January 2024
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Archives of Obstetrics and Gynaecology
Purpose: Current treatments of urgency urinary incontinence (UUI) are aimed to reduce the neurological influence on bladder detrusor muscle function. A previous observation after posterior exenteration led to the hypothesis that UUI is caused by a laxity of the uterosacral ligaments (USL). In a previous Clinical Phase I trial in patients with UUI continence was achieved in 40% of patients by replacement of the USL. The results supported the concept of a Clinical Phase II trial in which only patients who lost urine after urgency (advanced UI) were treated by replacement of the USL. The aim of the study was to evaluate the cause why some patients became continent while others remained incontinent after replacement of the USL. Methods: In this Clinical Phase II trial, patients with advanced UI were included. The USL was replaced by specially designed polyvinylidene fluoride (PVDF) structures. During laparoscopy these structures were fixed at the promontory and at the cervical stump after supracervical hysterectomy (cervicosacropexy, CESA) or at the vaginal stump (vaginosacropexy, VASA). The USL replacing parts of the structures had an identical length of 8.8 cm in CESA and 9.3 cm in VASA. Patients who remained incontinent after tensioning of the vagina were offered a suburethral trans-obturator tape (TOT). Results: 339 patients with advanced urinary incontinence (UI) were evaluable. Continence was re-established in 39% of patients after CESA and in 32.9% after VASA. The statistical analysis revealed that the Continence Rates (CR) after CESA or VASA were significantly (p<0.001) dependent on patients age at surgery (<60 years vs ≥60 years). The respective CR after CESA were 50% vs 26% and after VASA 41.5% vs 28.9%. After an additional transobturator tape (TOT) the overall CR was between 67.5% and 87.5%. Conclusion: The replacement of the USL by PVDF-tapes of defined length led to continence in between 32.9% and 39% of the patients. After the additional placement of a TOT 8/4 the percentage of continent patients increased by 30.5% to 37.3%. These findings support the hypothesis that continence is dependent on the physiological function of the USL and PUL. The observation that the CR after USL replacement decreased in patients ≥60 years indicates that ageing affected some additional other part in the area of the urethra-vesical junction (UVJ). The CR after CESA or VASA (and a TOT) in patients with advanced UI deserve further clinical evaluation.