A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence

• Percent change in the mean number of urge urinary incontinence episodes per 24 hours [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
• Change in the mean number of urge urinary incontinence episodes per 24 hours [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
  urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 3 in the voiding diary
• Change in the mean frequency of urination per 24 hours [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
• Percent change in the mean frequency of urination [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
• Changes in the mean and sum rating on the Bladder Sensation Scale per 24 hours [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
• Change in the mean number of severe urgency episodes per 24 hours [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
  severe urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 4 in the voiding diary
• Changes in overactive bladder symptom score (OABSS) questionnaire [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
  Change in total and each of OABSS items
• Changes in short urogenital distress inventory (UDI-6) [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
  Change in total and each UDI-6 items
• Changes in short incontinence impact questionnaire (IIQ-7) [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
  Change in total and each of IIQ-7 items
• Safety assessed by the incidence and severity of side effects [ Time Frame: For 12 weeks ] [ Designated as safety issue: No ]

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.

• Stress Urinary Incontinence
• Urgency Urinary Incontinence

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