Genital nerve stimulation for bowel issues in spinal cord injury patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of genital nerve stimulation (GNS) on fecal incontinence in individuals with spinal cord injuries (SCI). Participants will undergo a screening visit to assess their response to GNS, followed by a series of assessments including anorectal manometry to evaluate bowel function. The study aims to collect comprehensive data on bowel-related issues and the potential effectiveness of GNS in reducing fecal incontinence. The research is designed to identify which patients may benefit from this intervention and how it may improve their quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Traumatic SCI
* Minimum 6 months post-injury
* Aged 18 years or older
* Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI
* Response to genital nerve stimulation upon screening
* Able to understand and provide informed consent

Exclusion Criteria:

* Currently enrolled in another functional electrical stimulation (FES) research trial
* Females who are pregnant or planning to become pregnant during the trial
* Presence of cardiac pacemaker, implanted defibrillator or other implanted FES device if, upon clinical exam, it may have an interaction with GNS.
* In the judgement of the PI or Co-Investigators, presence of medical complications that may interfere with the execution of the study.

Where it's running

• MetroHealth Medical System Old Brooklyn Campus
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Kim Anderson, PhD — MetroHealth Medical Center
• Study coordinator: Mayson Moore
• Email: MMoore12@metrohealth.org
• Phone: 2169573558

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.