Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder

The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with Urinary Sensation Scale (USS) rating of greater than or equal to (\>=) 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.

Time frame: End of Treatment (up to Week 82)

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. Missing values were imputed using last observation carried forward (LOCF).

The daily sum rating was calculated as the mean rating score on the USS multiplied by the mean number of micturitions per 24 hours 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. Numerical decrease indicates improvement.

Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \[(Highest possible raw score-Actual total raw score)/Raw score range\]\*100. Higher transformed scores indicative of better HRQL.

Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, and severity of urinary symptoms). Each domain score ranged: 0-100, where 0=best outcome/response and 100=worst outcome/response.

Time frame: Baseline, End of Treatment (EOT) (Week 82)

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points.

The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 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.

Time frame: Baseline, Month 3, 6, 9, 12, 15, 18

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. 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.

Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. 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 nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.

Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

The mean number of severe micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\>=) 4 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.

Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

UUI episodes were defined as those with the USS rating of 5 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.

Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

The mean number of urinary incontinence pads (IP), barrier creams (BC) and powder used per 24 hours is calculated as the total number of IP, BC and powder used divided by the total number of diary days collected at that visit.

Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Population: FAS: all enrolled participants who had taken at least one dose of study treatment during study and completed at least one micturition diary. N (number of participants analyzed) signifies participants who had baseline UUI episodes \>0 per 24 hours. 'n' signifies participants evaluable for this measure at specified time points. LOCF was used.

PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than \[\<\]0).

Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Score of 0 (usually not able to hold urine), 1 (usually able to hold urine \[without leaking\] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet \[without leaking\]). Change = observation minus baseline. Deterioration: negative difference of scores; improvement: increase of 1 or more points in difference of scores, relative to baseline.

Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

OAB-s assessed OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Question (Q) 5 evaluates OAB medication expectations (exceeds/meets or does not meet expectation). Q9 to 11 assessed satisfaction with OAB medication's ability to allow reaching bathroom without urine loss (Q9), decrease: sudden urgencies to urinate (Q10a), urine loss due to urgency (Q10b), waking up at night to urinate (Q10c) and urination during day (Q10d), and improve control of urine loss (Q11a) and need to urinate (Q11b). Q9 to 11 were answered as 'very satisfied', 'somewhat satisfied', 'neither dissatisfied nor satisfied', 'somewhat dissatisfied', and 'very dissatisfied'. The results for Q9 to 11 are reported as satisfied (participants who answered 'very satisfied' or 'somewhat satisfied' for all 7 questions) or not satisfied (participants who answered 'neither dissatisfied nor satisfied' or 'somewhat dissatisfied' or 'very dissatisfied' for all 7 questions).

Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82)

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale \[(Actual total raw score - lowest possible value of raw score)/range\]\*100. Higher scores values indicative of greater symptom bother.

Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 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.

Time frame: Baseline

Population: Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary.

UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 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.

Time frame: Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Population: FAS: all enrolled participants who had taken at least one dose of study treatment during study and completed at least one micturition diary. N (number of participants analyzed) signifies participants who had baseline UUI episodes \>0 per 24 hours. 'n' signifies participants evaluable for this measure at specified time points. LOCF was used.