Efficacy and Safety of Selective Serotonin Reuptake Inhibitor (SSRI) in Overactive Bladder Patients

• 3-month, prospective, open-label, comparative trial
• Primary Objectives:

• To investigate the changes of OAB symptoms in patients who did not showed therapeutic benefits after 3 months of treatment with antimuscarinic agents and who then treated with SSRI (escitalopram) for 3 months.
• Secondary Objectives

• To investigate the change of patient perception of urgency and bladder condition
• To investigate the change of patient perception of quality of life
• To investigate the change of psychologic parameters
• To investigate the patient perception of treatment benefit
• To find the predictive factors of patients who respond to the 3 month-treatment with escitalopram
• To explore the efficacy of escitalopram on the tolerability and safety

Inclusion criteria

• Female aged ≥ 18 and ≤80 years
• On a stable dose of an antimuscarinic agents for at least 3 months
• Persistent symptoms of OAB as verified by the screening 5 day micturition diary, defined by:

• Mean urinary frequency ≥8 times/24 hours
• Mean number of urgency episodes, with/without urgency incontinence, ≥1 episode/24 hours (with a Urinary Sensation Scale rating of ≥3 in the micturition diary)
• A rating of the bladder condition at Baseline prior to randomization as "Some Moderate Problems", "Severe Problems", or "Many Severe Problems" on the Patient Perception of Bladder Condition (PPBC) questionnaire
• 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

• Clinical significant stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test
• An average volume voided of > 200 ml per micturition as verified on the baseline micturition diary
• Total daily urine volume of > 3000 ml as verified on the baseline micturition diary
• Patients who have past psychiatric disease such as major depression, anxiety disorder, panic disorder, and so on.
• Significant hepatic or renal disease, defined as having twice the upper limit of the reference ranges for serum concentrations of aspartate aminotransferase (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 UTIs defined as having been treated for symptomatic UTIs > 4 times in the last year
• Diagnosed or suspected interstitial cystitis
• Uninvestigated hematuria or hematuria secondary to malignant disease
• Clinically significant bladder outlet obstruction defined by clinical symptoms and investigator's opinion according to local standard of care
• Patients with marked cystocele or other clinically significant pelvic prolapse.
• On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
• Receipt of any electrostimulation or bladder training within the 14 days before the start of tolterodine SR, or expected to start such treatment during the study
• An indwelling catheter or practicing intermittent self-catheterization Use of any investigational drug within 2 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).
• Patients who have bladder cancer
• Use of any nonselective, irreversible MAO inhibitor
• Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion