A non-randomized prospective observational cohort trial comparing the single-incision-sling (TVT Altis ®) versus Bulkamid®-injections in the treatment of female stress urinary incontinence

one0 个研究点目标入组 224 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•Predominant stress urinary incontinence (e.g. on a weekly basis more incontinence episodes related to physical exercise, coughing or sneezing, as compared to incontinence associated with a feeling of urgency).
•The stress urinary incontinence is confirmed during physical examination, stress test or urodynamic assessment.
•Moderate to severe incontinence as identified by use of the Sandvik score
•Women should be able to understand the Dutch language both verbally as well as in writing.

•A post voiding bladder volume of more than 100 ml, as determined by bladder catheterisation or ultrasound (Bladderscan®)
•History of anti-incontinence surgery
•Genital prolapse Stage 2 (Ba >0) or more according to the POP-Q classification
•Patients desire for future pregnancy and childbirth
•Co-morbidity which is associated with increased surgical risks, for instance women with ASA 3 or 4 classification > up to the physician to decide.
•History of recurrent lower urinary tract infection (> 3 times/year)
•History of current major psychiatric illness, as subjectively assessed by the physician
•History of chronic or current neurological disease, as subjectively assessed by the physician
•Poor cognitive function, as subjectively assessed by the physician

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