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Recruiting NCT06078176

Stimulation for Bowel Emptying

No phase Interventional Neurogenic Bowel Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrical Rectal Stimulation.
Who it may be relevant to
Registry conditions: Neurogenic Bowel Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Electrical Rectal Stimulation to Promote Bowel Emptying After Spinal Cord Injury

Overview

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.

Interventions

  • Other Electrical Rectal Stimulation
    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.

Primary outcome measures

  • Time required to complete bowel emptying [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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
  • At least 18 years old
  • At least 12 months post neurological injury or disease diagnosis

Exclusion criteria

  • Active sepsis
  • Open pressure sores on or around pelvis
  • Significant colon trauma or colostomy
  • Crohn's disease
  • Colonic obstruction or gastrointestinal surgery within last 3 months
  • Significant history of autonomic dysreflexia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Syracuse VA Medical Center, Syracuse, NY — Syracuse

Identifiers

NCT: NCT06078176 · B4529-R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