intraurethral devices

Product Name: e.g. FemSoft, NEAT Expandable Tip Continence Device™
Country: United Kingdom (UK)

NETSCC, HTA – NIHR Coordinating Centre for Health Technology Assessment

Outcome Measure

Primary- Number of women cured, number of women cured or improved (this outcome is henceforth referred to in the text as improvement), adverse events, condition-specific (and generic measures of health-related) quality of life, Secondary - Quantification of symptoms (number of incontinent episodes over24 hours, number of pad changes over 24 hours, mean volume or weight of urine loss on pad test, number of micturitions over 24 hours), participant satisfaction or desire for further treatment, Long-term data (number of women having incontinence surgery, return of symptoms/recurrence), socioeconomic measures, other intermediate, explanatory or treatment specific outcomes (measure of pelvic floor muscle function, treatment adherence, volume and type of fluid intake or change in body mass index) (p. 32)

Body Classification

Female Reproductive System

Device Type

Delivery device

Device Category

Treatment of disease

Risk Classification

IIa

Indication

stress urinary incontinence

ICD-10

N39.3

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