Urinary Bladder, Overactive
Conditions
Keywords
Bladder Overactive, Overactive urinary bladder, Overactive Bladder
Brief summary
Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.
Interventions
DRUGFesoterodine 8 mg
Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.
DRUGPlacebo
Matching placebo for fesoterodine 4 and 8 mg for a total of 12 weeks.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of overactive bladder with symptoms for at least 6 months. * Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine * Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception
Exclusion criteria
* Conditions or prior treatment that may also affect bladder function * Clinically significant urinary tract infection (UTI) * Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours | Baseline, Week 12 | UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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 Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 | Baseline, Week 12 | UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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 |
|---|---|---|
| Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline, Week 12 | PPBC: single-item, self-administered validated questionnaire. Participant answered: Which of the following statements describes your bladder condition best at the moment? on a 6-point scale, 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. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of \>=2). |
| Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Baseline, Week 12 | UPS: single-item, self-administered validated questionnaire. Participant answered: Which of the following would typically describe your experience when you have a desire to urinate? on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change). |
| Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 | Baseline, Week 12 | OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale \[(Actual total raw score - lowest possible value of raw score)/range\]\*100. Higher scores values indicative of greater symptom bother. Change=observation minus baseline. |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | Baseline, Week 12 | Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. |
| Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2 | Week -2, Week 12 | UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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. |
| Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline | Baseline, Week 12 | UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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. |
| Percentage of Participants With No UUI Episodes (Diary Dry Rate) | Week 4, Week 12 | UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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 Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Baseline, Week 12 | OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \[(Highest possible raw score-Actual total raw score)/Raw score range\]\*100. Higher transformed scores indicative of better HRQL. |
| Change From Baseline in Mean Number of 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 rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS range from 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. |
Countries
Bulgaria, Canada, Czechia, Egypt, Finland, Germany, Hungary, Mexico, Poland, Russia, South Africa, South Korea, Sweden, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had \<= 50 percent change in UUI episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase. | 990 |
| Total | 990 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Between Open-Label and Double Blind | Did Not Enter Double-Blind Phase | 2 | 0 | 0 |
| Double-Blind Treatment Phase | Adverse Event | 0 | 10 | 10 |
| Double-Blind Treatment Phase | Did Not Meet Entrance Criteria | 0 | 0 | 2 |
| Double-Blind Treatment Phase | Lack of Efficacy | 0 | 2 | 4 |
| Double-Blind Treatment Phase | Lost to Follow-up | 0 | 2 | 1 |
| Double-Blind Treatment Phase | Other | 0 | 4 | 9 |
| Double-Blind Treatment Phase | Protocol Violation | 0 | 3 | 6 |
| Double-Blind Treatment Phase | Withdrawal by Subject | 0 | 6 | 14 |
| Tolterodine Open-Label Run-In Phase | Adverse Event | 13 | 0 | 0 |
| Tolterodine Open-Label Run-In Phase | Did Not Meet Entrance Criteria | 314 | 0 | 0 |
| Tolterodine Open-Label Run-In Phase | Lack of Efficacy | 4 | 0 | 0 |
| Tolterodine Open-Label Run-In Phase | Lost to Follow-up | 17 | 0 | 0 |
| Tolterodine Open-Label Run-In Phase | Other | 7 | 0 | 0 |
| Tolterodine Open-Label Run-In Phase | Protocol Violation | 8 | 0 | 0 |
| Tolterodine Open-Label Run-In Phase | Withdrawal by Subject | 16 | 0 | 0 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 13.7 |
| Sex: Female, Male Female | 810 Participants |
| Sex: Female, Male Male | 180 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 90 / 990 | 76 / 308 | 48 / 301 |
| serious Total, serious adverse events | 3 / 990 | 5 / 308 | 7 / 301 |
Outcome results
Primary
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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: Full Analysis set (FAS): all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes \>0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 | Baseline | 3.93 episodes per 24 hours | Standard Deviation 2.53 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 | Change at Week 12 | -2.32 episodes per 24 hours | Standard Deviation 2.67 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 | Baseline | 3.83 episodes per 24 hours | Standard Deviation 2.52 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 | Change at Week 12 | -1.76 episodes per 24 hours | Standard Deviation 2.46 |
Comparison: Multiple hypothesis testing was carried out in a hierarchical sequentially rejective manner. Statistical testing between fesoterodine and placebo (Analysis of covariance \[ANCOVA\]) was carried out only if the change from baseline at Week 12 in UUI episodes for fesoterodine group was found statistically significant (paired t-test).p-value: 0.007995% CI: [-0.87, -0.13]ANCOVA
Primary
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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: Full analysis set:all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Last Observation Carried Forward(LOCF) was used. N(number of participants analyzed):participants with baseline UUI episodes \>0 per 24 hours and non-missing change from baseline at Week 12(LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine: Double-Blind Baseline | Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours | 3.93 episodes per 24 hours | Standard Deviation 2.53 |
| Fesoterodine: Double-Blind Week 12 | Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours | 1.60 episodes per 24 hours | Standard Deviation 2.56 |
p-value: <0.000195% CI: [-2.63, -2.02]t-test, 1 sided
Secondary
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \[(Highest possible raw score-Actual total raw score)/Raw score range\]\*100. Higher transformed scores indicative of better HRQL.
