Urinary Bladder, Overactive
Conditions
Keywords
Overactive bladder syndrome, fesoterodine, elderly, flexible dose regimen, urgency, frequency, urge urinary incontinence, anticholinergic, antimuscarinic
Brief summary
The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged \> 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.
Interventions
DRUGPlacebo
placebo administered orally in the morning or evening.
Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥65 years old. * Overactive bladder symptoms for at least 3 months prior to study start. * Eight or more micturitions per 24 hours as confirmed by diary records
Exclusion criteria
* Predominant Stress Urinary Incontinence * Active or recurrent bladder infections * Other bladder and genital conditions that could be the predominant cause of symptoms or interfere with treatment assessment and success.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | Baseline and Week 12 | Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of greater than or equal to (\>=) 3 divided by number of days that diary data was collected at that visit. USS ranged 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). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Improvement at Week 12 | Week 12 | Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment. Improvement was defined as a rating of 1 or 2. |
| Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24 | Weeks 12 and 24 | OAB-S: validated self-administered instrument that evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication and included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1-5: (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Change = score at Week 24 minus score at Week 12 where higher scores indicated better satisfaction. |
| Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24 | Weeks 12 and 24 | OAB-S: evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Medication expectation coded on scale 1=Greatly exceeds my expectations to 5=Does not meet my expectations at all. Coding reversed by subtracting initial response value from 6, so higher final response value associated with better fulfilment of OAB medication expectations. |
| Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline and Week 12 | 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, severity of urinary symptoms). Range: 0-100, where 0=best outcome/response and 100=worst outcome/response. Change = observation minus baseline, where lower scores indicated better outcome/response. |
| Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12 | Baseline and Week 12 | EQ-5D: participant rated questionnaire to assess HRQL in terms of single index value. Visual Analogue Scale (VAS) component rated current health state on scale from 0 (worst imaginable health state) to 100 (best imaginable health state). For each question, scores categorized into 3 levels of response, level 1=no health problems, 2=some problems and 3= extreme problems, and health state profile utility score derived from these, which could range from 1 prefect health to -0.594 worst possible health. Change = observation minus baseline, where higher scores indicated a better health state. |
| Change From Baseline in EQ-5D- Each Dimension Score at Week 12 | Baseline and Week 12 | EQ-5D: participant rated questionnaire to assess HRQL in terms of a single utility score. Health State Profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state; 3 indicated worst health state. Scoring formula assigned utility value for each domain in profile. Score was transformed and results in total score could have ranged from -0.594 to 1.000; Change = observation minus baseline, where higher scores indicated a better health state. |
| Change From Baseline in Mini Mental State Examination (MMSE) at Week 12 | Baseline and Week 12 | MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change = observation minus baseline where higher scores indicated better cognitive functioning. |
| Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Baseline and Weeks 4, 8, and 12 | Micturition-related urgency episodes per 24 hours defined as those with USS Scale rating of \>=3 marked for corresponding micturition in diary. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine. Percent change calculated as: 100\* (Urgency Episode at Week x - baseline)/baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes. |
| Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Baseline and Weeks 4, 8, and 12 | Severe micturition-related urgency episodes defined as those with the USS rating \>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency episodes. |
| Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Baseline and Weeks 4, 8, and 12 | Severe micturition-related urgency episodes defined as those with USS rating \>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency. |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Baseline and Weeks 4, 8, and 12 | Micturitions included episodes of voluntary micturition and episodes of UUI, defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary of participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions. |
| Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Baseline and Weeks 4, 8, and 12 | Micturitions included episodes of voluntary micturition and episodes of UUI. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions. |
| Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Baseline and Weeks 4, 8, and 12 | Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and 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. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions. |
| Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Baseline and Weeks 4, 8, and 12 | Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and 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. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions. |
| Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 | Baseline and Weeks 4, 8, and 12 | UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes. |
| Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12 | Baseline and Weeks 4, 8, and 12 | UUI episodes defined as those with the USS rating of 5 (unable to hold; leak urine)in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes. |
| Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 | Baseline and Weeks 4, 8, and 12 | 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). Change = observation minus baseline, where lower scores were an improvement/decrease in urinary sensation. |
| Percentage of Participants Who Were Incontinent at Baseline and Became Dry | Weeks 8 to 12 | Percentage of participants who had at least 1 UUI episode during baseline period and were dry (no UUI episodes) in the 3 days prior to study visits at week 8 and 12. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. |
| Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Baseline and Weeks 4, 8, and 12 | Skin protective agents included incontinence pads, barrier creams, and powders. Change = observation minus baseline, where lower scores were an improvement/decrease in protective skin agents used. |
| Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 | Baseline and Week 4 | 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). |
| Change From Baseline in PPBC at Week 8 | Baseline and Week 8 | 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 \<0). |
| Change From Baseline in PPBC at Week 12 | Baseline and Week 12 | 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 \<0). |
| Change From Baseline in PPBC at Week 24 | Baseline and Week 24 | 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 \<0). |
| Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4 | Baseline and Weeks 4 | 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. Scale 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. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline. |
| Change From Baseline in PPUS at Week 8 | Baseline and Week 8 | 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. Scale 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. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline. |
| Change From Baseline in PPUS at Week 12 | Baseline and Week 12 | 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. Scale 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. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline. |
| Change From Baseline in PPUS at Week 24 | Baseline and Week 24 | 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. Scale 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. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline. |
| Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 | Baseline and Weeks 4, 8, 12, and 24 | OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = baseline minus observation and higher scores were an improvement. |
| Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 | Baseline and Weeks 4, 8, 12, and 24 | OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = observation minus baseline and higher scores were an improvement. |
| Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Baseline and Weeks 4, 8, 12, and 24 | OAB-q: self-administered, 33-item, questionnaire assessed how much participant bothered by bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to 0-100 score where higher scores were less favorable outcome. Questions 1-8 constituted symptom severity/bother score. Questions 9-33 constitute HRQL component, which included domains of coping, concern, sleep, and social function. Change = observation minus baseline and higher scores were an improvement. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24 | Baseline and Week 24 | Severe micturition-related urgency episodes defined as those with the USS rating \>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes. |
| Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 24 | Baseline and Week 24 | 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. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions. |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 24 | Baseline and Week 24 | Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary in participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions. |
| Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24 | Baseline and Week 24 | UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes. |
| Percentage of Participants With Improvement at Week 24 | Pre-baseline and Week 24 | Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment. Treatment Response was set to Yes if the first 2 categories (1 or 2) of the scale selected and No if the last 2 categories (3 or 4) were selected. Improvement was defined as a rating of 1 or 2. |
| Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24 | Baseline and Week 24 | Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of \>=3 divided by number of days that diary data was collected at that visit. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes. |
Countries
Austria, Belgium, Denmark, Finland, Germany, Israel, Italy, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo/Fesoterodine Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary). | 393 |
| Fesoterodine/Fesoterodine Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary). | 392 |
| Total | 785 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-Blind | Adverse Event | 22 | 46 |
| Double-Blind | Death | 0 | 1 |
| Double-Blind | Did Not Meet Entrance Criteria | 2 | 1 |
| Double-Blind | Lack of Efficacy | 8 | 12 |
| Double-Blind | Lost to Follow-up | 1 | 0 |
| Double-Blind | Not Treated | 3 | 6 |
| Double-Blind | Other | 1 | 0 |
| Double-Blind | Protocol Violation | 1 | 4 |
| Double-Blind | Withdrawal by Subject | 17 | 14 |
| Open-Label | Adverse Event | 33 | 11 |
| Open-Label | Lack of Efficacy | 5 | 11 |
| Open-Label | Not Treated | 0 | 1 |
| Open-Label | Other | 1 | 2 |
| Open-Label | Protocol Violation | 1 | 0 |
| Open-Label | Withdrawal by Subject | 2 | 7 |
Baseline characteristics
| Characteristic | Placebo/Fesoterodine | Fesoterodine/Fesoterodine | Total |
|---|---|---|---|
| Age, Customized 65-75 years | 267 participants | 264 participants | 531 participants |
| Age, Customized 76-84 years | 114 participants | 116 participants | 230 participants |
| Age, Customized greater than or equal to 85 years | 12 participants | 12 participants | 24 participants |
| Micturition-Related Urgency Episodes per 24 Hours | 8.7 Episodes per 24 hours | 8.5 Episodes per 24 hours | 8.7 Episodes per 24 hours |
| Micturitions per 24 Hours | 11.5 Episodes per 24 hours | 11.3 Episodes per 24 hours | 11.3 Episodes per 24 hours |
| Nocturnal Micturitions per 24 Hours | 2.7 Episodes per 24 hours | 2.7 Episodes per 24 hours | 2.7 Episodes per 24 hours |
| Patient Perception of Bladder Condition (PPBC) at Baseline many severe problems | 37 Participants | 23 Participants | 60 Participants |
| Patient Perception of Bladder Condition (PPBC) at Baseline no problems at all | 0 Participants | 0 Participants | 0 Participants |
| Patient Perception of Bladder Condition (PPBC) at Baseline severe problems | 157 Participants | 158 Participants | 315 Participants |
| Patient Perception of Bladder Condition (PPBC) at Baseline some minor problems | 2 Participants | 2 Participants | 4 Participants |
| Patient Perception of Bladder Condition (PPBC) at Baseline some moderate problems | 185 Participants | 190 Participants | 375 Participants |
| Patient Perception of Bladder Condition (PPBC) at Baseline some very minor problems | 1 Participants | 0 Participants | 1 Participants |
| Severe Micturition-Related Urgency Episodes per 24 Hours | 3.0 Episodes per 24 hours | 2.7 Episodes per 24 hours | 2.7 Episodes per 24 hours |
| Sex: Female, Male Female | 205 Participants | 213 Participants | 418 Participants |
| Sex: Female, Male Male | 188 Participants | 179 Participants | 367 Participants |
| UUI Episodes per 24 Hours | 0.0 Episodes per 24 hours | 0.0 Episodes per 24 hours | 0.0 Episodes per 24 hours |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 71 / 393 | 187 / 392 | 49 / 313 | 119 / 341 |
| serious Total, serious adverse events | 9 / 393 | 14 / 392 | 11 / 313 | 7 / 341 |
Outcome results
Primary
Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12
Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of greater than or equal to (\>=) 3 divided by number of days that diary data was collected at that visit. USS ranged 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). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.
Time frame: Baseline and Week 12
Population: Full Analysis Set (FAS)=randomized participants who took at least 1 dose of double-blind (DB) treatment, had baseline and post-baseline efficacy data for at least 1 endpoint and at least 1 time point during DB treatment; number of participants analyzed (n)=participants with evaluable data at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | Baseline (n=381, 374) | 8.80 Episodes per 24 hours | Standard Deviation 3.97 |
| Placebo | Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | Change at Week 12 (n=356, 338) | -2.48 Episodes per 24 hours | Standard Deviation 4.53 |
| Fesoterodine | Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | Baseline (n=381, 374) | 8.48 Episodes per 24 hours | Standard Deviation 3.62 |
| Fesoterodine | Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | Change at Week 12 (n=356, 338) | -3.84 Episodes per 24 hours | Standard Deviation 4.1 |
Comparison: Based on a 2-sided t-test (5% significance). Null hypothesis: no difference in mean change in mean micturition-related urgency episodes per 24 hours at Week 12 for the 2 groups. Last observation carried forward (LOCF) method used for statistical analyses of the FAS (change from baseline to Week 12).p-value: <0.000195% CI: [-2.12, -0.97]ANCOVA
Secondary
Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12
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). Change = observation minus baseline, where lower scores were an improvement/decrease in urinary sensation.
Time frame: Baseline and Weeks 4, 8, and 12
Population: FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 | Baseline (n=381, 374) | 37.55 Scores on a scale | Standard Deviation 13.95 |
| Placebo | Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 | Change at Week 4 (n=365, 356) | -4.35 Scores on a scale | Standard Deviation 11.7 |
| Placebo | Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -6.53 Scores on a scale | Standard Deviation 12.5 |
| Placebo | Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 | Change at Week 12 (n=356, 338) | -7.33 Scores on a scale | Standard Deviation 12.7 |
| Fesoterodine | Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 | Change at Week 12 (n=356, 338) | -11.59 Scores on a scale | Standard Deviation 10.7 |
| Fesoterodine | Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 | Baseline (n=381, 374) | 36.07 Scores on a scale | Standard Deviation 11.16 |
| Fesoterodine | Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -10.81 Scores on a scale | Standard Deviation 10.7 |
| Fesoterodine | Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 | Change at Week 4 (n=365, 356) | -8.52 Scores on a scale | Standard Deviation 10 |
Comparison: Week 12 LOCFp-value: <0.000195% CI: [-6.3, -3.1]ANCOVA
Secondary
Change From Baseline in EQ-5D- Each Dimension Score at Week 12
EQ-5D: participant rated questionnaire to assess HRQL in terms of a single utility score. Health State Profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state; 3 indicated worst health state. Scoring formula assigned utility value for each domain in profile. Score was transformed and results in total score could have ranged from -0.594 to 1.000; Change = observation minus baseline, where higher scores indicated a better health state.
Time frame: Baseline and Week 12
Population: Not analyzed
Secondary
Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12
EQ-5D: participant rated questionnaire to assess HRQL in terms of single index value. Visual Analogue Scale (VAS) component rated current health state on scale from 0 (worst imaginable health state) to 100 (best imaginable health state). For each question, scores categorized into 3 levels of response, level 1=no health problems, 2=some problems and 3= extreme problems, and health state profile utility score derived from these, which could range from 1 prefect health to -0.594 worst possible health. Change = observation minus baseline, where higher scores indicated a better health state.
Time frame: Baseline and Week 12
Population: FAS; N=participants with evaluable data; n=participants with evaluable data a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12 | Baseline (n=381, 373) | 0.7825 Scores on a scale | Standard Deviation 0.2246 |
| Placebo | Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12 | Change at Week 12 (n=362, 346) | 0.0230 Scores on a scale | Standard Deviation 0.1963 |
| Fesoterodine | Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12 | Baseline (n=381, 373) | 0.8092 Scores on a scale | Standard Deviation 0.2068 |
| Fesoterodine | Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12 | Change at Week 12 (n=362, 346) | 0.0064 Scores on a scale | Standard Deviation 0.1854 |
p-value: 0.895995% CI: [-0.0229, 0.0262]ANCOVA
Secondary
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
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, severity of urinary symptoms). Range: 0-100, where 0=best outcome/response and 100=worst outcome/response. Change = observation minus baseline, where lower scores indicated better outcome/response.
Time frame: Baseline and Week 12
Population: FAS; N=participants with evaluable data at sites in the United Kingdom only; n=participants with evaluable data for specific KHQ category. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline General Health Perception (n=23, 32) | 35.87 Scores on a scale | Standard Deviation 19.69 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 General Hlth Perception n=21, 29 | -2.38 Scores on a scale | Standard Deviation 15.62 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Incontinence Impact (n=23, 32) | 75.36 Scores on a scale | Standard Deviation 25.06 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Incontinence Impact (n=21, 29) | -12.70 Scores on a scale | Standard Deviation 32.45 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Role Limitations (n=22, 32) | 48.48 Scores on a scale | Standard Deviation 34.85 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Role Limitations (n=20, 29) | -10.83 Scores on a scale | Standard Deviation 45.33 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Physical Limitations (n=22, 32) | 50.76 Scores on a scale | Standard Deviation 31.49 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Physical Limitations (n=20, 29) | -13.33 Scores on a scale | Standard Deviation 30.4 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Social Limitations (n=22, 32) | 24.75 Scores on a scale | Standard Deviation 23.43 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Social Limitations (n=20, 29) | -7.50 Scores on a scale | Standard Deviation 23.17 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Personal Relationships (n=16,17) | 15.63 Scores on a scale | Standard Deviation 28.85 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Personal Relationship (n=11, 14) | 4.55 Scores on a scale | Standard Deviation 18.4 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Emotions (n=22, 32) | 32.32 Scores on a scale | Standard Deviation 25.64 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Emotions (n=20, 29) | -2.78 Scores on a scale | Standard Deviation 28.58 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Sleep/Energy (n=22, 32) | 46.97 Scores on a scale | Standard Deviation 27.04 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Sleep/Energy (n=20, 29) | -8.33 Scores on a scale | Standard Deviation 26.21 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Severity USS (n=22, 32) | 43.94 Scores on a scale | Standard Deviation 22.69 |
| Placebo | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Severity USS (n=20, 29) | -2.00 Scores on a scale | Standard Deviation 18.99 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Emotions (n=20, 29) | -6.51 Scores on a scale | Standard Deviation 25.63 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline General Health Perception (n=23, 32) | 25.00 Scores on a scale | Standard Deviation 17.96 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Social Limitations (n=20, 29) | -8.62 Scores on a scale | Standard Deviation 24.2 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 General Hlth Perception n=21, 29 | 2.59 Scores on a scale | Standard Deviation 13.93 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Severity USS (n=20, 29) | -8.51 Scores on a scale | Standard Deviation 16.7 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Incontinence Impact (n=23, 32) | 73.96 Scores on a scale | Standard Deviation 29 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Personal Relationships (n=16,17) | 19.61 Scores on a scale | Standard Deviation 27.15 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Incontinence Impact (n=21, 29) | -16.09 Scores on a scale | Standard Deviation 34.06 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Sleep/Energy (n=22, 32) | 57.29 Scores on a scale | Standard Deviation 27.74 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Role Limitations (n=22, 32) | 46.35 Scores on a scale | Standard Deviation 30.15 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Personal Relationship (n=11, 14) | -5.95 Scores on a scale | Standard Deviation 18.03 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Role Limitations (n=20, 29) | -12.64 Scores on a scale | Standard Deviation 25.45 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Severity USS (n=22, 32) | 44.38 Scores on a scale | Standard Deviation 25.99 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Physical Limitations (n=22, 32) | 44.79 Scores on a scale | Standard Deviation 32.91 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Emotions (n=22, 32) | 32.64 Scores on a scale | Standard Deviation 29.18 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Physical Limitations (n=20, 29) | -13.79 Scores on a scale | Standard Deviation 28.2 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Change at Week 12 Sleep/Energy (n=20, 29) | -11.49 Scores on a scale | Standard Deviation 23.61 |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline Social Limitations (n=22, 32) | 29.86 Scores on a scale | Standard Deviation 33.89 |
Comparison: General Health Perception; LOCFp-value: 0.316395% CI: [-4.13, 12.49]ANCOVA
Comparison: Incontinence Impact; LOCFp-value: 0.469895% CI: [-23.7, 11.11]ANCOVA
Comparison: Role Limitations; LOCFp-value: 0.532195% CI: [-24.58, 12.88]ANCOVA
Comparison: Physical Limitations; LOCFp-value: 0.652395% CI: [-20.74, 13.12]ANCOVA
Comparison: Social Limitations; LOCFp-value: 0.634495% CI: [-10.47, 16.99]ANCOVA
Comparison: Personal Relationships; LOCFp-value: 0.201395% CI: [-28.71, 6.49]ANCOVA
Comparison: Emotions; LOCFp-value: 0.383195% CI: [-19.96, 7.83]ANCOVA
Comparison: Sleep/Energy; LOCFp-value: 0.516795% CI: [-9.3, 18.23]ANCOVA
Comparison: Severity of Urinary Symptoms; LOCFp-value: 0.053295% CI: [-20.53, 0.15]ANCOVA
Secondary
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12
Micturitions included episodes of voluntary micturition and episodes of UUI, defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary of participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.
Time frame: Baseline and Weeks 4, 8, and 12
Population: FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Baseline (n=382, 374) | 12.10 Micturitions per 24 hours | Standard Deviation 3.12 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=366, 356) | -0.69 Micturitions per 24 hours | Standard Deviation 2.26 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -1.11 Micturitions per 24 hours | Standard Deviation 2.37 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=359, 338) | -1.15 Micturitions per 24 hours | Standard Deviation 2.56 |
| Fesoterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=359, 338) | -2.09 Micturitions per 24 hours | Standard Deviation 2.33 |
| Fesoterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Baseline (n=382, 374) | 11.89 Micturitions per 24 hours | Standard Deviation 2.9 |
| Fesoterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -1.95 Micturitions per 24 hours | Standard Deviation 2.33 |
| Fesoterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=366, 356) | -1.47 Micturitions per 24 hours | Standard Deviation 2.19 |
Comparison: Week 12 LOCFp-value: <0.000195% CI: [-1.33, -0.64]ANCOVA
Secondary
Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12
Severe micturition-related urgency episodes defined as those with the USS rating \>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency episodes.
Time frame: Baseline and Weeks 4, 8, and 12
Population: FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Baseline (n=381, 374) | 4.11 Episodes per 24 hours | Standard Deviation 4.24 |
| Placebo | Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=365, 356) | -0.96 Episodes per 24 hours | Standard Deviation 3.39 |
| Placebo | Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -1.53 Episodes per 24 hours | Standard Deviation 3.79 |
| Placebo | Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=356, 338) | -1.78 Episodes per 24 hours | Standard Deviation 3.85 |
| Fesoterodine | Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=356, 338) | -2.43 Episodes per 24 hours | Standard Deviation 3.14 |
| Fesoterodine | Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Baseline (n=381, 374) | 3.53 Episodes per 24 hours | Standard Deviation 3.4 |
| Fesoterodine | Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -2.12 Episodes per 24 hours | Standard Deviation 3.07 |
| Fesoterodine | Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=365, 356) | -1.81 Episodes per 24 hours | Standard Deviation 2.96 |
Comparison: Week 12 LOCFp-value: 0.000195% CI: [-1.28, -0.42]ANCOVA
Secondary
Change From Baseline in Mini Mental State Examination (MMSE) at Week 12
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change = observation minus baseline where higher scores indicated better cognitive functioning.
Time frame: Baseline and Week 12
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mini Mental State Examination (MMSE) at Week 12 | Baseline | 28.09 Scores on a scale | Standard Deviation 1.98 |
| Placebo | Change From Baseline in Mini Mental State Examination (MMSE) at Week 12 | Change at Week 12 | 0.23 Scores on a scale | Standard Deviation 1.82 |
| Fesoterodine | Change From Baseline in Mini Mental State Examination (MMSE) at Week 12 | Baseline | 28.20 Scores on a scale | Standard Deviation 1.94 |
| Fesoterodine | Change From Baseline in Mini Mental State Examination (MMSE) at Week 12 | Change at Week 12 | 0.24 Scores on a scale | Standard Deviation 1.76 |
Secondary
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12
Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and 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. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.
Time frame: Baseline and Weeks 4, 8, and 12
Population: FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Baseline (n=382, 374) | 2.92 Micturitions per 24 hours | Standard Deviation 1.46 |
| Placebo | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=366, 356) | -0.22 Micturitions per 24 hours | Standard Deviation 1.15 |
| Placebo | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -0.30 Micturitions per 24 hours | Standard Deviation 1.13 |
| Placebo | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=359, 338) | -0.33 Micturitions per 24 hours | Standard Deviation 1.15 |
| Fesoterodine | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=359, 338) | -0.55 Micturitions per 24 hours | Standard Deviation 1.13 |
| Fesoterodine | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Baseline (n=382, 374) | 2.80 Micturitions per 24 hours | Standard Deviation 1.47 |
| Fesoterodine | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -0.51 Micturitions per 24 hours | Standard Deviation 1.03 |
| Fesoterodine | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=366, 356) | -0.38 Micturitions per 24 hours | Standard Deviation 0.99 |
Comparison: Week 12 LOCFp-value: 0.002695% CI: [-0.4, -0.09]ANCOVA
Secondary
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12
Skin protective agents included incontinence pads, barrier creams, and powders. Change = observation minus baseline, where lower scores were an improvement/decrease in protective skin agents used.
Time frame: Baseline and Weeks 4, 8, and 12
Population: FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Incontinence pads at Baseline (n=374, 369) | 1.49 Skin protective agents | Standard Deviation 2.7 |
| Placebo | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Incontinence pads Change at Week 4 (n=360, 350) | -0.20 Skin protective agents | Standard Deviation 1.97 |
| Placebo | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Incontinence pads Change at Week 8 (n=342, 326) | -0.15 Skin protective agents | Standard Deviation 2.01 |
| Placebo | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Incontinence pads Change at Week 12 (n=350, 332) | -0.16 Skin protective agents | Standard Deviation 1.98 |
| Placebo | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Creams at Baseline (n=374, 368) | 0.12 Skin protective agents | Standard Deviation 0.72 |
| Placebo | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Creams Change at Week 4 (n=360, 349) | -0.01 Skin protective agents | Standard Deviation 0.55 |
| Placebo | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Creams Change at Week 8 (n=342, 325) | 0.06 Skin protective agents | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Creams Change at Week 12 (n=350, 331) | 0.04 Skin protective agents | Standard Deviation 0.41 |
| Placebo | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Powder at Baseline (n=374, 368) | 0.03 Skin protective agents | Standard Deviation 0.29 |
| Placebo | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Powder Change at Week 4 (n=360, 349) | 0.03 Skin protective agents | Standard Deviation 0.27 |
| Placebo | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Powder Change at Week 8 (n=342, 325) | 0.03 Skin protective agents | Standard Deviation 0.39 |
| Placebo | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Powder Change at Week 12 (n=350, 331) | 0.03 Skin protective agents | Standard Deviation 0.44 |
| Fesoterodine | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Powder Change at Week 8 (n=342, 325) | -0.01 Skin protective agents | Standard Deviation 0.29 |
| Fesoterodine | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Incontinence pads at Baseline (n=374, 369) | 1.35 Skin protective agents | Standard Deviation 2.01 |
| Fesoterodine | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Creams Change at Week 8 (n=342, 325) | -0.03 Skin protective agents | Standard Deviation 0.47 |
| Fesoterodine | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Incontinence pads Change at Week 4 (n=360, 350) | -0.27 Skin protective agents | Standard Deviation 1.33 |
| Fesoterodine | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Powder Change at Week 4 (n=360, 349) | -0.02 Skin protective agents | Standard Deviation 0.24 |
| Fesoterodine | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Incontinence pads Change at Week 8 (n=342, 326) | -0.38 Skin protective agents | Standard Deviation 1.57 |
| Fesoterodine | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Creams Change at Week 12 (n=350, 331) | -0.03 Skin protective agents | Standard Deviation 0.54 |
| Fesoterodine | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Incontinence pads Change at Week 12 (n=350, 332) | -0.50 Skin protective agents | Standard Deviation 1.35 |
| Fesoterodine | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Powder Change at Week 12 (n=350, 331) | -0.02 Skin protective agents | Standard Deviation 0.22 |
| Fesoterodine | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Creams at Baseline (n=374, 368) | 0.16 Skin protective agents | Standard Deviation 0.68 |
| Fesoterodine | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Powder at Baseline (n=374, 368) | 0.02 Skin protective agents | Standard Deviation 0.23 |
| Fesoterodine | Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 | Creams Change at Week 4 (n=360, 349) | -0.02 Skin protective agents | Standard Deviation 0.39 |
Comparison: Incontinence pads at Week 12 LOCFp-value: 0.02395% CI: [-0.47, -0.04]ANCOVA
Comparison: Creams at Week 12 LOCFp-value: 0.090995% CI: [-0.12, 0.01]ANCOVA
Comparison: Powder at Week 12 LOCFp-value: 0.203995% CI: [-0.08, 0.02]ANCOVA
Secondary
Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12
UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.
Time frame: Baseline and Weeks 4, 8, and 12
Population: FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 | Baseline (n=381, 374) | 0.0 Episodes per 24 hours |
| Placebo | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=365, 356) | 0.0 Episodes per 24 hours |
| Placebo | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | 0.0 Episodes per 24 hours |
| Placebo | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=356, 338) | 0.0 Episodes per 24 hours |
| Fesoterodine | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=356, 338) | 0.0 Episodes per 24 hours |
| Fesoterodine | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 | Baseline (n=381, 374) | 0.0 Episodes per 24 hours |
| Fesoterodine | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | 0.0 Episodes per 24 hours |
| Fesoterodine | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=365, 356) | 0.0 Episodes per 24 hours |
Comparison: Week 12 LOCFp-value: 0.100595% CI: [0, 0]Van-Elteren's Test
Secondary
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24
OAB-q: self-administered, 33-item, questionnaire assessed how much participant bothered by bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to 0-100 score where higher scores were less favorable outcome. Questions 1-8 constituted symptom severity/bother score. Questions 9-33 constitute HRQL component, which included domains of coping, concern, sleep, and social function. Change = observation minus baseline and higher scores were an improvement.
Time frame: Baseline and Weeks 4, 8, 12, and 24
Population: FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Coping at Baseline (n=380, 374) | 57.52 Scores on a scale | Standard Deviation 24.36 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Coping Change at Week 4 (n=368, 358) | 8.35 Scores on a scale | Standard Deviation 19.28 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Coping Change at Week 8 (n=348, 329) | 10.46 Scores on a scale | Standard Deviation 20.96 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Coping Change at Week 12 (n=365, 358) | 10.60 Scores on a scale | Standard Deviation 22.78 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Coping Change at Week 24 | NA Scores on a scale | — |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Concern at Baseline (n=380, 374) | 62.10 Scores on a scale | Standard Deviation 23.32 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Concern Change at Week 4 (n=368, 358) | 7.96 Scores on a scale | Standard Deviation 17.8 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Concern Change at Week 8 (n=348, 329) | 10.88 Scores on a scale | Standard Deviation 21.23 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Concern Change at Week 12 (n=365, 358) | 11.25 Scores on a scale | Standard Deviation 21.39 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Concern Change at Week 24 | NA Scores on a scale | — |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Sleep at Baseline (n=380, 374) | 53.79 Scores on a scale | Standard Deviation 23.69 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Sleep Change at Week 4 (n=368, 358) | 7.31 Scores on a scale | Standard Deviation 20.13 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Sleep Change at Week 8 (n=348, 329) | 9.01 Scores on a scale | Standard Deviation 21.42 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Sleep Change at Week 12 (n=365, 358) | 9.36 Scores on a scale | Standard Deviation 22.08 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Sleep Change at Week 24 | NA Scores on a scale | — |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Social at Baseline (n=380, 374) | 79.10 Scores on a scale | Standard Deviation 21.84 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Social Change at Week 4 (n=368, 355) | 4.41 Scores on a scale | Standard Deviation 16.01 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Social Change at Week 8 (n=349, 328) | 5.84 Scores on a scale | Standard Deviation 18.58 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Social Change at Week 12 (n=364, 357) | 5.29 Scores on a scale | Standard Deviation 18.56 |
| Placebo | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Social Change at Week 24 | NA Scores on a scale | — |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Social Change at Week 8 (n=349, 328) | 8.17 Scores on a scale | Standard Deviation 17.24 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Coping at Baseline (n=380, 374) | 58.31 Scores on a scale | Standard Deviation 24.05 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Sleep at Baseline (n=380, 374) | 57.52 Scores on a scale | Standard Deviation 23.83 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Coping Change at Week 4 (n=368, 358) | 11.90 Scores on a scale | Standard Deviation 17.98 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Social at Baseline (n=380, 374) | 81.02 Scores on a scale | Standard Deviation 20.43 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Coping Change at Week 8 (n=348, 329) | 14.98 Scores on a scale | Standard Deviation 20.48 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Sleep Change at Week 4 (n=368, 358) | 9.07 Scores on a scale | Standard Deviation 18.61 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Coping Change at Week 12 (n=365, 358) | 15.65 Scores on a scale | Standard Deviation 21.52 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Social Change at Week 24 | NA Scores on a scale | — |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Coping Change at Week 24 | NA Scores on a scale | — |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Sleep Change at Week 8 (n=348, 329) | 10.87 Scores on a scale | Standard Deviation 20.07 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Concern at Baseline (n=380, 374) | 64.67 Scores on a scale | Standard Deviation 22.47 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Social Change at Week 4 (n=368, 355) | 6.25 Scores on a scale | Standard Deviation 14.27 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Concern Change at Week 4 (n=368, 358) | 11.88 Scores on a scale | Standard Deviation 18.2 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Sleep Change at Week 12 (n=365, 358) | 11.99 Scores on a scale | Standard Deviation 21.33 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Concern Change at Week 8 (n=348, 329) | 15.39 Scores on a scale | Standard Deviation 19.77 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Social Change at Week 12 (n=364, 357) | 7.02 Scores on a scale | Standard Deviation 17.4 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Concern Change at Week 12 (n=365, 358) | 15.48 Scores on a scale | Standard Deviation 20.23 |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Sleep Change at Week 24 | NA Scores on a scale | — |
| Fesoterodine | Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 | Concern Change at Week 24 | NA Scores on a scale | — |
Comparison: Coping Subscale at Week 12; LOCFp-value: 0.000295% CI: [2.57, 8.22]ANCOVA
Comparison: Concern Subscale at Week 12; LOCFp-value: <0.000195% CI: [2.84, 7.93]ANCOVA
Comparison: Sleep Subscale at Week 12; LOCFp-value: 0.003295% CI: [1.38, 6.81]ANCOVA
Comparison: Social Subscale at Week 12; LOCFp-value: 0.015295% CI: [0.49, 4.53]ANCOVA
Secondary
Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24
OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = baseline minus observation and higher scores were an improvement.
Time frame: Baseline and Weeks 4, 8, 12, and 24
Population: FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 | Change at Week 4 (n=369, 358) | -9.03 Scores on a scale | Standard Deviation 17.74 |
| Placebo | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 | Change at Week 12 (n=366, 357) | -12.16 Scores on a scale | Standard Deviation 20.19 |
| Placebo | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 | Change at Week 8 (n=349, 328) | -12.86 Scores on a scale | Standard Deviation 18.95 |
| Placebo | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 | Change at Week 24 | NA Scores on a scale | — |
| Placebo | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 | Baseline (n=381, 373) | 52.90 Scores on a scale | Standard Deviation 18.75 |
| Fesoterodine | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 | Change at Week 24 | NA Scores on a scale | — |
| Fesoterodine | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 | Baseline (n=381, 373) | 50.58 Scores on a scale | Standard Deviation 19.35 |
| Fesoterodine | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 | Change at Week 4 (n=369, 358) | -14.05 Scores on a scale | Standard Deviation 18.37 |
| Fesoterodine | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 | Change at Week 8 (n=349, 328) | -18.03 Scores on a scale | Standard Deviation 19.25 |
| Fesoterodine | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 | Change at Week 12 (n=366, 357) | -18.37 Scores on a scale | Standard Deviation 21.38 |
Comparison: Week 12 LOCFp-value: <0.000195% CI: [-9.65, -4.59]ANCOVA
Secondary
Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24
OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = observation minus baseline and higher scores were an improvement.
Time frame: Baseline and Weeks 4, 8, 12, and 24
Population: FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 | Change at Week 24 | NA Scores on a scale | — |
| Placebo | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 | Baseline (n=373, 379) | 62.45 Scores on a scale | Standard Deviation 20.2 |
| Placebo | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 | Change at Week 4 (n=367, 354) | 7.28 Scores on a scale | Standard Deviation 15.48 |
| Placebo | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 | Change at Week 8 (n=348, 328) | 9.36 Scores on a scale | Standard Deviation 17.98 |
| Placebo | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 | Change at Week 12 (n=363, 357) | 9.56 Scores on a scale | Standard Deviation 18.75 |
| Fesoterodine | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 | Change at Week 12 (n=363, 357) | 13.19 Scores on a scale | Standard Deviation 17.49 |
| Fesoterodine | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 | Change at Week 8 (n=348, 328) | 12.96 Scores on a scale | Standard Deviation 16.76 |
| Fesoterodine | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 | Baseline (n=373, 379) | 64.42 Scores on a scale | Standard Deviation 19.82 |
| Fesoterodine | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 | Change at Week 24 | NA Scores on a scale | — |
| Fesoterodine | Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 | Change at Week 4 (n=367, 354) | 10.24 Scores on a scale | Standard Deviation 14.92 |
Comparison: Week 12 LOCFp-value: <0.000195% CI: [2.24, 6.73]ANCOVA
Secondary
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4
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 and Week 4
Population: FAS; N=participants with evaluable data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 | Improvement | 168 Participants |
| Placebo | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 | No Change | 202 Participants |
| Placebo | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 | Deterioration | 40 Participants |
| Fesoterodine | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 | Improvement | 192 Participants |
| Fesoterodine | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 | No Change | 168 Participants |
| Fesoterodine | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 | Deterioration | 16 Participants |
Secondary
Change From Baseline in PPBC at Week 12
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 \<0).
Time frame: Baseline and Week 12
Population: FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in PPBC at Week 12 | Improvement | 204 Participants |
| Placebo | Change From Baseline in PPBC at Week 12 | No Change | 164 Participants |
| Placebo | Change From Baseline in PPBC at Week 12 | Deterioration | 33 Participants |
| Fesoterodine | Change From Baseline in PPBC at Week 12 | Improvement | 256 Participants |
| Fesoterodine | Change From Baseline in PPBC at Week 12 | No Change | 104 Participants |
| Fesoterodine | Change From Baseline in PPBC at Week 12 | Deterioration | 17 Participants |
Comparison: Week 12 LOCFp-value: <0.000195% CI: [1.767, 3.556]Regression, Logistic
Secondary
Change From Baseline in PPBC at Week 24
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 \<0).
Time frame: Baseline and Week 24
Population: Not analyzed
Secondary
Change From Baseline in PPBC at Week 8
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 \<0).
Time frame: Baseline and Week 8
Population: FAS; N=participants with evaluable data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in PPBC at Week 8 | Improvement | 185 Participants |
| Placebo | Change From Baseline in PPBC at Week 8 | No Change | 166 Participants |
| Placebo | Change From Baseline in PPBC at Week 8 | Deterioration | 22 Participants |
| Fesoterodine | Change From Baseline in PPBC at Week 8 | Improvement | 210 Participants |
| Fesoterodine | Change From Baseline in PPBC at Week 8 | No Change | 119 Participants |
| Fesoterodine | Change From Baseline in PPBC at Week 8 | Deterioration | 13 Participants |
Secondary
Change From Baseline in PPUS at Week 12
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. Scale 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. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.
Time frame: Baseline and Week 12
Population: FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in PPUS at Week 12 | Improvement | 109 Participants |
| Placebo | Change From Baseline in PPUS at Week 12 | No Change | 226 Participants |
| Placebo | Change From Baseline in PPUS at Week 12 | Deterioration | 32 Participants |
| Fesoterodine | Change From Baseline in PPUS at Week 12 | Improvement | 133 Participants |
| Fesoterodine | Change From Baseline in PPUS at Week 12 | No Change | 200 Participants |
| Fesoterodine | Change From Baseline in PPUS at Week 12 | Deterioration | 28 Participants |
Comparison: LOCFp-value: 0.000995% CI: [1.305, 2.811]Regression, Logistic
Secondary
Change From Baseline in PPUS at Week 24
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. Scale 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. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.
Time frame: Baseline and Week 24
Population: Not analyzed
Secondary
Change From Baseline in PPUS at Week 8
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. Scale 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. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.
Time frame: Baseline and Week 8
Population: FAS; N=participants with evaluable data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in PPUS at Week 8 | Improvement | 95 Participants |
| Placebo | Change From Baseline in PPUS at Week 8 | No Change | 224 Participants |
| Placebo | Change From Baseline in PPUS at Week 8 | Deterioration | 32 Participants |
| Fesoterodine | Change From Baseline in PPUS at Week 8 | Improvement | 111 Participants |
| Fesoterodine | Change From Baseline in PPUS at Week 8 | No Change | 194 Participants |
| Fesoterodine | Change From Baseline in PPUS at Week 8 | Deterioration | 25 Participants |
Secondary
Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4
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. Scale 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. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.
Time frame: Baseline and Weeks 4
Population: FAS; N=participants with evaluable data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4 | Improvement | 74 Participants |
| Placebo | Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4 | No Change | 263 Participants |
| Placebo | Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4 | Deterioration | 33 Participants |
| Fesoterodine | Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4 | Improvement | 90 Participants |
| Fesoterodine | Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4 | No Change | 250 Participants |
| Fesoterodine | Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4 | Deterioration | 21 Participants |
Secondary
Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24
OAB-S: evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Medication expectation coded on scale 1=Greatly exceeds my expectations to 5=Does not meet my expectations at all. Coding reversed by subtracting initial response value from 6, so higher final response value associated with better fulfilment of OAB medication expectations.
Time frame: Weeks 12 and 24
Population: FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24 | Week 12 | 2.21 Scores on a scale | Standard Deviation 1.07 |
| Placebo | Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24 | Change at Week 24 | 0.74 Scores on a scale | Standard Deviation 1.22 |
| Fesoterodine | Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24 | Week 12 | 2.85 Scores on a scale | Standard Deviation 1.1 |
| Fesoterodine | Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24 | Change at Week 24 | 0.17 Scores on a scale | Standard Deviation 1.04 |
Comparison: LOCFp-value: <0.000195% CI: [2.045, 4.058]Regression, Logistic
Secondary
Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24
OAB-S: validated self-administered instrument that evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication and included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1-5: (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Change = score at Week 24 minus score at Week 12 where higher scores indicated better satisfaction.
Time frame: Weeks 12 and 24
Population: FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24 | Week 12 | 44.97 Scores on a scale | Standard Deviation 28.42 |
| Placebo | Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24 | Change at Week 24 | 21.22 Scores on a scale | Standard Deviation 28.47 |
| Fesoterodine | Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24 | Week 12 | 63.01 Scores on a scale | Standard Deviation 24.16 |
| Fesoterodine | Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24 | Change at Week 24 | 3.58 Scores on a scale | Standard Deviation 20.27 |
Comparison: LOCFp-value: <0.00195% CI: [2.281, 5.484]Regression, Logistic
Secondary
Percentage of Participants Who Were Incontinent at Baseline and Became Dry
Percentage of participants who had at least 1 UUI episode during baseline period and were dry (no UUI episodes) in the 3 days prior to study visits at week 8 and 12. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.
Time frame: Weeks 8 to 12
Population: FAS; N=number of participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Were Incontinent at Baseline and Became Dry | 45.0 Percentage of participants |
| Fesoterodine | Percentage of Participants Who Were Incontinent at Baseline and Became Dry | 53.2 Percentage of participants |
Comparison: LOCFp-value: 0.111395% CI: [0.909, 2.528]Regression, Logistic
Secondary
Percentage of Participants With Improvement at Week 12
Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment. Improvement was defined as a rating of 1 or 2.
Time frame: Week 12
Population: FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Improvement at Week 12 | 42.9 Percentage of participants |
| Fesoterodine | Percentage of Participants With Improvement at Week 12 | 67.7 Percentage of participants |
Comparison: Week 12 LOCFp-value: <0.000195% CI: [2.181, 4.395]Regression, Logistic
Secondary
Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12
Micturition-related urgency episodes per 24 hours defined as those with USS Scale rating of \>=3 marked for corresponding micturition in diary. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine. Percent change calculated as: 100\* (Urgency Episode at Week x - baseline)/baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.
Time frame: Baseline and Weeks 4, 8, and 12
Population: FAS;N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=365, 356) | 6.7 Percent change |
| Placebo | Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | 5.7 Percent change |
| Placebo | Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=356, 338) | 5.3 Percent change |
| Fesoterodine | Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=365, 356) | 5.3 Percent change |
| Fesoterodine | Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | 4.3 Percent change |
| Fesoterodine | Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=356, 338) | 3.7 Percent change |
Comparison: Week 12 LOCFp-value: <0.000195% CI: [-14.67, -14.25]2-sided Van Elteren's test
Secondary
Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12
Micturitions included episodes of voluntary micturition and episodes of UUI. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.
Time frame: Baseline and Weeks 4, 8, and 12
Population: FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=366, 356) | -0.7 Percent change |
| Placebo | Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -1.0 Percent change |
| Placebo | Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=359, 338) | -1.3 Percent change |
| Fesoterodine | Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=366, 356) | -1.3 Percent change |
| Fesoterodine | Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -1.7 Percent change |
| Fesoterodine | Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=359, 338) | -2.0 Percent change |
Comparison: Week 12 LOCFp-value: <0.000195% CI: [-7.4, -7.19]2-sided Van Elteren's test
Secondary
Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12
Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and 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. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.
Time frame: Baseline and Weeks 4, 8, and 12
Population: FAS; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=366, 356) | -0.3 Percent change |
| Placebo | Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -0.3 Percent change |
| Placebo | Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=359, 338) | -0.3 Percent change |
| Fesoterodine | Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=366, 356) | -0.3 Percent change |
| Fesoterodine | Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -0.7 Percent change |
| Fesoterodine | Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=359, 338) | -0.7 Percent change |
Comparison: Week 12 LOCFp-value: 0.001295% CI: [-9.52, -9.09]2-sided Van Elteren's test
Secondary
Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12
Severe micturition-related urgency episodes defined as those with USS rating \>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency.
Time frame: Baseline and Weeks 4, 8, and 12
Population: FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=365, 356) | -0.7 Percent change |
| Placebo | Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -1.0 Percent change |
| Placebo | Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=356, 338) | -1.3 Percent change |
| Fesoterodine | Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=365, 356) | -1.3 Percent change |
| Fesoterodine | Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | -1.7 Percent change |
| Fesoterodine | Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=356, 338) | -2.0 Percent change |
Comparison: Week 12 LOCFp-value: 0.000595% CI: [0, 0]2-sided Van Elteren's test
Secondary
Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12
UUI episodes defined as those with the USS rating of 5 (unable to hold; leak urine)in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.
Time frame: Baseline and Weeks 4, 8, and 12
Population: FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=365, 356) | 0.0 Percent change |
| Placebo | Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | 0.0 Percent change |
| Placebo | Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=356, 338) | 0.0 Percent change |
| Fesoterodine | Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 4 (n=365, 356) | 0.0 Percent change |
| Fesoterodine | Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 8 (n=349, 331) | 0.0 Percent change |
| Fesoterodine | Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12 | Change at Week 12 (n=356, 338) | 0.0 Percent change |
Comparison: Week 12 LOCFp-value: 0.021895% CI: [0, 0]2-sided Van Elteren's test
Other Pre-specified
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 24
Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary in participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.
Time frame: Baseline and Week 24
Population: FAS; N=participants with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 24 | -2.28 Micturitions per 24 hours | Standard Deviation 2.89 |
| Fesoterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 24 | -2.36 Micturitions per 24 hours | Standard Deviation 2.57 |
Other Pre-specified
Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24
Severe micturition-related urgency episodes defined as those with the USS rating \>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.
Time frame: Baseline and Week 24
Population: FAS; N=participants with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24 | -2.57 Episodes per 24 hours | Standard Deviation 4.37 |
| Fesoterodine | Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24 | -2.41 Episodes per 24 hours | Standard Deviation 3.3 |
Other Pre-specified
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24
UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.
Time frame: Baseline and Week 24
Population: FAS; N=participants with evaluable data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24 | 0.0 Episodes per 24 hours |
| Fesoterodine | Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24 | 0.0 Episodes per 24 hours |
Other Pre-specified
Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24
Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of \>=3 divided by number of days that diary data was collected at that visit. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.
Time frame: Baseline and Week 24
Population: FAS; N=participants with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24 | -4.24 Episodes per 24 hours | Standard Deviation 4.62 |
| Fesoterodine | Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24 | -4.07 Episodes per 24 hours | Standard Deviation 4.23 |
Other Pre-specified
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 24
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. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.
Time frame: Baseline and Week 24
Population: FAS; N=participants with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 24 | -0.60 Micturitions per 24 hours | Standard Deviation 1.24 |
| Fesoterodine | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 24 | -0.67 Micturitions per 24 hours | Standard Deviation 1.18 |
Other Pre-specified
Percentage of Participants With Improvement at Week 24
Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment. Treatment Response was set to Yes if the first 2 categories (1 or 2) of the scale selected and No if the last 2 categories (3 or 4) were selected. Improvement was defined as a rating of 1 or 2.
Time frame: Pre-baseline and Week 24
Population: Not analyzed