All interventions, effective stim applied first for Bowel Incontinence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Bowel IncontinenceClinical exam - DiagnosticTest
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Bowel Incontinence

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 11 Secondary · Reporting Duration: During enrollment, up to one week

During enrollment, up to one week
Clinical exam - Anal sphincter tone
Clinical exam - Evaluation of sacral reflexes
Clinical exam - Sensation
Clinical exam - Voluntary contraction
Clinical exam - abdominal exam
International SCI Bowel Function Basic Dataset Version 2.1 (ISCI BF BDS)
International Standards of Neurological Classification of SCI (ISNCSCI)
SCI Common Data Elements - Demographics
SCI Common Data Elements - History of injury
SCI Common Data Elements - Medical history
SCI-QOL Bowel Management Difficulties (SCI-QOL BMD)
Up to three weeks after enrollment
ARM outcome - Anal sphincter function
ARM outcome - Presence of hyper reflexive rectal contractions
ARM outcome - Rectal sensation
ARM outcome - Rectal wall tension
ARM outcome - Rectoanal reflex activity (RAIR)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

All interventions, effective stim applied first
1 of 2
All interventions, Sham applied first
1 of 2

Experimental Treatment

52 Total Participants · 2 Treatment Groups

Primary Treatment: All interventions, effective stim applied first · No Placebo Group · N/A

All interventions, effective stim applied firstExperimental Group · 7 Interventions: Clinical exam, Collection of SCI common data elements, Genital Nerve Stimulation, Response to genital nerve stimulation (GNS), Anorectal Manometry testing (ARM), Bowel function survey completion, International Standard for Neurological Classification of SCI (ISNCSCI) · Intervention Types: DiagnosticTest, DiagnosticTest, Device, DiagnosticTest, DiagnosticTest, DiagnosticTest, DiagnosticTest
All interventions, Sham applied firstExperimental Group · 7 Interventions: Clinical exam, Collection of SCI common data elements, Genital Nerve Stimulation, Response to genital nerve stimulation (GNS), Anorectal Manometry testing (ARM), Bowel function survey completion, International Standard for Neurological Classification of SCI (ISNCSCI) · Intervention Types: DiagnosticTest, DiagnosticTest, Device, DiagnosticTest, DiagnosticTest, DiagnosticTest, DiagnosticTest
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clinical exam
2010
N/A
~350

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: during enrollment, up to one week

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor
105 Previous Clinical Trials
20,904 Total Patients Enrolled
VA of Northeast Ohio Health SystemUNKNOWN
Kim Anderson, PhDPrincipal InvestigatorMetroHealth Medical Center

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a spinal cord injury and your neurological level is T12 or higher.

Who else is applying?

What state do they live in?
Ohio100.0%
What site did they apply to?
MetroHealth Medical System Old Brooklyn Campus100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
0100.0%

How responsive is this trial?

Most responsive sites:
  1. MetroHealth Medical System Old Brooklyn Campus: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call50.0%
Email50.0%