Prospective non-randomised trial investigating the effect of vaginal vault Suspension on urge symptomatology in female patients with pelvic organ prolapse
A multicenter multinational Trial is performed in 250 female patients with pelvic organ prolapse (POP) and symptoms of urinary urge incontinence. Dependent on the presence or abscence of the uterus patients are treated with bilateral sacrospinous uterine or vaginal vault suspension (BSC) by means of a tape specifically designed for this purpose.
Study Type
OBSERVATIONAL
Enrollment
250
Helios Medical Center
Schleswig, Germany
RECRUITINGInfluence of BSC placement on symptoms of urinary urge expressed by change in clinical examination
The change in symptoms after the surgical intervention is evaluated by clinical examination . The clinical examination is descriptive, not quantitative and no units are applicable or reportable.
Time frame: Checked after 6 weeks, six months and twelve months
Change in score of standardized ICIQ documentation
The International Consultation on Incontinence Questionnaire is used to evaluate Change in Quality of life and urge symptomatology
Time frame: Checked after 6 weeks, six months and twelve months
Anatomical correction of female pelvic organ prolapse
Clinical examination of pelvic floor anatomy
Time frame: Checked after 6 weeks, six months and twelve months
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