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 Wetness Sensing System (NCT05454813), a na na study. The primary outcome is Sensor Detection.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05454813 |
| Phase | NA |
| Condition | System Validation |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 56 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Medline Industries |
| Results posted | Yes |
2. Clinical Question
Population
Participants in a system-validation study using an adult brief. The registry record does not report participant characteristics or a more detailed description of the participant population. Four participants were removed from the primary analysis because of deviations; the number included in that analysis is not reported in the registry record.
Intervention
The FitRight® ConnectTM Wetness Sensing System, described as including a pod, app, charger or adapter, sensing brief, and alert indicator. Participants were to use the system during the study, with real-life measurement data collected to assess it.
Comparator
No comparator group is reported. The study is listed as single-group, with allocation recorded as NA and no masking. The registry record does not describe a control condition or a comparison between different devices.
Primary question
Can the sensor detect when an adult brief has absorbed enough normal saline, poured to simulate a urinary void, to trigger an alert to change the brief? The stated assessment covers approximately ~90-360 milliliters of saline and sitting, supine, and right or left side positions. Detection was assessed 5 minutes after each pour.
3. Trial Design
This is a completed, single-group device-validation study registered as NCT05454813. The official title is Evaluation of a Wetness Sensing System for Continence Care. The registry lists an enrollment of 56 and Medline Industries as the sponsor. The recorded study start date is 2022-06-08, and the primary completion date is 2022-06-29. Allocation is recorded as NA, masking as none, and the study model as single group.
Participants were to use the FitRight® System for the duration of the study. The stated aim was to collect real-life measurement data while assessing sensor detection. The primary endpoint description focuses on a simulated urinary void: normal saline is poured into an adult brief, and the sensor's ability to trigger an alert to change the brief is evaluated. The endpoint timeframe is 5 minutes after each amount of saline is poured. The registry describes amounts of ~90-360 milliliters, up to four pours for each brief, and 3 briefs, one for each position. It names sitting, supine, and right or left side positions.
The record does not describe a randomized comparison or a parallel control group. A single-group design can describe measurements made with the system but does not, on its own, estimate a difference against another device or care approach. The registry does not report a protocol-level account of how positions and pours were assigned or ordered, how a pass was defined, or how measurement observations were combined for analysis.
The primary outcome is Sensor Detection, expressed as percentage of passes and summarized as a mean with a 95% confidence interval. Rewet Test is listed as a secondary outcome. The registry record does not report numerical results for either outcome, or a detailed statistical analysis plan. Four participants were removed from the analysis because of deviations, but the resulting analysis population size 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: All participants are combined in one arm for the analysis because the first two positions are the same for all participants.
Overall Study
| Stage | All Participants |
|---|---|
| STARTED | 56 |
| COMPLETED | 56 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Four participants were removed from the analysis because of deviations. The measure type mean was chosen below because the unit of measure is the percentage of passes.
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 | All Participants |
|---|---|---|
| Participants analysed | 56 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 19 |
| Age, Categorical: >=65 years | Participants | 37 |
| Sex/Gender, Customized: Male | Participants | 18 |
| Sex/Gender, Customized: Female | Participants | 38 |
| Sex/Gender, Customized: Other | Participants | 0 |
| Sex/Gender, Customized: Decline to Answer | Participants | 0 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 56 |
6. Primary Endpoint
The registry lists the primary outcome as Sensor Detection, measured over 5 minutes after each amount (90-360 milliliters) saline is poured into the brief. There could be up to four pours for each brief and 3 briefs (one for each position)..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of passes |
| Endpoint classification | Continuous Endpoint |
The primary endpoint, Sensor Detection, concerns whether the FitRight® System sensor detects liquid in an adult brief and triggers an alert to change it. The study description uses normal saline poured into the brief to simulate a urinary void. It specifies assessment 5 minutes after each pour, for amounts of ~90-360 milliliters, with the assessment intended to cover sitting, supine, and right or left side positions.
The outcome is expressed as percentage of passes, and the registry says the measure type is a mean because the unit is percentage of passes. In general, a pass-based measure describes the frequency of successful detection under the conditions included in its denominator. The registry record does not define what counted as a pass, how many detection opportunities contributed to each percentage, or how participant, brief, position, and pour-level observations were aggregated. Those details are important for interpreting the mean and its uncertainty.
The endpoint is relevant to the stated technical aim because the system is intended to signal when a brief has absorbed enough liquid to prompt a change. However, a sensor-detection measure is not itself a measure of clinical outcomes or of how people use the system in routine care. The endpoint's numerical mean and 95% confidence interval are not reported in the registry record. Rewet Test is listed as a secondary outcome, but its result and measurement details are also not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes what the study set out to assess, but it does not report the primary endpoint estimate. Sensor Detection was intended to be summarized as a mean percentage of passes with a 95% confidence interval. Neither that mean nor its confidence interval is reported in the registry record. Therefore, the posted record does not establish the observed detection proportion, the precision of that estimate, or whether performance varied across the listed liquid amounts or positions. The secondary Rewet Test result is also not reported.
In general, a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A relatively narrow interval would indicate greater precision than a relatively wide one, but no interval is available to interpret in this case. The record also does not report a p-value or a detailed inferential analysis. No conclusion about statistical significance can be drawn from the registry information.
The record states that four participants were removed from the analysis because of deviations. It does not specify the number analyzed, the nature of those deviations, whether the exclusions were decided before analysis, or how those participants' measurements were handled. Without the analysis population and outcome data, it is not possible to assess the influence of these exclusions or the extent of missing information.
The single-group design is suited to describing system measurements under the study conditions, but it does not provide a between-group estimate against a control device or alternative approach. The registry does not report a comparator. It also does not state whether observations from multiple pours or briefs were modeled as repeated measurements within participants. That matters because measurements from the same participant may be related rather than statistically independent; the analysis method would need to account for the actual data structure where appropriate.
The safety entries list 56 participants at risk for serious adverse events and 0 affected, and 56 at risk for other adverse events and 0 affected. Deaths are listed as 0. These entries describe the registry's recorded counts; they do not measure sensor detection and do not substitute for missing endpoint results. The adverse-event collection period and detailed ascertainment methods are not reported in the registry record.
Overall, the record establishes the study's stated validation question, single-group design, and intended outcome summary. It does not give the outcome values needed to judge the observed sensor-detection performance or its statistical precision. Any planning illustrations based on an observed effect also cannot be interpreted from the registry record because the observed effect and the illustration values are not reported there.
9. Statistical Methods Explained
The registry describes a continuous primary measure summarized as a mean, with a 95% confidence interval. The underlying unit is percentage of passes. No numerical estimate or interval is reported, and the registry does not give a detailed account of the statistical procedures used to obtain them.
What does a mean percentage of passes describe?
In general, a mean combines measured values into a central summary. Here, the registry's stated rationale is that the outcome unit is percentage of passes. To interpret such a mean fully, a reader needs to know how each percentage was calculated: what counted as a pass, what opportunities were included in the denominator, and whether percentages were calculated separately for participants, briefs, positions, or pours before being averaged. Those definitions are not reported in the registry record.
The protocol description allows for up to four pours for each brief and 3 briefs, one for each position. It also says detection is assessed 5 minutes after each saline amount. This describes potential repeated observations, but does not say how many were actually collected or how they entered the primary analysis. The endpoint description names sitting, supine, and right or left side positions. The registry does not explain how the position categories were mapped to the stated number of briefs.
What does a confidence interval add?
In general, a confidence interval gives a range of values compatible with an estimate under the statistical model and sampling assumptions used. It conveys precision, which a point estimate alone cannot show. A confidence interval does not guarantee that the true value lies within the particular interval, and it does not establish whether a result is clinically meaningful. The registry specifies a 95% confidence interval for the mean but does not report its endpoints or explain the method used to calculate it.
Because the measure is based on pass percentages, the choice of analysis can matter. In general, percentages have boundaries, and their variability can depend on how many opportunities contribute to each value. If participants contribute multiple briefs or pours, observations within a participant may be correlated. Treating correlated observations as independent can make uncertainty appear smaller than it is. Appropriate methods depend on the actual data structure and analysis objective. The registry record does not report whether clustering, repeated measurements, or varying numbers of opportunities were addressed.
What can be inferred from the study design?
The study is recorded as single-group, with no masking and allocation recorded as NA. This is not a randomized comparison. In general, a single-group measurement study can describe performance under its observation conditions, but cannot isolate a comparative effect against a control group that is not part of the design. The registry does not report a separate comparator or a hypothesis test comparing groups.
The brief summary frames the assessment around normal saline as a simulated urinary void and the sensor's alert after liquid absorption. That is the stated test context; it should not be conflated with an endpoint measuring clinical outcomes. The record does not describe a statistical model for differences by amount, position, brief, or participant, and it does not report subgroup estimates.
How should the planning approach be read?
In general, a sample-size planning calculation estimates how many participants may be needed for a specified statistical objective under stated assumptions. The registry describes a planning illustration based on a fraction of the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It distinguishes participants per arm for ordinary outcomes from total events for time-to-event outcomes. These are planning assumptions, not a description of this study's observed design: this study is listed as single-group, and the registry does not report a two-arm comparison.
The sample-size justification for the actual study is not reported in the registry record. Neither the observed effect nor numerical planning-illustration results are reported in the registry record, so no such estimate can be interpreted from it. Planning illustrations are not observed power and do not replace an outcome estimate or its uncertainty.
What analysis details remain unknown?
The registry records no listed analyses. It does not report an inferential test, a missing-data procedure, a prespecified analysis population, adjustments for repeated observations, or a method for handling the four participants removed because of deviations. It also does not report whether the primary outcome was analyzed exactly as described in the endpoint definition. These omissions limit reproducibility and make it difficult to assess whether the chosen summary and uncertainty estimate match the study's data structure.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists Sensor Detection as the primary outcome and Rewet Test as a secondary outcome. It does not report a multiplicity strategy, such as whether any adjustment was planned when considering more than one outcome or multiple comparisons. The registry also does not provide a detailed analysis plan, so it is not possible to determine whether separate amounts, positions, briefs, or other subgroups were analyzed as distinct comparisons. Such a plan is not reported in the registry record.
Missing-data handling is not described. The record says four participants were removed from the analysis because of deviations, but does not describe the deviations, how they were identified, whether all their measurements were excluded, or whether other outcome data were missing. It also does not state whether any attempted sensor detections failed to produce an assessable measurement. The number included in the analysis is not reported in the registry record.
In general, excluding participants or observations can affect an estimate if the excluded data differ systematically from the retained data. The extent and direction of any effect cannot be assessed without the exclusion details and outcome data. The registry does not identify an intention-to-treat or per-protocol analysis population, nor does it report sensitivity analyses.
Because the study description permits multiple pours and briefs for participants, the unit of analysis is also important. The registry does not state whether the analysis used participant-level summaries or individual detection opportunities, or how dependence among measurements was handled. These issues are distinct from multiplicity and missingness, but they affect interpretation of the mean and its confidence interval. The relevant analysis choices are not reported in the registry record.
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 |
|---|---|---|---|
| All Participants | 0 | 56 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| All Participants | 0 of 56 |
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 |
|---|---|
| All Participants | 0 of 56 |
The registry lists 56 participants at risk for serious adverse events, with 0 affected. It also lists 56 participants at risk for other adverse events, with 0 affected. The number of deaths is recorded as 0, and no top serious adverse-event terms are listed.
These are event counts in the registry record. They do not establish that risk was absent, and they should not be read as a measure of how accurately the sensor detected wetness. The record does not report detailed adverse-event definitions, collection procedures, or the period over which events were assessed. The zero counts therefore describe what was recorded, rather than providing evidence about unobserved events or risk outside the study's observation conditions.
The safety entries also do not resolve the missing primary endpoint result. Sensor Detection and adverse events are different kinds of information: the former concerns the stated device-validation measure, while the latter records event counts. The registry does not report numerical results for the primary endpoint alongside these safety figures.
12. What the Result Does, and Does Not, Mean
The registry record gives a clear technical question: whether the FitRight® System sensor detects liquid in an adult brief and triggers an alert under a simulated-void assessment. The described conditions include normal saline amounts of ~90-360 milliliters, assessment 5 minutes after each pour, and sitting, supine, and right or left side positions. The study was completed as a single-group evaluation with an enrollment of 56.
However, the record does not report the primary mean percentage of passes or its 95% confidence interval. Without those values, readers cannot determine the observed sensor-detection result or its precision from the registry record. The secondary Rewet Test result is also not reported. The fact that the study is marked completed does not supply the missing endpoint estimates.
Even if the detection result were reported, the interpretation would remain tied to the tested conditions and the endpoint's definition. The registry does not define a pass or explain how multiple briefs and pours were summarized. It also does not report how well the saline simulation represents use beyond the stated study assessment. A technical sensor endpoint should not be treated as a direct measure of clinical outcomes or routine-care impact.
The single-group design has no reported comparator. It can characterize observations made with the system, but does not estimate a difference against another system or control condition. Four participants were removed from the analysis because of deviations; the record does not explain the deviations or report the final analysis population. These gaps limit assessment of both the estimate and its generalizability.
The safety record contains zero affected participants for serious and other adverse events, and zero deaths among the listed counts. Those entries are not proof of no risk and do not answer the sensor-detection question. The record supports describing the study's design and intended measurement, but not a conclusion about the observed detection performance.
13. Why This Trial Matters Statistically
This study illustrates why an endpoint definition and an analysis description matter alongside a device-validation question. Sensor Detection is stated as a mean percentage of passes, but interpreting that measure depends on what qualifies as a pass and how opportunities are counted. The registry does not report those operational details. If participants contribute multiple pours or briefs, the way measurements are grouped can also affect the estimate and its uncertainty.
In general, repeated measurements from one participant may be related. Statistical methods should reflect the data structure when that dependence is present. The registry describes the possibility of up to four pours for each brief and 3 briefs, but does not report the actual number of observations or whether dependence was handled in the analysis. This is a useful reminder that a mean and confidence interval cannot be evaluated in isolation from the unit of analysis.
The record also distinguishes a single-group validation study from a comparative trial. With no reported comparator, the design does not provide a between-group contrast. The study's stated objective is sensor detection under a saline simulation, not a comparison of clinical outcomes. Keeping the design and endpoint aligned prevents a technical measurement from being interpreted as broader evidence than it addresses.
Finally, the record demonstrates the importance of complete results reporting. It specifies the primary measure and intended confidence interval but does not report their values. It identifies four exclusions due to deviations without describing their handling in detail. As a result, readers can understand the planned measurement context but cannot assess the observed effect, precision, or analysis population. Those distinctions are central to sound statistical 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.
The primary limitation for interpretation is that the registry record does not report the numerical Sensor Detection result or its 95% confidence interval. It also does not report the Rewet Test result. The study's stated objective and endpoint can be described, but observed performance cannot be assessed from the record.
The endpoint definition is incomplete for statistical interpretation. The record does not define a pass, describe the denominator for percentage of passes, or explain whether the mean was calculated from participant-level, brief-level, or pour-level values. Although the description allows up to four pours for each brief and 3 briefs, the number of observations actually collected is not reported. The relationship between the listed positions and the number of briefs is not clarified.
Four participants were removed from the analysis because of deviations, but the reasons, timing, and handling of their measurements are not reported. The analysis population size and missing-data procedures are also not reported. This prevents assessment of the effect of exclusions or the completeness of endpoint data.
The study has a single-group design and no reported comparator, so comparative performance cannot be estimated from its design. The registry does not report whether repeated measurements were accounted for, whether outcomes were examined by position or saline amount, or how uncertainty was calculated beyond naming a 95% confidence interval. The statistical analysis plan and sample-size justification are not reported in the registry record. These limitations constrain reproducibility and the scope of conclusions that can be drawn.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Wetness Sensing System — NCT05454813.
- Registry record last updated 2023-10-03; status last verified 2023-08.
- Results first posted 2023-09-15.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT05454813 is a completed, single-group device-validation study titled Evaluation of a Wetness Sensing System for Continence Care. Medline Industries is listed as sponsor, with enrollment of 56. The study start date is 2022-06-08, and the primary completion date is 2022-06-29.
The primary outcome is Sensor Detection, measured as mean percentage of passes with a 95% confidence interval, following saline pours into a brief and assessment 5 minutes after each pour. Rewet Test is listed as a secondary outcome. Four participants were removed from the analysis because of deviations. Numerical endpoint results, confidence-interval limits, the final analysis population, and detailed statistical methods are not reported in the registry record.