Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.
- Conditions
- -N329 Bladder disorder, unspecifiedBladder disorder, unspecifiedN329
- Registration Number
- PER-078-08
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Outpatient male or female patients> 18 years of age.
• Overactive bladder symptoms (reported by the patient) for> 3 months before the selection / enrollment visit (visit 1)
• Have reported, on average, 1 episode of UUI per 24 hours in the 3-day voiding card before the randomization / baseline visit (visit 2)
• Average urinary frequency of> 8 micturition for 24 hours as verified by the micturition chart before the randomization / baseline visit (visit 2)
• Able and interested in completing the voiding booklets and all the questionnaires related to the study and in complying with the scheduled clinical visits and the clinical study procedures.
• 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
• Any condition that may contraindicate your use of fesoterodine including: hypersensitivity to the active substance (fesoterodine fiimarate) or peanut or soy or any of the excipients, urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, insufficiency severe liver disease (Child Pugh C), severe ulcerative colitis, and toxic megacolon
• Clinically significant liver or kidney disease, and / or a test to select AST, ALT, ALP, urea nitrogen, or creatinine greater than 1.5 times the upper limit of the normal range (ULN)
• Neurological conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson´s disease, which is known or suspected to influence bladder function of the subject.
• Prolapse of the pelvic organ stage 3 or more defined as visible tissue through the introitus in the position of resting lithotomy (without increase in intra-abdominal pressure)
• History of lower urinary tract surgery (for example, surgery for incontinence or surgery to reduce the size of the prostate) within the last 6 months
• 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 genital organs, or obstruction of bladder outlet due to contraction of the bladder neck, clinical suspicion of carcinoma to the prostate, mullerian duct cysts, urethral obstruction due to narrowing / valves / sclerosis or urethral tumor, radiation cystitis, genitourinary tuberculosis, bladder stones, or detrusor-sphincter dyssynergia.
• Prior history of acute urinary retention that requires catheterization, or severe evacuation difficulties in the case of the investigator, before the baseline
• Use of an internal catheter or an intermittent auto-catheterization program
• Incontinence symptoms that are predominantly of the stress urinary incontinence type as determined by the investigator
• Polyuria (> 3000mL / 24hrs.) Or an evacuated volume> 500mL for any urination during the period of admission
• Urinary tract infection (UTI) as demonstrated by the urinalysis results of recurrent urinary tract infection or selection (TIUR) defined as treatment for UTI> 3 times during the previous year
• The use of any type of electrostimulation, bladder training, or pelvic floor exercises (with doctors specialized in incontinence) within 4 weeks prior to visit 1
• Have received study medication in a clinical trial with feosterodine.
• Treatment with the following drugs within 2 weeks prior to visit 1: Any pharmacological treatment for overactive bladder, including antimuscarinic medication for OAB, Any drug with significant anticholinergic or antispasmodic effects.
• Have begun treatment with tricyclic antidepressants or estrogens within 4 weeks prior to Visit 1 and / or not be in a stable dose.
• Have begun treatment with diuretics or alpha blockers within 2 weeks prior to Visit 1 and / or not be in a stable dose.
• Treatment with potent inhibitors of CYP3 A4, such as clarithromycin, ketoconazole and itraconazole within 2 weeks prior to visit 1.
• Administration of drugs capable of inducing the metabolism or transport of liver enzymes (such as barbiturates, rifampicin, carbamazepine, phenytoin, pyrmidone, or St. John´s Wort) during the 2 weeks prior to visit 1.
• Treatment with any investigational drug duri
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Episodes of urinary urgency incontinence (UUI) are defined as those with a graduation of 5 on the Bladder Sensation Scale in the voiding card.<br>Measure:Change in the average number of episodes of urgency urinary incontinence (UUI) for 24 hours to week 12 compared to baseline<br>Timepoints:12 weeks<br>
- Secondary Outcome Measures
Name Time Method