Pilot Trial of the Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction
The University of Texas Health Science Center, Houston
Summary
The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.
Description
The purpose of this study is to see how well the Vibrant capsule works at treating people with spinal cord injury (SCI)-induced upper motor neuron (UMN) neurogenic bowel. This study will test the safety of the Vibrant capsule. This Vibrant capsule has been approved by the Food and Drug Administration (FDA) for chronic idiopathic constipation.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Individuals with chronic spinal cord injury (SCI) of more than one year. * Stable neurological level and function of SCI for at least six months. * Consistent bowel program without changes for at least 3 months. * At least one scheduled bowel movement (BM) every three days. * Use of digital stimulation, suppositories, enemas, or mini enemas, as part of the scheduled bowel program. * Use of oral medications as part of the bowel program. Exclusion Criteria: * Bowel incontinence occurring more than once per week. * Non-English-speaking individuals. * History of bowel obst…
Interventions
- DeviceVibrant Capsule
The Vibrant capsule is designed to alleviate chronic constipation by stimulating the colon through gentle vibrations. The Vibrant capsule will be swallowed and tracked through the digestive system of spinal cord injury patients.
Location
- TIRR Memorial HermannHouston, Texas