Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

Study Overview
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Brief Summary
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This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine.

Detailed Description
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patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Official Title
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Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.

Conditions
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Overactive Bladder, Urinary Incontinence

Intervention / Treatment
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* Drug: fesoterodine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms. Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome Due to intolerance: persistent and/or unacceptable adverse events Exclusion Criteria: Hypersensitivity to the active substance or to peanut or soya or any of the excipients. History of acute urinary retention (requiring catheterisation) Gastric retention Uncontrolled narrow angle glaucoma Myasthenia gravis Severe hepatic impairment (Child Pugh C) Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment Severe ulcerative colitis Toxic megacolon.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fesoterodine<br> | Drug: fesoterodine<br>* 4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment<br>* Other names: TOVIAZ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit. | Baseline, Month 1, Month 2, Month 3 or Early Termination (ET) | 
| Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit. | Baseline, Month 1, Month 2, Month 3 or ET | 
| Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit). | Baseline, Month 1, Month 2, Month 3 or ET | 
| Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit. | Baseline, Month 1, Month 2, Month 3 or ET | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | The PVR urine volume: measured by an ultrasound scan. | Baseline, Month 1, Month 2, Month 3 or ET | 
| Patient's Global Evaluation of Fesoterodine | The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'. | Baseline, Month 3 or ET | 
| Clinical Global Evaluation of Fesoterodine | Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.' | 12 weeks | 
| Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4 | Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given. | Month 3 or ET | 
| Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale | Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity. | Baseline, Month 3 or ET | 
| Change From Baseline in Total Scores of OAB-q at Visit 4 | Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity. | Baseline, Month 3 or ET | 
| Time To Onset Of Treatment Response | Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment. | Month 1, Month 2, Month 3 or ET | 
| Study Doses | Number of subjects that changed doses throughout the study period. | Month 3 or ET | 
| Reasons for Study Treatment Dose Changes | Possible change in the dose and the reasons for the change were collected and documented. | Month 3 or ET | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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observational