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Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

RecruitingNA

Sponsor: The University of Texas Health Science Center, Houston

Conditions: Neurogenic Bowel Dysfunction, Spinal Cord Injury

Interventions: Vibrant Capsule

Countries: United States

The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.

Eligibility overview

Sex: ALL

Age: 21 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 obstruction, ileus, diverticulitis, or bowel surgery for a disease (appendix removal is ok).
* Persistent autonomic dysreflexia (AD) triggered by bowel movements.
* Recent changes to spasticity medications within the past month.
* History of significant gastrointestinal disorders
* History of Zenker's diverticulum
* Dysphagia
* Esophageal stricture
* Eosinophilic esophagitis or achalasia
* Pregnancy.
* Presence of implanted devices that could be affected by proximity to a direct current magnetic field.

Locations (1)

Houston, Texas, United States