Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy (Part II): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy (Part II) (NCT01215721), a na na study. The primary outcome is Time to Continence.

2. Clinical Question

The clinical question concerns time to continence in men with severe incontinence following robotic-assisted radical prostatectomy who were prescribed Vesicare. The endpoint is the time, in days, until a participant reported being pad-free. The record describes patient self-report using a pad-free continence declaration card. It lists the primary measure as a median, with standard deviation as the dispersion measure, over a 12 months timeframe.

This is a single-group question, not a randomized comparison of Vesicare against an untreated or alternative-treatment group. The record therefore does not directly estimate how continence timing differs between Vesicare and another treatment. Nor does it establish what would have happened to the same participants without Vesicare. The study description gives a clinical rationale involving postoperative urgency, frequency, and incontinence, but the primary question captured by the listed endpoint is specifically about time to zero-pad continence.

The registry record does not report a numerical median time, a standard deviation, or a hazard ratio for this outcome. It also does not report a comparison with another group. The clinical question is identifiable from the endpoint definition and intervention description, but its answer cannot be quantified from the posted results.

3. Trial Design

The registry record identifies NCT01215721 as a completed study sponsored by the University of California, Irvine. Enrollment is listed as 40. The study is marked as single-group, with allocation listed as NA and masking as NONE. Its phase is listed as NA. The intervention is Vesicare, described as 5mg daily for 90 days, prescribed for men presenting with severe incontinence after robotic-assisted radical prostatectomy.

The primary outcome is time to continence, measured in days to zero-pad continence over 12 months. The description says continence was assessed through a patient self-reported pad-free declaration card. The registry record lists the outcome parameter as median and the dispersion as standard deviation. It does not give a numerical value for either statistic in the posted results.

The study began in 2010-10, reached primary completion in 2013-05, and is marked completed. These dates describe the registry record’s study timeline; they do not supply outcome follow-up details for individual participants. The record does not report how often continence status was checked, how a declaration date was assigned, or how follow-up ending before a declaration was handled.

Because there is no separate comparator arm and no random allocation, the design does not support a randomized between-group treatment contrast. The record lists no analysis entries. It does not report a statistical analysis plan, a sample-size justification for the study itself, or details of any interim analyses. Those omissions limit what can be concluded about the planned and conducted analyses.

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: Only men who at the 6th or 7th day post-catheter removal are multiple pad users (3 pads or more) will be invited to participate in this trial.

Overall Study

Reasons for not completing this period:

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.

Population: Baseline Population: Men presenting with urinary incontinence requiring 3 pads or more at post-catheter day 6 or 7 after RARP (robotic assisted radical prostatectomy).

6. Primary Endpoint

The registry lists the primary outcome as Time to Continence, measured over 12 months.

The primary endpoint is time to continence, expressed as days to zero-pad continence and assessed over 12 months. It is based on a participant’s self-reported declaration of being pad-free on a continence declaration card. The registry record lists the summary measure as the median and identifies standard deviation as the dispersion measure.

Time-to-event endpoints are generally useful when the timing of an event matters, rather than only whether it occurred by a fixed assessment. They can, in principle, represent both the occurrence and timing of a defined event. In this study, reaching zero-pad continence is the event of interest. This is a general explanation of the endpoint type, not confirmation of the exact analysis used in this study.

Self-report makes the endpoint directly reflect a participant’s declaration, but the record does not describe verification, the schedule for collecting declarations, or the rules for assigning the event date. It also does not explain how participants without a recorded declaration during follow-up were handled. These details matter for interpreting a time-to-event summary.

No numerical median time or standard deviation is reported in the registry record. The endpoint definition is available, but the posted results do not quantify how long participants took to declare zero-pad continence.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies the primary endpoint as a time-to-continence measure, but gives no numerical primary outcome result or analysis entry. The following concepts explain how this kind of endpoint is commonly interpreted; they do not establish which procedures were used in this study.

What does a time-to-event measure describe?

In general, a time-to-event measure records the time from a defined starting point until a specified event. Here, the event is the participant’s declaration of zero-pad continence, and the unit is days. Unlike a simple yes-or-no outcome at a single time, time-to-event data retain information about when the event is recorded. The registry record does not specify the individual time origin, assessment schedule, or rules for dating a declaration, so those operational details cannot be inferred.

A median time is a summary of the distribution of event times. It does not describe every participant’s experience, and it is not an average. The registry record lists the median as the primary parameter but does not report its value. It also lists standard deviation as the dispersion measure without reporting a numerical value. Without those results, neither the typical recorded time nor the spread of recorded times can be assessed from the posted results.

Why can follow-up and censoring matter?

Generally, some participants in a time-to-event study may not have a recorded event by the end of their observation, or may stop being observed earlier. Such observations are often treated as censored: the event time is not known, but it is known that the event had not been recorded up to some point. Correct interpretation depends on the study’s rules for follow-up and censoring. The registry record does not report whether censoring occurred or how it was handled, so no particular method should be attributed to this analysis.

For a self-reported declaration endpoint, the observed date can depend on when participants are asked to report status and how the declaration card is completed. The record names the card but does not describe its administration, confirmation process, or handling of incomplete reports. These are relevant measurement details, not evidence that the recorded endpoint is inaccurate.

What would a hazard ratio mean?

In general, a hazard ratio compares event rates over follow-up between groups, under the assumptions of the analysis used. Its interpretation depends on there being groups to compare and on the model and data meeting relevant conditions. The registry record marks the study as single-group and does not report a hazard ratio. A comparative hazard ratio cannot therefore be interpreted from the posted results. A single-group time-to-event description and a between-group hazard ratio answer different questions.

Why does over-dispersion matter?

In general, over-dispersion means that observed variability is greater than a statistical model expects. If a model assumes less variability than the data contain, standard errors and uncertainty estimates can be too small. The registry record does not report a count model, an over-dispersion assessment, or an analysis that relies on a count distribution. Over-dispersion is therefore a general concept, not a documented issue in this study’s primary endpoint.

How should the planning assumptions be read?

The stated sample-size assumptions describe a planning illustration: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. For time-to-event planning, the assumptions say that tables give the total number of events using the Schoenfeld approach; other planning tables give participants per arm. These are not trial design details or observed results. In particular, equal allocation between two arms is a hypothetical planning setup, whereas the trial itself is listed as single-group.

Sample-size calculations are planning illustrations, never observed power. They depend on assumptions about an effect and analysis design; they do not recover missing trial outcomes or demonstrate that an intervention caused an outcome. The registry record does not report the study’s own sample-size justification, and no numerical planning outputs are stated in the record summarized for this analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists one outcome measure and zero analysis entries. It does not report a multiplicity adjustment, a hierarchy of endpoints, or a plan for handling multiple statistical tests. With no analysis entries, the posted results do not show whether any inferential tests were performed or how multiple comparisons, if any, were addressed. This is an absence of analysis detail, not evidence that multiplicity was or was not a concern in the study’s conduct.

The primary outcome is described, but the record does not report a numerical result, an analysis population, or a participant flow for the endpoint. The enrollment entry is 40; it does not establish how many participants contributed usable endpoint data. Missing outcome data, withdrawals, and reasons for any missingness are not reported in the registry record. It is also not reported whether any participants were excluded from an analysis.

The population field for the primary outcome is blank. The treatment description identifies men presenting with severe incontinence after robotic-assisted radical prostatectomy, but the registry record does not provide further endpoint-specific eligibility or analysis-population details. It does not state whether analyses followed an intention-to-treat principle, included only participants who began treatment, or used another population definition.

These omissions make it difficult to judge the completeness of follow-up and the robustness of the endpoint estimate. They also prevent assessment of whether the analyzed participants differed from those enrolled or whether missingness could have affected the result. No assumptions about missing-data handling or analysis populations can be made from the registry record.

11. 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 non-serious adverse event terms

The adverse-event entries list a Vesicare treatment group with 40 at risk for serious adverse events and 0 affected. For other adverse events, the entry lists 40 at risk and 2 affected. These are counts in the registry record, not rates calculated. The entries do not provide a comparison group, so they cannot show how these counts compare with another treatment or with no treatment.

The record does not list serious adverse event terms. The death count is not reported in the registry record. It also does not explain the definitions used for the serious and other adverse-event categories, the period during which events were collected, or whether the counts represent participants or event episodes beyond the labels shown. The figures should therefore be read as the posted safety counts, with those reporting limits in mind.

A count of 0 in the serious-event field means that no serious adverse events are recorded for the listed group in this entry. It does not establish that risk is absent, particularly when follow-up and ascertainment details are not given. Similarly, the 2 other adverse events are not, by themselves, evidence of a causal relationship to Vesicare. The registry record does not provide the detail needed for comparative or causal safety conclusions.

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

The posted record establishes the basic structure of the study: a completed single-group evaluation of Vesicare in men described as presenting with severe incontinence after robotic-assisted radical prostatectomy. The intervention was 5mg daily for 90 days. The primary endpoint was time in days to a self-reported declaration of zero-pad continence, with a 12 months timeframe. The registry record also lists the enrollment and safety counts.

What the record does not establish is the observed median time to continence, the variability in that time, or a treatment-effect estimate. Those primary numerical results are not reported in the registry record. There is no listed comparator group, so the design does not provide a randomized comparison against another intervention or usual care. The outcome description alone cannot demonstrate that Vesicare changed continence timing.

The result also cannot be interpreted as evidence that participants generally did or did not become continent, because the registry record does not report the number who declared zero-pad continence or the endpoint analysis population. The safety entries describe recorded counts but do not establish comparative risk or causation. No conclusions about missing outcomes, follow-up completeness, or analysis procedures can be drawn from details that are not reported.

In general, a study can be informative about measurement feasibility and the observed course in a treated group, but those conclusions require numerical outcomes and sufficient methods detail. Here, the endpoint and treatment are identifiable while the numerical primary result and key analysis details are absent. The appropriate interpretation is therefore limited to what was recorded, not a claim that treatment works or does not work.

13. Why This Trial Matters Statistically

This study is statistically notable because its primary question concerns the timing of a patient-reported event, rather than only a status at one assessment. Time to zero-pad continence can capture when a participant reaches the stated endpoint. Interpreting that measure, however, requires clear information about how time is measured, follow-up is collected, and participants without a recorded event are handled. The registry record identifies the endpoint but does not report those details.

The single-group design is also central to interpretation. Without a comparator, an outcome in the treated group cannot distinguish an intervention-associated change from the course that might otherwise occur after surgery. A clear endpoint does not remove this limitation. The lack of a reported numerical primary result adds another constraint: readers cannot assess the observed timing or its precision.

The record also illustrates why planning calculations and study results answer different questions. The planning assumptions describe a hypothetical two-arm setup, while the trial is listed as single-group. Planning illustrations are not outcomes, and they cannot repair an absent treatment-effect estimate. They should not be interpreted as observed power.

Finally, safety counts are most useful when their definitions, observation period, and comparison context are clear. The registry lists counts but does not report those supporting details. Taken together, these features make the study’s endpoint and design identifiable while limiting the strength and scope of statistical conclusions available from its registry record.

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 principal limitation for interpretation is that the registry record does not report the numerical primary outcome result. Although it specifies a median time-to-continence endpoint and standard deviation, neither value is given. No hazard ratio is reported, and the record contains zero analysis entries. Consequently, the primary outcome’s magnitude and precision cannot be evaluated.

The study is listed as single-group, with allocation NA and masking NONE. There is no like-for-like control comparison described. The design therefore does not provide a randomized estimate of differences attributable to Vesicare. Enrollment is listed as 40, but endpoint-specific participant counts and the analysis population are not reported.

The endpoint relies on a self-reported pad-free declaration card. The registry record does not describe the timing or frequency of assessments, how declarations were verified, or the method used to assign event dates. It also does not report censoring, follow-up completion, missing-data handling, or reasons for missing observations. These omissions prevent assessment of whether the recorded event times represent complete and consistently collected follow-up.

The safety information is limited to the posted counts. Serious adverse event terms are not listed, the death count is not reported in the registry record, and event definitions and observation duration are not described. There is no comparator for interpreting those counts comparatively.

Finally, the planning assumptions describe equal allocation between two arms despite the single-group trial design. These assumptions are illustrations, not a description of the trial’s design or its observed outcomes. The registry record does not report a study-specific sample-size justification, so the rationale for enrollment cannot be assessed.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy (Part II) — NCT01215721.
• Registry record last updated 2014-01-23; status last verified 2013-12.
• Results first posted 2014-01-23.
• 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.

18. Record Summary

NCT01215721 is a completed, single-group study sponsored by the University of California, Irvine. Enrollment is listed as 40. The intervention was Vesicare 5mg daily for 90 days, prescribed for men presenting with severe incontinence after robotic-assisted radical prostatectomy.

The primary endpoint was time in days to zero-pad continence over 12 months, assessed by a self-reported pad-free continence declaration card. The registry record lists a median and standard deviation but does not report their numerical values. It also contains zero analysis entries and describes no comparator group.

Safety entries list 0 serious adverse events among 40 at risk and 2 other adverse events among 40 at risk. Serious-event terms are not listed, and the death count is not reported in the registry record. Outcome analysis population, missing-data handling, and follow-up details are not reported.