Overnight Pant Study for Children With Nocturnal Enuresis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Overnight Pant Study for Children With Nocturnal Enuresis (NCT05178641), a randomized na study. The primary outcome is Number, Frequency and Severity of Product Related Adverse Events.

2. Clinical Question

3. Trial Design

NCT05178641 is listed as a randomized, single-masked crossover trial with enrollment of 32 participants. The study status is completed. The registry record lists the study start as 2022-01-13 and primary completion as 2022-02-28. The sponsor is Procter and Gamble, and the phase is listed as NA.

In a crossover design, participants receive more than one study condition in sequence, so each participant may contribute information under both conditions. In this trial, one sequence began with Ninjamas Pyjama Pants for 3 weeks and then switched to the participant’s Overnight Current Standard of Care for 3 weeks. The other sequence used the standard of care first and Ninjamas Pyjama Pants second, with the same stated period lengths. Randomization was to sequence, rather than to a permanently separate product group.

This design can support within-participant comparisons when outcomes are measured consistently across periods. Interpretation can also depend on period effects, the order in which products are used, and whether experience during one period influences the next. How the study addressed these considerations is not reported in the registry record. The identity of the person or persons masked is also not reported in the registry record; “single” is the masking designation recorded.

The registry describes home diary assessment and adverse-event tracking twice daily. The primary outcome timeframe is from admission to discharge, up to 6 weeks. The record does not report the detailed diary definitions, compliance summaries, or analysis population. Although the registry lists 32 participants enrolled, the posted adverse-event summaries use different denominators for sequence and product categories. The reason for these denominator differences is not reported in the registry record.

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: Participants were given 4 days practice time to get used to the study procedures (Jan 13th - Jan 16th), before the first period started on Jan 17th.

First 3 Weeks of Study (Week 1-3)

Reasons for not completing this period:

Last 3 Weeks of Study (Week 3-6)

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.

6. Primary Endpoint

The registry lists the primary outcome as Number, Frequency and Severity of Product Related Adverse Events, measured over From admission to discharge, up to 6 weeks.

The primary endpoint is titled “Number, Frequency and Severity of Product Related Adverse Events.” Its stated unit is the number of product-related adverse events, and its parameter type is listed as number. The description says that Adverse Device Effects and Adverse Events were tracked twice daily using a safety in-use diary. The stated observation period runs from admission to discharge, up to 6 weeks.

Safety monitoring is used to identify unwanted events during product use and to describe their occurrence and seriousness. The endpoint’s title indicates attention to number, frequency, and severity, but the registry record does not give operational definitions for these dimensions or explain how a diary entry was classified as product-related. It also does not report a separate numerical result for this primary endpoint or a statistical comparison between products.

The posted adverse-event summaries distinguish serious events from other events. Those summaries offer descriptive safety information, but they do not by themselves reproduce the full primary endpoint as titled. In particular, the registry record does not show a result that combines event counts, frequency, and severity into a comparative estimate. The secondary outcome, parent-assessed product performance in terms of urine leaking, is listed, but its result is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies randomization, single masking, and a crossover model. It does not report a statistical analysis plan, a model used to analyse outcomes, or an inferential result. There are no analyses listed in the posted record. Statistical interpretation should therefore remain descriptive and should not substitute a newly constructed comparison for an analysis the registry does not report.

What does randomization to sequence mean?

In this study, randomization assigned participants to the order of product use. One group used Ninjamas Pyjama Pants and then the participant’s Overnight Current Standard of Care; the other used the standard of care and then Ninjamas Pyjama Pants. Each period was 3 weeks. Randomizing sequence can reduce systematic differences in which order is used, but it does not remove the need to account for the paired observations and the time period in which each observation was made.

In a crossover analysis, outcomes from the same participant are generally related. A paired analysis uses that within-participant structure rather than treating observations from the two periods as though they came from unrelated people. This is a general statistical principle, not a description of an analysis documented for this trial. The registry record does not report whether the outcome was analysed as paired, how sequence or period was handled, or whether any carryover effect was assessed.

Why can period and order matter?

In general, an outcome can change over time for reasons other than the product being used. A period effect is a systematic difference between the first and later periods. An order effect means outcomes may differ depending on which product was used first. Carryover refers to an influence of an earlier condition on observations in a later condition. These considerations can matter in crossover studies, but the registry record does not state whether they occurred or how the statistical plan addressed them.

The primary outcome is described as a number of product-related adverse events, with frequency and severity also named. Count outcomes can be analysed using methods suited to counts, but the appropriate method depends on how the outcome was defined, its distribution, and the design. General methods for count data can account for the possibility that variability exceeds what a simple count model expects; this is often called over-dispersion. The registry record does not report a count model, a dispersion assessment, or enough outcome detail to identify the method used.

What can the posted event counts establish?

The registry lists serious-event counts and other-event counts for sequence groups and product-specific categories. Counts and denominators are useful for describing what is recorded. They do not, by themselves, quantify uncertainty or establish whether a difference is compatible with chance. A confidence interval, in general, expresses the precision of an estimate under a statistical model and its assumptions. No confidence interval or comparative estimate for the primary outcome is reported in the registry record.

The sequence summaries are organized by assigned order, while the product summaries are organized by product. Because this is a crossover study, a product comparison would ordinarily need to respect which observations came from the same participants and which period they came from. The posted summaries do not show that paired structure. The record also does not explain why the at-risk denominators differ between sequence and product categories, so no reconciliation should be assumed.

What do the planning assumptions mean?

The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It specifies that the effect to detect is a stated fraction of the observed effect. The record does not present a single selected comparison for this multi-category or multi-time-point primary outcome, and the outcome is not reduced to one comparison. Consequently, a usable single observed effect and resulting participant requirement are not reported in the registry record. Such planning illustrations, when available, describe assumptions for future design; they are not observed evidence from the trial and are not a measure of the study’s observed power.

Overall, the record allows the design and posted safety counts to be described, but not the statistical analysis to be reconstructed. The model specification, handling of repeated observations, analysis population, missing-data strategy, and inferential results are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome and one secondary outcome. It does not report how the outcomes were prioritized for statistical testing, whether any multiplicity adjustment was planned, or whether analyses were designated as confirmatory or exploratory. Without that information, no family-wise error strategy or other method for interpreting multiple statistical tests can be attributed to the study.

The primary outcome itself includes number, frequency, and severity, while the secondary outcome concerns parent-assessed urine leakage. Multiple dimensions or repeated diary assessments can create several possible summaries and comparisons. The record does not say which time points, categories, or contrasts were intended to support a formal conclusion. No numerical secondary-outcome result is reported in the registry record, and no statistical analysis is listed.

Missing data are also not described. The record does not report diary completion, participant withdrawals, missing outcome observations, imputation, or sensitivity analyses. It is therefore not possible to determine from the registry record whether all enrolled participants contributed complete observations or how incomplete diaries affected the posted counts.

The record lists enrollment of 32 participants but does not define an analysis population, such as participants who started both periods or those with usable diary information. It also does not report whether the analysis followed randomized sequence assignment or applied other inclusion rules. These omissions matter because results can depend on which participants and observations enter an analysis. No assumptions about missingness or population selection should be inferred from enrollment alone.

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.

Most frequent non-serious adverse event terms

The posted safety summaries list 0 serious adverse events for each sequence group and for each product-specific category. The sequence groups each list 16 participants at risk. The product-specific summaries list 30 at risk for Ninjamas Pyjama Pants and 28 at risk for the participant’s Overnight Current Standard of Care. The record does not explain the difference between these denominators and the sequence-group denominators.

For other adverse events, the record lists 12 affected among 16 at risk in the Ninjamas-first sequence and 14 among 16 at risk in the standard-of-care-first sequence. Product-specific entries list 21 affected among 30 at risk for Ninjamas Pyjama Pants and 19 among 28 at risk for the standard of care. These are descriptive entries; the registry record does not report a statistical comparison or confidence interval for them.

A zero serious-event count means no serious events are listed in the relevant posted category. It is not proof that serious events cannot occur or that the products have identical safety profiles. The registry record does not provide definitions for the “other” category, details of event relatedness, or a complete comparative analysis.

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

The record establishes that a randomized crossover study of Ninjamas Pyjama Pants and participants’ Overnight Current Standard of Care was completed, with 32 participants enrolled. Participants were assigned to one of two product sequences, with each period lasting 3 weeks. The stated objectives included adverse-event monitoring and parent assessment of urine leakage.

The posted safety summaries list no serious adverse events in the sequence or product-specific categories. They also list other adverse-event counts, including 12 affected participants in the Ninjamas-first sequence and 14 in the standard-of-care-first sequence. Product-specific summaries list 21 affected for Ninjamas Pyjama Pants and 19 for the standard of care. These counts describe the registry entries; they are not adjusted estimates of comparative risk, and their denominators differ across the two types of summary.

The posted information does not establish that one product is safer or performs better than the other. The registry record does not report the primary endpoint’s comparative statistical result, a confidence interval, or a test of a treatment difference. It also does not report a result for parent-assessed urine leakage. Without those results and the analysis details, it is not possible to assess the size or precision of a product difference from the registry record.

Absence of a reported result is not evidence of no difference. Similarly, a count of zero serious events does not demonstrate that the underlying risk is zero. The record does not report the event definitions, how product relatedness was determined, how missing diary observations were handled, or which participants were included in each analysis. The appropriate reading is therefore limited: the record describes the design and presents event counts, while leaving the comparative outcome questions unanswered.

13. Why This Trial Matters Statistically

This study illustrates the distinction between a trial design and a statistical result. Randomized crossover assignment can provide observations under both products within participants, but valid comparative interpretation depends on analysis that respects this structure. The registry record describes the sequences and period lengths yet does not report a paired analysis, a model, or an inferential comparison.

It also demonstrates why safety counts need context. The record reports zero serious events and lists other adverse events, but provides different denominators for sequence groups and product-specific summaries. Without an explanation of those denominators, definitions of event categories, and a comparative analysis, the counts should remain descriptive rather than be read as a ranking of products.

The endpoint description names several features—number, frequency, and severity—while the posted record does not give a single comparative estimate for them. That makes it important to distinguish the stated outcome from the results actually available. The secondary question about urine leakage is listed, but its result is not reported in the registry record.

For biostatisticians and clinical researchers, this record is a useful reminder that enrollment, randomization, and completion do not alone establish what a study found. Interpretation also requires outcome definitions, analysis populations, methods that match the design and outcome type, and transparent handling of missing observations. Where those details or results are absent, the statistically sound conclusion is a bounded description of what is posted, not an inferred effect.

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 main limitation for interpretation is that the registry record does not report a statistical analysis for the primary endpoint, despite posting adverse-event summaries. There is no comparative estimate, confidence interval, or hypothesis test. The secondary outcome, parent-assessed urine leakage, is listed without a reported result. The study’s central safety and performance questions therefore cannot be answered from the posted results alone.

The primary endpoint description does not give operational definitions for event number, frequency, severity, or product relatedness. The record does not explain how diary entries were classified, whether an event could be counted more than once, or how the “other” adverse-event category relates to the primary endpoint. These details are needed to understand what the counts represent.

The study uses a crossover design, but the record does not report an analysis accounting for within-participant observations, sequence, period, or possible carryover. The reason for the difference between sequence-group denominators of 16 and product-specific denominators of 30 and 28 is not reported in the registry record. The posted summaries do not reveal how many participants contributed paired data.

Enrollment is listed as 32, but participant characteristics, diary completeness, withdrawals, the analysis population, and missing-data handling are not reported in the registry record. Further details about masking are also absent beyond the designation “single.” The record does not report a sample-size justification or a statistical plan. Together, these gaps limit assessment of precision, representativeness, and the robustness of any comparative interpretation.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Overnight Pant Study for Children With Nocturnal Enuresis — NCT05178641.
• Registry record last updated 2024-10-01; status last verified 2024-06.
• Results first posted 2024-10-01.
• 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

NCT05178641, “Overnight Pant Study for Children With Nocturnal Enuresis,” is listed as a completed randomized, single-masked crossover study sponsored by Procter and Gamble. Enrollment was 32. The study compared Ninjamas Pyjama Pants with each participant’s Overnight Current Standard of Care in two sequences, with 3 weeks per product.

The primary outcome was the number, frequency, and severity of product-related adverse events tracked twice daily by diary, from admission to discharge, up to 6 weeks. The secondary outcome was parent-assessed urine leakage. Posted safety summaries list 0 serious adverse events and counts for other adverse events. A comparative statistical result for the primary outcome and a result for urine leakage are not reported in the registry record. Analysis methods, missing-data handling, and the reasons for differing denominators are also not reported in the registry record.