科研之友
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摘要
Objective. To evaluate the efficacy and safety of the new injectable implant, Urolastic, in women with stress urinary incontinence (SUI) after 12-month followup. Materials and Methods. A prospective, cohort study included adult women with SUI. Patients were treated with Urolastic periurethral injections under local anaesthesia. The injection procedure was repeated after 6 weeks when indicated. Patients were evaluated for efficacy and safety parameters 6 weeks, 3 months, and 12 months after therapy. Results. Twenty women 56 (33每71) years old were included. Thirteen patients (65%) received one injection each (overall average of 2,1ˋmL); 7 patients (35%) received a second injection. Nineteen patients complete the 12-month followup. The mean Stamey incontinence grade significantly decreased from 1.9 at baseline to 0.4 at 12 months (visit IV) ( ). None of the patients were dry at baseline; 68% of them were dry at 12 months. The mean number of incontinence episodes significantly decreased from 6/day at baseline to 1.6/day at visit IV ( ). Reduction in pad weight went from 20.2 to 7.8ˋg at one year. The mean I-QoL score significantly increased from 51 at baseline to 76 at visit IV ( ). Six patients (30%) developed minor complications related to the injection procedure. Conclusions. Urolastic is effective and long-standing urethral bulking agent with moderate adverse events. 1. Introduction Urinary incontinence (UI) is defined as ※the complaint of any involuntary leakage of urine.§ It is classified as stress urinary incontinence (SUI) when the leakage occurs on efforts or exertion, or on sneezing or coughing; urge urinary incontinence (UUI) when leakage is accompanied by or immediately preceded by urgency; or mixed urinary incontinence (MUI) when leakage is associated with urgency and also with efforts or exertion, or when sneezing or coughing [1]. UI is common in women with negative impact on their life quality. Hunskaar et al. [2] reported about 35% prevalence of UI in a study that included women from 4 European countries. SUI was the most overall prevalent subtype of UI in these women. Surgical approach could provide ultimate cure for the SUI. However, a substantial number of women with SUI seek for less invasive procedures with lower risk of complications [3]. Injection therapy with urethral bulking agents is a good example for a less invasive treatment of the SUI. Many urethral bulking materials have been used in clinical trials. An ideal bulking agent should be biocompatible, nonimmunogenic, causes no fibrosis after infiltration of the urethral tissue,
