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 An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia (NCT00605319), a na phase 4 study. The primary outcome is IPSS Obstructive.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00605319 |
| Phase | Phase 4 |
| Condition | Bladder Outlet Obstruction |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Weill Medical College of Cornell University |
| Results posted | Yes |
2. Clinical Question
Population
Patients with bladder outlet obstruction who had undergone treatment for the obstruction and continued to have symptoms associated with overactive bladder were the focus. The brief summary describes symptoms such as frequent bathroom trips and urgency, with or without difficulty holding urine until reaching the toilet. The registry record does not report further eligibility details or a more specific description of the population contributing to the primary outcome.
Intervention
The intervention was Toviaz (fesoterodine), with the arm description stating Toviaz 4mg to 8mg. The study was open label, so masking was listed as none. The registry record does not specify further details about how dosing was selected or adjusted.
Comparator
There was no separate comparator group. The design is listed as single group, with allocation recorded as NA. This means the study does not provide a concurrent control-group comparison from which to separate changes over time from other influences.
Primary question
The study asked whether fesoterodine could be assessed in relation to continued detrusor overactivity symptoms after treatment for bladder outlet obstruction. The registered primary outcome was the mean IPSS Obstructive score, assessed at screening (Month 0), 2-months, 3-months, and 7-months. The registry record does not report the observed scores or an analysis of change, so it does not establish the size or precision of any change.
3. Trial Design
This completed Phase 4 study is titled as an open-label evaluation of fesoterodine after surgery for benign prostatic hyperplasia. Its official title describes continued detrusor overactivity in patients who had undergone treatment for bladder outlet obstruction. The registry lists Weill Medical College of Cornell University as sponsor, a start date of 2010-01, and a primary completion date of 2013-01. Enrollment is recorded as 17.
The design is single group, with allocation listed as NA and masking listed as none. The intervention is Toviaz (fesoterodine), described as Toviaz 4mg to 8mg. There is no randomized or concurrent control arm in the record. Consequently, the design is suited to describing observations in the treated group over the registered follow-up schedule, but it cannot provide a like-for-like comparison with an untreated or alternative-treatment group.
The primary endpoint was IPSS Obstructive, expressed as a mean with standard deviation and measured in units on a scale. The registered assessment times were screening (Month 0), 2-months, 3-months, and 7-months. The record lists seven outcome measures and no analyses. It does not report details of the surgical procedures, the timing of surgery relative to study treatment, the treatment duration, or the analysis population for the primary endpoint. Those details are not reported in the registry record.
The study is marked completed. That status indicates the trial is recorded as finished; it does not by itself establish that outcome results were reported or that the intended follow-up was complete for every participant.
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 | Toviaz (Fesoterodine) |
|---|---|
| STARTED | 17 |
| COMPLETED | 11 |
| NOT COMPLETED | 6 |
Reasons for not completing this period:
| Reason | Toviaz (Fesoterodine) |
|---|---|
| Adverse Event | 6 |
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 | Toviaz (Fesoterodine) |
|---|---|---|
| Participants analysed | 17 | |
| Age, Continuous | years | 72.1 (53 to 91) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 17 |
| Region of Enrollment: United States | participants | 17 |
| BMI | kg/m^2 | 28.3 (19.1 to 35.9) |
| Voided Volume | mL | 86 (20 to 292) |
| Laser | participants | 13 |
| TURP | participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as IPSS Obstructive, measured over screening (Month 0), 2-months, 3-months, 7-months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome, IPSS Obstructive, is a symptom score intended to characterize obstructive urinary symptoms associated with benign prostatic hyperplasia. The registry describes the International Prostate Symptom Score (IPSS) as a 7 point scale used to screen, track, and manage symptoms associated with BPH, including obstructive, irritative, and nocturia symptoms. The listed questions cover incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia.
The outcome description states that scores range from 1 to 5 for a total of maximum 35 points, and identifies 0-7 as mildly symptomatic, 8-19 as moderately symptomatic, and 20-35 as severely symptomatic. For the obstructive measure, the description focuses on hesitancy or difficulty initiating the stream, straining to void, reduced flow, an intermittent stream, or a sensation of incomplete emptying. These details explain what the registered measure is intended to capture; they do not show how participants scored.
The endpoint is reported as a mean with standard deviation at screening (Month 0), 2-months, 3-months, and 7-months. A mean describes the group’s average score, while the standard deviation describes variability among individual scores. The registry record does not report the mean or standard deviation at any assessment time, nor a contrast between times. Therefore, the direction, magnitude, and precision of the observed endpoint are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clinically relevant symptom question: assessment of obstructive urinary symptoms in patients treated for bladder outlet obstruction who were given fesoterodine. It also identifies the intended measure and follow-up schedule. However, the posted registry information contains no primary outcome values. There is no reported mean IPSS Obstructive score at screening or at the later assessments, and no reported estimate of change over time. The record therefore does not show whether scores increased, decreased, or remained similar.
The design is important for interpreting any change that might be observed. Because this was a single-group study with no comparator, changes across assessments could not be directly contrasted with outcomes in a concurrent control group. General statistical interpretation: repeated measurements can describe how scores in a group vary over time, but without a comparison group, the observed pattern alone cannot isolate the contribution of the intervention from other influences. This limitation applies even when a change is measured precisely.
The study was open label, with masking recorded as none. General statistical interpretation: when participants and study personnel know which treatment is being used, expectations or awareness may influence symptom reporting, follow-up, or assessment. This is a potential source of measurement or conduct bias, not evidence that bias occurred in this study. The registry record does not provide information that would quantify or rule out such effects.
The outcome is a continuous score, and the registered summary is a mean with standard deviation. A mean can communicate the group’s average symptom score, but it does not convey the full distribution of individual scores. The standard deviation describes spread, not the uncertainty in the estimated mean. General statistical interpretation: a confidence interval would describe uncertainty around an estimate under the stated analysis assumptions. No confidence interval, standard error, p-value, or inferential result for the primary outcome is reported in the registry record.
Enrollment is listed as 17, but that number alone does not establish how many participants contributed data at each assessment. The registry does not report endpoint-specific denominators, missing outcome data, or an analysis population. It also lists no analyses. Accordingly, the posted registry information supports a description of the design and measurement plan, not a conclusion about efficacy or the size and precision of an observed effect.
The adverse-event record separately lists no serious adverse events and no deaths in the fesoterodine group, with 6 affected in the other adverse-event category. These are descriptive counts in the registry record. Without event descriptions, follow-up details, or a comparison group, they should not be used to infer comparative safety or to attribute an event pattern to treatment.
9. Statistical Methods Explained
What does a mean endpoint describe?
The primary endpoint is a continuous measure summarized as a mean. A mean is the arithmetic average of the recorded scores in the group included in a particular assessment. It can provide a compact description of the group’s average symptom level, but it does not show whether every participant had a similar score. A group mean can coexist with substantial variation among individuals, or with participants whose scores move in different directions.
The registry specifies a standard deviation alongside the mean. General statistical explanation: the standard deviation describes how dispersed individual observations are around the group mean. It is a measure of variability in the observed scores, not by itself a measure of how precisely the mean has been estimated. Precision depends on the amount of information available and on the distribution of the observations. The registry record does not report the endpoint’s means or standard deviations, so these properties cannot be assessed for the study’s results.
How should repeated assessments be understood?
The registered assessment schedule includes screening (Month 0), 2-months, 3-months, and 7-months. Measurements at multiple time points can describe the course of scores within the observed group. To interpret them, it is useful to know the number of participants contributing scores at each time and whether the analysis accounts for the fact that repeated observations from the same participant are related. The registry record does not report assessment-specific participant counts, a model for repeated measures, or an estimate comparing follow-up with screening.
General statistical explanation: observations from the same participant are usually not independent in the way observations from unrelated participants may be. An analysis that accounts for this dependence can estimate patterns over time and their uncertainty more appropriately than one that treats every observation as unrelated. Different methods can make different assumptions about the pattern of missing observations and the relationship among measurements. The registry record does not identify a method, so no particular approach should be attributed to this study.
What would uncertainty measures add?
A point estimate, such as a mean or a change in means, gives a single value for the quantity estimated. General statistical explanation: a confidence interval gives a range of values compatible with the data under a specified method and assumptions. A narrower interval generally indicates greater precision than a wider interval, but the interval does not eliminate bias from the study design or measurement process. A p-value addresses compatibility with a specified statistical null model; it is not the probability that a treatment works or that a finding is true.
No confidence interval, p-value, standard error, or primary-outcome analysis is reported in the registry record. Since the actual endpoint estimates are also absent, neither the magnitude nor the statistical uncertainty of the primary outcome can be evaluated from the registry information.
Why does the single-group design matter?
This is a single-group study, not a randomized comparison. General statistical explanation: a comparison group can help distinguish changes associated with treatment from changes that might occur over time for other reasons. Without such a group, a before-and-after pattern cannot by itself establish what would have happened to similar participants without the intervention. Open-label conduct also means masking was not used, which can be relevant to subjective symptom measures. These are design considerations, not proof that any particular bias affected the study.
The registry identifies enrollment as 17, but does not provide endpoint-specific denominators, participant flow, or analysis-population definitions. Those details matter because the observed mean and its precision depend on which participants contributed data at each time point. It is not possible to assume that every enrolled participant contributed every scheduled score.
What do the planning assumptions mean?
The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. This is a planning framework rather than the design description of this single-group trial. In particular, the registry does not report the observed primary endpoint effect needed to assess such a calculation, and the study itself did not have two allocated arms.
General statistical explanation: sample-size planning asks how much information a future study might need to detect a specified effect under stated assumptions. Planning counts are not observed power, are not a result of the completed study, and do not show that an effect was detected. An illustration based on an observed effect also depends on that effect being estimated with adequate reliability. The record does not provide a trial-specific sample-size justification or statistical analysis plan, so neither should be inferred from the planning assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven outcome measures, but identifies IPSS Obstructive as the primary outcome. It lists no analyses. The statistical plan for handling multiple outcomes or multiple assessment times is not reported in the registry record. No adjustment procedure, hierarchy among outcomes, or prespecified testing strategy is described. General statistical explanation: when many outcomes or comparisons are examined, the chance of finding an apparently unusual result can increase; a prespecified approach helps readers understand how such results were interpreted. The registry information does not establish how multiplicity was handled.
The primary endpoint has four registered assessment times: screening (Month 0), 2-months, 3-months, and 7-months. The record does not say whether the primary inferential question concerned one follow-up time, a change across the schedule, or another summary. No endpoint results or analysis estimates are reported, so the relationship between repeated assessments and any statistical testing cannot be evaluated.
Missing-data procedures and analysis populations are also not reported in the registry record. There is no account of how many participants had an endpoint value at each assessment, reasons for missing scores, or whether any observations were excluded. The record does not identify an intention-to-treat, per-protocol, or other analysis population. Enrollment of 17 cannot be treated as the denominator for every primary endpoint assessment without supporting information. These omissions limit assessment of completeness, potential selection effects, and the precision of any outcome estimate.
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 |
|---|---|---|---|
| Toviaz (Fesoterodine) | 0 | 17 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Toviaz (Fesoterodine) | 0 of 17 |
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 |
|---|---|
| Toviaz (Fesoterodine) | 6 of 17 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Toviaz (Fesoterodine) |
|---|---|---|
| Constipation/Dry Mouth | Gastrointestinal disorders | 3 of 17 |
| Urinary Leakage | Renal and urinary disorders | 2 of 17 |
| Nausea/Vomiting | Gastrointestinal disorders | 1 of 17 |
The registry’s adverse-event entry lists the Toviaz (Fesoterodine) group with 17 at risk for serious adverse events and 0 affected. It also lists 17 at risk in the other adverse-event category and 6 affected. Deaths are recorded as 0. These are counts as entered in the registry, not comparisons between treatments.
The registry does not list serious adverse-event terms, and it does not provide descriptions of the events in the other category, their timing, severity, or relationship to treatment. It also does not explain further how the other category is defined. The figures therefore offer limited descriptive information and should not be interpreted as a complete account of the nature or course of adverse events.
General statistical explanation: an affected-participant count is not necessarily the same as an event count, because a participant may experience more than one event. The registry entry does not provide event-level detail that would allow that distinction to be assessed. With no comparator group, these counts cannot establish whether the event pattern differs from what would occur under another treatment or without treatment. The absence of recorded serious events does not, on its own, establish absence of risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed, open-label, single-group Phase 4 study of fesoterodine was registered for patients treated for bladder outlet obstruction, with continued detrusor overactivity described in the official title. It identifies Toviaz (fesoterodine) as the intervention and IPSS Obstructive as the primary outcome. It also specifies a follow-up schedule and describes the symptom domains the score is intended to capture. These are useful details for understanding the study question and measurement plan.
