ABOUT THIS STUDY
1. Female aged ≥ 18 and ≤ 80 years
2. Symptoms of OAB as verified by the screening 3 day micturition diary, defined by:
Mean urinary frequency ≥8 times/24 hours Mean number of urgency episodes ≥ 2 episode/24 hours
3. Symptoms of OAB for ≥ 3 months.
4. Ability and willingness to correctly complete the micturition diary and questionnaire
5. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
1. Subjects with stress incontinence or mixed stress/urge incontinence where stress
incontinence is the predominant component based on prior history.
2. Significant hepatic or renal disease, defined as having twice the upper limit of the
reference range for serum concentrations of aspartate amino- transferase (AST [SGOT]),
alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine.
3. Any condition that is a contraindication for anticholinergic treatment, including
uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
4. Symptomatic acute urinary tract infection (UTI) during the run-in period
5. Recurrent UTI defined as having been treated for symptomatic UTI > 4 times in the last
6. Diagnosed or suspected interstitial cystitis
7. Clinically significant bladder outlet obstruction or poor detrusor function defined by
clinical symptoms and investigator's opinion according to local standard of care
8. Previous history of major urethral and/or bladder surgery
9. History of radiation treatment (external or interstitial) to pelvic organs or external
genitalia for any reason.
10. Subjects with neuropathology that could affect the lower urinary tract or nerve supply
11. Patients with marked cystocele or other clinically significant pelvic prolapse.
12. Subjects with current (within 2 years) urogenital neoplasms or malignancies including
bladder, uterine or cervical cancer
13. Treatment within the 14 days preceding randomization, or expected to initiate
treatment during the study with: Any anticholinergic drugs other than trial drug Any
drug treatment for overactive bladder
14. On an unstable dosage of any drug with anticholinergic side effects, or expected to
start such treatment during the study
15. Subjects currently taking tricyclic antidepressants, diuretics or alpha blockers who
have not been on a stable dose of these medications for at least one month
16. Current administration of a selective serotonin reuptake inhibitor (SSRI) and has not
been on a stable dose for at least three months
17. Receipt of any electrostimulation or bladder training within the 14 days before
randomization, or expected to start such treatment during the study
18. An indwelling catheter or practicing intermittent self-catheterization
19. Use of any investigational drug within 1 months preceding the start of the study
20. Patients with chronic constipation or history of severe constipation
21. Pregnant or nursing women
22. Sexually active females of childbearing potential not using reliable contraception for
at least 1 month prior to study start 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 and
surgical procedures (tubal ligation or vasectomy).
23. Any other condition which makes the patient unsuitable for inclusion.
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