Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm (NCT05214131), a randomized na study. The primary outcome is Number of Wet Nights.

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group study of two bedwetting alarms: GoGoband® and the standard nocturnal enuresis alarm (SNEA). The allocation is recorded as randomized. Masking is recorded as none, so the record describes the study as unmasked. The model is parallel, meaning the arms are presented as separate groups rather than as a crossover comparison. The phase field is recorded as NA.

The recorded enrollment is 16. Yale University is listed as the sponsor. The study start date is 2022-04-29, the primary completion date is 2025-06-13, and the overall status is terminated. These registry fields describe the study record; they do not establish why the trial ended or whether its intended enrollment was reached. The reason for termination is not reported in the registry record.

The primary outcome is titled Number of Wet Nights and is expressed in wet nights/week. The registry specifies a mean with standard deviation over a 3 month period. The population description refers to patients with MNE and no underlying ADHD. The registry does not give additional eligibility criteria or a fuller description of recruitment and follow-up in the information recorded for this outcome.

The outcome description says the groups were to be compared using a T test, Kruskal Wallis, or anova, depending on the number of comparisons and whether the data distribution was normal. It also states that no statistical analysis would be performed if patient numbers were less than 10 per group. The registry reports zero analyses and does not post a numerical comparison for the primary outcome. It does not report which candidate test, if any, was ultimately used.

For the SNEA arm, the record states that 8 patients were enrolled and given alarms, while 3 returned monthly data sheets for analysis. The corresponding number of returned data sheets in the GoGoband® arm is not reported in the registry record. This gap limits what can be established about the analyzed population and the balance of available outcome data between arms.

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: patients were assigned randomly to gogoband group and standard alarm therapy

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 8 patients in the SNEA group were enrolled and given alarms but only 3 returned their monthly data sheets for 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.

6. Primary Endpoint

The registry lists the primary outcome as Number of Wet Nights, measured over 3 month period.

The primary endpoint is the number of wet nights, recorded as a mean in wet nights/week over a 3 month period. It is a continuous measure: each participant's observations can be represented by a numerical rate, and the group summaries can describe the average level of wet nights. The registry specifies standard deviation as the measure of dispersion, which describes how spread out observations are around a group mean.

A count of wet nights captures the frequency of the event named by the study and makes a group-level comparison possible. In general, repeated observations over a stated period can be summarized as a rate to describe a participant's experience during that period. The registry identifies the unit and timeframe, but does not describe the exact data-sheet questions, the calculation used to turn entries into a weekly rate, or how partially completed records were handled.

The endpoint is relevant to the stated comparison because the study aims to compare the two alarm groups on wet nights. However, a defined endpoint alone is not a result. The registry record does not post group means, standard deviations, an estimated between-group difference, a confidence interval, or a p-value. It also does not post a numerical primary outcome analysis. Consequently, the endpoint definition explains what was intended to be compared, but the posted record does not show the size or precision of any observed group contrast.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, parallel-group design with no masking. In a randomized study, assignment is intended to make the groups comparable on average with respect to characteristics that could affect the outcome. Randomization does not guarantee that every characteristic is balanced in a small study, and it cannot substitute for clear reporting of who was analyzed and what data were observed. The record does not report a detailed allocation procedure or additional safeguards around assignment.

What does the endpoint summary represent?

Number of Wet Nights is recorded as a continuous outcome, with the mean as the summary parameter and standard deviation as the dispersion measure. In general, a mean represents the arithmetic average of observed values. A standard deviation describes how much individual values vary around that average; it is not the uncertainty in the estimated mean. The registry specifies wet nights/week and a 3 month period, but does not detail the handling of incomplete diary or monthly sheet entries.

For a continuous endpoint, a comparison may focus on the difference between group means. The registry does not post either group mean or a between-group estimate, so no such contrast can be described. It also does not report a confidence interval. In general, a confidence interval communicates the precision of an estimate under the analysis assumptions. It is not possible to describe precision for this study's primary comparison without a posted estimate and interval.

Why are several candidate tests named?

The outcome description lists a T test, Kruskal Wallis, or anova and says the choice would depend on the number of comparisons and whether the data distribution is normal. These methods do not all answer questions in precisely the same way. In general, a T test compares means under assumptions about the data and model; anova is used for comparisons of means across groups; and Kruskal Wallis is a rank-based method that can be considered when a distributional approach based on means is unsuitable. The registry does not report which test was selected, whether assumptions were assessed, or whether a test was carried out.

The presence of multiple possible tests in a protocol description is not itself evidence that several tests were run. Likewise, the registry's reference to the number of comparisons does not specify how many comparisons were planned or whether the primary comparison was adjusted for multiple testing. Those details are not reported in the registry record. No p-value or test statistic is posted for the primary endpoint.

Why does distributional shape matter?

General statistical explanation: a method based on means can be sensitive to the way observations are distributed, particularly when samples are small or values are unusually dispersed. A rank-based method uses the ordering of observations rather than relying on the same distributional assumptions as a mean-based test. The choice of method should follow the estimand and analysis plan as well as the data characteristics; switching methods after inspecting results can complicate interpretation. The registry provides a broad conditional description, but does not say how distributional shape was evaluated or document a final decision.

Over-dispersion is a general concern when observed variability is greater than a model assumes. If a model understates variability, standard errors may be too small and statistical uncertainty may appear less than it is. The registry does not report an over-dispersion assessment or a model-based count analysis. Since the endpoint is identified as a mean continuous measure and no outcome data are posted, over-dispersion cannot be assessed from this record.

What does the analysis threshold tell readers?

The outcome description says no statistical analysis would be performed if patient numbers were less than 10 per group. This is a stated condition in the registry record, not a report of a completed analysis. The record reports 3 returned monthly data sheets among 8 SNEA patients who were enrolled and given alarms. It does not report how many GoGoband® participants returned data sheets, or whether the threshold was applied to enrollment, available endpoint data, or another analysis population. The zero analyses field is consistent with an absence of a reported analysis, but the registry does not explain the decision in more detail.

Small samples generally yield less precise estimates, and they can make assumptions difficult to assess. A non-significant result, if one were reported, would not by itself establish equivalence or absence of a meaningful difference. Here, no inferential result is posted, so even that limited distinction cannot be made for this study.

Are planning calculations trial results?

General statistical explanation: sample-size calculations are planning exercises that depend on assumptions about the effect to detect, variability, significance level, allocation, and analysis method. They do not measure the effect observed in a trial and are not observed power. The registry's planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. No numerical planning outputs or underlying observed effect are included in the record summarized for the primary comparison. Such planning calculations should not be mistaken for trial outcome estimates.

For this study, the central limitation for statistical interpretation is not a choice between the named tests but the lack of posted numerical outcome results and a documented analysis population. Without these, readers cannot evaluate the estimated group contrast, its uncertainty, or the assumptions behind a completed analysis.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome description names one endpoint, Number of Wet Nights, but the registry record notes that the primary outcome has several categories or time points and was not reduced to one comparison. It does not specify what those categories or time points are in the posted outcome information. The record does not report a multiplicity adjustment, a hierarchy among comparisons, or a prespecified rule for selecting a primary contrast. Therefore, the number and relationship of the intended comparisons cannot be determined from the registry record.

In general, testing multiple outcomes or time points can increase the chance of a false-positive finding if each is treated as an independent opportunity to declare a result. Statistical plans may address this through an adjustment or a prespecified testing sequence. Those approaches are not reported in the registry record. No numerical primary comparison is posted, and the record lists zero analyses.

Missing outcome data are a separate concern. The registry says 8 SNEA patients were enrolled and given alarms, while 3 returned monthly data sheets for analysis. It does not report why the other sheets were not returned, whether any returned sheets were incomplete, or what was done with missing entries. The number of returned sheets in the GoGoband® group is not reported in the registry record. No missing-data method, imputation approach, sensitivity analysis, or participant-level accounting for the primary endpoint is described.

The registry does not identify whether the primary analysis was based on all randomized participants, participants who received an alarm, or only those with returned data. It also does not report a separate intention-to-treat or per-protocol analysis population. These distinctions matter because the group estimate can depend on which participants contribute outcome data and how missing observations are handled. The available record does not allow readers to assess that dependency or the potential for bias from incomplete outcome reporting.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry's adverse-event figures list the number at risk and the number affected for serious events, other events, and deaths in each alarm group. For the Gogoband Alarm, the record lists 8 at risk for serious events and 0 affected, and 8 at risk for other events and 0 affected; deaths are listed as 0. For the Standard Nocturnal Enuresis Alarm (SNEA) Group, it lists 3 at risk for serious events and 0 affected, and 3 at risk for other events and 0 affected; deaths are listed as 0.

These entries describe what was recorded in the registry, not proof that no events occurred outside the reported data or that the groups have identical safety profiles. The numbers at risk differ between the listed groups, and the registry does not explain the relationship between those denominators and the full enrollment or follow-up. In particular, the SNEA denominator matches the number reported as returning monthly data sheets, not the 8 patients described as enrolled and given alarms. The record does not report adverse-event collection methods, observation periods, or a detailed listing of event terms. No top serious-event terms are listed.

Zero affected means no affected participants are recorded in these adverse-event fields. It should be read as a registry entry with the stated denominators, not as a general safety conclusion.

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

The record documents a randomized comparison of GoGoband® with a standard nocturnal enuresis alarm and identifies wet nights per week over a 3 month period as the intended primary endpoint. It also records total enrollment of 16, a terminated status, and limited return of monthly data sheets in the SNEA group. Those details establish the study's stated question and some features of its data availability.

