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

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, SSRI, Antimuscarinics Read More

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:

  1. Mean urinary frequency ≥8 times/24 hours
  2. 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