Overactive Bladder Syndrome
Conditions
Brief summary
To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.
Interventions
DRUGFesoterodine
Fesoterodine 4mg or 8mg
DRUGPlacebo
Placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men aged 40 years and above. * On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1). * Persistent symptoms of OAB with urinary frequency \>=8 times/24 hours and micturition-related urgency episodes \>=3 episode/24 hours.
Exclusion criteria
* Contraindication to fesoterodine (antimuscarinics). * Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline. * Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | Baseline, Week 12 | The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale \>= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | Micturition-related urgency episodes per 24 hours were defined as those with USS Scale rating of \>= 3 marked for the corresponding micturition in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100\* (Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline |
| Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Numeric change of micturitions per 24 hours at Week 4 and 12 relative to Baseline. |
| Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100\* (Micturitions at Week 4 or 12 - Baseline)/Baseline |
| Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. |
| Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100\* (Nocturnal micturitions at Week 4 or 12 - Baseline)/Baseline |
| Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and Week 12 | UUI episodes were defined as those micturitions with USS rating of 5 in the diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine. |
| Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | UUI episodes are defined as those micturitions with a USS rating of 5 in the bladder diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100\* (UUI Episodes at Week 4 or 12 - Baseline)/Baseline |
| Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | Severe micturition related urgency episodes were defined as those micturitions with USS rating \>=4 marked for the corresponding micturition in the diary. USS: 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. |
| Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | Severe micturition-related urgency episodes are defined as those with a USS rating ≥4 marked for the corresponding micturition in the bladder diary. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100\* (Severe Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline |
| Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject 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. |
| Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100\* (Nocturnal Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline |
| Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | The USS sum rating was defined as the total of USS ratings recorded for all micturitions over the course of a day in the bladder diary. 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. USS Sum rating per 24 hours was calculated as the mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. |
| Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. |
| Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q2, Q4, and Q7 range = 0-15 points. |
| Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q1, Q3, Q5, and Q6 range = 0-20 points. |
| Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Score of Q8 range = 0-5 points. |
| Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 | Baseline, Week 4 | The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale \>= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. |
| Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Baseline, Week 12 | The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. |
| Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 | Baseline, Week 4 | PPBC: self-administered, single-item, validated questionnaire. Rated on a 6-point scale: subject was asked: Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2. |
| Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 | Baseline, Week 12 | PPBC: self-administered, single-item, validated questionnaire. Rated on a 6-point scale: subject was asked: Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2. |
| Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4 | Baseline, Week 4 | Number of participants in 3-point category: improvement \[\>=1-point improvement\]; no change; deterioration \[\>=1-point decrease\], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables. |
| Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12. | Baseline, Week 12 | Number of participants in 3-point category: improvement \[\>=1-point improvement\]; no change; deterioration \[\>=1-point decrease\], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables. |
| Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | OAB-q is a self-administered, 33-item, validated questionnaire that assesses how much the subject has been bothered by selected bladder symptoms during the previous week. Each item rated by subject on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0-100. Once transformed, higher scores represent less favorable outcome. |
| Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 | Baseline, Week 4 and 12 | HRQL domain and total raw score derived as sum of scores (6-point scale: 1 = not at all/none of the time; 6 = a very great deal/all of the time). Transformed score range 0 to 100 (Total HRQL or domain)=\[(Highest possible raw score-Actual total raw score)/Raw score range\]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline. |
| Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain) | Baseline, Week 4 and 12 | The HRQL concern domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = \[(Highest possible score - Actual raw score)/ Range\]\*100, where range was the raw score range. Positive change in HRQL Score indicates improvement. |
| Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain) | Baseline, Week 4 and Week 12 | The HRQL coping domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = \[(Highest possible score - Actual raw score)/ Range\]\*100, where range was the raw score range. Positive change in HRQL Score indicates improvement. |
| Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain) | Baseline, Week 4 and Week 12 | The HRQL sleep domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = \[(Highest possible score - Actual raw score)/ Range\]\*100, where range was the raw score range. Positive change in HRQL Score indicates improvement. |
| Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain) | Baseline, Week 4 and Week 12 | The HRQL social interaction domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = \[(Highest possible score - Actual raw score)/ Range\]\*100, where range was the raw score range. Positive change in HRQL Score indicates improvement. |
| Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12 | Baseline, Week 4, 8 and 12 | Post-void residual volume measurement was measured by an ultrasound at Baseline, and at Weeks 4, 8 and 12. |
| Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12 | Baseline, Week 12 | Maximum urinary flow rate (Qmax) was recorded at Baseline and Week 12 visit. |
| Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities) | Baseline, Week 12 | Number of participants experiencing serious and non-serious adverse events of acute urinary retention requiring catheterization. |
| Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Baseline, Week 12 | Number of participants experiencing serious and non-serious adverse events related to increased voiding difficulty (ie, Dysuria, Urinary retention regardless of catheterization, Urine flow decreased, Residual urine volume, Residual urine volume increased, Residual urine, and Urinary hesitation) |
| Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Baseline, Week 4 | The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. |
Countries
Belgium, Brazil, Canada, Colombia, Germany, Greece, India, Malaysia, Netherlands, Norway, Philippines, Poland, Singapore, Slovakia, South Korea, Spain, Sweden, Thailand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fesoterodine 4mg or 8mg Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | 471 |
| Placebo Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. | 472 |
| Total | 943 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 46 | 20 |
| Overall Study | Lack of Efficacy | 5 | 5 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Other | 10 | 12 |
| Overall Study | Randomized, but not treated | 3 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 9 |
Baseline characteristics
| Characteristic | Fesoterodine 4mg or 8mg | Placebo | Total |
|---|---|---|---|
| Age, Customized 18 - 44 years | 7 participants | 9 participants | 16 participants |
| Age, Customized 45- 64 years | 211 participants | 189 participants | 400 participants |
| Age, Customized >=65 years | 253 participants | 274 participants | 527 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 471 Participants | 472 Participants | 943 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 176 / 471 | 72 / 472 |
| serious Total, serious adverse events | 11 / 471 | 11 / 472 |
Outcome results
Primary
Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale \>= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time frame: Baseline, Week 12
Population: The full analysis set (FAS) included all subjects who took at least one dose of assigned study drug and had at least one baseline or post-baseline efficacy assessment. Only FAS subjects with non-zero micturition-related urgency episodes at Baseline and non-missing change from Baseline to Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | -3.2 number of episodes | Standard Error 0.2 |
| Placebo | Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | -2.9 number of episodes | Standard Error 0.2 |
Comparison: The null hypothesis was that the mean change from Baseline in 24-hour micturition-related urgency was the same at Week 12 for the two treatment groups: fesoterodine + alpha-blocker vs. placebo + alpha-blocker. It was estimated that 900 randomized subjects would have 85% power to detect a mean difference of -0.93(SD = 4.15) between the 2 treatments on the primary endpoint,mean reduction of micturition-related urgency episodes/24hr from Baseline to Week 12,assuming a 10% non-evaluability rate.p-value: 0.195995% CI: [-0.9, 0.2]ANCOVA
Secondary
Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12
The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12 | Week 4 (n=453, n=454) | -3.4 scores on a scale | Standard Error 0.3 |
| Fesoterodine 4mg or 8mg | Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12 | Week 12 (n=454, n=456) | -4.4 scores on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12 | Week 4 (n=453, n=454) | -3.1 scores on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12 | Week 12 (n=454, n=456) | -4.4 scores on a scale | Standard Error 0.3 |
Comparison: Week 4p-value: 0.357995% CI: [-1, 0.4]ANCOVA
Comparison: Week 12p-value: 0.927495% CI: [-0.8, 0.7]ANCOVA
Secondary
Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12
The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Time frame: Baseline, Week 12
Population: FAS subjects with non-missing change from Baseline to Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q1 (sensation of not emptying bladder?) | -0.7 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q2 (urinate less than two hours after urination?) | -0.9 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q3 (stop and start several times during urination? | -0.5 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q4 (difficulty postponing urination?) | -0.9 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q5 (weak urinary stream?) | -0.6 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q6 (strain to begin urination?) | -0.3 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q7 (urinate at night?) | -0.5 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q4 (difficulty postponing urination?) | -0.8 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q1 (sensation of not emptying bladder?) | -0.8 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q7 (urinate at night?) | -0.6 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q2 (urinate less than two hours after urination?) | -0.8 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q5 (weak urinary stream?) | -0.6 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q3 (stop and start several times during urination? | -0.6 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | Q6 (strain to begin urination?) | -0.3 scores on scale | Standard Error 0.1 |
Comparison: Week 12 Q1p-value: 0.159595% CI: [0, 0.3]ANCOVA
Comparison: Week 12 Q2p-value: 0.061495% CI: [-0.3, 0]ANCOVA
Comparison: Week 12 Q3p-value: 0.203295% CI: [-0.1, 0.3]ANCOVA
Comparison: Week 12 Q4p-value: 0.063195% CI: [-0.3, 0]ANCOVA
Comparison: Week 12 Q5p-value: 0.970695% CI: [-0.2, 0.2]ANCOVA
Comparison: Week 12 Q6p-value: 0.805895% CI: [-0.1, 0.2]ANCOVA
Comparison: Week 12 Q7p-value: 0.330295% CI: [-0.1, 0.2]ANCOVA
Secondary
Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4
The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Time frame: Baseline, Week 4
Population: FAS subjects with non-missing change from Baseline to Week 4 were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q3 (stop and start several times during urination? | -0.4 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q5 (weak urinary stream?) | -0.5 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q2 (urinate less than two hours after urination?) | -0.8 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q6 (strain to begin urination?) | -0.2 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q4 (difficulty postponing urination?) | -0.7 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q7 (urinate at night?) | -0.3 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q1 (sensation of not emptying bladder?) | -0.6 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q7 (urinate at night?) | -0.3 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q1 (sensation of not emptying bladder?) | -0.6 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q2 (urinate less than two hours after urination?) | -0.5 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q3 (stop and start several times during urination? | -0.4 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q4 (difficulty postponing urination?) | -0.6 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q5 (weak urinary stream?) | -0.4 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | Q6 (strain to begin urination?) | -0.3 scores on scale | Standard Error 0.1 |
Comparison: Week 4 Q1p-value: 0.662195% CI: [-0.1, 0.2]ANCOVA
Comparison: Week 4 Q2p-value: <0.000195% CI: [-0.5, -0.2]ANCOVA
Comparison: Week 4 Q3p-value: 0.324295% CI: [-0.1, 0.2]ANCOVA
Comparison: Week 4 Q4p-value: 0.160495% CI: [-0.3, 0]ANCOVA
Comparison: Week 4 Q5p-value: 0.410295% CI: [-0.2, 0.1]ANCOVA
Comparison: Week 4 Q6p-value: 0.307995% CI: [-0.1, 0.2]ANCOVA
Comparison: Week 4 Q7p-value: 0.406695% CI: [-0.1, 0.2]ANCOVA
Secondary
Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12
The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Score of Q8 range = 0-5 points.
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12 | Week 4 (n=455, n=455) | -0.6 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12 | Week 12 (n=455, 457) | -1.0 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12 | Week 4 (n=455, n=455) | -0.5 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12 | Week 12 (n=455, 457) | -1.0 scores on scale | Standard Error 0.1 |
Comparison: Week 4p-value: 0.147295% CI: [-0.2, 0]ANCOVA
Comparison: Week 12p-value: 0.583995% CI: [-0.2, 0.1]ANCOVA
Secondary
Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12
The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q2, Q4, and Q7 range = 0-15 points.
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12 | Week 4 (n=456, n=457) | -1.8 scores on scale | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12 | Week 12 (n=456, n=458) | -2.4 scores on scale | Standard Error 0.2 |
| Placebo | Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12 | Week 4 (n=456, n=457) | -1.4 scores on scale | Standard Error 0.1 |
| Placebo | Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12 | Week 12 (n=456, n=458) | -2.1 scores on scale | Standard Error 0.2 |
Comparison: Week 4p-value: 0.022395% CI: [-0.7, -0.1]ANCOVA
Comparison: Week 12p-value: 0.174495% CI: [-0.6, 0.1]ANCOVA
Secondary
Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12
The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q1, Q3, Q5, and Q6 range = 0-20 points.
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12 | Week 4 (n=454, n=455) | -1.6 scores on scale | Standard Error 0.2 |
| Fesoterodine 4mg or 8mg | Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12 | Week 12 (n=455, n=457) | -2.1 scores on scale | Standard Error 0.2 |
| Placebo | Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12 | Week 4 (n=454, n=455) | -1.7 scores on scale | Standard Error 0.2 |
| Placebo | Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12 | Week 12 (n=455, n=457) | -2.3 scores on scale | Standard Error 0.2 |
Comparison: Week 4p-value: 0.756495% CI: [-0.4, 0.5]ANCOVA
Comparison: Week 12p-value: 0.40195% CI: [-0.3, 0.7]ANCOVA
Secondary
Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12
Maximum urinary flow rate (Qmax) was recorded at Baseline and Week 12 visit.
Time frame: Baseline, Week 12
Population: The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12 | 0.0 ml/sec |
| Placebo | Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12 | 0.0 ml/sec |
p-value: 0.2251Van Elteren's Test
Secondary
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12
OAB-q is a self-administered, 33-item, validated questionnaire that assesses how much the subject has been bothered by selected bladder symptoms during the previous week. Each item rated by subject on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0-100. Once transformed, higher scores represent less favorable outcome.
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12 | Week 12 (n=459, n=459) | -15.2 scores on scale | Standard Error 0.9 |
| Fesoterodine 4mg or 8mg | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12 | Week 4 (n=459, n=458) | -11.6 scores on scale | Standard Error 0.8 |
| Placebo | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12 | Week 12 (n=459, n=459) | -12.4 scores on scale | Standard Error 0.9 |
| Placebo | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12 | Week 4 (n=459, n=458) | -8.9 scores on scale | Standard Error 0.8 |
Comparison: Week 4p-value: 0.00495% CI: [-4.5, -0.9]ANCOVA
Comparison: Week 12p-value: 0.006895% CI: [-4.8, -0.8]ANCOVA
Secondary
Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12
Post-void residual volume measurement was measured by an ultrasound at Baseline, and at Weeks 4, 8 and 12.
Time frame: Baseline, Week 4, 8 and 12
Population: The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 4, Week 8 (LOCF), or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12 | Week 4 | 0.0 ml |
| Fesoterodine 4mg or 8mg | Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12 | Week 8 | 0.0 ml |
| Fesoterodine 4mg or 8mg | Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12 | Week 12 | 3.5 ml |
| Placebo | Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12 | Week 4 | 0.0 ml |
| Placebo | Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12 | Week 12 | 0.0 ml |
| Placebo | Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12 | Week 8 | 0.0 ml |
Comparison: Week 4p-value: 0.0005Van Elteren's Test
Comparison: Week 8p-value: <0.0001Van Elteren's Test
Comparison: Week 12p-value: 0.0003Van Elteren's Test
Secondary
Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain)
The HRQL concern domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = \[(Highest possible score - Actual raw score)/ Range\]\*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain) | Week 4 (n=459, n=458) | 9.7 scores on scale | Standard Error 0.9 |
| Fesoterodine 4mg or 8mg | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain) | Week 12 (n=459, n=459) | 12.4 scores on scale | Standard Error 0.9 |
| Placebo | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain) | Week 4 (n=459, n=458) | 8.0 scores on scale | Standard Error 0.9 |
| Placebo | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain) | Week 12 (n=459, n=459) | 11.1 scores on scale | Standard Error 0.9 |
Comparison: Week 4p-value: 0.094195% CI: [-0.3, 3.8]ANCOVA
Comparison: Week 12p-value: 0.227395% CI: [-0.8, 3.4]ANCOVA
Secondary
Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain)
The HRQL coping domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = \[(Highest possible score - Actual raw score)/ Range\]\*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.
Time frame: Baseline, Week 4 and Week 12
Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain) | Week 4 (n=459, n=458) | 9.6 scores on a scale | Standard Error 0.9 |
| Fesoterodine 4mg or 8mg | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain) | Week 12 (n=459, n=459) | 12.5 scores on a scale | Standard Error 1 |
| Placebo | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain) | Week 12 (n=459, n=459) | 10.6 scores on a scale | Standard Error 1 |
| Placebo | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain) | Week 4 (n=459, n=458) | 7.5 scores on a scale | Standard Error 0.9 |
Comparison: Week 4p-value: 0.050795% CI: [0, 4.3]ANCOVA
Comparison: Week 12p-value: 0.113695% CI: [-0.4, 4.1]ANCOVA
Secondary
Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain)
The HRQL sleep domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = \[(Highest possible score - Actual raw score)/ Range\]\*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.
Time frame: Baseline, Week 4 and Week 12
Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain) | Week 4 (n=459, n=458) | 9.6 scores on a scale | Standard Error 1 |
| Fesoterodine 4mg or 8mg | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain) | Week 12 (n=459, n=459) | 13.8 scores on a scale | Standard Error 1 |
| Placebo | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain) | Week 4 (n=459, n=458) | 7.6 scores on a scale | Standard Error 1 |
| Placebo | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain) | Week 12 (n=459, n=459) | 11.5 scores on a scale | Standard Error 1.1 |
Comparison: Week 4p-value: 0.084595% CI: [-0.3, 4.1]ANCOVA
Comparison: Week 12p-value: 0.066295% CI: [-0.2, 4.6]ANCOVA
Secondary
Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain)
The HRQL social interaction domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = \[(Highest possible score - Actual raw score)/ Range\]\*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.
Time frame: Baseline, Week 4 and Week 12
Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain) | Week 4 (n=459, n=458) | 5.2 scores on a scale | Standard Error 0.8 |
| Fesoterodine 4mg or 8mg | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain) | Week 12 (n=459, n=459) | 6.3 scores on a scale | Standard Error 0.8 |
| Placebo | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain) | Week 4 (n=459, n=458) | 3.7 scores on a scale | Standard Error 0.8 |
| Placebo | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain) | Week 12 (n=459, n=459) | 6.0 scores on a scale | Standard Error 0.8 |
Comparison: Week 4p-value: 0.108595% CI: [-0.3, 3.2]ANCOVA
Comparison: Week 12p-value: 0.768595% CI: [-1.6, 2.1]ANCOVA
Secondary
Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12
HRQL domain and total raw score derived as sum of scores (6-point scale: 1 = not at all/none of the time; 6 = a very great deal/all of the time). Transformed score range 0 to 100 (Total HRQL or domain)=\[(Highest possible raw score-Actual total raw score)/Raw score range\]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 | Week 4 (n=459, n=458) | 8.7 scores on scale | Standard Error 0.8 |
| Fesoterodine 4mg or 8mg | Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 | Week 12 (n=459, n=459) | 11.5 scores on scale | Standard Error 0.8 |
| Placebo | Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 | Week 4 (n=459, n=458) | 6.9 scores on scale | Standard Error 0.8 |
| Placebo | Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 | Week 12 (n=459, n=459) | 10.0 scores on scale | Standard Error 0.9 |
Comparison: Week 4p-value: 0.041295% CI: [0.1, 3.6]ANCOVA
Comparison: Week 12p-value: 0.137395% CI: [-0.5, 3.4]ANCOVA
Secondary
Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities)
Number of participants experiencing serious and non-serious adverse events related to increased voiding difficulty (ie, Dysuria, Urinary retention regardless of catheterization, Urine flow decreased, Residual urine volume, Residual urine volume increased, Residual urine, and Urinary hesitation)
Time frame: Baseline, Week 12
Population: The safety analysis set included all subjects who took at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine 4mg or 8mg | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Residual urine volume | 1 participants |
| Fesoterodine 4mg or 8mg | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Residual urine | 1 participants |
| Fesoterodine 4mg or 8mg | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Urine flow decreased | 4 participants |
| Fesoterodine 4mg or 8mg | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Urinary hesitation | 0 participants |
| Fesoterodine 4mg or 8mg | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Residual urine volume increased | 1 participants |
| Fesoterodine 4mg or 8mg | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Urinary retention (Regardless of catheterization) | 11 participants |
| Fesoterodine 4mg or 8mg | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Dysuria | 16 participants |
| Placebo | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Urinary retention (Regardless of catheterization) | 2 participants |
| Placebo | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Dysuria | 4 participants |
| Placebo | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Urine flow decreased | 0 participants |
| Placebo | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Residual urine volume | 0 participants |
| Placebo | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Residual urine volume increased | 0 participants |
| Placebo | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Residual urine | 0 participants |
| Placebo | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Urinary hesitation | 2 participants |
Secondary
Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)
Number of participants experiencing serious and non-serious adverse events of acute urinary retention requiring catheterization.
Time frame: Baseline, Week 12
Population: The safety analysis set included all subjects who took at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fesoterodine 4mg or 8mg | Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities) | 1 participants |
| Placebo | Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities) | 1 participants |
Secondary
Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12.
Number of participants in 3-point category: improvement \[\>=1-point improvement\]; no change; deterioration \[\>=1-point decrease\], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.
Time frame: Baseline, Week 12
Population: FAS subjects with non-missing Baseline and Week 12 values (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12. | Improvement | 132 participants |
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12. | No Change | 290 participants |
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12. | Deterioration | 37 participants |
| Placebo | Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12. | Improvement | 129 participants |
| Placebo | Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12. | No Change | 299 participants |
| Placebo | Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12. | Deterioration | 31 participants |
p-value: 0.9402Cochran-Mantel-Haenszel
Secondary
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4
PPBC: self-administered, single-item, validated questionnaire. Rated on a 6-point scale: subject was asked: Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2.
Time frame: Baseline, Week 4
Population: FAS subjects with non-missing Baseline and Week 4 values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 | Major Improvement | 83 participants |
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 | Minor Improvement | 171 participants |
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 | No Change | 180 participants |
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 | Deterioration | 25 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 | Deterioration | 22 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 | Major Improvement | 63 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 | No Change | 212 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 | Minor Improvement | 160 participants |
p-value: 0.1136Cochran-Mantel-Haenszel
Secondary
Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12
PPBC: self-administered, single-item, validated questionnaire. Rated on a 6-point scale: subject was asked: Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2.
Time frame: Baseline, Week 12
Population: FAS subjects with non-missing Baseline and Week 12 values (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 | Deterioration | 21 participants |
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 | Minor Improvement | 166 participants |
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 | No Change | 148 participants |
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 | Major Improvement | 124 participants |
| Placebo | Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 | No Change | 170 participants |
| Placebo | Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 | Major Improvement | 130 participants |
| Placebo | Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 | Deterioration | 21 participants |
| Placebo | Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 | Minor Improvement | 138 participants |
p-value: 0.5775Cochran-Mantel-Haenszel
Secondary
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4
Number of participants in 3-point category: improvement \[\>=1-point improvement\]; no change; deterioration \[\>=1-point decrease\], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.
Time frame: Baseline, Week 4
Population: FAS subjects with non-missing Baseline and Week 4 values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4 | Improvement | 111 participants |
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4 | No Change | 306 participants |
| Fesoterodine 4mg or 8mg | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4 | Deterioration | 41 participants |
| Placebo | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4 | No Change | 326 participants |
| Placebo | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4 | Deterioration | 34 participants |
| Placebo | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4 | Improvement | 98 participants |
p-value: 0.7433Cochran-Mantel-Haenszel
Secondary
Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale \>= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time frame: Baseline, Week 4
Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 | -2.3 number of episodes | Standard Error 0.2 |
| Placebo | Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 | -1.9 number of episodes | Standard Error 0.2 |
p-value: 0.062195% CI: [-1, 0]ANCOVA
Secondary
Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12
All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Numeric change of micturitions per 24 hours at Week 4 and 12 relative to Baseline.
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Week 4 (n=445, n=451) | -1.3 number of micturitions | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Week 12 (n=446, n=452) | -1.9 number of micturitions | Standard Error 0.1 |
| Placebo | Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Week 4 (n=445, n=451) | -0.8 number of micturitions | Standard Error 0.1 |
| Placebo | Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Week 12 (n=446, n=452) | -1.5 number of micturitions | Standard Error 0.1 |
Comparison: Week 4p-value: 0.005695% CI: [-0.8, -0.1]ANCOVA
Comparison: Week 12p-value: 0.00995% CI: [-0.7, -0.1]ANCOVA
Secondary
Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12
Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject 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.
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n= 424, n=433) | -0.7 number of episodes | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=425, n=434) | -0.9 number of episodes | Standard Error 0.1 |
| Placebo | Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n= 424, n=433) | -0.6 number of episodes | Standard Error 0.1 |
| Placebo | Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=425, n=434) | -0.9 number of episodes | Standard Error 0.1 |
Comparison: Week 4p-value: 0.174895% CI: [-0.3, 0]ANCOVA
Comparison: Week 12p-value: 0.657295% CI: [-0.1, 0.2]ANCOVA
Secondary
Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12
Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Week 4 (n=438, n=441) | -0.4 number of micturitions | Standard Error 0.1 |
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Week 12 (n=439, n=442) | -0.6 number of micturitions | Standard Error 0.1 |
| Placebo | Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Week 4 (n=438, n=441) | -0.3 number of micturitions | Standard Error 1 |
| Placebo | Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Week 12 (n=439, n=442) | -0.5 number of micturitions | Standard Error 0.1 |
Comparison: Week 4p-value: 0.111295% CI: [-0.2, 0]ANCOVA
Comparison: Week 12p-value: 0.085595% CI: [-0.3, 0]ANCOVA
Secondary
Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12
Severe micturition related urgency episodes were defined as those micturitions with USS rating \>=4 marked for the corresponding micturition in the diary. USS: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n=310, n=339) | -1.0 number of episodes | Full Range 2.7 |
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=311, n=340) | -1.3 number of episodes | Full Range 3.1 |
| Placebo | Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n=310, n=339) | -1.0 number of episodes | Full Range 2.6 |
| Placebo | Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=311, n=340) | -1.0 number of episodes | Full Range 2.8 |
Comparison: Week 4p-value: 0.0062Van Elteren's Test
Comparison: Week 12p-value: 0.0825Van Elteren's Test
Secondary
Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
UUI episodes were defined as those micturitions with USS rating of 5 in the diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Time frame: Baseline, Week 4 and Week 12
Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n=103, n=104) | -0.3 number of episodes | Full Range 1.9 |
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=103, n=104) | -0.7 number of episodes | Full Range 2.3 |
| Placebo | Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n=103, n=104) | -0.7 number of episodes | Full Range 1.7 |
| Placebo | Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=103, n=104) | -0.7 number of episodes | Full Range 1.4 |
Comparison: Week 4p-value: 0.3847Van Elteren's Test
Comparison: Week 12p-value: 0.4449Van Elteren's Test
Secondary
Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12
The USS sum rating was defined as the total of USS ratings recorded for all micturitions over the course of a day in the bladder diary. 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. USS Sum rating per 24 hours was calculated as the mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit.
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-missing change from Baseline (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12 | Week 4 (n=445, n=451) | -6.4 USS Sum rating per 24 hours | Standard Error 0.5 |
| Fesoterodine 4mg or 8mg | Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12 | Week 12 (n=446, n=452) | -8.9 USS Sum rating per 24 hours | Standard Error 0.6 |
| Placebo | Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12 | Week 4 (n=445, n=451) | -4.7 USS Sum rating per 24 hours | Standard Error 0.5 |
| Placebo | Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12 | Week 12 (n=446, n=452) | -7.8 USS Sum rating per 24 hours | Standard Error 0.6 |
Comparison: Week 4p-value: 0.005195% CI: [-2.9, -0.5]ANCOVA
Comparison: Week 12p-value: 0.123195% CI: [-2.3, 0.3]ANCOVA
Secondary
Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12
Micturition-related urgency episodes per 24 hours were defined as those with USS Scale rating of \>= 3 marked for the corresponding micturition in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100\* (Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n=445, 450) | -30.8 percent change | Full Range 56.9 |
| Fesoterodine 4mg or 8mg | Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=446, n=451) | -43.8 percent change | Full Range 60.8 |
| Placebo | Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n=445, 450) | -20.7 percent change | Full Range 49.1 |
| Placebo | Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=446, n=451) | -35.7 percent change | Full Range 58 |
Secondary
Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12
All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100\* (Micturitions at Week 4 or 12 - Baseline)/Baseline
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Week 4 (n=445, n=451) | -12.0 percent change | Full Range 18.8 |
| Fesoterodine 4mg or 8mg | Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Week 12 (n=446, n=452) | -14.9 percent change | Full Range 19.3 |
| Placebo | Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Week 4 (n=445, n=451) | -7.3 percent change | Full Range 18.9 |
| Placebo | Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Week 12 (n=446, n=452) | -12.5 percent change | Full Range 19.2 |
Comparison: Week 4p-value: 0.0012Ranked ANCOVA
Comparison: Week 12p-value: 0.0027Ranked ANCOVA
Secondary
Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12
Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100\* (Nocturnal Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n=424, n=433) | -33.3 percent change | Full Range 87.1 |
| Fesoterodine 4mg or 8mg | Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=425, n=434) | -50.0 percent change | Full Range 104.2 |
| Placebo | Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n=424, n=433) | -25.0 percent change | Full Range 68.9 |
| Placebo | Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=425, n=434) | -40.0 percent change | Full Range 70.4 |
Secondary
Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12
Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100\* (Nocturnal micturitions at Week 4 or 12 - Baseline)/Baseline
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Week 4 (n=438, n=441) | -16.7 percent change | Full Range 60.4 |
| Fesoterodine 4mg or 8mg | Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Week 12 (n=439, n=442) | -25.0 percent change | Full Range 66.1 |
| Placebo | Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Week 4 (n=438, n=441) | -11.1 percent change | Full Range 44.8 |
| Placebo | Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Week 12 (n=439, n=442) | -16.7 percent change | Full Range 58.2 |
Secondary
Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12
Severe micturition-related urgency episodes are defined as those with a USS rating ≥4 marked for the corresponding micturition in the bladder diary. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100\* (Severe Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n=310, n=339) | -78.6 percent change | Full Range 79.4 |
| Fesoterodine 4mg or 8mg | Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=311, n=340) | -100.0 percent change | Full Range 100.7 |
| Placebo | Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n=310, n=339) | -60.0 percent change | Full Range 130.7 |
| Placebo | Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=311, n=340) | -88.4 percent change | Full Range 90.1 |
Comparison: Week 4p-value: 0.0025Ranked ANCOVA
Secondary
Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12
UUI episodes are defined as those micturitions with a USS rating of 5 in the bladder diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100\* (UUI Episodes at Week 4 or 12 - Baseline)/Baseline
Time frame: Baseline, Week 4 and 12
Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4mg or 8mg | Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n=103, n=104) | -100.0 percent change | Full Range 85.3 |
| Fesoterodine 4mg or 8mg | Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=103, n=104) | -100.0 percent change | Full Range 77.2 |
| Placebo | Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12 | Week 4 (n=103, n=104) | -100.0 percent change | Full Range 136.7 |
| Placebo | Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12 | Week 12 (n=103, n=104) | -100.0 percent change | Full Range 79 |