Stimulation for Bowel Emptying

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

The investigators are testing the effect of electrical stimulation of the rectum on colonic motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. This slowed movement may result in chronic constipation and difficulty emptying the bowels. Individuals typically (without or without caregiver assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic motility for a brief period to empty the bowels. The investigators hypothesize that electrically stimulating the rectum, instead of mechanically stretching it, will produce the same beneficial effect of improving colonic motility. Therefore, this study will compare the two methods. If electrical stimulation effectively improves colonic motility, then the investigator shall develop the approach as a therapeutic intervention in future studies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Suprasacral spinal cord injury

Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation

Bowel routine requires at least 30 minutes or at least 3 cycles of digital rectal stimulation

Neurologically stable

Disqualifiers

Active sepsis

Open pressure sores on or around pelvis

Significant colon trauma or colostomy

Crohn's disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Electrical Rectal Stimulation

    Other intervention

    Electrical stimulation of the rectum will be applied to activate sensory afferent neurons of the rectum and evoke a recto-colonic reflex to improve colonic motility and facilitate bowel emptying. This intervention will compared to individuals' usual mechanical intervention of digital rectal stimulation.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Bowel emptyingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time required to complete bowel emptying

Two interventions will be tested, including the clinical standard of digital rectal stimulation and a novel approach using electrical stimulation of rectal sensory afferents, to determine the effect on colonic pressure. We will compare the time required for the participant to complete their bowel emptying routine between a control period with digital rectal stimulation and a treatment period with electrical rectal stimulation.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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VA Office of Research and Development

Lead sponsor

Cleveland Functional Electrical Stimulation Center

Collaborator