RECRUITING

Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Quick Facts

Study Start:2023-03-21
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05626816

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Traumatic SCI
  2. * Minimum 6 months post-injury
  3. * Aged 18 years or older
  4. * Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI
  5. * Response to genital nerve stimulation upon screening
  6. * Able to understand and provide informed consent
  1. * Currently enrolled in another functional electrical stimulation (FES) research trial
  2. * Females who are pregnant or planning to become pregnant during the trial
  3. * Presence of cardiac pacemaker, implanted defibrillator or other implanted FES device if, upon clinical exam, it may have an interaction with GNS.
  4. * In the judgement of the PI or Co-Investigators, presence of medical complications that may interfere with the execution of the study.

Contacts and Locations

Study Contact

Anvi Kshirsagar
CONTACT
2169573558
akshirsagar@metrohealth.org
Rob Hoey, PhD
CONTACT
2169573665
rhoey@metrohealth.org

Principal Investigator

Kim Anderson, PhD
PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center

Study Locations (Sites)

MetroHealth Medical System Old Brooklyn Campus
Cleveland, Ohio, 44109
United States

Collaborators and Investigators

Sponsor: MetroHealth Medical Center

  • Kim Anderson, PhD, PRINCIPAL_INVESTIGATOR, MetroHealth Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-21
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-03-21
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • bowel
  • spinal cord injury
  • electrical stimulation
  • anorectal manometry
  • incontinence
  • tetraplegia
  • paraplegia
  • paralysis

Additional Relevant MeSH Terms

  • Fecal Incontinence