INTRODUCTION AND HYPOTHESIS: The aim of the study was to assess the quality of life (QoL) in women with stress urinary incontinence (SUI) while using a novel disposable intravaginal device. METHODS: Fifty women with severe SUI who completed a 7-day control period followed by a 28-day device usage period underwent QoL assessments based on two validated questionnaires, the Incontinence Impact Questionnaire (IIQ-7) and the Urogenital Distress Inventory (UDI-6). RESULTS: Mean total score for the IIQ-7 decreased from 41.8 +/- 24.1 to 4.4 +/- 8.7 at the pre- and poststudy visits, respectively (P < 0.001). The mean total score for the UDI-6 decreased from 48.2 +/- 16.1 to 11.5 +/- 11.9 at the pre- and poststudy visits, respectively (P < 0.001). Statistically significant decreases in most subscale scores were observed by the end of the study for both questionnaires (all P values <0.001). CONCLUSION: The novel disposable intravaginal device significantly improved QoL in women with SUI.
INTRODUCTION AND HYPOTHESIS: The aim of the study was to assess the quality of life (QoL) in women with stress urinary incontinence (SUI) while using a novel disposable intravaginal device. METHODS: Fifty women with severe SUI who completed a 7-day control period followed by a 28-day device usage period underwent QoL assessments based on two validated questionnaires, the Incontinence Impact Questionnaire (IIQ-7) and the Urogenital Distress Inventory (UDI-6). RESULTS: Mean total score for the IIQ-7 decreased from 41.8 +/- 24.1 to 4.4 +/- 8.7 at the pre- and poststudy visits, respectively (P < 0.001). The mean total score for the UDI-6 decreased from 48.2 +/- 16.1 to 11.5 +/- 11.9 at the pre- and poststudy visits, respectively (P < 0.001). Statistically significant decreases in most subscale scores were observed by the end of the study for both questionnaires (all P values <0.001). CONCLUSION: The novel disposable intravaginal device significantly improved QoL in women with SUI.