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 Fall Prevention in Older Adults With OAB (NCT03946124), a na phase 4 study. The primary outcome is Measure of Physical Activity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03946124 |
| Phase | Phase 4 |
| Condition | Overactive Bladder |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 74 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Pennsylvania |
| Results posted | Yes |
2. Clinical Question
Population
Adults aged 65 or older with overactive bladder who were undergoing treatment with an anticholinergic medication. The primary-outcome description narrows the analyzed population to patients who were present at follow-up and completed accelerometer wear.
Intervention
Open-label fesoterodine. The study description specifies a 90-day supply at 4 mg per day, with treatment beginning 1 week after baseline. After 2 weeks of treatment, the dose could be increased to 8 mg by telephone based on symptom report.
Comparator
There was no concurrent control group described. The registry identifies a single-group study and no randomized allocation, so the study is not a like-for-like comparison of treatment groups.
Primary question
The primary outcome was physical activity, measured as average daily step counts derived from an accelerometer worn for 1 week at follow-up. The study summary also describes aims to validate physical-activity and medication-preference instruments and to examine whether preference for anticholinergic medication relates to adherence, physical activity, and falls risk. The registry record does not report the primary outcome value or results for those broader aims.
3. Trial Design
The registry describes a prospective cohort study of older adults with overactive bladder undergoing treatment with anticholinergic medication. It lists the study as Phase 4, completed, and sponsored by the University of Pennsylvania. Enrollment is recorded as 74. The study dates run from 2015-07-25 to primary completion on 2017-07-19.
The design is single-group, with allocation listed as not applicable and masking listed as none. Participants received open-label fesoterodine. The arm description specifies a 90-day supply of 4 mg per day, starting 1 week after the baseline visit. After 2 weeks of treatment, the dose could be increased to 8 mg over the telephone based on symptom report. The study therefore does not include a randomized untreated or alternative-treatment group in the record.
This design can describe observations made among participants receiving the study medication and can explore measurements collected during follow-up. It cannot, by itself, separate changes associated with treatment from changes that might have occurred over time or for other reasons. There is no like-for-like control comparison in the registry record.
The registry lists one outcome measure and zero analyses. It does not report a statistical analysis plan, a sample-size justification for the study, or details of any interim analysis. The sample-size assumptions described for planning illustrations are not a description of the study's enrollment design or an observed-power calculation.
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 |
|---|---|
| STARTED | 74 |
| COMPLETED | 55 |
| NOT COMPLETED | 19 |
Reasons for not completing this period:
| Reason | Fesoterodine |
|---|---|
| Withdrawal by Subject | 19 |
Analysis population for the primary outcome, as defined in the registry: Patients who were present at follow up and completed accelerometer wear were included in analysis.
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 |
|---|---|---|
| Participants analysed | 74 | |
| Age, Continuous | years | 76.5 (SD 7.2) |
| Sex: Female, Male: Female | Participants | 74 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 26 |
| Race (NIH/OMB): White | Participants | 47 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 74 |
| Physical Activity - Daily Steps | Steps per day | 2117.7 (988.5 to 2924.25) |
| Physical Activity - CHAMPS questionnaire caloric expenditure/week, all activities | Kcal/week | 2552.4 (SD 2560.12) |
| Physical Activity - IPAQ questionnaire total physical activity | MET-min/wk | 785.62 (SD 1609.84) |
| Short Physical Performance Battery total score | units on a scale | 7.82 (SD 2.21) |
| Mini Cog screening test: Normal cognition | Participants | 60 |
| Mini Cog screening test: Abnormal cognition | Participants | 8 |
| OABq-SF Symptoms Severity score | units on a scale | 61.9 (SD 23.8) |
| UDI-6 total score | units on a scale | 44.2 (SD 20.5) |
6. Primary Endpoint
The registry lists the primary outcome as Measure of Physical Activity, measured over 1 week.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | steps per day |
| Endpoint classification | Time-to-Event Analysis |
The primary outcome is titled “Measure of Physical Activity.” Its unit is steps per day, and the registry describes the summary as a median with an inter-quartile range. Participants wore an accelerometer over the course of a week at follow-up; average daily step counts were derived from this weeklong measurement. The listed timeframe is 1 week.
Accelerometer step counts provide an objective measure of movement captured during the wear period. A week of monitoring can describe activity during that measured interval, rather than relying only on a participant's recollection. The median represents the center of the observed values in a way that is less influenced by unusually high or low observations than a mean can be. The inter-quartile range describes the spread of the middle portion of the observations. These are general statistical interpretations of the specified summaries.
The analysis population is defined as patients present at follow-up who completed accelerometer wear. The registry record does not report how many participants met that definition, the median step count, or its inter-quartile range. It also does not report a comparison or a sponsor analysis for this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies a clinically relevant measurement question: whether physical activity in older adults with overactive bladder can be assessed using accelerometer-derived step counts, in the context of treatment with fesoterodine. The posted information describes how the primary measure was collected and who was eligible for its analysis, but it does not give the resulting median daily step count or inter-quartile range. Without those values, the magnitude and variability of the observed activity measurement cannot be characterized from the registry record.
The study is described as a single-group prospective cohort, with open-label treatment and no randomized allocation. Consequently, any changes measured within the treated group would not alone show what would have happened without treatment or under another treatment. A change over time can reflect more than the intervention, including natural variation, concurrent influences, or differences in which participants contribute follow-up measurements. This is a general limitation of uncontrolled before-and-after interpretation.
The registry summary also describes aims concerning instrument validation and the relationship between medication preference, adherence, physical activity, and falls risk. However, the record lists one outcome measure and zero analyses. Results for those additional aims, their estimates, and their uncertainty are not reported in the registry record. No conclusion about those aims can be drawn from the listed primary-outcome description or adverse-event counts.
There is a classification issue in the outcome metadata. The outcome description identifies a median and inter-quartile range for daily step counts, while the result classification characterizes the analysis as time-to-event and says that only sponsor-reported hazard ratios are used. A hazard ratio concerns relative event rates over time; it does not directly summarize the distribution of daily step counts. The registry record lists no analyses and no sponsor-reported hazard ratio. This inconsistency means the intended result format cannot be resolved from the posted information. It should not be treated as evidence that a time-to-event result was observed.
The adverse-event record lists no serious adverse events and no deaths in the fesoterodine group, and it lists 7 other adverse events. Those are descriptive counts in the registry record. They do not establish whether an event was caused by treatment, and the absence of a serious event entry is not proof that the risk is zero. In a single-group study, the figures also do not provide a comparative safety estimate.
Overall, the record supplies design and measurement details but no posted efficacy estimate, uncertainty interval, or sponsor analysis for the primary outcome. The numerical result needed to assess the observed physical-activity measurement is not reported in the registry record.
9. Statistical Methods Explained
The registry describes the primary measure as median daily steps with an inter-quartile range, derived from a week of accelerometer wear at follow-up. It also classifies the result as a median-time outcome and describes its result approach as time-to-event, using only sponsor-reported hazard ratios. These descriptions do not align cleanly: step counts per day are not themselves a time-to-event measure. The record lists zero analyses and no sponsor-reported hazard ratio, so the discrepancy cannot be clarified from posted analyses.
What does a median describe?
In general, a median is the central value after observations are ordered. It can be useful when a distribution is skewed or contains unusually extreme values, because the center is less affected by such observations than the arithmetic mean. An inter-quartile range gives information about the spread of the middle half of observations. It is a measure of variability, not an uncertainty interval for the estimated median. The registry specifies these summaries but does not post their values.
Why does the analysis population matter?
The outcome description says that patients present at follow-up who completed accelerometer wear were included. This is a follow-up-completer definition, not a statement that every enrolled participant contributed an endpoint value. In general, the value of an outcome among those with usable follow-up measurements may differ from the value that would have been seen among all enrolled participants, particularly if completion is related to health, activity, treatment experience, or other factors. The registry record does not report the number completing wear, reasons for noncompletion, or a comparison of completers with those without a usable measurement.
How should a time-to-event method be understood?
In general, time-to-event methods analyze how long it takes for a defined event to occur while accounting for participants whose event time is not observed during follow-up. A hazard ratio compares event rates over time between groups or conditions, subject to the model and its assumptions. Such a result requires a clearly defined event and follow-up time. The listed primary endpoint instead describes daily step counts, and no event definition, hazard ratio, or time-to-event analysis is reported. Therefore, a time-to-event interpretation cannot be made from the record.
What is over-dispersion, in general?
For count outcomes, over-dispersion means that the observed variability is greater than a simple count model would expect. If count data were analyzed with a model that assumes too little variability, standard errors can be too small and uncertainty can be understated. This is a general consideration for count data, not a claim about the analysis used in this study. The registry does not report a count model, a dispersion assessment, or model-based estimates for step counts.
What do the planning assumptions describe?
The registry's sample-size assumptions describe planning illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They describe detecting a stated fraction of an observed effect. The record also distinguishes total events for time-to-event planning from participants per arm for other planning calculations. These are planning conventions, not evidence that the trial itself randomized participants between arms. The study is listed as single-group, with allocation not applicable. A sample-size illustration is not observed power, and it does not substitute for a trial-specific design rationale. The trial's sample-size justification is not reported in the registry record.
Because no outcome estimate, uncertainty interval, analysis details, or sponsor-reported hazard ratio is listed, recalculated estimates cannot be interpreted as a substitute for a sponsor analysis. No sponsor analysis is available in the posted record to take precedence over any recalculation.
10. Multiplicity, Missing Data and Analysis Populations
The record lists one outcome measure and zero analyses. It does not describe a hierarchy of primary and secondary hypotheses, a multiplicity adjustment, or a prespecified method for handling multiple comparisons. The broader study aims include instrument validation and questions about medication preference, adherence, physical activity, and falls risk, but results or analysis details for those aims are not reported in the registry record.
Multiplicity matters in general when several outcomes, time points, subgroups, or comparisons are examined. Testing many hypotheses can increase the chance that at least one result appears notable by chance. A prespecified hierarchy or adjustment can help make the interpretation more transparent. Since the record does not describe such methods, it is not possible to determine how multiplicity was handled or whether any particular result was selected from multiple analyses.
The primary outcome definition includes only participants present at follow-up who completed accelerometer wear. The number meeting that definition, missing-data handling, reasons for missing measurements, and any imputation or sensitivity analyses are not reported in the registry record. These omissions matter because incomplete follow-up can affect the population represented by the observed endpoint. In general, an analysis limited to participants with complete measurements can be biased if availability of those measurements is related to the outcome or its determinants.
The record also does not report an intention-to-treat approach or another named analysis population. Because the study is single-group rather than randomized, the usual contrast between randomized intention-to-treat and per-protocol groups is not specified in the posted record. The available information is insufficient to determine how medication changes, discontinuation, or incomplete treatment exposure were handled in the outcome analysis.
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 | 0 | 74 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Fesoterodine | 0 of 74 |
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 | 7 of 74 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fesoterodine |
|---|---|---|
| Side effects | Gastrointestinal disorders | 6 of 74 |
| Dizziness, edema | Vascular disorders | 1 of 74 |
The registry reports 0 serious adverse events among 74 participants at risk in the fesoterodine group. It reports 7 other adverse events among 74 participants at risk and 0 deaths. No serious adverse-event terms are listed.
These are counts as recorded, not estimates of comparative risk. With no control group, the record cannot show whether the frequency of events differed from what would have occurred without fesoterodine or under another treatment. The listed at-risk counts do not establish that every participant had the same duration of observation or that every event was captured in the same way; those details are not reported in the registry record.
A serious adverse event is a category distinct from other adverse events. The absence of a listed serious event should be read as no serious events reported in this registry entry, not as proof that serious events are impossible or that the treatment has no safety risks. Likewise, the other-event count does not by itself establish causation, severity, or clinical importance. The record does not provide event-level descriptions for the 7 other events.
12. What the Result Does, and Does Not, Mean
The record describes a completed study of fesoterodine treatment in older adults with overactive bladder and an accelerometer-based primary measure of physical activity. It identifies the measure, collection period, and analysis-population definition. It does not report the primary outcome value, its inter-quartile range, a treatment effect estimate, or a sponsor analysis. Therefore, the posted information cannot establish the size, direction, or precision of any change in daily steps.
The study's single-group, open-label structure is important to interpretation. Even if a before-and-after result were available, observations in one treated group would not establish what would have happened under a different treatment or without treatment. A controlled comparison is needed to make a stronger comparative inference, and the registry does not describe one. The record also does not provide results for the stated aims involving instrument validation, medication preference, adherence, or falls risk.
The listed safety counts provide descriptive information for the treated group: no serious adverse events or deaths are reported, while other adverse events are recorded. Those counts are not a comparative safety analysis and cannot establish that events were caused by, or unrelated to, treatment.
The record's time-to-event classification does not match the primary-outcome description of median daily steps with an inter-quartile range. No hazard ratio or analysis is posted to resolve that mismatch. The statistical result should therefore not be interpreted as a time-to-event treatment effect. In short, the registry record documents study conduct and intended measurement but does not report enough outcome analysis to determine what the observed physical-activity data show or how precisely they were estimated.
13. Why This Trial Matters Statistically
This study is statistically notable for combining a practical measurement question with a treatment cohort. Physical activity is described through accelerometer-derived daily step counts, while the study summary also emphasizes validating instruments that could measure activity in older adults. The endpoint definition makes clear that the intended measure depends on both follow-up attendance and completed device wear, so the availability of usable measurements is central to interpreting any result.
The record also illustrates why outcome definitions and analysis labels need to agree. Median daily steps and an inter-quartile range describe a distribution of activity values. A time-to-event classification and hazard ratio describe a different kind of statistical question. Since the record lists no analyses or hazard ratio, readers cannot determine which result format was intended or whether the classification is an error.
Design information is equally important. This is a single-group, open-label cohort rather than a randomized comparison. That distinction limits what can be concluded about treatment effects, regardless of how precisely an outcome is measured. Clear reporting of outcome estimates, uncertainty, missing follow-up, and the analysis population would help readers understand both the observed activity data and their limitations.
Finally, the record's stated interest in medication preference, adherence, physical activity, and falls risk extends beyond its listed primary measure. Statistical interpretation of those questions requires corresponding analyses and results, which are not reported in the registry record. The gap between stated aims and posted results is a reporting limitation, not evidence for or against an association.
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 most direct limitation is the absence of a posted primary-outcome result. Although the registry specifies median daily steps and an inter-quartile range, neither value is reported. The record also lists zero analyses, so it does not provide an estimate, uncertainty interval, or sponsor analysis for the primary outcome.
The analysis population is limited by its stated definition to people present at follow-up who completed accelerometer wear. The number meeting that definition and information about participants without usable follow-up measurements are not reported in the registry record. Without these details, the extent and possible consequences of missing endpoint data cannot be assessed.
The study is single-group and open-label, with no randomized allocation or control comparison. This precludes a direct estimate of how the measured outcome would differ under an alternative treatment or no treatment. The record does not report the timing or number of follow-up assessments beyond the primary measure's 1-week timeframe, or details of adherence and treatment exposure beyond the dosing description.
There is also a mismatch between the step-count endpoint description and the time-to-event result classification. No analysis or hazard ratio is posted to resolve it. The study summary identifies additional aims concerning instrument validation, medication preference, adherence, and falls risk, but their results are not reported. Multiplicity procedures, missing-data methods, and a trial-specific sample-size justification are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Fall Prevention in Older Adults With OAB — NCT03946124.
- Registry record last updated 2023-05-06; status last verified 2023-05.
- Results first posted 2019-12-11.
- 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
NCT03946124 is a completed Phase 4, prospective, single-group study sponsored by the University of Pennsylvania. It enrolled 74 adults aged 65 or older with overactive bladder and describes open-label fesoterodine treatment. The primary outcome was accelerometer-derived average daily steps, summarized as a median with an inter-quartile range over a 1-week measurement period at follow-up.
The primary analysis population was patients present at follow-up who completed accelerometer wear. The registry lists one outcome measure and zero analyses, and does not report the primary outcome value or a sponsor analysis. It lists 0 serious adverse events, 7 other adverse events, and 0 deaths in the fesoterodine group. The absence of a control group limits comparative interpretation, and the record's time-to-event classification is not reconciled with its step-count endpoint description.