title: [Clinical trials with medical devices: lack of quality illustrated for faecal incontinence].
abstract: BACKGROUND
  Medical devices must be safe and functioning states the law. Treatments with medical devices need not be efficacious to be allowed. We investigated special requirements and problems arising from the law.
  
  
  METHODS
  The market for medical devices is contrasted with that for drugs. The requirements of relevant laws are discussed. Finally, published clinical studies on anal incontinence are analysed with respect to their methodological quality.
  
  
  RESULTS
  Clinical trials of medical devices for treat-ing anal incontinence are of poor methodological quality thus preventing evaluation of the devices' utility.
  
  
  CONCLUSIONS
  Large, high quality clinical studies of the efficacy of medical devices for treating anal incontinence are urgently needed. Only such studies enable health technology assessment and comprehensible decisions on reimbursement by health insurance.
authors: Universität zu Lübeck, Universitätsklinikum Schleswig Holstein, Campus Lübeck, Institut für Medizinische Biometrie und Statistik. Reinhard.Vonthein@imbs.uniluebeck.de
authors: R
authors: R
authors: Vonthein
authors: C
authors: C
authors: Hemmelmann
authors: I R
authors: IR
authors: König
authors: T
authors: T
authors: Schwandner
authors: H-P
authors: HP
authors: Bruch
authors: A
authors: A
authors: Ziegler
mesh_terms: D001676:Biofeedback, Psychology / Q000295:instrumentation; D003625:Data Collection / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004599:Electric Stimulation Therapy / Q000295:instrumentation; D004867:Equipment Design; D004868:Equipment Failure; D004869:Equipment Safety; D019317:Evidence-Based Medicine / Q000592:standards; D005242:Fecal Incontinence / Q000628:therapy*; D005858:Germany; D019983:Guideline Adherence / Q000331:legislation & jurisprudence; D006801:Humans; D009313:National Health Programs / Q000331:legislation & jurisprudence; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D016896:Treatment Outcome