The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.
Urge Urinary Incontinence affects 30% of postmenopausal women. The etiology is unknown therefore treatment is symptomatic. For that purpose the nerval stimulation of the bladder muscle is interfered by several drugs, e.g. solifenacin. We observed that the surgical repair of critical pelvic structures, i.e. the uteri-sacral ligaments (USL) can restore continence in a considerable number of patients. In this study the surgical treatment is compared with the solifenacin treatment. According to outcome after three months patients who are still incontinent are referred to the opposite treatment group. Outcome will be differentiated in cure (primary aim) and improvement of symptoms (secondary aim).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
surgical repair of USL
Abt. Beckenbodenchirugie der Universitäts-Frauenklinik Köln
Cologne, North Rhine-Westphalia, Germany
RECRUITINGcure from urge urinary symptoms
At the start of the study urge symptoms are categorized from 0 (no symptom for the specific item) to 2 (worst expression of symptom). Cure is defined when sum of category points is 0, improvement is defined when category points are less after than before treatment
Time frame: 12 months
cure from urge urinary symptoms
When the assigned first line treatment did not cure patients receive the treatment of the other arm (cross-over). Before cross-over urge symptoms of each patient are categorized from 0 (no symptom for the specific item) to 2 (worst expression of symptom). Cure is defined when sum of category points is 0, improvement is defined when category points are less after than before treatment
Time frame: 12 months
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