None listed
Conditions
Interventions
GROUP 1 Type of group
Single Blind Period: All the patients of this treatment will be treated with Fesoterodine Placebo, in tablets, PO, QD + Tolterodine Placebo, in capsules, PO, QD
for 2 weeks.
Double Blind Treatment Period: This group will continue with Fesoterodine Placebo, in tablets, PO, QD. + Tolterodine Placebo, capsules, PO, QD for 12 weeks.
Sponsors
PFIZER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients ≥18 years of age. 2. Symptoms of overactive bladder for ≥ 3 months before. 3. Have reported, on average, 1 episode of UU1 per 24 hours in the 3-day voiding card before the randomization / baseline visit. 4. Average urinary frequency of ≥ 8 voids for 24 hours. 5. Able and interested in completing the voiding booklets and all the questionnaires related to the study and in complying with the scheduled clinic visits and the clinical study procedures. 6. Trained to understand and having signed the informed consent form after a detailed discussion of the nature of the treatment investigation and its risks and benefits.
Exclusion criteria
Exclusion criteria: 1. Any condition that could contraindicate the use of fesoterodine. 2. Clinically significant liver or kidney disease, and / or with a test of AST, ALT, ALP, urea nitrogen, or creatinine greater than 1.5 times the upper limit of the normal range (ULN). 3. Neurological conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson´s disease. 4. Prolapse of the pelvic organ stage 3 or more defined. 5. History of lower urinary tract surgery within the last 6 months. 6. A known history of interstitial cystitis or significant pain component associated with symptoms of overactive bladder, untreated hematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia, or obstruction of bladder outlet contraction of the bladder neck, clinical suspicion of carcinoma to the prostate, müllerian duct cysts, urethral obstruction due to narrowing / valves / sclerosis or urethral tumor, radiation cystitis, genitourinary tuberculosis, bladder stones, or detrusor-sphincter dyssynergia. 7. Previous history of acute urinary retention that requires catheterization. 8. Use of an internal catheter or an intermittent auto-catheterization program. 9. Incontinence symptoms that are predominantly of the type of stress urinary incontinence. 10. Polyuria or an evacuated volume> 500mL for any urination. 11. Urinary tract infection (UTI) or recurrent urinary tract infection (RUTI). 12. The use of any type of electrostimulation, bladder training, or pelvic floor exercises within the previous 4 weeks. 13. Treatment with antimuscarinic drugs for overactive bladder, 2 weeks before. 14. Expectations of starting treatment during the study with: a) Any pharmacological treatment for overactive bladder. b) Any drug with anticholinergic, antispasmodic, parasympathetic, or significant cholinergic agonist effects. 15. Intermittent or unstable use of diuretics. 16. Treatment with potent inhibitors of CYP3A4. 17. Administration of drugs capable of inducing the metabolism or transport of liver enzymes. 18. Treatment with any investigational drug for 30 days prior to visit 1, or it is expected that such treatment be initiated during the study. 19. Abuse of alcohol and / or any drug. 20. Female patients who are pregnant, breastfeeding, or have a positive pregnancy test or who wish to become pregnant during the 3 months after the termination of the study. 21. Potentially fertile female patients heterosexually active but not willing or able to use an adequate contraceptive method. 22. Patients who have any medical or psychological condition or social circumstances that would impair their ability to participate reliably in the study, or that may increase the risk to themselves or others due to their participation in this study. 23. Patients who, in the opinion of the investigator, are likely not to complete the study, regardless of the reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Voiding card completed by the patient: In it, the Bladder Sensation Scale is evaluated in the micturition card, and a score of 5 or more points must be obtained to be classified as a UUI. Measure:Average number of urinary urinary incontinence episodes (UUI) for 24 hours, from baseline to the end of treatment. Timepoints:Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:All these criteria will be evaluated in the micturition record completed by the patient. The UUI have been defined previously. Episodes of urinary urgency are defined as those with a graduation of ≥ 3 on the Bladder Sensation Scale. Severe micturition urges are defined as those with a ≥4 rating on the Bladder Sensation Scale. The average graduation of the Bladder Sensation by voiding and the sum of the Graduation of the Bladder Sensation, are defined as the sum of the scores of the graduation of the bladder sensation per day of the micturition card. Measure:Secondary efficacy: 1) Changes in the Mictional Record. 2) Change in the average volume evacuated by urination. 3) Change in the average number of urinations during 24 hours. 4) Percent change in urination during 24. 5) Change in the average number of nighttime voidings for 24 hours. 6) Percent change in nocturnal urination for 24 hours. 7) Change in the average number of urinary urinary incontinence episodes (UUI) for 24 hours to weeks 1 and 4. 8) Percentage change in UUI for 24 hours to weeks 1.4, and 12 relative to the baseline. 9) Change in the average number of micturition urgency episodes during 24 hours. 10) Percentage change of episodes of urgency for 24 hours. 11) Change in the average number of severe urinary urgency episodes during 24 hours. 12) Percentage change in episodes of severe urgency for 24 hours. 13) Change in the average graduation of the Bladder Sensation by urination and the sum of the Graduation of the Bladder Sensation during 24 hours. Timepoints:Criteria 1 - 6 and 8 - 13: Weeks 1, 4 and 12. Criterion 7: Weeks 1 and 4. ; Outcome name:Criterion 1: The PPBC is a self-administered questionnaire, which asks patients to describe their perception of problems related to their bladder. Criterion 2: The PPUS is a self-administered questionnaire, which measures the patient s perception of urinary urgency. It is sensitive to changes in perceptions of | — |
Countries
Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Germany, Greece, Hungary, India, Italy, Malasya, Netherlands, Norway, Peru, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, United States
Outcome results
None listed