Therapiestudien mit Medizinprodukten: Mangelnde Qualität illustriert anhand analer Inkontinenz

Abstract

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.

Triple-Target Treatment Versus Low-Frequency Electrostimulation for Anal Incontinence

“…Although the categories of EMG-BF and lowfrequency electrical stimulation (LFS) have been included in the HMV as prescribable and reimbursable interventions for a number of years, their efficacy has never been adequately demonstrated. In multiple systematic reviews (4)(5)(6), it has been found that the flawed methods of the available clinical trials made it impossible to arrive at any definitive judgment about efficacy (7). Poor compliance also affects the effectiveness of LFS (8).…”