PubMed · 9677930
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D Bray. 1998. Biofeedback.. https://doi.org/10.1016/s1353-6117(98)80009-7
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The aim of the study was to evaluate the efficacy of pelvic floor training with EMG-controlled home biofeedback in the treatment of stress and mixed incontinence in women. Subjects were recruited from the urodynamic outpatient clinic and performed pelvic muscle training with an EMG-controlled biofeedback device for 20 minutes daily for 6 months. The number of pads used per day, the number of incontinence and urgency episodes, voiding frequency, maximum urethral closure pressure, functional urethral length and pressure/transmission ratio during stress were assessed before and after treatment. Thirty-three patients (13 with stress and 20 with mixed incontinence) completed the study. There was a significant decrease in the number of pads used per day, the number of incontinence and urgency episodes, and the voiding frequency. Twenty-eight patients (85%) reported that they were cured or improved. Urodynamic parameters did not change significantly. It was concluded that home pelvic floor training with EMG-controlled biofeedback is efficient in 85% of patients in alleviating the symptoms of genuine stress and mixed incontinence without causing side effects.
The Raynaud's Treatment Study (RTS) exemplified clinical trials with treatments that differ qualitatively both in their modes and in their methods of delivery. The RTS compared finger-temperature biofeedback to slow-release nifedipine, a calcium channel blocker, in patients with primary Raynaud's disease. Factors influencing the study design were the nature of the interventions and control measures of the protocol, the possibility of perceived differences by the patients between the treatments once the final protocol was developed, and concern on the part of the investigators over the fact that the primary endpoint was self-reported. This paper presents the final statistical model: a double parallel design with both a placebo group and a nonspecific behavioral control group.