Overactive bladder (OAB) is a symptom complex defined by the International Continence Society (ICS) as the symptoms of urgency, with or without urgency incontinence, usually with frequency and nocturia. While incontinence is often considered the most bothersome symptom of OAB, urgency and increased urinary frequency also severely impair the quality of life of patients and reduce their well-being and social contacts. MedDRA version: 8.1 Level: LLT Classification code 10059617 Term: Overactive bl
Conditions
Interventions
Product Name: Fesoterodine
Product Code: PF-00695838
Pharmaceutical Form: Prolonged-release tablet
CAS Number: 286930-03-8
Current Sponsor code: PF-00695838
Other descriptive name: Fesoterodine Fumara
Sponsors
Pfizer Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Male or female outpatients NLT 18 years old. 2. Overactive bladder symptoms (subject-reported) for NLT 3 months prior to Screening/Visit 1. 3. Previously treated (within 2 years prior to Screening) or being treated with tolterodine or tolterodine ER for OAB. 4. Reported being “somewhat dissatisfied” or “very dissatisfied” with their prior treatment with tolterodine or tolterodine ER on the prior Treatment Satisfaction Question (pTSQ) at Screening/ Visit 1. 5. Mean urinary frequency of NLT 8 micturitions per 24 hours as verified by the screening micturition diary prior to Baseline/Visit 2. 6. Mean number of Urgency episodes NLT 3 per 24 hours as verified by the screening micturition diary prior to Baseline/Visit 2 (Urgency episodes are defined as those with Bladder Sensation Scale rating NLT 3). 7. Rate their bladder condition as “Some Moderate Problems”, “Severe Problems”, or “Many Severe Problems” on the Patient Perception of Bladder Condition (PPBC) questionnaire at Baseline/Visit 2. 8. Able and willing to complete the micturition diaries and all trial related questionnaires, comply with scheduled clinic visits and clinical trial procedures. 9. Capability of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risk and benefits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the trial: 1. Any condition that would contraindicate their usage of fesoterodine, including: • Hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients • urinary retention • gastric retention • uncontrolled narrow angle glaucoma • myasthenia gravis • severe hepatic impairment (Child Pugh C) • severe ulcerative colitis • toxic megacolon. 2. Documented significant hepatic or renal disease, defined as twice the upper limit of the reference ranges for serum concentrations of AST, ALT, ALP, urea nitrogen, or creatinine. 3. Neurologic conditions, such as stroke, multiple sclerosis, spinal cord injury, or Parkinson’s disease. 4. Stage 3 or greater pelvic organ prolapse defined as tissue visible through introitus in lithotomy position at rest (without increase in intra abdominal pressure). 5. History of lower urinary tract surgery (e.g. incontinence surgery or surgery to reduce prostate size) within the past 6 months. 6. A known history of interstitial cystitis or a significant pain component associated with OAB symptoms, uninvestigated hematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia, or bladder outlet obstruction due to vesical neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor, radiation cystitis, genito-urinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia. 7. Previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline. 8. Use of an indwelling catheter or an intermittent self-catheterization program. 9. Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator. 10. Urinary tract infection (UTI) as shown by the results of the urinalysis at Screening or recurrent urinary tract infection (RUTIs) defined as treatment for UTI >3 times in the last year. 11. Have started any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks of Visit 1. 12. Previously treated with 3 or more antimuscarinic OAB medications within 12 months prior to screening [Note: any current treatment must stop at screening]; the antimuscarinic OAB medication may include: • darifenacin, oxybutynin, propiverine, solifenacin, tolterodine, and trospium 13. Expectation of initiating treatment during the study with: • Any drug treatment for overactive bladder • Any drugs with significant anticholinergic, antispasmodic, parasympathetic, or cholinergic agonistic effects 14. Intermittent or unstable use of diuretics throughout study duration. Treatment with diuretics initiated within 2 weeks prior to baseline is not permitted. 15. Treatment with potent CYP3A4 inhibitors, such as macrolide antibiotics (erythromycin, clarithromycin), immunosuppressants (cyclosporine), azole antifungal agents (i.e., ketoconazole, itraconazole), protease inhibitors, or the expectation to start such a treatment during the trial. 16. Administration of medications capable of inducing hepatic enzyme metabolism or transport (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John’s Wort) in the past 30 days. 17. Previously received any investigational drug within 30 days prior to study ent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.;Secondary Objective: 1. To evaluate the effects of fesoterodine on quality of life (QoL) and secondary micturition diary endpoints in OAB patients who were dissatisfied with their prior therapy with tolterodine. 2. To evaluate tolerability and safety of fesoterodine in OAB patients who were dissatisfied with their prior therapy with tolterodine.;Primary end point(s): • Percentage of subjects reporting satisfaction (including ‘very satisfied’ and ‘somewhat satisfied’) with their current OAB treatment using the Treatment Satisfaction Question at Week 12 • Change in mean number of micturition episodes per 24 hours at week 12 relative to baseline. • Change in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at week 12 relative to the baseline in subjects with a baseline of UUI not less than 1 episode(s) during the 5-day urinary diary period. • Change in mean number of urgency episodes per 24 hours at week 12 relative to baseline (Urgency episodes are defined as those with Bladder Sensation Scale rating of NLT 3 in the diary). | — |
Countries
Germany
Outcome results
None listed