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

• Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit [ Time Frame: Baseline, Month 1, Month 2, Month 3 or Early Termination (ET) ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 [ Time Frame: Baseline, Month 1, Month 2, Month 3 or ET ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 [ Time Frame: Baseline, Month 1, Month 2, Month 3 or ET ] [ Designated as safety issue: No ]
  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).
  
  
• Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 [ Time Frame: Baseline, Month 1, Month 2, Month 3 or ET ] [ Designated as safety issue: No ]
  The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.
  
  

• Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 [ Time Frame: Baseline, Month 1, Month 2, Month 3 or ET ] [ Designated as safety issue: No ]
  The PVR urine volume: measured by an ultrasound scan.
  
  
• Patient's Global Evaluation of Fesoterodine [ Time Frame: Baseline, Month 3 or ET ] [ Designated as safety issue: Yes ]
  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'.
  
  
• Clinical Global Evaluation of Fesoterodine [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  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.'
  
  
• Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4 [ Time Frame: Month 3 or ET ] [ Designated as safety issue: No ]
  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.
  
  
• Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale [ Time Frame: Baseline, Month 3 or ET ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline in Total Scores of OAB-q at Visit 4 [ Time Frame: Baseline, Month 3 or ET ] [ Designated as safety issue: No ]
  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.
  
  
• Time To Onset Of Treatment Response [ Time Frame: Month 1, Month 2, Month 3 or ET ] [ Designated as safety issue: No ]
  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.
  
  
• Study Doses [ Time Frame: Month 3 or ET ] [ Designated as safety issue: Yes ]
  Number of subjects that changed doses throughout the study period.
  
  
• Reasons for Study Treatment Dose Changes [ Time Frame: Month 3 or ET ] [ Designated as safety issue: Yes ]
  Possible change in the dose and the reasons for the change were collected and documented.
  
  

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