Hypothesis / aims of study
The etiology of urinary incontinence is unknown. Beside stress urinary incontinence (SUI), current treatment options are based on a neurological disorder or the detrusor. Ulmsten and DeLancey hypothesized an anatomical defect of the anterior vaginal wall: laxity of the 3 levels (the paraurethral tissue, the apical end and vesicourethral junction). Except SUI, and in regard to materials (length/width) and fixation/implantation sides no standardized surgical treatment for these levels were developed.
We evaluated the effect of bilateral replacement of the uterosacral ligaments (USL) on urgency urinary incontinence and mixed urinary incontinence.
Study design, materials and methods
Randomized clinical trial comparing solifenacin and cervicosacropexy (CESA) or vaginosacropexy (VASA) in 96 women aged 35-80years with urgency urinary incontinence and mixed urinary incontinence and without previous treatment (ClinicalTrails.gov Identifier: NCT01737411). Efficacy of each treatment arm was assessed 4 months after. Cure was defined as voiding frequency <8 times/day and no involuntary leakage of urine. Patients were randomized either in the pharmacological therapy arm (10mg solifenacin for 4 months) or in the surgical procedure arm (CESA or VASA surgery). After 4 months the efficacy of each treatment arm was assessed by incontinence questionnaires. Cure was defined by the following: voiding frequency <8 times/day, no involuntary leakage of urine and no stress urinary incontinence. The non-responders were crossed-over.
For open abdominal augmentation of the uterosacral ligaments polyvinylidene fluoride (PVDF) tapes of identical length were used and named cervico-sacropexy (CESA) or vagino-sacropexy (VASA) depending on the site of fixation (sacrum/cervix or sacrum/vagina). These tapes were sutured either on the cervix or vaginal stump and placed under the left and right peritoneal fold of the USL from the rectum and attached to the pre-sacral fascia in front of the S1/S2 sacral vertebra.
Interpretation of results
Compared to the standard pharmacological treatment these surgical procedure depicts an option in the treatment of UUI.