Overactive Bladder
Conditions
Brief summary
To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.
Interventions
12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary) * OAB patients dissatisfied with their prior therapy with tolterodine
Exclusion criteria
* Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients. * Patients with significant hepatic and renal disease or other significant unstable diseases. * OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Micturition Episodes Per 24 Hours | Baseline and Week 12 | The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit. |
| Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours | Baseline and Week 12 | The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine. |
| Mean Number of Urgency Episodes Per 24 Hours | Baseline and Week 12 | The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) \>= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine. |
| Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment | Week 12 | Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change) | Baseline and Week 12 | Improvement: negative score change; No change: score change=0; Deterioration: positive score change |
| Urgency Perception Scale (UPS) | Baseline and Week 12 | UPS scores range from 0 (I am usually not able to hold urine) to 2 (I am usually able to finish what I am doing before going to the toilet \[without leaking\]). |
| Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change) | Baseline and Week 12 | Improvement: positive score change; No improvement: zero or negative score change |
| Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain | Baseline and Week 12 | Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome. |
| Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain | Baseline and Week 12 | Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome. |
| Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain | Baseline and Week 12 | Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome. |
| Nocturnal Micturitions Per 24 Hours | Baseline and Week 12 | Nocturnal micturitions (synonymous with the term nighttime micturitions) were those recorded in the bedtime section of the bladder diary. |
| Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale | Baseline and Week 12 | Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome. |
| Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale | Baseline and Week 12 | Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent less favorable outcome. |
| Satisfaction With OAB Control Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S) | Week 12 | Module coded on scale (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically & results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Satisfied on TSQ = very or somewhat satisfied; Not satisfied on TSQ =very or somewhat dissatisfied or neither dissatisfied nor satisfied. |
| Sum Rating on the Urinary Sensation Scale | Baseline and Week 12 | The sum rating per 24 hours was calculated as the mean rating score on the Urinary Sensation Scale multiplied by the mean number of micturitions per 24 hours at that visit. The scale ranges from 1 no feeling of urgency to 5 unable to hold; leak urine. |
| Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis) | Week 12 | Number of participants who responded satisfied = (very satisfied or somewhat satisfied) or dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question at Week 12 in the safety set. |
| Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain | Baseline and Week 12 | Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome. |
| Severe Urgency Episodes Per 24 Hours | Baseline and Week 12 | Severe urgency episodes defined as Urinary Sensation Scale (USS) rating ≥4. Subjects rated the feeling of urgency associated with each micturition episode using USS provided in the bladder diary. Scale ranges from 1=no feeling of urgency to 5=unable to hold; leak urine; decrease indicates an improvement with respect to urgency symptoms. |
| Mean Rating on the Urinary Sensation Scale | Baseline and Week 12 | The mean rating was calculated as the sum of rating scores on the Urinary Sensation Scale divided by the total number of micturitions with non-missing rating at that visit. The scale ranges from 1 no feeling of urgency to 5 unable to hold; leak urine. |
| Patient Perception of Bladder Condition (PPBC) Score | Baseline and Week 12 | The PPBC score ranges from 1 no problems at all to 6 many severe problems. |
Countries
Belgium, Costa Rica, Czechia, Germany, Poland, Slovakia, South Korea, Ukraine, United States
Participant flow
Recruitment details
Subjects were enrolled at 59 centers (Belgium 5 centers, Costa Rica 2, Czech Republic 4, Germany 7, Republic of Korea 6, Poland 2, Slovakia 5, Ukraine 5, United States 23). Two centers in the United States did not randomize subjects.
Pre-assignment details
595 subjects were screened. Responses to a 5-day bladder diary (during a 2-week screening period) identified subjects who met all other entry criteria for enrollment for study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Open Label-fesoterodine All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study. | 516 |
| Total | 516 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 36 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Open Label-fesoterodine |
|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 13.6 |
| Sex: Female, Male Female | 398 Participants |
| Sex: Female, Male Male | 118 Participants |
Outcome results
Primary
Mean Number of Micturition Episodes Per 24 Hours
The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Mean Number of Micturition Episodes Per 24 Hours | 12.7 number of episodes | Standard Deviation 3.9 |
| Open Label Week 12 | Mean Number of Micturition Episodes Per 24 Hours | 9.7 number of episodes | Standard Deviation 3.4 |
Comparison: Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of micturition episodes per 24 hours at Week 12 is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.p-value: <0.000195% CI: [-3.2, -2.7]2-sided paired t-test
Primary
Mean Number of Urgency Episodes Per 24 Hours
The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) \>= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)).The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Mean Number of Urgency Episodes Per 24 Hours | 10.0 number of episodes | Standard Deviation 4.5 |
| Open Label Week 12 | Mean Number of Urgency Episodes Per 24 Hours | 5.0 number of episodes | Standard Deviation 4.7 |
Comparison: Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency episodes per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.p-value: <0.000195% CI: [-5.4, -4.5]2-sided paired t-test
Primary
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment. Restricted to subjects with UUI at baseline \>0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours | 2.3 number of episodes | Standard Deviation 2.8 |
| Open Label Week 12 | Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours | 0.6 number of episodes | Standard Deviation 1.3 |
Comparison: Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency urinary incontinence per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.p-value: <0.000195% CI: [-2, -1.4]2-sided paired t-test
Primary
Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment
Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.
Time frame: Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing value at Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Label Baseline | Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment | Satisfied (very satisfied or somewhat satisfied) | 378 participants |
| Open Label Baseline | Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment | Neither dissatisfied nor satisfied | 42 participants |
| Open Label Baseline | Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment | Dissatisfied (somewhat or very dissatisfied) | 54 participants |
Secondary
Mean Rating on the Urinary Sensation Scale
The mean rating was calculated as the sum of rating scores on the Urinary Sensation Scale divided by the total number of micturitions with non-missing rating at that visit. The scale ranges from 1 no feeling of urgency to 5 unable to hold; leak urine.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Mean Rating on the Urinary Sensation Scale | 3.2 scores on a scale | Standard Deviation 0.6 |
| Open Label Week 12 | Mean Rating on the Urinary Sensation Scale | 2.5 scores on a scale | Standard Deviation 0.7 |
Comparison: This is an open-label study with statistical comparison between baseline and Week 12.p-value: <0.00012-sided paired t-test
Secondary
Nocturnal Micturitions Per 24 Hours
Nocturnal micturitions (synonymous with the term nighttime micturitions) were those recorded in the bedtime section of the bladder diary.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Nocturnal Micturitions Per 24 Hours | 2.6 number of nocturnal micturitions | Standard Deviation 1.6 |
| Open Label Week 12 | Nocturnal Micturitions Per 24 Hours | 1.8 number of nocturnal micturitions | Standard Deviation 1.4 |
Comparison: This is an open-label study with statistical comparison between baseline and Week 12.p-value: <0.00012 sided paired t-test
Secondary
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain | 50.5 scores on a scale | Standard Deviation 25.3 |
| Open Label Week 12 | Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain | 79.1 scores on a scale | Standard Deviation 21.2 |
Comparison: This is an open-label study with statistical comparison between baseline and Week 12.p-value: <0.00012-sided paired t-test
Secondary
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain | 44.7 scores on a scale | Standard Deviation 25.3 |
| Open Label Week 12 | Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain | 75.3 scores on a scale | Standard Deviation 24.3 |
Comparison: This is an open-label study with statistical comparison between baseline and Week 12.p-value: <0.00012-sided paired t-test
Secondary
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain | 47.4 scores on a scale | Standard Deviation 25.5 |
| Open Label Week 12 | Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain | 72.3 scores on a scale | Standard Deviation 23.3 |
Comparison: This is an open-label study with statistical comparison between baseline and Week 12.p-value: <0.00012-sided paired t-test
Secondary
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain | 71.3 scores on a scale | Standard Deviation 23.5 |
| Open Label Week 12 | Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain | 88.1 scores on a scale | Standard Deviation 18.6 |
Comparison: This is an open-label study with statistical comparison between baseline and Week 12.p-value: <0.00012-sided paired t-test
Secondary
Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale
Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent less favorable outcome.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale | 57.4 scores on a scale | Standard Deviation 18.7 |
| Open Label Week 12 | Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale | 28.6 scores on a scale | Standard Deviation 20.2 |
Comparison: This is an open-label study with statistical comparison between baseline and Week 12.p-value: <0.00012-sided paired t-test
Secondary
Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale | 52.2 scores on a scale | Standard Deviation 21.8 |
| Open Label Week 12 | Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale | 78.3 scores on a scale | Standard Deviation 20.2 |
Comparison: This is an open-label study with statistical comparison between baseline and Week 12.p-value: <0.00012-sided paired t-test
Secondary
Patient Perception of Bladder Condition (PPBC) Score
The PPBC score ranges from 1 no problems at all to 6 many severe problems.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Patient Perception of Bladder Condition (PPBC) Score | 4.9 scores on a scale | Standard Deviation 0.7 |
| Open Label Week 12 | Patient Perception of Bladder Condition (PPBC) Score | 3.1 scores on a scale | Standard Deviation 1.2 |
Comparison: This is an open-label study with statistical comparison between baseline and Week 12.p-value: <0.00012-sided paired t-test
Secondary
Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)
Improvement: negative score change; No change: score change=0; Deterioration: positive score change
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Label Baseline | Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change) | Improvement | 405 participants |
| Open Label Baseline | Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change) | No change | 72 participants |
| Open Label Baseline | Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change) | Deterioration | 10 participants |
Secondary
Satisfaction With OAB Control Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)
Module coded on scale (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically & results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Satisfied on TSQ = very or somewhat satisfied; Not satisfied on TSQ =very or somewhat dissatisfied or neither dissatisfied nor satisfied.
