This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder (NCT00943735), a registered phase not stated study. The primary outcome is Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment.

2. Clinical Question

The study also set out to describe prescription filling, use of the YourWay website, views about the website and materials, and self-reported lifestyle changes. Those outcomes can provide context about participant engagement with the program, but the registry record does not report their observed results either. With no reported outcome estimates, the central statistical question is not whether one approach outperformed another; the design contains no stated comparator. Instead, it is whether the planned adherence and engagement measures were observed at a clearly defined level and with sufficient precision. The posted record does not supply the estimates needed to answer that question.

3. Trial Design

This was a 13-week, single-arm, open-label, multicenter study of fesoterodine plus the Your Way patient support plan in participants with symptoms of overactive bladder. The record lists Pfizer as sponsor, an enrollment of 774, a start in 2009-07, primary completion in 2010-11, and a completed status. These are design and registry entries, not outcome findings.

Participants were described as people presenting with overactive bladder symptoms at medical office visits who appeared to be candidates for fesoterodine therapy. The intervention listing includes fesoterodine, classified as a drug, and Your Way, classified as behavioral. Because the trial was single-arm and open-label, participants and investigators were not described as masked to the intervention, and the record does not provide a randomized control arm. Allocation details are not stated in the registry record. A usual-care or untreated comparison should not be inferred.

The primary measure concerned prescription fills within 90 days of enrollment. The endpoint description identifies a typical way to reach the 90-day supply threshold: three distinct prescriptions, each for a 30-day supply, with example fill opportunities at enrollment, Day 30, and Day 60. Participants could instead wait until a 14-day medication sample was exhausted before their first prescription fill. Investigators had no prescribing restrictions, although they were advised not to write a 90-day prescription at enrollment. Participants whose first observed fesoterodine prescription was for at least a 90-day supply were non-evaluable for the primary endpoint.

The endpoint population was defined using consent, an enrollment questionnaire, evidence of at least one LRx database prescription for any medication class, and the initial-prescription exclusion. Although enrollment was 774, the count in this endpoint population is not reported in the registry record. The record lists 30 outcome measures and 0 analyses. A statistical analysis plan, details of interim analyses, and a sample-size justification are not reported in the registry record.

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.

Before assignment: The use and dosage recommendations for fesoterodine 4 milligram (mg) or 8 mg tablet taken by mouth (PO) once daily (QD) adhered completely to the approved product label and was adjusted solely according to medical and therapeutic necessity.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Per Protocol (PP) population: all participants who returned a signed informed consent form (Intent to Treat) and enrollment questionnaire, had evidence of ≥1 prescription in LRx database for any medication class, and did not receive an initial fesoterodine prescription for ≥ a 90-day supply.

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.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment, measured over Enrollment (Day 0) up to 90 days.

The primary endpoint was the percentage of participants who filled at least 90 days’ supply of fesoterodine, at 4mg once daily or 8mg once daily, within 90 days of study enrollment. It is a binary participant-level outcome: each eligible participant either met the stated fill threshold during the defined period or did not. The registry record specifies a 95% confidence interval as the measure of dispersion, but does not report the observed percentage or interval.

Prescription fills are a way to operationalize medication acquisition. They can indicate that a prescription was obtained, but a fill does not establish that medication was taken as prescribed. The endpoint description also makes clear that the threshold could be reached through more than one prescription pattern. It gives three separate 30-day prescriptions as a typical pattern, while noting that participants could delay the first fill until after a 14-day sample. Investigators were advised against writing a 90-day prescription at enrollment, but prescribing was not otherwise restricted. A participant whose first observed prescription was for at least a 90-day supply was defined as non-evaluable for this endpoint.

Using a specified threshold and observation window can make an adherence measure concrete and reproducible. At the same time, interpretation depends on knowing who entered the denominator, how non-evaluable participants and missing prescription data were handled, and how the confidence interval was calculated. Those details are not fully reported in the registry record. The primary endpoint result itself is also not reported, so its frequency and statistical precision cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a percentage endpoint represent?

The primary outcome is a participant-level binary measure summarized as a percentage. In general, a binary outcome records whether a defined event or condition was observed for each participant. The percentage expresses the share of the analysis population meeting the definition. For this trial, the definition was filling at least 90 days’ supply of fesoterodine within 90 days after enrollment. The percentage depends on both the count meeting that definition and the denominator chosen for analysis. Neither the observed count nor the primary analysis denominator is reported in the registry record, so no observed percentage can be stated.

The definition combines a medication quantity threshold with a time window. A participant’s fills had to add up to the stated supply threshold within the stated period. The endpoint description gives a typical pattern of three separate 30-day prescriptions and notes that fills could begin at enrollment, Day 30, or Day 60. It also describes a possible first fill after a 14-day sample was exhausted. These details matter because the same threshold could be reached through different sequences of fills. The endpoint is about recorded fills, not confirmed ingestion.

What does a confidence interval add?

In general, a confidence interval presents a range of values compatible with an estimate under the method used to calculate the interval. It helps readers judge sampling uncertainty: a narrower interval indicates greater precision under that method, while a wider interval indicates less precision. An interval does not correct for selection, measurement, or other systematic biases, and it does not turn a single-arm estimate into a comparison. The registry record identifies a 95% confidence interval for the primary percentage, but its limits and calculation method are not reported in the registry record. The precision of the estimate therefore cannot be assessed.

For a binary percentage, statistical uncertainty is influenced by the number of participants contributing to the estimate and by the observed distribution of outcomes. In general, a confidence interval should be read together with its point estimate and denominator. Reporting only a percentage can obscure how much information supports it; reporting an interval without the analysis population can also leave important context unclear. In this record, the primary point estimate, interval, and endpoint population size are all absent.

Why does the analysis population matter?

The primary endpoint specifies a Per Protocol population. It includes participants who returned signed informed consent and an enrollment questionnaire, had evidence of at least one prescription in the LRx database for any medication class, and did not have an initial fesoterodine prescription for at least a 90-day supply. The enrollment total is not necessarily the number satisfying all these endpoint criteria. The record does not state the count included in the primary analysis or provide an outcome flow showing how participants were classified.

In general, an analysis population defines which participants contribute to an estimate. Different inclusion rules can produce different denominators and can affect how broadly an estimate applies. Excluding participants who meet a particular non-evaluable definition can be appropriate for a stated endpoint, but readers need to know how many were excluded and why. The registry record identifies the exclusion for a first observed 90-day-or-longer prescription, but does not report how many participants this affected.

How should open-label, single-arm evidence be read?

In general, an open-label design means the intervention is known to participants and investigators, and a single-arm design does not provide a concurrent comparison group. Such a design can describe what happened among participants observed under the study conditions. It cannot isolate the effects of separate components or establish what would have happened under a different intervention. Here, fesoterodine and the Your Way support plan were assessed together, and no randomized comparator is stated. The record therefore does not support a treatment-effect estimate comparing the combination with an alternative.

Open-label measurement can also matter for outcomes based on self-report, such as website usefulness, reading materials, or lifestyle changes. In general, responses may reflect participants’ awareness of the program or expectations, as well as their experiences. This is not evidence that reported responses were biased in this study; the registry record does not provide results or details to assess that possibility. It is a reason to interpret self-reported outcomes according to their measurement and design context.

What can be concluded from absent analysis details?

The record lists 30 outcome measures and 0 analyses. It does not report a statistical analysis plan, a sample-size justification, interim analyses, or the method used to calculate the primary confidence interval. These omissions do not establish what methods investigators did or did not use outside the registry entry. They mean those methods cannot be described from the registry record.

