Study Description: Our goal is to address the problem of Fecal Incontinence (FI) by developing therapies that modulate peripheral and central neuronal perturbations and thereby improve visceromotor control and sensori-motor dysfunctions, and to understand the neurobiologic basis of these treatments. Our expected outcomes include development of new treatment approaches for FI which are mechanistically based, effective, safe, low cost, less invasive, low risk and less dependent on patient compliance. The impact of our project include a new non-invasive treatment modality for FI, a scientific basis for the development of this treatment and improved understanding of the peripheral and central neuroenteric axis in FI.
Principal Investigator: Satish Rao
Eligibility Criteria: Inclusion criteria: a) Recurrent episodes of FI for 6 months; b) No mucosal disease (colonoscopy + biopsy); and c) On a 2-week stool diary patients reported at least one episode of solid or liquid FI/week.
Compensation: Yes, subjects will be compensated.
Compensation Explanation: FINANCIAL INFORMATION Will I be paid for taking part in the study? You will receive up to $200 for completing this study. Payment for your participation in this study will be prorated as follows: Screening visit and completion of all screening activities (two weeks); baseline brain-gut study and first treatment session. $100.00 Completion of all six treatment sessions and final visit procedures (repeated procedures from screening) $100.00 You will be paid after your completion of the study. We ask that you allow approximately two weeks for payment processing. You will be responsible for the costs of transportation to participate in the study. If you are receiving compensation over $100.00 from participating in this study, you will be required to complete a W-9 form. If you are a GRU employee, your compensation will be transmitted as part of your institutional compensation. This payment will be subject to Federal and Georgia state withholding taxes as well as FICA tax, these payments will be included in your payroll check and will reflect on the W-2 form at calendar year end. If you are not a GRU employee and your total compensation from GRU exceeds $600.00 in a calendar year, a 1099 will be issued to you and the IRS at the end of the year. Will it cost me anything to take part in the study? There will be no cost to you for participating in this study.
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