The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence (NCT02396160), a randomized na study. The primary outcome is Day Urinary Frequency.

2. Clinical Question

The registry describes a randomized, quadruple-masked, parallel-group trial of Urox and placebo for overactive bladder and urinary incontinence. The primary outcome is a continuous measure: a mean number of daytime micturitions per day. Its outcome population is restricted to participants whose baseline day urinary frequency met the stated criterion. The posted arm summaries describe the outcome at 8 weeks, but the registry does not report a numerical estimate of the difference between arms or a statistical test of that difference.

This distinction matters when reading the result. The mean in each arm describes its participants’ recorded day urinary frequency at the endpoint. It is not, by itself, an estimate of how much the treatment changed frequency relative to placebo. A comparison would need to account for both arms and be reported as a treatment contrast or through a specified comparative analysis. That contrast, its uncertainty, and its analysis method are not reported in the registry record.

The stated outcome is one measure among several symptoms and quality-of-life measures described in the trial summary. The registry lists secondary measures concerning urinary urgency frequency, urge incontinence frequency and stress incontinence frequency. The primary result is specifically daytime urination frequency, not nocturia, urgency, incontinence episodes or a composite measure of bladder symptoms.

3. Trial Design

The registry describes a randomized, quadruple-masked, parallel trial comparing Urox with placebo. The trial status is completed. Enrollment is listed as 150, with a start date of 2013-08 and primary completion date of 2014-12. These are registry entries; they do not establish how many participants contributed to each posted outcome. For the primary endpoint, the registry reports 50 participants in the treatment arm and 57 in the placebo arm.

The treatment description is two capsules per day of Urox, with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root. The placebo is described as an identical vegetarian capsule containing color-matched cellulose. Both arms are described in the registry summary as lasting 8 weeks after eligibility screening. The primary outcome is recorded at 8 weeks.

Random allocation is intended to make comparison groups similar on average at the start of a study, while masking is intended to reduce the influence of expectations or knowledge of assignment on care, reporting or assessment. These are general features of randomized masked trials; the registry record does not describe the allocation sequence, concealment procedures, or which groups of people were included in quadruple masking. It also does not report the methods used to maintain masking or whether masking was assessed.

A parallel design assigns participants to a group and follows that group’s assigned intervention over the study period, rather than having participants cross between interventions. The registry names the design as parallel but does not provide further operational details. The primary outcome population is limited by the stated baseline criterion of 10 or more daytime micturitions per day. The registry explicitly notes that participants did not necessarily meet the criteria for every outcome, which helps explain why outcome-specific counts need not align with the enrollment entry.

The registry lists the phase as NA and identifies The University of Queensland as sponsor. It does not report the protocol’s sample-size justification, detailed eligibility criteria, recruitment process, or a fuller schedule of assessments. Those details should not be inferred from the randomized design or from the enrollment entry.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Analysis includes participants who met the criteria for this outcome being day urination frequency ≥10 daytime micturitions per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.

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: This data includes all those who met criteria (minimum of 2 of the following symptoms per day for 6 months - Urinary Day Frequency ≥10 daytime micturitions; Nocturia ≥2 night time micturitions; Urinary Urgency ≥2 episodes and/or Incontinence ≥1 episode) and were entered into randomisation at the commencement of their enrollment into the study

6. Primary Endpoint

The registry lists the primary outcome as Day Urinary Frequency, measured over 8 weeks.

The primary endpoint is day urinary frequency, defined as the number of voluntary daytime micturitions per day and recorded in a validated urinary diary. A micturition is an episode of urination. The outcome is reported as a mean with a 95% confidence interval for each arm at 8 weeks. The registry restricts this outcome population to participants with 10 or more daytime micturitions per day at baseline.

As a continuous measure, day urinary frequency can retain information about the amount of variation in recorded counts rather than reducing each participant to a yes-or-no category. A diary can also capture repeated events over time, which may be useful when the symptom varies from day to day. These are general reasons such measures may be used; the registry does not give a rationale for selecting this endpoint or further details about diary completion and scoring.

