Stress Urinary Incontinence
Conditions
Keywords
Phase 2 stress urinary incontinence Fesoterodine
Brief summary
The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence
Interventions
DRUGFesoterodine
Fesoterodine 4 mg and 8 mg and placebo - each dosed for 7 days with 7 day washout between dosing periods
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female, 18 - 65 years * SUI symptoms for longer than 3 months * Subjects must be non-pregnant and not breastfeeding
Exclusion criteria
* Disease or medical condition affecting the bladder or urinary tract (other tan stress urinary incontinence) * Subjects taking medication with effects on the bladder or urinary tract * Subejcts with medical conditions which could be adversely affected by administration of fesoterodine - gastrointestinal tract disease, glaucoma, hepatic impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 | Baseline, Day 7 of each period | OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Opening Urethral Elastance at Day 7 | Baseline, Day 7 of each period | Opening urethral elastance measured by urethral reflectometry calculated as the mean of each of the opening urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. |
| Change From Baseline in Closing Urethral Elastance at Day 7 | Baseline, Day 7 of each period | Closing urethral elastance measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. |
| Incontinence Episode Frequency Per 24 Hours | Baseline, Day 7 of each period | Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period. |
| Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours | Baseline, Day 7 of each period | Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period. |
| Change From Baseline in Closing Urethral Pressure at Day 7 | Baseline, Day 7 of each period | Closing urethral pressure measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. |
| Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours | Baseline, Day 7 of each period | Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period. |
| Urgency Urinary Incontinence Episode Frequency Per 24 Hours | Baseline, Day 7 of each period | Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period. |
| Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours | Baseline, Day 7 of each period | Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period. |
| Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration | Baseline, Day 7 of each period | Plasma 5-HMT concentration data pre and post reflectometry following multiple doses of fesoterodine 4 mg OD and fesoterodine 8 mg OD. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.02 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0. |
| Stress Incontinence Episode Frequency Per 24 Hours | Baseline, Day 7 of each period | Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period. |
Countries
Denmark
Participant flow
Pre-assignment details
Participants randomized to receive sequenced dosing of Fesoterodine 4 milligrams (mg) (A), or Fesoterodine 8 milligrams (B), or Placebo matching study treatment (C). Each dosed for 7 days with a 7 day washout between dosing periods. Dosing sequenced as ABC, ACB, BAC, BCA, CAB, or CBA.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive Fesoterodine (4mg) first, Fesoterodine (8mg) first, and Placebo first. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Treatment Period 1 | Adverse Event | 0 | 1 | 0 | 0 | 1 | 0 |
| Treatment Period 3 | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
| Treatment Period 3 | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age Continuous | 47.9 Years STANDARD_DEVIATION 8.4 |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 0 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 | 8 / 20 | 17 / 22 | 8 / 20 |
| serious Total, serious adverse events | 0 / 20 | 1 / 22 | 0 / 20 |
Outcome results
Primary
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7
OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Time frame: Baseline, Day 7 of each period
Population: Per Protocol Analysis Set (PPAS): all randomized participants who completed the study, received treatment in all 3 study periods until end of treatment visit in the third study period, and had not violated any of the inclusion / exclusion criteria or deviated from the protocol in a way that could affect the outcome of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine (4 mg) | Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 | Absolute value at Day 7 | 47.92 centimeter of water (cmH2O) | Standard Deviation 12.971 |
| Fesoterodine (4 mg) | Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 | Baseline | 49.86 centimeter of water (cmH2O) | Standard Deviation 14.86 |
| Fesoterodine (4 mg) | Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 | Mean change at Day 7 | -1.94 centimeter of water (cmH2O) | Standard Deviation 4.767 |
| Fesoterodine (8 mg) | Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 | Absolute value at Day 7 | 49.16 centimeter of water (cmH2O) | Standard Deviation 14.406 |