The record does not provide a numerical estimate comparing the arms. There are no posted group means or standard deviations for the primary endpoint, no confidence interval, and no p-value. Consequently, readers cannot determine the observed direction or magnitude of a difference, how precise an estimate would be, or whether the data are compatible with a range of possible effects. The record also does not identify the final analysis population or explain how missing monthly data were handled.

It would be incorrect to interpret the absence of a posted comparison as evidence that the alarms had the same outcome. It would also be incorrect to infer a difference from the study's design or its stated objective. Randomization describes assignment, not the results. The registry's status of terminated does not establish the reason for termination, and the record does not report that reason.

General statistical explanation: an inconclusive or unavailable estimate is different from evidence of equivalence. Equivalence requires a defined margin and an analysis that evaluates whether uncertainty is sufficiently narrow relative to that margin. The registry record does not report such a margin or an equivalence analysis. The objective's wording about whether one alarm is as effective or more effective does not, on its own, establish an equivalence or superiority result.

The most supportable conclusion is therefore about reporting, not comparative performance: the registry records the trial design and endpoint but does not post the outcome analysis needed to answer the primary question. The adverse-event entries list zero affected participants in the stated groups, but their denominators and reporting context should be kept in view. These entries do not fill the gap in primary outcome results.

13. Why This Trial Matters Statistically

This study illustrates an important distinction between a registered clinical question and a reportable statistical result. A randomized design can define how groups are intended to be compared, while conclusions still depend on outcome data, a clear analysis population, and transparent reporting of estimates and uncertainty. In this record, the endpoint is named and its unit and timeframe are stated, but no numerical primary comparison is posted.

The data-return information is especially relevant. The record reports that 8 SNEA patients were enrolled and given alarms, while 3 returned monthly data sheets for analysis. That difference makes it important to distinguish enrollment from the availability of usable endpoint data. Without corresponding information for the GoGoband® group and a documented missing-data approach, readers cannot establish how representative the analyzed data would be or how the observed comparison, if calculated, would relate to all randomized participants.

The record also shows why methods should be reported as completed, not only as possibilities. It names a T test, Kruskal Wallis, or anova depending on data characteristics, and states a condition under which no analysis would be performed. But it does not identify a selected method, an analysis set, or a result. Statistical transparency requires enough information to understand what was estimated and how uncertainty was assessed.

More generally, registry records can help identify planned outcomes and design features, but incomplete outcome reporting limits independent assessment. Here, the posted information supports description of the trial's question and reporting gaps; it does not support a quantitative comparison of the alarms. That distinction matters for researchers evaluating evidence and for readers learning how to separate study design, observed results, and interpretation.

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.

Several limitations specific to this study restrict statistical interpretation. The registry records enrollment of 16 and a terminated status, but does not report the reason for termination or explain whether enrollment and follow-up proceeded as planned. The primary completion date is 2025-06-13, yet the record does not provide context about the timing or completeness of the outcome data.

For the SNEA group, 8 patients were enrolled and given alarms, but only 3 returned monthly data sheets for analysis. The number of GoGoband® participants with returned data sheets is not reported in the registry record. There is no participant flow accounting for the primary outcome, and no explanation of missing or incomplete forms. This prevents a clear assessment of which participants contributed to the endpoint or whether missingness might affect the comparison.

The registry does not post group means, standard deviations, an estimated contrast, confidence intervals, or p-values for Number of Wet Nights. It lists zero analyses, and the primary outcome was not reduced to one comparison because it has several categories or time points. The categories and time points are not detailed in the posted information. The final analysis method, handling of distributional assumptions, and any multiplicity approach are not reported in the registry record.

The endpoint description gives the unit and timeframe, but does not specify how monthly data were converted to a weekly rate, how incomplete observations were handled, or whether the stated mean and standard deviation were calculated for all randomized participants or a subset. The record also provides no detailed outcome-data collection protocol in the information available for this analysis.

Finally, the no-masking design is recorded, but the record does not describe how outcome collection or analysis may have been protected from awareness of group assignment. These limitations do not establish the direction of any bias; they identify information gaps that prevent readers from judging the robustness and precision of a primary comparison.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm — NCT05214131.
• Registry record last updated 2026-03-09; status last verified 2026-02.
• Results first posted 2026-03-09.
• 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

NCT05214131 is a randomized, parallel-group, unmasked study sponsored by Yale University. It compares the GoGoband® nocturnal enuresis device with the standard nocturnal enuresis alarm (SNEA). The registry records enrollment of 16, phase NA, status terminated, a start date of 2022-04-29, and a primary completion date of 2025-06-13.

The primary endpoint is Number of Wet Nights, recorded as a mean in wet nights/week over a 3 month period, with standard deviation specified for dispersion. The outcome description names possible tests but does not report a completed analysis. The registry lists zero analyses and posts no numerical primary outcome comparison. It states that 8 SNEA patients were enrolled and given alarms, and that 3 returned monthly data sheets for analysis. The corresponding GoGoband® data-return count and the reason for termination are not reported in the registry record.