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 PureWick™ France and U.S. At-Home Pilot Study (NCT05710718), a randomized na study. The primary outcome is Daily Average Urine Capture Rate (Percentage).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05710718 |
| Phase | NA |
| Condition | Nocturnal Enuresis |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | C. R. Bard |
| Results posted | Yes |
2. Clinical Question
Population
Women with urinary incontinence who required diapers at night, enrolled in a prospective, post-market, multi-site home study. The registry reports enrollment of 17 and says all enrolled and randomized participants were included in the primary endpoint analysis.
Intervention
The PureWick™ System, an external urine collection device used overnight during a treatment phase.
Comparator
The Hollister® Female Urinary Pouch External Collection Device, also used overnight. Participants crossed over between the devices according to randomized treatment sequence.
Primary question
How did the devices compare on daily average urine capture rate, measured as the percentage of urine captured by the device, and on safety assessed using the Draize Scale?
The clinical question is about device performance and safety in the home setting for overnight incontinence. Capture rate was derived from urine collected in the device canister relative to captured and leaked urine, with daily measurements averaged within each treatment phase. The registry describes the primary objectives as evaluating safety, using skin injury assessment, and efficacy, using capture rate.
The crossover design means participants used both devices, in different randomized sequences. The intended comparison is therefore between device experiences within treatment phases, while taking account of the order in which devices were used. However, the primary efficacy estimate, its uncertainty, and the statistical comparison are not reported in the registry record. The available record consequently describes the question and measurement approach, but does not establish which device had a higher capture rate or how precisely any difference was estimated.
3. Trial Design
This was a randomized, open-label, crossover, post-market study conducted in France and the U.S. The registry lists the study status as completed, enrollment of 17, and a multi-site home setting. The study start date is 2023-10-31 and the primary completion date is 2024-08-25. The registry describes follow-up as approximately 10 weeks across two treatment phases.
Participants were randomized 1:1 to treatment sequences. In Treatment Sequence 1, participants used the PureWick™ System for the first 4 weeks and then crossed over to the Hollister Female Urinary Pouch. In Treatment Sequence 2, they used the Hollister Female Urinary Pouch for the first 4 weeks and then crossed over to the PureWick™ System. The registry does not describe a washout period between phases, so whether one was used is not reported in the registry record.
The study was unmasked: participants and study personnel were not described as blinded. That feature is relevant for outcomes involving comfort, tolerability, ease of use, and quality of life, because expectations and knowledge of device assignment can influence subjective reporting. The primary capture-rate measure is based on weights, but the registry does not describe blinded assessment of those measurements.
The registry lists Nocturnal Enuresis as the condition and identifies the study as not having an applicable phase designation. It also lists secondary outcomes involving Nocturia Quality of Life, PROMIS Sleep Disturbance, tolerability, comfort, and ease of use. The protocol details, sample-size justification, and further information about site conduct are 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 enrolled participants were randomized to a treatment assignment; however, four (4) participants discontinued prior to starting treatment. The number of Started participants (13) represents those participants that were randomized and treated.
Overall Study
| Stage | PureWick System, Then Hollister Female Urinary Pouch | Hollister Female Urinary Pouch, Then PureWick System |
|---|---|---|
| STARTED | 6 | 7 |
| Completed Treatment 1 | 5 | 1 |
| Completed Treatment 2 | 1 | 4 |
| COMPLETED | 1 | 4 |
| NOT COMPLETED | 5 | 3 |
Reasons for not completing this period:
| Reason | PureWick System, Then Hollister Female Urinary Pouch | Hollister Female Urinary Pouch, Then PureWick System |
|---|---|---|
| Withdrawal by Subject | 5 | 1 |
| Lost to Follow-up | 0 | 1 |
| Death | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All enrolled and randomized participants were included in the endpoint analysis (ITT Population)
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: All participants were randomized and treated.
| Characteristic | Unit | PureWick, Then Hollister Female Urinary Pouch | Hollister Female Urinary Pouch, Then PureWick | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 7 | 13 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 1 | 2 |
| Age, Categorical: >=65 years | Participants | 5 | 6 | 11 |
| Age, Continuous | years | 74.3 (SD 11.1) | 76.3 (SD 18.0) | 75.3 (SD 14.6) |
| Sex: Female, Male: Female | Participants | 6 | 7 | 13 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 | 7 | 12 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 7 | 10 |
| Race (NIH/OMB): White | Participants | 3 | 0 | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 6 | 7 | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Daily Average Urine Capture Rate (Percentage), measured over Daily for 28 days during each treatment phase.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percentage of urine captured |
| Endpoint classification | Continuous Endpoint |
The primary efficacy endpoint is daily average urine capture rate, expressed as a percentage of urine captured. Before nightly use, the empty canister and dry absorbent pad were weighed. After overnight use, the canister and pad were weighed again. The change in canister weight represents captured urine, and the change in pad weight represents leaked urine. Capture rate is calculated from captured urine divided by the sum of captured and leaked urine, multiplied by 100. The phase endpoint is the mean of daily capture rates during that phase.
This measure is intended to quantify how much urine the device collects relative to the urine captured plus the urine that leaks onto the absorbent pad. Repeated daily measurement can reflect device performance across nights rather than relying on a single night's observation. Averaging daily values produces a continuous outcome that can be compared between treatment phases.
The registry states that measurement was daily for 28 days during each treatment phase. It identifies the endpoint population as all enrolled and randomized participants, described as the ITT Population. The primary endpoint’s observed values, variability, and comparison between devices are not reported in the registry record. Therefore, the measurement definition is available, but the size and precision of the observed device comparison cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a randomized crossover comparison and defines a continuous primary efficacy endpoint, but it does not report the primary capture-rate results. There is no posted mean for either device, no estimate of the within-participant comparison, and no confidence interval or p-value for the primary efficacy question in the registry record. The direction and magnitude of any observed difference therefore cannot be determined from the reported record, nor can its precision be judged.
This absence of a reported estimate should not be read as evidence that the devices performed equally, or that either device performed better. It means the registry record does not provide the outcome information needed to make those statistical interpretations. The same caution applies to the primary safety objective: the study description identifies skin injury assessment using the Draize Scale, but the corresponding primary safety results are not reported in the registry record.
The trial design makes the intended comparison potentially informative because each participant was assigned to use both devices in sequence. In a crossover study, participants can serve as their own comparison, which can reduce the influence of stable differences between people. This advantage depends on appropriate handling of repeated observations and treatment sequence, and on assumptions about effects that may persist from one phase into the next. The registry record does not report the statistical model, handling of sequence or period effects, or assessment of carryover.
Because the study was open-label, outcomes based on participant opinion may be affected by awareness of the device being used. The urine capture endpoint is based on measured weights, although the registry does not describe whether measurement or data handling was blinded. These design features do not establish bias; they indicate considerations for interpreting results if results are reported elsewhere.
The posted safety figures describe adverse events by device group, but the record does not explain the event-attribution approach for a crossover design. The figures should therefore be read as registry-reported group summaries, not as proof that a device caused an event. The registry’s overall enrollment is 17, but that figure alone does not establish the amount of information available for any particular endpoint, especially when outcomes can be missing or measured repeatedly. The reasons for missing measurements are not reported in the registry record.
Any planning illustrations based on an observed effect are conditional calculations, not evidence of observed power and not a substitute for a reported endpoint estimate. Their assumptions describe a planning scenario. Without the primary result and its uncertainty, the central efficacy comparison remains unresolved in the registry record.
9. Statistical Methods Explained
The study identifies daily average urine capture rate as a continuous outcome summarized by a mean and standard deviation. A mean describes the average of the measured values, while a standard deviation describes how spread out those values are around the mean. These summaries can help characterize an outcome, but they do not by themselves show the uncertainty in a comparison between devices. A confidence interval around an estimated comparison would communicate a range of values compatible with the data under the statistical method used. No primary comparison estimate or confidence interval is reported in the registry record.
How does the crossover comparison work?
In general, a crossover design assigns participants to sequences so that they receive each treatment in a different order. Measurements from the same person are related, because they come from that participant. A suitable analysis generally accounts for this within-participant correlation rather than treating every daily measurement as independent. It may also consider treatment, period, and sequence effects. These are general considerations, not a description of the analysis used in this study: the statistical model and its treatment of these effects are not reported in the registry record.
In general, crossover interpretation also depends on whether effects from an earlier treatment persist into a later period. Such persistence is often called carryover. A washout interval may be used in some designs, but the registry record does not report whether this study used one or how carryover was assessed. The treatment sequence descriptions establish that participants crossed from one device to the other; they do not establish how the analysis addressed possible order effects.
What does the endpoint calculation represent?
The daily capture-rate calculation compares the weight gain in the canister with the combined weight gain in the canister and absorbent pad. It is intended to express the captured portion of measured urine as a percentage. The registry states that daily values were averaged for each study phase. This produces a phase-level outcome for each participant when the required measurements are available. The record does not describe how incomplete daily measurements were handled, whether the average required a minimum number of observed nights, or whether any values were excluded.
The registry identifies an ITT Population comprising all enrolled and randomized participants for endpoint analysis. In general, an intention-to-treat approach aims to retain participants in their randomized assignment for analysis, even if their experience differs from the planned sequence. In a crossover study, the exact implementation can require explicit decisions about how outcomes from each phase and sequence contribute. The registry does not report those details, so the population label alone does not reveal the analysis model or the handling of missing phase outcomes.
Why does variability matter?
Daily measurements can vary from night to night, and participant-level averages can also differ from one another. The standard deviation describes observed spread, whereas a confidence interval describes uncertainty in an estimate. These quantities answer different questions. A broad spread in individual values does not automatically imply that an average comparison is imprecise, and a narrow confidence interval does not mean every participant experienced a similar result. For a crossover analysis, the variability of within-participant differences is especially relevant; the registry does not report that quantity.
Over-dispersion is a general statistical concern when observed variability exceeds what a model assumes. If a model understates variability, uncertainty intervals may be too narrow and statistical evidence may appear stronger than warranted. The capture-rate endpoint is continuous, and the registry identifies mean and standard deviation summaries; it does not report a model, distributional assumptions, or an over-dispersion assessment. Thus, over-dispersion is a general consideration, not a reported problem in this trial.
What can planning calculations say?
In general, sample-size planning calculations depend on assumptions about the target effect, outcome variability, allocation, significance level, and desired power. The registry’s stated planning illustration uses a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and an effect specified as a fraction of the observed effect. Such calculations are hypothetical planning aids. They do not measure the trial’s observed power, establish that the original study was adequately powered, or show that the chosen assumptions match the actual design. The registry record does not report a trial-specific sample-size justification or power calculation.
The record’s planning description refers to equal allocation between arms, while the clinical design is a crossover with randomized treatment sequences. A planning calculation based on an arm-based approximation may not capture the precision of a paired crossover comparison. The assumptions and calculation should therefore be interpreted as an illustration rather than as a complete description of the trial’s design or analysis.
Finally, a p-value, when reported, addresses compatibility between observed data and a specified statistical model under a null hypothesis; it does not measure the size or clinical importance of an effect. A confidence interval and an interpretable effect estimate are needed to assess magnitude and precision. Neither the primary effect estimate nor a p-value is reported in the registry record. No specific inferential method can be attributed to the sponsor from the information available in the record.
10. Multiplicity, Missing Data and Analysis Populations
The study lists a primary efficacy outcome and a primary safety objective, alongside secondary outcomes involving quality of life, sleep disturbance, tolerability, comfort, and ease of use. When a study evaluates multiple outcomes or repeated comparisons, multiplicity can increase the chance that at least one result appears statistically notable by chance. In general, a statistical plan may specify which outcomes are primary, how repeated measures are summarized, and whether or how multiplicity is controlled. The adjustment strategy, if any, is not reported in the registry record.
The record lists one analysis, but does not provide enough detail to determine the model, contrasts, or inferential procedure used for the primary endpoint. It also does not report whether analyses were prespecified, whether there were interim analyses, or how any deviations from the planned analysis were handled. Those details are not reported in the registry record and should not be inferred from the endpoint description alone.
The primary endpoint population is described as all enrolled and randomized participants, labeled ITT Population. The registry does not report the number of participants with evaluable data by device or phase, the amount or pattern of missing daily measurements, or the method used to handle missing data. In general, missingness can affect both the estimated mean and its uncertainty, particularly if the chance of a missing observation is related to the outcome or treatment experience. The record does not establish why measurements may have been absent or whether sensitivity analyses were conducted.
The outcome description specifies daily measurement during each phase, but does not report how many daily observations were required to calculate a phase mean. It is also not reported in the registry record whether participants who did not complete both phases contributed partial data to the primary analysis. These gaps limit assessment of analysis completeness and robustness.
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 |
|---|---|---|---|
| PureWick System | 1 | 11 | 9.1% |
| Hollister Female Urinary Pouch External Collection Device | 1 | 5 | 20.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| PureWick System | 0 of 11 |
| Hollister Female Urinary Pouch External Collection Device | 1 of 5 |
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 |
|---|---|
| PureWick System | 1 of 11 |
| Hollister Female Urinary Pouch External Collection Device | 0 of 5 |
Most frequent serious adverse event terms
| Event term | Organ system | PureWick System | Hollister Female Urinary Pouch External Collection Device |
|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | 1 of 11 | 0 of 5 |
| Dehydration | Metabolism and nutrition disorders | 1 of 11 | 0 of 5 |
| Death | General disorders | 0 of 11 | 1 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | PureWick System | Hollister Female Urinary Pouch External Collection Device |
|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | 1 of 11 | 0 of 5 |
| Urinary Tract Infection | Infections and infestations | 1 of 11 | 0 of 5 |
Serious events with the highest arm-level rate: death (20.0%), urinary tract infection (9.1%), dehydration (9.1%).
The registry reports serious adverse event summaries by device group. For PureWick System, 11 participants were at risk, 1 was affected by a serious adverse event, 11 were at risk for other adverse events, 1 was affected by an other adverse event, and 0 deaths were listed. For the Hollister Female Urinary Pouch External Collection Device, 5 participants were at risk, 1 was affected by a serious adverse event, 5 were at risk for other adverse events, 0 were affected by an other adverse event, and 1 death was listed.
The registry also lists Death at 20.0%, Urinary Tract Infection at 9.1%, and Dehydration at 9.1% among the top serious adverse event terms. The record does not explain the denominator or attribution method for these term percentages, so they should be read as registry-reported summaries rather than recalculated or compared with the group figures.
These counts do not establish that a device caused an event. Because participants crossed over between devices, interpretation depends on the registry’s event attribution rules and timing, which are not reported in the registry record. The reported death should not be attributed to a device on the basis of the group summary alone. The figures are descriptive safety information, not a statistical estimate of comparative risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes the study question, device sequences, endpoint definition, and some safety summaries. It does not report the primary urine-capture results or the primary skin-injury results. Consequently, it cannot support a conclusion about the direction or size of the primary efficacy comparison, nor about the precision of that comparison. A missing result is not evidence that there was no difference.
The trial’s crossover structure is relevant because each participant was intended to use both devices, with sequence randomized. In general, this design can make a within-participant comparison less affected by stable differences between participants. It does not remove the need to account for period, sequence, repeated measurements, and possible carryover. The registry does not report how these issues were addressed in the analysis.
The adverse-event summaries show that serious events and a death were recorded in the device-group listings, alongside other event information. They do not, by themselves, demonstrate a causal relationship to either device or provide a reliable comparative risk estimate. The registry does not describe event attribution in enough detail to resolve those questions.
The study also lists participant-reported outcomes, including quality of life, sleep disturbance, comfort, tolerability, and ease of use. The record does not provide their results, so their direction, magnitude, and precision cannot be assessed. The open-label design is particularly relevant to interpretation of these subjective measures, although it does not establish that responses were biased.
Overall, the record is informative about how the comparison was planned and how capture rate was defined, but incomplete for judging the principal statistical findings. No claim that one device is better, equivalent, or worse follows from the information reported. A numerical efficacy estimate, uncertainty interval, full analysis description, and complete outcome reporting would be needed for a more definitive statistical interpretation.
13. Why This Trial Matters Statistically
This study raises practical statistical issues that are common in evaluations of devices used in daily life. Its primary efficacy measure is built from repeated nightly measurements and is then averaged within a treatment phase. That structure makes the analysis more involved than a comparison of independent observations: nights from the same participant are related, and each participant’s experience with one device is paired with their experience with the other.
Randomized treatment sequence is important in a crossover study because device order can matter. Separating treatment effects from period or sequence effects depends on the design and analysis, and possible carryover needs consideration. The registry describes the randomized sequences, but the statistical model and handling of these issues are not reported. Readers cannot determine from the record whether the analysis fully reflected the repeated, paired structure.
The endpoint also illustrates the distinction between measurement definition and evidence of performance. A detailed calculation can clarify what an outcome is intended to represent, but it cannot replace reported group summaries, a comparative estimate, and an assessment of uncertainty. Those primary efficacy results are not reported in the registry record.
Safety interpretation presents a related challenge. Group-specific event summaries are available, but participants crossed between devices and event attribution details are not reported. Counts alone do not identify cause or quantify a reliable comparative safety effect. This makes clear why event definitions, timing, exposure attribution, and analysis methods matter alongside the raw summaries.
Finally, the record lists subjective outcomes in an open-label study. Awareness of treatment can affect reported comfort or ease of use, so design features and outcome type should be considered together. The study is statistically relevant as an example of how crossover design, repeated measurement, missing-data reporting, multiplicity, and safety attribution shape interpretation. Its registry record leaves several of those analytical details unresolved.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for statistical interpretation is that the primary efficacy results are not reported in the registry record. The mean capture rates, comparative estimate, uncertainty interval, and inferential result are unavailable. The primary safety outcome, skin injury assessed using the Draize Scale, is also described without corresponding results. This prevents assessment of the size, direction, and precision of either primary comparison.
Enrollment was 17. The registry does not provide endpoint-specific evaluable counts by treatment phase or sequence, so the amount of information contributing to the capture-rate analysis cannot be established. Daily measurements were planned for 28 days during each treatment phase, but completeness of those measurements and the handling of missing values are not reported.
The study was open-label, and several listed secondary outcomes are participant-reported. Knowledge of the device in use can influence subjective responses. The registry does not describe blinded measurement or analysis, and it does not report an adjustment strategy for multiple outcomes. The methods used to account for within-participant correlation, period effects, sequence effects, and possible carryover are also not reported.
The adverse-event summaries are not accompanied by enough information to assess how events were assigned to devices in this crossover study. The registry record does not report a trial-specific sample-size justification, interim analyses, or a detailed statistical plan. These limitations concern what can be interpreted from the registry record; they do not establish that the study’s conduct or analysis was inadequate.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: PureWick™ France and U.S. At-Home Pilot Study — NCT05710718.
- Registry record last updated 2025-07-16; status last verified 2025-05.
- Results first posted 2025-07-16.
- 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
NCT05710718 is the completed PureWick™ France and U.S. At-Home Pilot Study, sponsored by C. R. Bard. It is described as a randomized, open-label, multi-site crossover study comparing the PureWick™ System with the Hollister® Female Urinary Pouch External Collection Device for overnight use at home among women with urinary incontinence who required diapers at night. Enrollment was 17.
Participants were assigned to treatment sequences, with each device used during a treatment phase. The primary efficacy endpoint was daily average urine capture rate, measured from canister and absorbent-pad weights. The registry identifies skin injury as the safety objective and lists quality-of-life, sleep, tolerability, comfort, and ease-of-use outcomes.
The primary efficacy and skin-injury results, analysis details, and missing-data handling are not reported in the registry record. The record includes adverse-event summaries by device group, but does not provide enough attribution detail to establish causality or a comparative safety effect.