This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy (NCT00691093), a registered phase not stated study. The primary outcome is Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00691093 |
| Phase | Phase not stated |
| Condition | Overactive Bladder, Urinary Incontinence |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 823 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Patients with overactive bladder whose previous antimuscarinic therapy had failed because of ineffectiveness or intolerance. The registry reports an enrollment of 823.
Intervention
Fesoterodine, marketed as Toviaz. The adverse-event group is described as receiving fesoterodine 4 mg or 8 mg.
Comparator
No like-for-like control comparison is described. The record does not state an allocation method, and this is not a randomized comparison.
Primary question
How did mean daytime micturition frequency per 24 hours change from baseline at follow-up visits or early termination among patients who received fesoterodine?
The study concerns patients with overactive bladder, a condition also recorded alongside urinary incontinence. Its focus is treatment following a prior antimuscarinic therapy that was considered ineffective or intolerable. The stated primary outcome is a within-participant change in daytime urination frequency, assessed from baseline through follow-up visits.
This is an observational question about outcomes among treated patients, rather than a randomized comparison of fesoterodine with another treatment or with no treatment. The record also identifies patient and clinical global evaluations, comparisons with previous medication, symptom and bother measures, time to treatment response, and study doses as secondary outcomes. However, their results are not reported in the registry record. Nor are the primary outcome estimates, so the direction and size of any observed change cannot be described from this record.
3. Trial Design
This completed study is described as observational. It enrolled 823 patients with overactive bladder who had failed previous antimuscarinic therapy because of ineffectiveness or intolerance, and assessed patients treated with fesoterodine. The intervention is listed as a drug; the adverse-event group is labeled fesoterodine 4 mg or 8 mg. The record does not describe a separate comparison group or a like-for-like control comparison.
The study began in 2008-07, with primary completion in 2009-06. Its status is completed. The registry does not state how participants were allocated, and it does not report a randomization procedure. It also does not report the treatment setting, recruitment locations, eligibility criteria beyond the prior-treatment failure described, or a detailed schedule for treatment decisions. Those details should not be inferred from the outcome visit labels.
The primary outcome was planned as change from baseline in micturition frequency per 24 hours at each visit. The listed timepoints are baseline, Month 1, Month 2, Month 3, or early termination. Frequency is defined as the mean number of daytime micturitions per 24 hours, calculated using the total number of daytime urinations divided by the total diary days collected at that visit. The analysis population is described as the full analysis set: patients who received at least one dose and had at least one post-baseline efficacy measurement.
The record lists 13 outcome measures and reports no analyses. It does not report the study’s statistical analysis plan, sample-size justification, interim analyses, or a detailed protocol for handling deviations. The study design therefore supports describing the planned assessment and the recorded safety counts, but not making a controlled treatment-effect estimate from the registry entry.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Fesoterodine 4 mg or 8 mg |
|---|---|
| STARTED | 823 |
| COMPLETED | 816 |
| NOT COMPLETED | 7 |
Reasons for not completing this period:
| Reason | Fesoterodine 4 mg or 8 mg |
|---|---|
| Adverse Event | 1 |
| Lost to Follow-up | 1 |
| Lack of Efficacy | 1 |
| Ongoing at Date of Cut-Off | 4 |
Analysis population for the primary outcome, as defined in the registry: The full analysis set (FAS) included all patients who received at least one dose of the study medication and who had at least one post baseline efficacy measurement.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Fesoterodine 4 mg |
|---|---|---|
| Participants analysed | 823 | |
| Age, Customized: <18 years | participants | 11 |
| Age, Customized: 18-44 years | participants | 102 |
| Age, Customized: 44-64 | participants | 497 |
| Age, Customized: >=65 years | participants | 213 |
| Sex: Female, Male: Female | Participants | 574 |
| Sex: Female, Male: Male | Participants | 249 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit, measured over Baseline, Month 1, Month 2, Month 3 or Early Termination (ET).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | episodes |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in micturition frequency per 24 hours at each follow-up visit or early termination. It is a continuous measure reported as a mean, with standard deviation specified as the dispersion measure. The frequency definition counts daytime urinations while the participant is awake and divides the total by the number of diary days collected at the relevant visit.
A baseline value provides a reference for assessing how the recorded frequency changes during follow-up. Repeated measurements at Month 1, Month 2, Month 3, or early termination can describe the course of the measure over the observed period. A mean summarizes the average change across the analysis population, while a standard deviation describes variation among individual measurements around that average. These statistics answer different questions: the mean concerns the group average, and the standard deviation concerns how dispersed the observations are.
Daytime frequency is a direct, count-based measure of the symptom the study set out to assess. Diary-based measurement can capture repeated daily experiences rather than relying only on a single retrospective judgment. The record does not report the diary completion requirements, the actual endpoint values, the number of participants contributing data at each visit, or uncertainty intervals. Consequently, the endpoint’s planned definition is clear, but its observed change and precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies the primary outcome and defines how it was to be measured, but it does not post outcome estimates or analyses. In particular, the mean change in daytime micturition frequency, its standard deviation, and the number of participants contributing to each visit are not reported in the registry record. No direction, magnitude, or precision of change can therefore be assessed from the posted results.
The design is observational and does not describe a randomized comparison. A change from baseline among treated patients would describe what happened over follow-up in the observed group; by itself, it would not isolate the effect of fesoterodine from other explanations. Changes over time could reflect treatment, the natural course of symptoms, other care, measurement variation, or factors related to choosing or continuing treatment. These are general interpretive considerations for an uncontrolled before-and-after assessment, not findings about this study.
The stated full analysis set includes patients who received at least one dose and had at least one post-baseline efficacy measurement. The enrollment of 823 does not establish how many met that definition or contributed observations at each timepoint. Those counts are not reported in the registry record. The amount and pattern of missing diary data, and any approach to missing visits, are also not reported.
For safety, the record lists 0 serious adverse events among 823 participants at risk and 78 other adverse events among 823 at risk. It gives no serious adverse-event terms and does not report deaths. These are registry counts, not comparative estimates; without a control group or further detail on event definitions, timing, severity, and attribution, they cannot establish comparative safety or explain individual events.
The registry also lists patient and clinical global evaluations, an overall treatment-effect comparison with previous medication, questionnaire outcomes, time to response, and dose. Their results are not reported in the registry record. The completed status indicates that the study is recorded as completed, but it does not supply the missing statistical results. Overall, the record describes the clinical question and planned measurements more fully than it describes the findings.
9. Statistical Methods Explained
What does a mean change describe?
The primary outcome is a continuous measure summarized by its mean. A mean change describes the average within-participant difference between baseline and a later measurement, across the participants included in the analysis for that visit. It is not the same as the change experienced by every participant. Some individual values may be larger or smaller than the average, or may move in a different direction.
The record specifies standard deviation as the measure of dispersion. In general, a standard deviation describes how spread out observed values are around their mean. It is not an estimate of how precisely the mean itself has been estimated. A confidence interval, if reported, would address uncertainty around an estimate; no confidence interval for the primary outcome is reported in the registry record.
What is the role of repeated visits?
The planned timepoints are baseline, Month 1, Month 2, Month 3, or early termination. Repeated measurement can describe how the outcome varies over follow-up, but interpreting such a pattern requires knowing which participants contributed data at each visit and how incomplete records were handled. The registry record does not report visit-specific analysis counts or a missing-data method. A reader therefore cannot determine from the record whether the same set of participants contributed at every visit.
The frequency measure is derived from daytime urinations and diary days collected at a visit. As a general measurement principle, the number of diary days and completeness of diary entries can affect how stable a participant’s recorded average is. The registry defines the calculation but does not report diary completion details or the observed data distribution. It is not possible to assess measurement completeness or variability from the definition alone.
What does the analysis population mean?
The full analysis set includes all patients who received at least one dose and had at least one post-baseline efficacy measurement. This definition identifies a group eligible for the primary efficacy analysis; it does not mean that all enrolled participants necessarily contributed a value at every visit. The record does not give the number in the full analysis set or explain how individual missing visits were treated.
As a general statistical concept, excluding people without a post-baseline measure can make the analyzed group differ from the enrolled group. The direction or importance of any such difference depends on why measurements are missing and on the analysis approach. Neither the reasons for missing measurements nor methods for addressing them are reported in the registry record, so no study-specific conclusion about missing-data bias is possible.
How should the design shape interpretation?
This is an observational study, not a randomized comparison, and the record does not describe a control group. A before-and-after analysis can estimate change over time among those observed, but it cannot, on its own, distinguish treatment-related change from other influences. General sources of uncertainty in an uncontrolled comparison include symptom fluctuation, differences in patient characteristics, changes in other care, and selective follow-up. The record does not provide information that would quantify or rule out these possibilities.
The record describes the endpoint as a mean with standard deviation but does not report a model, hypothesis test, confidence interval, adjustment variables, or other inferential method. The statistical analysis plan is not reported in the registry record. It would therefore be inappropriate to attribute a particular modeling approach or adjustment strategy to the investigators.
What can a planning illustration establish?
General sample-size calculations can illustrate how a hypothetical study might be planned under stated assumptions. The planning assumptions associated with this record describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of an observed effect. They describe a planning illustration, not the study’s own design or an observed-power calculation. The record does not report the study’s sample-size justification.
The planning assumptions do not turn this observational study into a two-arm randomized trial. The registry does not describe a like-for-like control comparison, and no actual primary outcome estimate is reported from which to assess the observed effect or its precision. The calculated planning values themselves are not reported in the registry record, so no specific required sample size can be stated. In general, a planning illustration depends on its assumptions and should not be read as evidence that the completed study was adequately powered or that an effect was detected.
Why can over-dispersion matter?
As a general concept, over-dispersion occurs when observed variability is greater than a statistical model assumes. For count outcomes, a model that understates variability can produce uncertainty estimates that are too narrow. The primary outcome is summarized as a continuous mean, and the registry does not report a count model or a distributional assessment. Whether over-dispersion was relevant or addressed is not reported in the registry record; it should not be presumed to have affected the analysis.
In short, the definitions establish what the study intended to measure, while the absence of posted estimates and methods limits statistical interpretation. The registry record does not report enough analysis detail to evaluate endpoint precision, model assumptions, or the handling of incomplete observations.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures, including the primary change in micturition frequency and secondary assessments of residual urine volume, global evaluations, comparison with previous medication, questionnaire scores, time to response, and study doses. It reports no analyses. The primary and secondary results, including any statistical tests or confidence intervals, are not reported in the registry record.
When a study evaluates multiple outcomes or timepoints, the chance of at least one apparently notable result can increase if many tests are conducted. General approaches include prespecifying a primary comparison, controlling error across tests, or treating secondary analyses as exploratory. The registry record does not report whether a multiplicity strategy, testing hierarchy, or distinction between confirmatory and exploratory analyses was specified. No adjustment should be assumed.
The full analysis set is defined as patients who received at least one dose and had at least one post-baseline efficacy measurement. The number in that set and the visit-specific numbers analyzed are not reported. Nor are the amount, reasons, or patterns of missing outcome data, or the method used to address missing data. As a general matter, incomplete follow-up can affect both the estimate and its precision, particularly if missingness is related to participants’ outcomes. The record does not permit a study-specific assessment of that possibility.
Interim analyses, stopping rules, and other details of the statistical plan are not reported in the registry record. The registry’s completed status does not resolve these uncertainties. Without the outcome estimates, analysis methods, and missing-data accounting, multiplicity and robustness cannot be evaluated from the posted results.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Fesoterodine 4 mg or 8 mg | 0 | 823 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Fesoterodine 4 mg or 8 mg | 78 of 823 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fesoterodine 4 mg or 8 mg |
|---|---|---|
| Dry mouth | Gastrointestinal disorders | 66 of 823 |
| Constipation | Gastrointestinal disorders | 11 of 823 |
| Adverse event | General disorders | 2 of 823 |
| Gastrointestinal disorder | Gastrointestinal disorders | 1 of 823 |
| Headache | Nervous system disorders | 1 of 823 |
The serious adverse-event summary lists 0 participants affected among 823 at risk in the fesoterodine 4 mg or 8 mg group. The record lists 78 participants affected by other adverse events among 823 at risk. No serious adverse-event terms are listed. Deaths are not reported in the registry record.
These figures are counts recorded for the study group, not a comparison with an untreated group or another treatment. They do not provide event-level detail, timing, duration, severity beyond the serious-versus-other categorization, or an assessment of whether an event was attributed to treatment. The record also does not explain the definitions used for these categories.
As a general principle, an adverse-event count describes events recorded under a study’s reporting process; it does not by itself establish cause. The reported counts should therefore be read as descriptive safety information for the recorded group, not as evidence that treatment caused or prevented an event. The registry record does not report comparative safety analyses or further detail needed to interpret the events.
12. What the Result Does, and Does Not, Mean
The registry record establishes that an observational study of fesoterodine was completed in patients with overactive bladder after previous antimuscarinic therapy failed because of ineffectiveness or intolerance. It defines the primary endpoint as change from baseline in mean daytime micturition frequency per 24 hours, using diary data at follow-up visits or early termination. It also records an enrollment of 823 and lists a full analysis set definition.
Those design details do not reveal the observed primary outcome. The mean changes, standard deviations, participant counts at each visit, confidence intervals, and statistical tests are not reported in the registry record. It is therefore not possible to describe whether frequency increased or decreased, how large any change was, or how precisely it was estimated. The other listed outcome results are also not reported.
Even if a within-group change were available, this observational design would not provide a randomized comparison. General statistical interpretation would need to distinguish change over time from a treatment effect, since other influences could contribute to a before-and-after pattern. The record does not report enough information to assess those influences or the handling of missing data.
The safety summary reports no serious adverse events among 823 at risk and 78 participants with other adverse events among 823 at risk. These counts are descriptive and do not establish causation or comparative safety. No serious-event terms are listed, and deaths are not reported in the registry record.
Accordingly, the registry entry is useful for identifying the study population, intervention, intended measurements, and some safety counts. It does not support a conclusion about the magnitude or precision of the primary outcome, nor does it establish a comparative treatment effect.
13. Why This Trial Matters Statistically
This record illustrates why a clearly defined endpoint and a reported result are both necessary for statistical interpretation. The endpoint definition specifies the unit, the daytime period, the diary-based calculation, the follow-up visits, and the summary measure. Yet without the observed means, standard deviations, analysis counts, and uncertainty estimates, readers cannot assess the size or precision of the change.
The observational design also matters. Within-participant measurement from baseline can describe a trajectory among people receiving treatment, but it does not supply a randomized counterfactual. A statistical summary of change would not, on its own, separate treatment-related change from other influences. This distinction is central when interpreting clinical outcomes, especially when previous treatment failure is part of the population description.
The record’s full analysis set definition makes the analysis population more explicit than enrollment alone, while leaving open how many people met that definition and how incomplete follow-up was handled. That gap demonstrates why participant flow and visit-specific denominators are important for evaluating both representativeness and precision.
Finally, the safety counts show why descriptive event summaries must be kept distinct from causal or comparative claims. The registry reports serious and other adverse-event counts, but does not supply event terms or a comparison group. Together, these features make the record a useful example of the difference between a planned measurement, a descriptive registry entry, and an interpretable treatment-effect analysis.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation is that the registry record does not report the primary outcome results or analyses. Although it specifies the mean change in daytime micturition frequency as the endpoint, it gives no mean changes, standard deviations, confidence intervals, tests, or visit-specific participant counts. The observed direction, magnitude, and precision are therefore unknown from this record.
The study is observational and does not describe a like-for-like control group or an allocation method. It cannot be interpreted as a randomized treatment comparison. The record does not report details that would permit adjustment for potential differences among participants or other factors that may influence change over time.
The analysis population is defined, but its size is not reported. Missing-data methods, reasons for incomplete diaries or follow-up, and the number of observations at each visit are also not reported in the registry record. The effects of missing measurements on the estimates cannot be assessed.
Other study details are limited in the registry entry. The statistical analysis plan, multiplicity approach, interim analyses, sample-size justification, and outcome estimates for the listed secondary measures are not reported. The safety information is also limited: no serious-event terms are listed, deaths are not reported, and further event details or comparative safety results are absent. These limitations constrain interpretation of both efficacy measurements and safety counts without implying that unreported procedures or results were absent from the full study documentation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy — NCT00691093.
- Registry record last updated 2018-11-02; status last verified 2018-10.
- Results first posted 2010-11-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT00691093 is a completed observational study of fesoterodine in patients with overactive bladder after failure of previous antimuscarinic therapy because of ineffectiveness or intolerance. The record reports an enrollment of 823, a start date of 2008-07, and primary completion in 2009-06.
The primary outcome is change from baseline in mean daytime micturition frequency per 24 hours at baseline, Month 1, Month 2, Month 3, or early termination. The full analysis set includes patients who received at least one dose and had at least one post-baseline efficacy measurement. Primary and secondary outcome results and statistical analyses are not reported in the registry record.
The adverse-event summary records 0 serious adverse events and 78 other adverse events among 823 participants at risk. No serious-event terms are listed, and deaths are not reported. The observational design and lack of a reported control comparison limit causal and comparative interpretation.