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
Parameter	TVS2000	TVS3000	TVS4000	TVS5000
Recruitment	Previous participants in TVS1000	Through the Aller Media test panel	Visitors at the gym Tilling Träning	Urotherapist at Skelefteå Hospital
Study size	34	40	19	9
Treatment length	4 weeks	4 weeks	6 weeks	6 weeks
Target group	Women clinically diagnosed with SUI	Women self-diagnosed with SUI	Women with urine leakage during weightlifting	Women with urine leakage during cross-fit training
Study objectives	Change in the IIQ-7 score after 4 w device usage	Change in the IIQ-7 score after 4 w device usage	User satisfaction when using Efemia during weight training	User satisfaction when using Efemia during cross-fit training