Trial Information

Summary: Overactive Bladder patients dissatisfied with previous anticholinergic therapy

This study is designed to find out if the study medication is safe and has beneficial effects in people who have a condition called overactive bladder (OAB). People with OAB may have to urinate often during the day and night, and they may feel a strong sudden sensation to urinate, which makes it difficult to reach the bathroom before having an "accident."

Patient Inclusion Criteria

• Males and females = 18 years
• Symptoms of OAB for at least six months prior to randomization
  • = 8 micturitions on average/24 hours
  • = 1 urgency episodes on average/24 hours
  • with or without UUIE
• Patient’s dissatisfaction with previous oxybutynin extended release or tolterodine extended release treatment whichever was the most recent treatment for OAB prior to this study. Patients had to be under this treatment for at least 1 week and within a time frame of up to 12 months preceding this study.
• Patients being naive to darifenacin treatment
• Patients capable of understanding the given information and having signed Patient Informed Consent Form after full discussion of the research nature of the treatment and its risks and benefits
• Patients capable of independently completing the bladder diary
• Patients capable of independent toileting
• Patients able to swallow the study medication in accordance to the protocol
• Body Mass Index (BMI) = than 18.5 kg/m² and = 35.0 kg/m²

Patient Exclusion Criteria

• Patients who have answered the PPBC questionnaire with "Does not cause me any problems at all"
• A mean daily urinary volume >3000 mL or a mean volume voided/micturition of >300 mL as verified on two consecutive days in the micturition diary prior to Baseline
• Males with post-void residual (PVR) urinary volume >200 mL at Baseline
• Clinically predominant and bothersome stress urinary incontinence, as determined by the investigator
• Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator
• Neurological diseases affecting urinary bladder function including but not limited to Parkinson’s disease, multiple sclerosis, stroke, spinal cord injury
• Any clinically significant congenital or acquired disorder of the urogenital tract or any urinary bladder dysfunction (other than OAB)
• Females with urinary symptoms secondary to cystocele or pelvic organ prolapse greater than stage 2, i.e. the most distal portion of the prolapse exceeding 1 cm beyond the plane of the hymen
• Chronic persistent local pathology that in the opinion of the investigator may lead to urinary symptoms, such as one of the genito-urinary pain syndromes [Abrams et al 2002], interstitial cystitis, fecal impaction and severe constipation (defined by the Rome II criteria as two or less bowel movements per week accompanied by all, some, or none of the following symptoms of straining, hard stool, abdominal fullness, and incomplete evacuation)
• Three or more urinary tract infections (UTIs) per year over the preceding 12 months or acute UTI at Visit 1 (Note: Patient may be included once the UTI has resolved)
• Unexplained hematuria, as determined by the investigator
• Concomitant diseases in which the use of darifenacin is contraindicated, e.g. gastric retention, uncontrolled narrow-angle glaucoma, severe hepatic impairment (Child Pugh C). In addition, patients with moderate hepatic impairment (Child Pugh B) should also be excluded from this study
• Any history of carcinoma of the urogenital tract. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
• Significant medical problems, including but not limited to the following: uncontrolled severe hypertension, uncontrolled severe heart failure, myocardial infarction in the last 6 months, uncontrolled thyroid disease (unless the patient is on controlled thyroid hormone for at least 3 months), or evidence (from direct questioning and/or physical examination) of any clinically significant systemic disease that in the investigator’s opinion makes the patient unfit to participate in the study
• Evidence, based on laboratory tests done at Visit 1, of:
  • Hepatic disorder (ALT or AST > 1.5 x upper normal limit [ULN]; bilirubin > 1.2 x ULN unless secondary to Gilbert’s disease in the opinion of the investigator)
  • Blood coagulation disorder (e.g. hemophilia)
  • Anemia (hemoglobin > 2 g/dL [20 g/L] below the lower limit of normal)
• Any urogenital surgery (including thermotherapy, ultrasound or laser therapy of the prostate, prostatectomy, hysterectomy, incontinence surgery) within 12 months prior to Visit 1; bladder or prostate biopsy 30 days prior to Visit 1; instrumentation of the lower urinary tract (including cystoscopy, urodynamics) within 14 days prior to Visit 1
• Any history of pelvic radiation therapy
• Indwelling catheter or intermittent self-catheterization
• Participation in a bladder-training program or any electro stimulation therapy within the 2 weeks prior to Visit 1 or at any time during the study
• Treatment with drugs known to affect mainly the urinary bladder function (e.g. anticholinergics, antispasmodics, serotonin-noradrenalin-reuptake-inhibitors) 14 days prior to Visit 2 and at any time during the study (treatment with solifenacin 21 days prior to Visit 2 and at any time during the study). Treatment with botulinum toxin, capsaicin or resiniferatoxin in the last 6 months prior to Visit 2 and at any time during the study. Note: patients with benign prostatic hyperplasia on a stable dose of alpha blockers during the 3 months prior to Visit 1 or 5-alpha-reductase inhibitors during the 6 months prior to Visit 1 may be included
• Currently receiving or have received the following medications within two weeks prior to Visit 2 and at any time during the study:
  • Cholinergic agonists and cholinesterase inhibitors e.g. bethanecol, donepezil, rivastigmine
  • Potent inhibitors of cytochrome CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone) and potent P-glycoprotein inhibitors such as cyclosporine and verapamil. Note: Caution should be exercised in patients receiving concomitant treatment with drugs that are predominantly metabolized by CYP2D6 and have a narrow therapeutic window, such as flecainide
• Treatment with an unstable dose of any drug having significant anticholinergic side effects in the last 4 weeks prior to Visit 1 and at any time during the study, e.g. tricyclic antidepressants, selective-serotonin-reuptake-inhibitors, and first generation antihistamines.
• Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Acceptable methods of contraception may include total abstinence at the discretion of the investigator. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
• Any investigational drug during the 30 days or five times the plasma half-life (if known), whichever is longer, preceding Visit 1 and at any time during the study
• History of hypersensitivity to darifenacin or to drugs with similar chemical structures
• Abusers of alcohol and/or other drugs which in the judgment of the investigator would interfere with participation in the study
• Intention to donate blood or blood products during the study or within one month following the completion of the study

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.