Long-term results of the FemSoft urethral insert for the management of female stress urinary XXXX .

@entity1 @entity322 @entity353 @entity811 @entity2654 @entity293 @entity130
A 5-year ongoing, controlled multicenter study enrolled 150 @entity1 . Outcome measures included @entity353 ( @entity353 ), @entity2654 ( @entity2654 ), quality of life (QOL) and satisfaction questionnaires. Outcome measures during the baseline period were compared to evaluations during follow-up. Concurrent evaluations with and without device use were also performed. Safety evaluations included urinalysis and culture, leak-point pressure (LPP) and cystoscopy. Adverse events (AE) were recorded throughout the study. One to 2 years of follow-up were collected on all study @entity1 (mean 15 months). Statistically significant reductions in overall daily @entity322 episodes (P<0.001) and @entity353 urine loss (P<0.001) were observed with the device at all follow-up intervals, and 93% of @entity1 had a negative @entity353 at 12 months. @entity1 were satisfied with ease of use of the device, comfort and dryness, and significant improvements in QOL were observed (P<0.001). Subgroup analysis revealed that the insert was effective, despite the presence of urgency, low LPP, failed surgery and advanced age. AE included symptomatic @entity293 in 31.3%, mild @entity130 with insertion in 6.7%, @entity811 in 3.3%, and migration in 1.3% of @entity1 . The results of @entity353 and @entity2654 demonstrated device efficacy. @entity1 were satisfied and significant improvements in QOL were observed. AE were transient and required minimal or no treatment. The urethral insert should be considered as an option for the management of SUI.
