrollment, up to one week
measure: International Standards of Neurological Classification of SCI (ISNCSCI)
timeFrame: During enrollment, up to one week
measure: SCI Common Data Elements - Medical history
timeFrame: During enrollment, up to one week
measure: SCI Common Data Elements - History of injury
timeFrame: During enrollment, up to one week
measure: SCI Common Data Elements - Demographics
timeFrame: During enrollment, up to one week
measure: Clinical exam - abdominal exam
timeFrame: During enrollment, up to one week
measure: Clinical exam - Evaluation of sacral reflexes
timeFrame: During enrollment, up to one week
measure: Clinical exam - Anal sphincter tone
timeFrame: During enrollment, up to one week
measure: Clinical exam - Sensation
timeFrame: During enrollment, up to one week
measure: Clinical exam - Voluntary contraction
timeFrame: During enrollment, up to one week
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical System Old Brooklyn Campus
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Kim Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: