Efficacy and Tolerance of the Tampsec Vaginal Tampon for Treating Stress Urinary Incontinence. A Randomized Controlled Trial.

Abstract

Introduction and hypothesis: Stress urinary incontinence (SUI) is a highly prevalent condition in women. We hypothesized that the Tampsec™ vaginal tampon will be efficacious and well tolerated in its treatment.

Methods: This was a multicenter open-label parallel-group randomized control trial. All participants were recommended to make lifestyle modifications and perform pelvic floor muscle training for SUI treatment. Additionally, women in the tampon group were instructed to use a Tampsec™ throughout the day. The primary outcome measure was a ≥50% reduction in pad weight by the end of treatment. Secondary outcome measures were women's perception of improvement evaluated using the Patient Global Impression of Improvement (PGI-I) questionnaire, decrease in the mean number of SUI episodes/day, and improvement in the impact of urinary incontinence (UI) on everyday life. Tampon tolerance and usability were also evaluated.

Results: Forty-six women with a positive urinary stress test were randomized 1:1 to tampon or control treatments. Regarding the primary outcome, a ≥50% reduction was achieved in 69.9% of patients in the tampon group and 26.1% in controls (RR 2.7; 95%CI 1.3-5.4). On the basis of PGI-I responses, the treatment was successful in 60.9% of women in the tampon group and 17.4% of controls (p = 0.003). The tampon group also reported greater decreases in SUI episodes/day (mean 2.0±2.2 vs 0.5±1.1; p = 0.007) and more improvement in the impact of UI on everyday life. Tolerance and usability were good in most women.

Conclusion: The Tampsec™ tampon is efficacious and well tolerated in women with SUI. This treatment decreases the number of SUI episodes/day and improves UI-related quality of life.