| Fesoterodine (8 mg) | Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 | Baseline | 49.86 centimeter of water (cmH2O) | Standard Deviation 14.86 |
| Fesoterodine (8 mg) | Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 | Mean change at Day 7 | -0.70 centimeter of water (cmH2O) | Standard Deviation 5.512 |
| Placebo | Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 | Baseline | 49.86 centimeter of water (cmH2O) | Standard Deviation 14.86 |
| Placebo | Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 | Mean change at Day 7 | -1.34 centimeter of water (cmH2O) | Standard Deviation 5.178 |
| Placebo | Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 | Absolute value at Day 7 | 48.53 centimeter of water (cmH2O) | Standard Deviation 12.859 |
Comparison: Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.p-value: 0.490795% CI: [-1.18, 2.41]ANCOVA
Comparison: Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.p-value: 0.594495% CI: [-2.27, 1.32]ANCOVA
Secondary
Change From Baseline in Closing Urethral Elastance at Day 7
Closing urethral elastance measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Time frame: Baseline, Day 7 of each period
Population: PPAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine (4 mg) | Change From Baseline in Closing Urethral Elastance at Day 7 | Mean change at Day 7 | -0.28 cmH2O/mm^2 | Standard Deviation 0.391 |
| Fesoterodine (4 mg) | Change From Baseline in Closing Urethral Elastance at Day 7 | Baseline | 1.85 cmH2O/mm^2 | Standard Deviation 0.607 |
| Fesoterodine (4 mg) | Change From Baseline in Closing Urethral Elastance at Day 7 | Absolue value at Day 7 | 1.56 cmH2O/mm^2 | Standard Deviation 0.347 |
| Fesoterodine (8 mg) | Change From Baseline in Closing Urethral Elastance at Day 7 | Mean change at Day 7 | -0.10 cmH2O/mm^2 | Standard Deviation 0.532 |
| Fesoterodine (8 mg) | Change From Baseline in Closing Urethral Elastance at Day 7 | Absolue value at Day 7 | 1.74 cmH2O/mm^2 | Standard Deviation 0.632 |
| Fesoterodine (8 mg) | Change From Baseline in Closing Urethral Elastance at Day 7 | Baseline | 1.85 cmH2O/mm^2 | Standard Deviation 0.607 |
| Placebo | Change From Baseline in Closing Urethral Elastance at Day 7 | Mean change at Day 7 | -0.09 cmH2O/mm^2 | Standard Deviation 0.46 |
| Placebo | Change From Baseline in Closing Urethral Elastance at Day 7 | Absolue value at Day 7 | 1.75 cmH2O/mm^2 | Standard Deviation 0.647 |
| Placebo | Change From Baseline in Closing Urethral Elastance at Day 7 | Baseline | 1.85 cmH2O/mm^2 | Standard Deviation 0.607 |
Comparison: Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.p-value: 0.860295% CI: [-0.26, 0.22]ANCOVA
Comparison: Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.p-value: 0.127195% CI: [-0.43, 0.06]ANCOVA
Secondary
Change From Baseline in Closing Urethral Pressure at Day 7
Closing urethral pressure measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Time frame: Baseline, Day 7 of each period
Population: PPAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine (4 mg) | Change From Baseline in Closing Urethral Pressure at Day 7 | Absolute value at Day 7 | 37.84 cmH20 | Standard Deviation 12.666 |
| Fesoterodine (4 mg) | Change From Baseline in Closing Urethral Pressure at Day 7 | Baseline | 40.62 cmH20 | Standard Deviation 14.379 |
| Fesoterodine (4 mg) | Change From Baseline in Closing Urethral Pressure at Day 7 | Mean change at Day 7 | -2.78 cmH20 | Standard Deviation 5.571 |
| Fesoterodine (8 mg) | Change From Baseline in Closing Urethral Pressure at Day 7 | Absolute value at Day 7 | 38.75 cmH20 | Standard Deviation 13.172 |
| Fesoterodine (8 mg) | Change From Baseline in Closing Urethral Pressure at Day 7 | Baseline | 40.62 cmH20 | Standard Deviation 14.379 |
| Fesoterodine (8 mg) | Change From Baseline in Closing Urethral Pressure at Day 7 | Mean change at Day 7 | -1.88 cmH20 | Standard Deviation 5.475 |
| Placebo | Change From Baseline in Closing Urethral Pressure at Day 7 | Baseline | 40.62 cmH20 | Standard Deviation 14.379 |
| Placebo | Change From Baseline in Closing Urethral Pressure at Day 7 | Mean change at Day 7 | -1.96 cmH20 | Standard Deviation 5.915 |
| Placebo | Change From Baseline in Closing Urethral Pressure at Day 7 | Absolute value at Day 7 | 38.66 cmH20 | Standard Deviation 11.953 |
Comparison: Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.p-value: 0.98795% CI: [-1.91, 1.94]ANCOVA
Comparison: Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.p-value: 0.416795% CI: [-2.71, 1.15]ANCOVA
Secondary
Change From Baseline in Opening Urethral Elastance at Day 7
Opening urethral elastance measured by urethral reflectometry calculated as the mean of each of the opening urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Time frame: Baseline, Day 7 of each period
Population: PPAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine (4 mg) | Change From Baseline in Opening Urethral Elastance at Day 7 | Absolue value at Day 7 | 1.66 cmH2O/millimeter(mm)^2 | Standard Deviation 0.431 |
| Fesoterodine (4 mg) | Change From Baseline in Opening Urethral Elastance at Day 7 | Baseline | 1.93 cmH2O/millimeter(mm)^2 | Standard Deviation 0.551 |
| Fesoterodine (4 mg) | Change From Baseline in Opening Urethral Elastance at Day 7 | Mean Change at Day 7 | -0.27 cmH2O/millimeter(mm)^2 | Standard Deviation 0.396 |
| Fesoterodine (8 mg) | Change From Baseline in Opening Urethral Elastance at Day 7 | Absolue value at Day 7 | 1.85 cmH2O/millimeter(mm)^2 | Standard Deviation 0.684 |
| Fesoterodine (8 mg) | Change From Baseline in Opening Urethral Elastance at Day 7 | Baseline | 1.93 cmH2O/millimeter(mm)^2 | Standard Deviation 0.551 |
| Fesoterodine (8 mg) | Change From Baseline in Opening Urethral Elastance at Day 7 | Mean Change at Day 7 | -0.08 cmH2O/millimeter(mm)^2 | Standard Deviation 0.651 |
| Placebo | Change From Baseline in Opening Urethral Elastance at Day 7 | Baseline | 1.93 cmH2O/millimeter(mm)^2 | Standard Deviation 0.551 |
| Placebo | Change From Baseline in Opening Urethral Elastance at Day 7 | Mean Change at Day 7 | -0.10 cmH2O/millimeter(mm)^2 | Standard Deviation 0.685 |
| Placebo | Change From Baseline in Opening Urethral Elastance at Day 7 | Absolue value at Day 7 | 1.83 cmH2O/millimeter(mm)^2 | Standard Deviation 0.69 |
Comparison: Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.p-value: 0.188195% CI: [-0.42, 0.09]ANCOVA
Comparison: Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.p-value: 0.940395% CI: [-0.24, 0.26]ANCOVA
Secondary
Incontinence Episode Frequency Per 24 Hours
Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Time frame: Baseline, Day 7 of each period
Population: PPAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine (4 mg) | Incontinence Episode Frequency Per 24 Hours | Baseline | 1.52 Episodes per 24 hours. | Standard Deviation 1.099 |
| Fesoterodine (4 mg) | Incontinence Episode Frequency Per 24 Hours | Change at Day 7 | -0.81 Episodes per 24 hours. | Standard Deviation 0.866 |
| Fesoterodine (4 mg) | Incontinence Episode Frequency Per 24 Hours | Absolute value at Day 7 | 0.71 Episodes per 24 hours. | Standard Deviation 0.781 |
| Fesoterodine (8 mg) | Incontinence Episode Frequency Per 24 Hours | Absolute value at Day 7 | 0.98 Episodes per 24 hours. | Standard Deviation 0.996 |
| Fesoterodine (8 mg) | Incontinence Episode Frequency Per 24 Hours | Change at Day 7 | -0.54 Episodes per 24 hours. | Standard Deviation 1.114 |
| Fesoterodine (8 mg) | Incontinence Episode Frequency Per 24 Hours | Baseline | 1.52 Episodes per 24 hours. | Standard Deviation 1.099 |
| Placebo | Incontinence Episode Frequency Per 24 Hours | Change at Day 7 | -0.70 Episodes per 24 hours. | Standard Deviation 0.866 |
| Placebo | Incontinence Episode Frequency Per 24 Hours | Baseline | 1.52 Episodes per 24 hours. | Standard Deviation 1.099 |
| Placebo | Incontinence Episode Frequency Per 24 Hours | Absolute value at Day 7 | 0.82 Episodes per 24 hours. | Standard Deviation 0.698 |
Secondary
Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours
Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Time frame: Baseline, Day 7 of each period
Population: PPAS; (n)=only participants with \>0 episodes at baseline were to be included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fesoterodine (4 mg) | Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours | -66.67 Percent |
| Fesoterodine (8 mg) | Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours | -55.56 Percent |
| Placebo | Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours | -60.00 Percent |
Secondary
Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours
Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Time frame: Baseline, Day 7 of each period
Population: PPAS; (n)=only participants with \>0 episodes at baseline were to be included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fesoterodine (4 mg) | Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours | -66.67 Percent |
| Fesoterodine (8 mg) | Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours | -55.56 Percent |
| Placebo | Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours | -60.00 Percent |
Secondary
Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours
Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Time frame: Baseline, Day 7 of each period
Population: PPAS; (n)=only subjects with \>0 participants at baseline were to be included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fesoterodine (4 mg) | Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours | -50.00 Percent |
| Fesoterodine (8 mg) | Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours | -100.00 Percent |
| Placebo | Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours | -100.00 Percent |
Secondary
Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration
Plasma 5-HMT concentration data pre and post reflectometry following multiple doses of fesoterodine 4 mg OD and fesoterodine 8 mg OD. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.02 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.
Time frame: Baseline, Day 7 of each period
Population: Full Analysis Set (FAS): all randomized subjects who had taken at least one dose of study treatment; (n)=number of participants with observations (non-missing concentrations)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine (4 mg) | Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration | Pre-Reflectometry (n=18, 18) | 2.303 nanogram/milliliter (ng/mL) | Standard Deviation 1.2798 |
| Fesoterodine (4 mg) | Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration | Post-Reflectometry (n=18, 17) | 2.185 nanogram/milliliter (ng/mL) | Standard Deviation 1.197 |
| Fesoterodine (8 mg) | Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration | Pre-Reflectometry (n=18, 18) | 4.902 nanogram/milliliter (ng/mL) | Standard Deviation 2.1554 |
| Fesoterodine (8 mg) | Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration | Post-Reflectometry (n=18, 17) | 4.971 nanogram/milliliter (ng/mL) | Standard Deviation 1.8195 |
Secondary
Stress Incontinence Episode Frequency Per 24 Hours
Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Time frame: Baseline, Day 7 of each period
Population: PPAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine (4 mg) | Stress Incontinence Episode Frequency Per 24 Hours | Change at Day 7 | -0.75 Episodes per 24 hours. | Standard Deviation 0.812 |
| Fesoterodine (4 mg) | Stress Incontinence Episode Frequency Per 24 Hours | Baseline | 1.44 Episodes per 24 hours. | Standard Deviation 1.052 |
| Fesoterodine (4 mg) | Stress Incontinence Episode Frequency Per 24 Hours | Absolute value at Day 7 | 0.69 Episodes per 24 hours. | Standard Deviation 0.759 |
| Fesoterodine (8 mg) | Stress Incontinence Episode Frequency Per 24 Hours | Absolute value at Day 7 | 0.98 Episodes per 24 hours. | Standard Deviation 0.996 |
| Fesoterodine (8 mg) | Stress Incontinence Episode Frequency Per 24 Hours | Change at Day 7 | -0.46 Episodes per 24 hours. | Standard Deviation 1.043 |
| Fesoterodine (8 mg) | Stress Incontinence Episode Frequency Per 24 Hours | Baseline | 1.44 Episodes per 24 hours. | Standard Deviation 1.052 |
| Placebo | Stress Incontinence Episode Frequency Per 24 Hours | Baseline | 1.44 Episodes per 24 hours. | Standard Deviation 1.052 |
| Placebo | Stress Incontinence Episode Frequency Per 24 Hours | Change at Day 7 | -0.62 Episodes per 24 hours. | Standard Deviation 0.897 |
| Placebo | Stress Incontinence Episode Frequency Per 24 Hours | Absolute value at Day 7 | 0.82 Episodes per 24 hours. | Standard Deviation 0.698 |
Secondary
Urgency Urinary Incontinence Episode Frequency Per 24 Hours
Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Time frame: Baseline, Day 7 of each period
Population: PPAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine (4 mg) | Urgency Urinary Incontinence Episode Frequency Per 24 Hours | Absolute value at Day 7 | 0.02 Episodes per 24 hours. | Standard Deviation 0.081 |
| Fesoterodine (4 mg) | Urgency Urinary Incontinence Episode Frequency Per 24 Hours | Baseline | 0.08 Episodes per 24 hours. | Standard Deviation 0.251 |
| Fesoterodine (4 mg) | Urgency Urinary Incontinence Episode Frequency Per 24 Hours | Change at Day 7 | -0.06 Episodes per 24 hours. | Standard Deviation 0.243 |
| Fesoterodine (8 mg) | Urgency Urinary Incontinence Episode Frequency Per 24 Hours | Absolute value at Day 7 | 0.00 Episodes per 24 hours. | Standard Deviation 0 |
| Fesoterodine (8 mg) | Urgency Urinary Incontinence Episode Frequency Per 24 Hours | Baseline | 0.08 Episodes per 24 hours. | Standard Deviation 0.251 |
| Fesoterodine (8 mg) | Urgency Urinary Incontinence Episode Frequency Per 24 Hours | Change at Day 7 | -0.08 Episodes per 24 hours. | Standard Deviation 0.251 |
| Placebo | Urgency Urinary Incontinence Episode Frequency Per 24 Hours | Baseline | 0.08 Episodes per 24 hours. | Standard Deviation 0.251 |
| Placebo | Urgency Urinary Incontinence Episode Frequency Per 24 Hours | Change at Day 7 | -0.08 Episodes per 24 hours. | Standard Deviation 0.251 |
| Placebo | Urgency Urinary Incontinence Episode Frequency Per 24 Hours | Absolute value at Day 7 | 0.00 Episodes per 24 hours. | Standard Deviation 0 |