Advances in Urology / 2021 / Article / Tab 1

Research Article

A Vaginal Inlay for Reduction of Stress Urinary Incontinence: Outcome of a Randomized Clinical Trial and Four User Acceptance Studies

Table 1

Comparison of study design of the four postmarket surveillance studies.

Study
ParameterTVS2000TVS3000TVS4000TVS5000

RecruitmentPrevious participants in TVS1000Through the Aller Media test panelVisitors at the gym Tilling TräningUrotherapist at Skelefteå Hospital
Study size3440199
Treatment length4 weeks4 weeks6 weeks6 weeks
Target groupWomen clinically diagnosed with SUIWomen self-diagnosed with SUIWomen with urine leakage during weightliftingWomen with urine leakage during cross-fit training
Study objectivesChange in the IIQ-7 score after 4 w device usageChange in the IIQ-7 score after 4 w device usageUser satisfaction when using Efemia during weight trainingUser satisfaction when using Efemia during cross-fit training