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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2025 → Dec 31, 2026
See other at-risk trials from MetroHealth Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 31, 2025 to Dec 31, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 10 of 11 entries
    • Study description expanded, about 5 words
  2. Site contact updated
    • Collaborators: 1 to 2
    v8
  3. Site contact updatedv7
  4. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v6
  5. Site contact updatedv5
Show 3 earlier versionsHide 3 earlier versions
  1. Eligibility criteria shortened, about 11 wordsv4
  2. Start date changed from estimate of Jan 31, 2023 to Mar 21, 2023v3
  3. Start date: Dec 1, 2022 to Jan 31, 2023
    • Study description expanded, about 89 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05626816
Lead Sponsor MetroHealth Medical Center
Collaborators: VA of Northeast Ohio Health System, Congressionally Directed Medical Research Programs
Conditions
(from sponsor)		 Fecal Incontinence
Related terms Fecal Incontinence, Paralysis, Paraplegia, Quadriplegia, Spinal Cord Injuries
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov