Fesoterodine add-on Male Overactive Bladder Study
- Conditions
- -N328 Other specified disorders of bladderOther specified disorders of bladderN328
- Registration Number
- PER-092-08
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 0
• 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.
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12<br>Timepoints:Week 12<br>
- Secondary Outcome Measures
Name Time Method