The record does not report the primary outcome values, changes over time, uncertainty estimates, or a statistical analysis. It therefore cannot show the size or direction of an observed symptom-score pattern, how precise any estimate was, or whether a statistical test supported a difference over time. The fact that the study is marked completed does not substitute for outcome results.
The single-group design also limits what could be concluded even if measurements over time were available. Without a concurrent comparator, changes cannot be separated confidently from other influences through a direct treatment comparison. Open-label conduct may also be relevant to a subjective symptom score, although the registry information does not establish that this affected the observations.
The safety entry records zero serious adverse events, zero deaths, and 6 affected in the other adverse-event category, with 17 at risk in each listed category. The event descriptions and further context are not reported in the registry record. These counts are descriptive and do not support a comparative safety conclusion.
In short, the registry provides the design, registered outcome, schedule, enrollment, and limited adverse-event counts. It does not provide enough outcome or analysis information to determine the observed primary result or its precision.
13. Why This Trial Matters Statistically
This trial illustrates why a registered outcome and a completed status are not the same as a report of results. The record names a specific symptom measure, describes its content, and specifies follow-up assessments. Those details make the intended measurement question understandable. Yet without endpoint values and an analysis, readers cannot assess the observed pattern or its uncertainty.
The single-group design also highlights the distinction between describing a treated cohort and estimating a comparative treatment effect. Repeated scores can characterize what happened in the study group, but there is no concurrent control group for a like-for-like contrast. This matters particularly when outcomes are symptoms reported by participants, because time, expectations, and other influences may be relevant to interpretation. These are general design considerations rather than findings that bias occurred in this trial.
The registry’s adverse-event counts demonstrate another important statistical distinction: descriptive counts do not by themselves establish comparative risk. Event terms, timing, and comparison data are not reported in the registry record. The limited safety information should therefore be read as an account of the entered counts, not as a full safety evaluation.
Finally, the record’s planning assumptions should be kept separate from trial results. Sample-size planning is a forward-looking exercise under chosen assumptions; it is not evidence that an outcome was observed or that a statistical finding was precise. The record does not report a trial-specific analysis plan or primary outcome analysis. Together, these features make the study useful for discussing outcome definition, repeated measurement, control groups, and the difference between planned calculations and reported evidence.
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 for interpreting efficacy is that the registry record does not report the primary endpoint results. Although IPSS Obstructive is named and its assessment schedule is specified, there are no posted means, standard deviations, changes, confidence intervals, or test results. The magnitude and precision of the primary outcome are therefore not reported in the registry record.
The study is open label and single group, with no comparator. As a result, any observed change, if available elsewhere, would not have a concurrent control comparison in this record. The registry also does not report details of the surgical treatment or its timing relative to fesoterodine, limiting contextual interpretation of the post-treatment setting.
Information needed to assess data completeness is absent. The registry does not report participant counts at each outcome assessment, reasons for missing measurements, or the analysis population. It also does not describe the statistical model or approach to repeated measures. The record lists seven outcome measures, but does not report how multiple outcomes or time points were handled.
For safety, event descriptions and further detail about the other adverse-event category are not reported in the registry record. The counts cannot be compared against a control group, and the record does not provide event timing or treatment attribution. These limitations constrain both outcome interpretation and the ability to assess how comprehensively results and safety information were reported.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia — NCT00605319.
- Registry record last updated 2018-04-10; status last verified 2018-03.
- Results first posted 2018-04-10.
- 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
NCT00605319 is a completed Phase 4, open-label, single-group study sponsored by Weill Medical College of Cornell University. The registry lists enrollment as 17, a start date of 2010-01, and a primary completion date of 2013-01. The intervention is Toviaz (fesoterodine), described as Toviaz 4mg to 8mg, for a study focused on continued detrusor overactivity after treatment for bladder outlet obstruction.
The primary outcome is mean IPSS Obstructive, with standard deviation, assessed at screening (Month 0), 2-months, 3-months, and 7-months. The record lists no analyses and does not report primary outcome values or an analysis plan. It records 0 serious adverse events, 6 affected in the other adverse-event category, and 0 deaths. Further event details are not reported in the registry record.