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New treatment option for Fecal Incontinence
Official title Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
ClinicalTrials.gov ID: NCT05626816
What this study is testing
- What it's testing
- Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Compensation & support
Some study costs may be covered. A stipend or compensation may be offered.
Higher-pay potential.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.