Faecal Incontinence — Computational Model of SNS (Sacral Nerve Stimulation) Induced Electrical Current Flow Using Tractography Imaging
Citation(s)
Cotterill N, Norton C, Avery KN, Abrams P, Donovan JL A patient-centered approach to developing a comprehensive symptom and quality of life assessment of anal incontinence. Dis Colon Rectum. 2008 Jan;51(1):82-7. Epub 2007 Nov 15.
Jorge JM, Wexner SD Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. Review.
Maeda Y, Lundby L, Buntzen S, Laurberg S Outcome of sacral nerve stimulation for fecal incontinence at 5 years. Ann Surg. 2014 Jun;259(6):1126-31. doi: 10.1097/SLA.0b013e31829d3969.
Maeda Y, Lundby L, Buntzen S, Laurberg S Suboptimal outcome following sacral nerve stimulation for faecal incontinence. Br J Surg. 2011 Jan;98(1):140-7. doi: 10.1002/bjs.7302. Epub 2010 Oct 27.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
