a study to estimate the efficacy and safety of solifenacin in female with stress urinary incontinence and urgency urinary incontinence

Conditions: Stress Urinary Incontinence; Urgency Urinary Incontinence

Summary: this study is to investigate the effects of solifenacin on urgency urinary incontinence symptoms and incontinence quality-of-life (i-qol) in female patients with clinically significant stress urinary incontinence accompanied by urgency urinary incontinence.


Eligibility criteria:
inclusion criteria: * patients are selected from those who meets one of criteria * patients with a positive cough provocation test * based on 3-day voiding diary, patients with: * urinary frequency (eight or more micturitions per day or 24 hours) * urinary urgency (two or more episodes per day or 24 hours) * urge incontinence (three or more episodes for 3 days) exclusion criteria: * breast-feeding women or females of childbearing potential with the intention to become pregnant during the study * post-void residual urine volume (prv) of 150 cc or more * patients who experienced acute ureteral obstruction requiring an indwelling catheter * patients who experienced clinically significant pelvic organ prolapse or lower urinary tract surgery within 6 months prior to the initiation of the present study * patients who underwent a urinary incontinence operation within 1 year * any condition that, in the opinion of the investigator, is a contraindication for anticholinergic treatment, including severe narrow-angled glaucoma, urinary retention, gastric retention, severe myasthenia, severe hepatic insufficiency or severe ulcerative colitis * significant hepatic or renal disease, defined as having greater than twice the upper limit of the reference ranges for serum concentrations of aspartate aminotransferase (ast \[sgot\]), alanine aminotransferase (alt \[sgpt\]), alkaline phosphatase or creatinine * patients who have any of neurological disorders such as stroke, multiple sclerosis, spinal cord injury, and parkinson's disease * patients who use an indwelling catheter or practice intermittent self-catheterization * recurrent utis defined as having been treated for symptomatic utis 3 times or more in the last year * symptomatic acute urinary tract infection (uti) during the run-in period * patients who received any of the following prohibited concomitant drugs within 14 days prior to randomization: treatment performed within the 14 days preceding randomization, or expected to initiate treatment during the study with: * any anticholinergics other than the trial drug * any drug treatment for overactive bladder. estrogen treatment started more than 2 months prior to inclusion is allowed * patients taking an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study * patients with chronic constipation or history of severe constipation * treatment with any of potent cyp3a4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole) * sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study initiation and not agreeing to use such methods during the entire study period and for at least 1 month thereafter. reliable contraceptive methods are defined as intrauterine devices (iuds), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives, surgical procedures (tubal ligation or vasectomy), or continence * any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Keywords: solifenacin bladder symptom