Time frame: Week 12
Population: Population included subjects in FAS (described above) with non-missing values on OAB-S at Week 12, referred to in table below as All Subjects. Summary was presented for All Subjects and 2 subgroups, based on categorization for treatment satisfaction question used in primary endpoint assessing satisfaction.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Baseline | Satisfaction With OAB Control Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S) | All Subjects (N=473) | 74.7 scores on a scale | Standard Deviation 22.3 |
| Open Label Baseline | Satisfaction With OAB Control Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S) | Subjects satisfied on TSQ (n=377) | 82.7 scores on a scale | Standard Deviation 14 |
| Open Label Baseline | Satisfaction With OAB Control Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S) | Subjects not satisfied on TSQ (n=96) | 43.6 scores on a scale | Standard Deviation 21.5 |
Secondary
Severe Urgency Episodes Per 24 Hours
Severe urgency episodes defined as Urinary Sensation Scale (USS) rating ≥4. Subjects rated the feeling of urgency associated with each micturition episode using USS provided in the bladder diary. Scale ranges from 1=no feeling of urgency to 5=unable to hold; leak urine; decrease indicates an improvement with respect to urgency symptoms.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with baseline severe urgency episodes \>0 and non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Severe Urgency Episodes Per 24 Hours | 5.0 number of episodes | Standard Deviation 4.4 |
| Open Label Week 12 | Severe Urgency Episodes Per 24 Hours | 1.5 number of episodes | Standard Deviation 2.7 |
Comparison: This is an open-label study with statistical comparison between baseline and Week 12.p-value: <0.00012-sided paired t-test
Secondary
Sum Rating on the Urinary Sensation Scale
The sum rating per 24 hours was calculated as the mean rating score on the Urinary Sensation Scale multiplied by the mean number of micturitions per 24 hours at that visit. The scale ranges from 1 no feeling of urgency to 5 unable to hold; leak urine.
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Sum Rating on the Urinary Sensation Scale | 40.4 scores on a scale | Standard Deviation 15.6 |
| Open Label Week 12 | Sum Rating on the Urinary Sensation Scale | 25.2 scores on a scale | Standard Deviation 13.2 |
Comparison: This is an open-label study with statistical comparison between baseline and Week 12.p-value: <0.00012-sided paired t-test
Secondary
Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)
Number of participants who responded satisfied = (very satisfied or somewhat satisfied) or dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question at Week 12 in the safety set.
Time frame: Week 12
Population: Subjects in safety set included subjects who took at least one dose of study drug. Missing responses to the Treatment Satisfaction Question at Week 12 were imputed as not satisfied for calculating the most conservative treatment satisfaction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Label Baseline | Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis) | Satisfied (very satisfied or somewhat satisfied) | 378 participants |
| Open Label Baseline | Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis) | Neither Dissatisfied nor Satisfied | 42 participants |
| Open Label Baseline | Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis) | Dissatisfied (somewhat or very dissatisfied) | 54 participants |
| Open Label Baseline | Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis) | Missing Response (imputed as dissatisfied) | 42 participants |
Secondary
Urgency Perception Scale (UPS)
UPS scores range from 0 (I am usually not able to hold urine) to 2 (I am usually able to finish what I am doing before going to the toilet \[without leaking\]).
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Baseline | Urgency Perception Scale (UPS) | 0.8 scores on a scale | Standard Deviation 0.5 |
| Open Label Week 12 | Urgency Perception Scale (UPS) | 1.4 scores on a scale | Standard Deviation 0.6 |
Comparison: This is an open-label study with statistical comparison between baseline and Week 12.p-value: <0.00012-sided paired t-test
Secondary
Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)
Improvement: positive score change; No improvement: zero or negative score change
Time frame: Baseline and Week 12
Population: Subjects in the Full Analysis Set (FAS) with non-missing change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Label Baseline | Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change) | Improvement | 237 participants |
| Open Label Baseline | Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change) | No improvement | 248 participants |