Clinical trial NCT06836739: At-Home Genital Nerve Stimulation for SCI Bowel
Official title: At-Home Feasibility Trial of Genital Nerve Stimulation to Modulate Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: fecal incontinence
neurogenic bowel
tetraplegia
paraplegia
paralysis
electrical stimulation
neuromodulation
bowel
feasibility
anorectal manometry
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Traumatic SCI.
2. Minimum of 6 months' post-injury.
3. Aged 18 years and older.
4. Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI.
5. Score of 14 or higher on the ISCI BF BDS v2.1.
6. Response to genital nerve stimulation able to be elicited upon screening.
7. Able to understand and provide informed consent.

Exclusion Criteria:

1. Currently enrolled in another functional electrical stimulation (FES) research trial.
2. Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report).
3. 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.
4. In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.

Primary outcomes:
measure: The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.
timeFrame: From baseline to the end of 6 weeks
measure: The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.
timeFrame: From baseline to the end of 6 weeks
measure: The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.
timeFrame: From baseline to the end of 6 weeks
Secondary outcomes:
measure: Anorectal Manometry (ARM)
timeFrame: From baseline to the end of 6 weeks
measure: Clinical exam
timeFrame: From baseline to the end of 6 weeks
measure: Bowel diary
timeFrame: From baseline to the end of 6 weeks.
measure: Stimulation diary
timeFrame: From baseline to the end of 6 weeks.
measure: International SCI (ISCI) Bowel Function (BF) Basic Dataset (BDS) version 2.1
timeFrame: From baseline to the end of 6 weeks.
measure: SCI-QoL Bowel Management Difficulties (SCI-QoL BMD)
timeFrame: From baseline to the end of 6 weeks.
measure: SCI Common Data Elements (CDEs)
timeFrame: At baseline.
Other outcomes:
measure: Treatment questionnaire
timeFrame: At the end of 6 weeks.
measure: Study exit questionnaire
timeFrame: At the end of 6 weeks.
Locations:
city: Cleveland
country: United States
facility: MetroHealth Center for Rehabilitation Research
state: Ohio
Study officials:
affiliation: MetroHealth System, Ohio
name: Kim Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: