Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder

• Objectives

• Primary objective: To explore the "Patient-reported Goal Attainment (PGA)" after 12 weeks of treatment with tolterodine extended-release (ER) 4mg in female overactive bladder (OAB) patients.
• Secondary objective: To explore the patient-reported treatment goals and the efficacy of tolterodine on the patient-reported outcomes (PROs), micturition diary parameters, and safety parameters from baseline to 12 weeks of treatment in female OAB patients.
• Specific aim

: To compare the efficacy of tolterodine ER 4mg with that of placebo, on PROs in terms of PGA after 12 weeks of treatment in female OAB patients.

• Experimental/research design

• 12-week randomized, placebo-controlled, double-blind, parallel-group, prospective study in Korean women with symptoms of OAB
• Treatment: Each patient will receive tolterodine ER (4 mg, qd) or placebo (randomized in the ratio of 1:1) for 12 weeks.
• Time schedule Start date: 01/Jan/2009 Finish date: 01/Sep/2009 Duration of washout: 7 days Duration of run-in: 7 days Duration of enrollment period: 5 months Duration of treatment period: 12 weeks Completion of analysis: 6 weeks

Inclusion criteria

• Female aged ≥ 18 and ≤ 80 years
• 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

• Symptoms of OAB for ≥ 3 months.
• Ability and willingness to correctly complete the micturition diary and questionnaire
• 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

Exclusion criteria

• Subjects with stress incontinence or mixed stress/urge incontinence where stress incontinence is the predominant component based on prior history.
• 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.
• Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
• Symptomatic acute urinary tract infection (UTI) during the run-in period
• Recurrent UTI defined as having been treated for symptomatic UTI > 4 times in the last year
• Diagnosed or suspected interstitial cystitis
• Clinically significant bladder outlet obstruction or poor detrusor function defined by clinical symptoms and investigator's opinion according to local standard of care
• Previous history of major urethral and/or bladder surgery
• History of radiation treatment (external or interstitial) to pelvic organs or external genitalia for any reason.
• Subjects with neuropathology that could affect the lower urinary tract or nerve supply
• Patients with marked cystocele or other clinically significant pelvic prolapse.
• Subjects with current (within 2 years) urogenital neoplasms or malignancies including bladder, uterine or cervical cancer
• 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
• On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
• 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
• Current administration of a selective serotonin reuptake inhibitor (SSRI) and has not been on a stable dose for at least three months
• Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study
• An indwelling catheter or practicing intermittent self-catheterization
• Use of any investigational drug within 1 months preceding the start of the study
• Patients with chronic constipation or history of severe constipation
• Pregnant or nursing women
• 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).
• Any other condition which makes the patient unsuitable for inclusion.