AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - anyAllMetroHealth Medical Center
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 wh

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
๐Ÿ’Š

What it tests

  • Genital Nerve Stimulation
  • Clinical exam
  • Collection of SCI common data elements
  • Bowel function survey completion
  • International Standard for Neurological Classification of SCI (ISNCSCI)
๐Ÿ“

Where

1 site
MetroHealth Medical System Old Brooklyn Campus
Cleveland, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy