None listed
Conditions
Interventions
Group 1 Type of group
First fesoterodine 4 mg orally daily and after 4 weeks the dose can be increased to 8 mg until 12 weeks are completed.
Group name:Group 2 Type of group
Start with placebo equivalent to fesoterodine 4 mg orally daily and after 4 weeks you can raise the placebo dose equivalent to 8mg to complete 12 weeks.
Sponsors
PFIZER S.A.,
Eligibility
Sex/Gender
Male
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Men 40 years of age and older • In treatment with a stable dose and well tolerated with an alpha-blocker prescribed for LUTS in the 6 weeks prior to the selection, at least (visit 1). • Persistent OAB symptoms verified by the bladder diary 3 days after selection and defined as: Mean urinary frequency> 8 times / 24 hours, Average number of urgency episodes related to urination,> 3 episodes / 24 hours (with one score on the scale of urinary sensation,> 3 collected for the corresponding urination in the bladder diary). • A baseline assessment (visit 2) of the bladder disorder before randomization as some moderate problems, serious problems or many serious problems in the patient bladder disorder perception (PPBC) questionnaire. • Ability and willingness to properly fill the bladder diary and various questionnaires, meet the schedule of visits and follow the study procedures • Ability to understand and have signed the informed consent form after a full explanation of the research, the nature of the treatment, its risks and beneficial effects.
Exclusion criteria
Exclusion criteria: • Any contraindication to the use of fesoterodine, such as: hypersensitivity to the active substance (fesoterodine fumarate) or peanut, soy or any excipient, urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic insufficiency ( Child-Pugh C), severe ulcerative colitis and toxic megacolon • Poor tolerability of the current alpha-blocker treatment, or the investigator´s decision that it is inappropriate or that it is unlikely that alpha-blocker treatment will be maintained at the current dose throughout the study, as provided in the approved data sheet of each medication according to the country. • History of acute urinary retention that requires a probe or existence of obstruction of the exit of the bladder clinically significant, according to the researcher. • Residual urinary volume greater than 200 ml in the selection (visit 1) • Liver or kidney disease of clinical importance, and / or with a value of AST, ALT, alkaline phosphatase, urea nitrogen or creatinine more than 1.5 times higher than the normal upper limit (ULN) in the selection tests. • Antecedents or demonstration in the visit of selection of symptomatic postural hypotension or syncope by alpha-blockers (a reduction of more than 20 mm Hg of the systolic blood pressure or of 10 mm Hg of the diastolic when standing with relevant postural symptoms). • History, demonstration or suspicion of prostate cancer. A value of total prostate specific antigen (total PSA) greater than 10ng / ml in the selection prevents participation, unless data (biopsy, TRUSS, etc.) that rule out prostatic malignancy are provided. • Neurological processes such as stroke, multiple sclerosis, spinal cord injury or Parkinson´s disease • Known antecedents of bladder flow obstruction due to: bladder neck contracture, clinical suspicion of prostatic carcinoma, Muller´s duct cysts, urethral obstruction due to stenosis / valves / sclerosis or urethral tumor • Known antecedents of non-investigated hematuria, interstitial cystitis, genitourinary tuberculosis, bladder stones or detrusor-sphincter dyssynergia. • Antecedents of radiotherapy (external or interstitial) of pelvic organs or external genitalia for any reason. • History of surgical intervention in the prostate (including minimally invasive treatments) or other important urethral and / or bladder interventions. • Urinary infection (UI) demonstrated by the results of urinalysis in recurrent urinary selection or infection, defined as treatment of UI> 3 times in the last year • Treatment with potent inhibitors of CYP3A4 such as clarithromycin, ketoconazole and itraconazole in the 2 weeks prior to week I, or forecast to start receiving it during the study. • Treatment with inducers of liver enzymes (eg, barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John´s wort) in the 2 weeks prior to week 1, or expectations of starting such treatment during the study. • Treatment with the following medications in the 3 weeks prior to visit 1, or expectations to initiate such treatment during the study: Any pharmacological treatment for OAB, including antimuscarinics for OAB, Any medication with significant anticholinergic or antispasmodic effects. • Treatment with a 5-alpha reductase inhibitor started 6 months before the selection (visit 1), or plan to start receiving it during the study .. • Treatment with any medication for BP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Measure:Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12 Timepoints:Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Measure:Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 Timepoints:Week 4 ; Outcome name:Micturition-related urgency episodes per 24 hours were defined as those with USS Scale rating of >= 3 marked for the corresponding micturition in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline Measure:Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 Timepoints:Week 4 and 12 ; Outcome name:All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Numeric change of micturitions per 24 hours at Week 4 and 12 relative to Baseline. Measure:Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 Timepoints:Week 4 and 12 ; Outcome name:All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change a | — |
Countries
Belgium, Brazil, Canada, Colombia, Germany, Greece, India, Korea South, Malasya, Netherlands, Norway, Peru, Philippines, Poland, Singapore, Slovakia, Spain, Sweden, Thailand, United States
Contacts
Public ContactLuciana Obreros
PFIZER S.A.
Outcome results
None listed