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- Biofeedback Therapy: A Multi-center, Prospective, Non-randomized Study on Pathophysiology, Diagnosis, and Biofeedback Therapy in Fecal Incontinence (FI) Using Fecobionics (NORMAL and ABNORMAL-FI)
Clinical Trial
Biofeedback Therapy: A Multi-center, Prospective, Non-randomized Study on Pathophysiology, Diagnosis, and Biofeedback Therapy in Fecal Incontinence (FI) Using Fecobionics (NORMAL and ABNORMAL-FI)
This study will be comparing a research biofeedback device to the standard device used in office for performing biofeedback therapy to improve stool leakage. The new device will also be used to record data on anorectal activity. The investigational device called Fecobionics, will be used to perform biofeedback therapy and record data for participants in this study. The balloon-like device is inserted into the rectum by the study doctor and will record data during the biofeedback training and for assessing anorectal function. This is a treatment study and participants will receive either office biofeedback therapy (OBT) or Fecobionics biofeedback therapy (FBT) depending on which treatment arm they are randomized to. Additionally, the data collected from the study may or may not help the device manufacturer in the development of future devices that can be used to diagnose anorectal disorders and it also can be used to determine the effectiveness of treatments for anorectal disorders.
Eligibility Criteria
- GENERAL INCLUSION CRITERIA Candidates for this study are eligible if they meet ALL of the following criteria. All answers must be YES to the inclusion criteria to be in this study. Willing/able to provide informed consent and to undergo required study tests, surveys, and procedures; Adults >18years of age; History of FI for over 3 months; Fulfill the Rome IV diagnostic criteria for FI; No active mucosal disease (colonoscopy + biopsy) GENERAL EXCLUSION CRITERIA Candidates for this study are not eligible if they meet any of the following criteria. The answer must be ?NO? to all exclusion criteria: Female who is pregnant; Prior anorectal surgery; History of chronic constipation; Previous pelvic surgery/radiation, radical hysterectomy; Active anal fissure, anal abscess, congenital anorectal malformation, fistulae, or inflamed hemorrhoids