Time frame: Baseline, Week 12
Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Concern Subscale: Baseline | 43.63 units on a scale | Standard Deviation 26 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Concern Subscale: Change at Week 12 | 23.11 units on a scale | Standard Deviation 27.77 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Coping Subscale: Baseline | 38.74 units on a scale | Standard Deviation 26.24 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Coping Subscale: Change at Week 12 | 23.70 units on a scale | Standard Deviation 26.69 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Sleep Subscale: Baseline | 41.38 units on a scale | Standard Deviation 25.66 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Sleep Subscale: Change at Week 12 | 20.85 units on a scale | Standard Deviation 27.42 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Social Interaction Subscale: Baseline | 65.03 units on a scale | Standard Deviation 28.34 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Social Interaction Subscale: Change at Week 12 | 14.47 units on a scale | Standard Deviation 24.26 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Total HRQL Score: Baseline | 45.90 units on a scale | Standard Deviation 23.72 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Total HRQL Score: Change at Week 12 | 21.12 units on a scale | Standard Deviation 24.62 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Social Interaction Subscale: Change at Week 12 | 8.85 units on a scale | Standard Deviation 21.12 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Concern Subscale: Baseline | 44.25 units on a scale | Standard Deviation 25.58 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Sleep Subscale: Change at Week 12 | 14.79 units on a scale | Standard Deviation 25.74 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Concern Subscale: Change at Week 12 | 13.83 units on a scale | Standard Deviation 25.03 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Total HRQL Score: Change at Week 12 | 13.42 units on a scale | Standard Deviation 21.92 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Coping Subscale: Baseline | 41.15 units on a scale | Standard Deviation 26.04 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Social Interaction Subscale: Baseline | 68.40 units on a scale | Standard Deviation 26.29 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Coping Subscale: Change at Week 12 | 15.07 units on a scale | Standard Deviation 24.2 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Total HRQL Score: Baseline | 47.38 units on a scale | Standard Deviation 22.7 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Sleep Subscale: Baseline | 40.69 units on a scale | Standard Deviation 26.28 |
Comparison: Concern Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.p-value: <0.000195% CI: [5.12, 12.91]ANCOVA
Comparison: Coping Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.p-value: <0.000195% CI: [3.87, 11.62]ANCOVA
Comparison: Sleep Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.p-value: 0.001295% CI: [2.6, 10.45]ANCOVA
Comparison: Social Interaction Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.p-value: 0.012395% CI: [0.9, 7.36]ANCOVA
Comparison: Total HRQL - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.p-value: <0.000195% CI: [3.63, 10.57]ANCOVA
Secondary
Change From Baseline in Mean Number of 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 rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS range from 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: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here 'N' (number of participants analyzed): participants with baseline urgency episodes \>0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | Baseline | 11.38 episodes per 24 hours | Standard Deviation 3.98 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | Change at Week 12 | -3.33 episodes per 24 hours | Standard Deviation 4.47 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | Baseline | 11.26 episodes per 24 hours | Standard Deviation 4.01 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | Change at Week 12 | -2.52 episodes per 24 hours | Standard Deviation 4.45 |
Comparison: Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.p-value: 0.043895% CI: [-1.37, -0.02]ANCOVA
Secondary
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Time frame: Baseline, Week 12
Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here 'N' (number of participants analyzed): participants with baseline micturitions \>0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | Baseline | 12.44 micturitions per 24 hours | Standard Deviation 3.57 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | Change at Week 12 | -1.94 micturitions per 24 hours | Standard Deviation 3.15 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | Baseline | 12.48 micturitions per 24 hours | Standard Deviation 3.75 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | Change at Week 12 | -1.57 micturitions per 24 hours | Standard Deviation 3.13 |
Comparison: Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.p-value: 0.093195% CI: [-0.86, 0.07]ANCOVA
Secondary
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12
OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale \[(Actual total raw score - lowest possible value of raw score)/range\]\*100. Higher scores values indicative of greater symptom bother. Change=observation minus baseline.
Time frame: Baseline, Week 12
Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 | Baseline | 66.67 units on a scale | Standard Deviation 20.28 |
| Fesoterodine: Double-Blind Baseline | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 | Change at Week 12 | -24.61 units on a scale | Standard Deviation 25.57 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 | Baseline | 64.74 units on a scale | Standard Deviation 19.69 |
| Fesoterodine: Double-Blind Week 12 | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 | Change at Week 12 | -15.99 units on a scale | Standard Deviation 24.53 |
Comparison: Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.p-value: 0.000195% CI: [-11.1, -3.58]ANCOVA
Secondary
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
PPBC: single-item, self-administered validated questionnaire. Participant answered: Which of the following statements describes your bladder condition best at the moment? on a 6-point scale, 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. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of \>=2).
Time frame: Baseline, Week 12
Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline: Some Very Minor Problems | 4 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline: No Problems at all | 0 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline: Some Minor Problems | 15 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline: Some Moderate Problems | 60 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline: Severe Problems | 147 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline: Many Severe Problems | 65 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Change at Week 12: Deterioration | 17 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Change at Week 12: No Change | 80 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Change at Week 12: Minor Improvement | 84 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Change at Week 12: Major Improvement | 110 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Change at Week 12: No Change | 95 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline: Some Very Minor Problems | 6 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline: Many Severe Problems | 36 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline: No Problems at all | 0 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Change at Week 12: Major Improvement | 57 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline: Some Minor Problems | 9 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Change at Week 12: Deterioration | 32 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline: Some Moderate Problems | 75 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Change at Week 12: Minor Improvement | 83 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 | Baseline: Severe Problems | 141 participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
UPS: single-item, self-administered validated questionnaire. Participant answered: Which of the following would typically describe your experience when you have a desire to urinate? on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).
Time frame: Baseline, Week 12
Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Baseline: Not able to hold urine | 126 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Baseline:Able to hold urine until I reach a toilet | 158 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Baseline:Able to finish what I am doing | 7 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Change at Week 12: Deterioration | 17 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Change at Week 12: No Change | 167 participants |
| Fesoterodine: Double-Blind Baseline | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Change at Week 12: Improvement | 107 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Change at Week 12: No Change | 158 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Baseline: Not able to hold urine | 99 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Change at Week 12: Deterioration | 31 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Baseline:Able to hold urine until I reach a toilet | 157 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Change at Week 12: Improvement | 78 participants |
| Fesoterodine: Double-Blind Week 12 | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 | Baseline:Able to finish what I am doing | 11 participants |
p-value: 0.0095Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes \>0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fesoterodine: Double-Blind Baseline | Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline | 69.9 percentage of participants |
| Fesoterodine: Double-Blind Week 12 | Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline | 57.0 percentage of participants |
p-value: 0.0027Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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: Week -2, Week 12
Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with Week -2 UUI episodes \>0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fesoterodine: Double-Blind Baseline | Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2 | 72.8 percentage of participants |
| Fesoterodine: Double-Blind Week 12 | Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2 | 59.6 percentage of participants |
p-value: 0.0023Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With No UUI Episodes (Diary Dry Rate)
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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: Week 4, Week 12
Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes \>0 per 24 hours and non-missing change from baseline at Week 4 and 12 (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine: Double-Blind Baseline | Percentage of Participants With No UUI Episodes (Diary Dry Rate) | Week 4 | 25.4 percentage of participants |
| Fesoterodine: Double-Blind Baseline | Percentage of Participants With No UUI Episodes (Diary Dry Rate) | Week 12 | 39.0 percentage of participants |
| Fesoterodine: Double-Blind Week 12 | Percentage of Participants With No UUI Episodes (Diary Dry Rate) | Week 4 | 17.7 percentage of participants |
| Fesoterodine: Double-Blind Week 12 | Percentage of Participants With No UUI Episodes (Diary Dry Rate) | Week 12 | 32.3 percentage of participants |
p-value: 0.0427Cochran-Mantel-Haenszel
p-value: 0.1461Cochran-Mantel-Haenszel