In general, having many outcomes raises questions about which measures were designated as primary, whether analyses were prespecified, and how multiple statistical tests were handled. The record identifies the primary endpoint and lists secondary measures, but does not give analysis results or a multiplicity procedure. It is therefore not possible to evaluate selective reporting, multiplicity adjustment, or consistency between a planned analysis and the reported results. There are no posted estimates from which to assess statistical significance or clinical importance.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Fesoterodine 4 mg or 8 mg")
n      <- c(500)
events <- c(52)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Fesoterodine 4 mg or 8 mg  500  52  10.4  7.9  13.4  8.0  13.4  8.0  13.4

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 30 outcome measures, including the primary prescription-supply endpoint and secondary measures related to prescription fills, website use, perceived usefulness, reading support materials, and reported lifestyle choices. It also lists 0 analyses. The outcome list describes measures of interest, but does not report their observed results. A statistical analysis plan and any multiplicity procedure are not reported in the registry record.

In general, when a study considers many outcomes, the chance of finding an apparently notable result among multiple tests can differ from the chance associated with a single prespecified test. Whether and how to adjust for multiplicity depends on the study’s aims and analysis plan. No adjustment method, hierarchy beyond the stated primary endpoint, or testing strategy is reported in the registry record, so none should be assumed. With no analysis estimates reported, there is also no set of results on which to evaluate the consequences of multiplicity.

Missing-data handling is not reported in the registry record. The endpoint description defines a Per Protocol population and excludes participants whose first observed fesoterodine prescription was for at least a 90-day supply, but does not say how other unavailable prescription records or incomplete outcome information were treated. The number of participants in the endpoint population and any missingness counts are not reported. Thus, the impact of missing observations or exclusions on the endpoint cannot be assessed.

The record’s primary endpoint population definition should not be confused with a complete account of the analysis. The eligibility criteria identify who was intended to contribute, but the actual number analyzed and the handling of deviations or unavailable records are not stated. These gaps limit assessment of denominator selection, potential bias, and reproducibility.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: arrhythmia (0.1%), cardiac failure congestive (0.1%), hypertensive heart disease (0.1%), vision blurred (0.1%), chest pain (0.1%).

The registry record lists 774 participants at risk for the serious adverse event grouping and 13 affected. It also lists 774 at risk and 100 affected in the other adverse event grouping. The record does not define the other grouping in the details available, so it should not be assumed to represent a specific severity category. These are counts in a single-arm study, not comparative safety estimates.

Six serious adverse event terms are listed with a frequency of 0.1% each: Arrhythmia, Cardiac failure congestive, Hypertensive heart disease, Vision blurred, Chest pain, and Fall. The registry record does not provide event-specific counts alongside these terms or explain whether participants could contribute to more than one term. The terms should therefore be read as the listed event categories, not as a complete account of individual participants or events.

Deaths are not reported in the registry record. The record does not provide a comparator, a causal assessment for the events, or enough detail to infer whether an event was related to the intervention. In general, safety counts describe events observed in the population and period recorded; they do not by themselves establish causation. Because the study was single-arm, these figures cannot show how event frequencies compare with another treatment or with an untreated group.

13. What the Result Does, and Does Not, Mean

The study’s stated purpose was to assess medication adherence among participants receiving fesoterodine with the Your Way education and support materials. Its primary endpoint was framed as a fill-based threshold: at least 90 days’ supply within 90 days of enrollment. This makes the intended measurement specific, but the registry record does not report the observed percentage or its 95% confidence interval. No conclusion about the frequency of meeting the endpoint or the precision of that frequency can be drawn from the record.

Even if the endpoint estimate were available, it would describe prescription filling, not necessarily medication use. A pharmacy fill indicates that a prescription was obtained in the recorded data source; it does not verify that the medication was taken as directed. The primary endpoint also excluded participants whose first observed prescription was for at least a 90-day supply, and the endpoint population was otherwise defined by specific consent, questionnaire, and prescription-evidence criteria. The number included under those rules is not reported.

The design does not permit a comparison between fesoterodine plus support and a separate treatment or support condition. It is single-arm and open-label, with no stated randomized control group. As a result, the record cannot separate the contribution of the medication from the support plan or other factors associated with participant selection and care. No causal treatment effect is reported.

The secondary outcomes describe intended measures of prescription refills, website engagement, opinions about the website, reading of materials, and self-reported lifestyle choices. Their results are not reported in the registry record. A list of outcome measures is not evidence that participants achieved those outcomes, and no estimates are available to determine how common any listed experience was.

The record can therefore support a description of the study’s design, population criteria, outcome definitions, and safety counts. It cannot support claims about the observed adherence rate, satisfaction, behavior change, comparative effectiveness, or the precision of the primary estimate. The distinction is between what the study set out to measure and what the registry record reports as results.

14. Why This Trial Matters Statistically

This study illustrates why a clearly defined outcome and a reported result are both necessary for statistical interpretation. The primary endpoint specifies a medication supply threshold, an observation window, dosage options, and a Per Protocol population. Those details help define what would count as meeting the endpoint. Yet without the observed number meeting the definition, the analysis denominator, and the confidence interval, readers cannot assess either the outcome frequency or its statistical precision.

It also shows how the operational definition of adherence shapes interpretation. Prescription fills are observable records, while taking medication is a different behavior. The trial’s endpoint focuses on fill history, and its description allows more than one prescription pattern to satisfy the threshold. That is a concrete, record-based measure, but it should not be generalized to unmeasured medication-taking behavior.

The single-arm, open-label design is important to the scope of any inference. It can describe outcomes within the study cohort if estimates are reported, but it does not establish a contrast with another approach. This is especially relevant because the intervention combines a medication and a support plan. A single combined intervention arm cannot identify which component might account for an observed result.

Finally, the record lists many outcome measures but no analyses. This emphasizes the distinction between registering outcomes and reporting their analysis. Without estimates, denominators, uncertainty measures, and information about multiplicity and missing data, statistical evaluation cannot move beyond the design and measurement definitions. The study is statistically informative as an example of an adherence endpoint and its population rules, while its outcome evidence is unavailable in the registry record.

15. 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.

Several limitations are specific to the information recorded for this study. The primary endpoint result is not reported in the registry record, despite the endpoint definition specifying a 95% confidence interval. The estimate, interval bounds, and number of participants included in the primary analysis are also not reported. This prevents assessment of the endpoint’s magnitude and precision.

The endpoint population is narrower than the total enrollment by definition: participants needed signed consent, an enrollment questionnaire, evidence of at least one prescription in the LRx database for any medication class, and no initial fesoterodine prescription for at least a 90-day supply. The registry record does not report how many participants met these conditions or how many were excluded under each criterion. The denominator’s composition and the effects of exclusions therefore cannot be assessed.

The outcome measures focus in part on prescription fills and participant reports. A fill-based endpoint does not directly measure medication-taking behavior, while reported website use, usefulness, reading, and lifestyle changes depend on participant responses. The registry record does not provide results or further measurement details for these secondary outcomes.

The study was single-arm and open-label, and no randomized comparator is stated. Any observed outcome would therefore be descriptive of this cohort rather than a direct contrast between interventions. The record also does not report a statistical analysis plan, sample-size justification, interim analyses, missing-data methods, or multiplicity handling. These limitations concern what can be evaluated from the registry record; they do not establish what procedures may have occurred outside it.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder — NCT00943735.
• Registry record last updated 2018-12-04; status last verified 2018-11.
• Results first posted 2012-03-15.
• 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.

19. Record Summary

The registry record describes a completed, 13-week, single-arm, open-label, multicenter study of fesoterodine plus the Your Way patient support plan in participants with overactive bladder symptoms. Enrollment was 774. The primary endpoint was the percentage of participants filling at least 90 days’ supply of fesoterodine within 90 days of enrollment, with a stated 95% confidence interval. The endpoint population had specific eligibility requirements, including exclusion of an initial fesoterodine prescription for at least a 90-day supply.

The record lists 30 outcome measures and 0 analyses. It does not report the primary endpoint estimate, the confidence interval limits, secondary outcome results, or the primary analysis population size. It also does not report a randomized comparator, a statistical analysis plan, sample-size justification, or methods for missing data and multiplicity. Safety listings include 13 affected among 774 at risk for serious adverse events and 100 affected among 774 at risk in the other adverse event grouping. These registry entries describe the study and posted safety counts; they do not provide a comparative treatment-effect analysis.