The posted treatment-arm mean is 7.68, with a 95% confidence interval from 7.46 to 7.91. The placebo-arm mean is 10.95, with a 95% confidence interval from 10.7 to 11.2. These are arm-specific endpoint summaries, not a reported treatment-versus-placebo difference. The registry does not provide a baseline-to-endpoint change estimate, a direct between-arm confidence interval, or a test of the primary comparison.

Day urinary frequency is distinct from nocturia, urgency and incontinence. Although those symptoms and other quality-of-life measures appear in the trial description, the primary endpoint does not combine them. Its interpretation therefore concerns daytime urination frequency in the defined outcome population, not overall symptom burden or quality of life.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is continuous, and the registry reports its mean in each arm with a 95% confidence interval. A mean summarizes the arithmetic average of recorded values in a group. In general, it is useful for describing the central level of a continuous outcome, but it does not show the full distribution. The same mean can arise from different patterns of participant values, and the registry does not report a measure of spread for these arm summaries.

What does a 95% confidence interval describe?

In general, a confidence interval expresses uncertainty about an estimated quantity under the statistical method used to calculate it. A narrower interval indicates greater precision for that estimate under that method; it does not mean that nearly all individual observations fall inside the interval. The intervals are attached to each arm’s mean. The record does not explain the interval calculation method, so assumptions behind the calculation should not be guessed.

The treatment-arm mean is 7.68, with a 95% confidence interval from 7.46 to 7.91. The placebo-arm mean is 10.95, with a 95% confidence interval from 10.7 to 11.2. These intervals address uncertainty around separate means. A direct treatment comparison would ordinarily be represented by an estimated contrast between arms and an interval around that contrast, or by an appropriate test. Neither is reported in the registry record. Comparing arm-specific intervals by inspection is not a replacement for a direct comparative analysis.

Why does the analysis population matter?

The outcome population is defined by a baseline criterion: 10 or more daytime micturitions per day. This means the endpoint summaries apply to the participants meeting that criterion, rather than necessarily to every person enrolled. The registry says that not all participants met criteria for all outcomes. In general, defining an outcome population can be appropriate when the endpoint is meaningful only for people who meet a stated condition, but it also limits the population to which the estimate directly applies. The record does not report further details on how eligibility for this analysis was assessed or how the analysis population was established after randomization.

The outcome-specific counts are 50 for treatment and 57 for placebo. They should be read alongside the baseline criterion and not substituted for the enrollment figure. The record does not provide a participant flow account explaining the relationship between enrollment, assignment, outcome eligibility and the available endpoint records. It also does not say whether each participant’s diary data were complete or how incomplete diary records were summarized.

What can randomization and masking contribute?

In general, random allocation helps reduce systematic differences between groups at the time of assignment, while masking can reduce some biases related to expectations and knowledge of treatment. Here, the registry identifies the study as randomized and quadruple masked. Those design labels are useful context, but they do not report the randomization procedure, allocation concealment, masking roles, or the success of masking. They also do not replace a reported analysis comparing the randomized groups.

The parallel design means the registry characterizes the trial as comparing groups assigned to different arms, rather than as a crossover. The intervention description specifies Urox and a color-matched cellulose placebo, with an 8-week period. The registry does not provide enough detail to infer the analysis model, adjustment variables, or whether the reported endpoint means are adjusted for baseline measurements.

What is not reported about the statistical analysis?

The record does not report a treatment-effect estimate, its confidence interval, a p-value, or a statistical model for the primary outcome. It also does not report an analysis plan, including whether a particular analysis population was intended or whether any interim analyses occurred. Those omissions do not prove that no such procedures existed; they mean they are not reported in the registry record. The registry lists zero analyses, while endpoint means are posted. These registry entries support describing the means, but not attributing a comparative method or inferential result to the trial.

General statistical practice distinguishes estimation from testing. An estimate describes the magnitude and direction of a contrast, while its confidence interval describes uncertainty around that contrast under stated assumptions. A p-value, when reported, addresses how compatible data are with a specified null model under a particular analysis. None of these comparative quantities is available in the registry result, so no significance claim should be inferred from the arm summaries.

How should planning illustrations be read?

Any sample-size figures associated with planning are illustrations based on the observed effect, not observed power and not the trial’s own design rationale. The stated assumptions for such illustrations are a two-sided significance level of 0.05, equal allocation, a normal approximation, and detection of a stated fraction of the observed effect. General sample-size calculations depend on assumptions about the effect to detect and the analysis. They do not show the probability that this completed trial demonstrated an effect, and they cannot substitute for the missing comparative analysis. The registry record does not report a protocol-based sample-size justification.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies day urinary frequency as the primary outcome and lists three secondary outcomes: urinary urgency frequency, urge incontinence frequency and stress incontinence frequency. It also records five outcome measures overall. The record does not explain how these measures relate to one another in the planned hierarchy or whether any additional outcomes were prespecified. It does not report a multiplicity strategy, such as adjustment of statistical testing across outcomes. Without a reported comparative analysis, there are no posted p-values from which to assess how multiple testing was addressed.

The primary outcome is restricted to participants meeting the baseline criterion of 10 or more daytime micturitions per day. The registry notes that outcome eligibility criteria differ, meaning outcome-specific populations and counts may vary. That is important for interpretation: the primary endpoint count is not automatically the analysis population for a secondary outcome, and enrollment is not a substitute for an outcome-specific denominator.

Missing-data procedures are not reported in the registry record. There is no description of how incomplete diaries, missed visits, withdrawals, or unavailable endpoint values were handled. The record also does not provide a participant flow account that would clarify why endpoint counts differ from the enrollment entry. It would be inappropriate to assume that missing values were imputed, ignored, or handled by a particular model.

The analysis population beyond the endpoint’s baseline eligibility criterion is not reported. The registry does not state whether the primary result followed an intention-to-treat approach, a per-protocol approach, or another definition. These limitations leave uncertainty about how the posted means were assembled and how broadly they represent the randomized groups. They also prevent assessment of whether analyses across outcomes used consistent populations or missing-data rules.

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 registry reports serious adverse events for the treatment and placebo groups. In the treatment group, 69 participants are listed as at risk and 0 as affected by a serious adverse event. In the placebo group, 73 are listed as at risk and 0 as affected. These are the posted serious-event counts for the groups; they are not estimates of comparative risk and do not by themselves establish that the groups had equivalent safety outcomes.

The record also lists other adverse events: 5 in the treatment group and 8 in the placebo group, with 69 and 73 participants at risk, respectively. These entries are separate from the serious adverse event counts. The registry does not provide event descriptions for these other events in the registry record for this result, so they should not be characterized further.

The serious adverse event section does not report deaths. The registry does not provide enough information to assess event timing, severity details beyond the serious classification, relatedness to intervention, or how events were collected. The group counts also do not describe symptom outcomes or overall tolerability. They should be read as the adverse-event entries in the registry, not as a complete safety evaluation or a basis for treatment advice.

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

The posted result is a pair of arm-level means for day urinary frequency at 8 weeks in the primary outcome population. The treatment mean is 7.68, with a 95% confidence interval from 7.46 to 7.91; the placebo mean is 10.95, with a 95% confidence interval from 10.7 to 11.2. Descriptively, the treatment arm has the lower reported mean. The registry does not report the direct difference between arms or uncertainty around that difference.

This result does not establish the size or statistical precision of a treatment effect. The arm-specific confidence intervals concern the separate means, not a between-arm contrast. No primary comparison test or p-value is reported. It is therefore not possible to use the posted summaries to determine whether the observed descriptive difference is compatible with a range of comparative effects under a specified analysis.

The figures also do not show how much participants changed from baseline. The outcome population is selected using a baseline threshold, but the registry gives no baseline mean for the eligible analysis population and no change-from-baseline estimate. Nor does it report a threshold for a clinically meaningful difference. The clinical importance of the arm means or their descriptive separation is therefore not established by the registry result.

The endpoint is limited to daytime urination frequency. It should not be treated as a measure of nocturia, urgency, incontinence, quality of life, or all aspects of overactive bladder. Although the study summary describes additional measures, those results are not part of this primary endpoint interpretation.

Finally, the randomized and masked design provides relevant context but does not resolve gaps in outcome reporting. The analysis method, handling of missing data, and details of the analysis population beyond the stated baseline criterion are not reported in the registry record. A careful conclusion stays with what is posted: two endpoint means with arm-specific confidence intervals and outcome-specific counts, without a reported comparative effect estimate.

13. Why This Trial Matters Statistically

This trial is statistically instructive because its registry record combines a randomized design with arm-level endpoint summaries but no reported comparison estimate. Randomization is a basis for comparing assigned groups, yet interpretation still depends on seeing the contrast that answers the clinical question and the uncertainty around that contrast. Separate means are useful descriptive statistics, but they do not convey the full inferential result of a randomized comparison.

The endpoint population also illustrates why denominators require context. The registry enrollment entry is 150, while the primary endpoint summaries use 50 treatment participants and 57 placebo participants. The outcome requires meeting a baseline frequency criterion, and the record says participants did not necessarily meet criteria for every outcome. Without a participant flow account, these figures cannot be reconciled into a complete explanation of eligibility and endpoint availability. The appropriate reading is outcome-specific rather than assuming that every enrolled participant contributes to every measure.

Another statistical lesson is the distinction between precision for an arm mean and precision for a treatment contrast. A confidence interval around each mean communicates uncertainty about those means. A direct interval around the comparison would more directly answer how precisely the groups differ. Because that comparative interval is not reported, the arm summaries should not be treated as if they were a complete test of the primary question.

Finally, this record highlights the importance of reporting analytical details. A clear account of the analysis population, missing-data handling, model and multiplicity strategy helps readers understand how an estimate was obtained and what it represents. Those details are not reported. Recognizing these limits is part of statistical interpretation, rather than a judgment about the intervention or the conduct of the trial.

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 primary outcome applies only to participants meeting the stated baseline criterion of 10 or more daytime micturitions per day. This limits direct interpretation to that defined outcome population. The record notes that criteria differed across outcomes, but it does not provide a full account of how participants qualified for each measure or how outcome-specific populations were determined.

The registry reports arm-specific means and confidence intervals but no direct between-arm estimate, comparative confidence interval or p-value. The method used to calculate the confidence intervals is not described. The record also does not say whether the arm means were adjusted for baseline values or other factors. Consequently, the posted result cannot support a detailed assessment of the size or precision of the treatment contrast.

Participant flow and missing-data handling are not reported. Although the outcome-specific counts are given, the registry does not explain how they relate to enrollment, randomization, outcome eligibility, diary completion or unavailable observations. The analysis population is not characterized beyond the baseline criterion, and no intention-to-treat or per-protocol definition is reported.

The registry lists secondary outcomes and five outcome measures overall, but does not describe a multiplicity plan or provide comparative analyses for the primary endpoint. It also does not report a threshold for a clinically meaningful difference. These gaps limit interpretation of statistical evidence, clinical relevance, and the relationship between the primary and secondary outcomes. They are limits of the registry record and should not be filled by assumptions about the trial protocol.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence — NCT02396160.
• Registry record last updated 2016-05-05; status last verified 2016-04.
• Results first posted 2016-05-05.
• 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

The registry record describes a completed randomized, quadruple-masked, parallel trial of Urox versus placebo for overactive bladder and urinary incontinence. Enrollment is listed as 150; the recorded start is 2013-08 and primary completion is 2014-12. The intervention period is described as 8 weeks.

The primary outcome is mean day urinary frequency at 8 weeks, measured with a validated urinary diary among participants with 10 or more daytime micturitions per day at baseline. The treatment-arm mean is 7.68, with a 95% confidence interval from 7.46 to 7.91; the placebo-arm mean is 10.95, with a 95% confidence interval from 10.7 to 11.2. Outcome-specific counts are 50 and 57, respectively.

No between-arm estimate, comparative confidence interval, p-value, analysis method, missing-data procedure or analysis-population definition beyond the stated criterion is reported. Serious adverse events are listed as 0 in each group; deaths are not reported in the registry record.