Pelvic Floor Muscle Training Using the Perifit Device for the Treatment of Urinary Incontinence: A Pragmatic Trial Using Real-World Data.

Abstract

There is a need for home-based alternatives for women to self-manage urinary incontinence (UI). Using a real-world data approach, the aim of this analysis was to evaluate whether training with the Perifit device was effective in reducing UI symptoms. A total of 6060 women (45 ± 10 years) with UI who purchased the Perifit device, completed a validated symptoms questionnaire before training (T1) and again at one or several predefined timepoints during training: T2, after completing 40-60 games; T3, after 90-120 games; and/or T4, after 280-300 games. UI symptom score decreased progressively from 8.4 ± 4.8 points at T1; to 6.3 ± 4.7 points, 5.5 ± 4.5 points, and 4.6 ± 4.5 points at T2, T3, and T4, respectively (all p < 0.001). The percentage of respondents reporting objective improvement in UI symptoms increased from 71%, to 79%, to 85% at T2, T3, and T4, respectively. Effect size was medium (T2) to large (T3, T4). Higher symptom score at baseline was associated with higher likelihood of improvement. There was no effect of other characteristics including respondent age, menopausal status, time since childbirth, prolapse, or baseline strength on symptom improvement. This analysis of responses from over 6000 real-world users suggests that home training with the Perifit may be an effective way to reduce UI symptoms in women of all ages. Given the quality of life, economic, and social burdens of living with UI symptoms, home-based pelvic floor muscle training with the Perifit may be a promising tool to allow women to self-manage UI.