Pippa Pessary Study (Clinical Trial): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pippa Pessary Study (Clinical Trial) (NCT05611970), a na na study. The primary outcome is Proportion of Participants With Diagnosed Stress Urinary Incontinence (SUI) Who Achieved >50% Reduction of Urine Leakage With Intervention.

2. Clinical Question

The clinical question is framed around a threshold response rather than the average amount of leakage change. A participant counted toward the primary outcome if the endpoint criteria were met through either or both of its components. The registry record does not report the number or proportion of participants who met that definition, so the observed answer to the primary question cannot be described from the posted results.

General statistical context: a within-participant design compares measurements from the same person under different conditions. This can make the comparison less dependent on differences between people, but it does not by itself establish that the device caused any observed change. In an open-label study, expectations, awareness of device use, and the order or timing of measurement may also be relevant. The record does not report enough detail to assess those influences.

3. Trial Design

The Pippa Fitness Pessary study (NCT05611970) is listed as an interventional, open-label, single-group, multi-clinic study. The intervention was a vaginal pessary device. The registry lists masking as NONE and allocation as NA; it does not describe random assignment. Enrollment is recorded as 7, and the study status is TERMINATED.

The study’s design used participants as their own controls. Leakage during a control phase without device use was compared with leakage during an intervention phase with device use. This differs from a randomized parallel-group trial, in which separate groups receive different assignments. The record explicitly cautions that the arms are not a like-for-like control comparison. The within-participant structure is central to understanding the endpoint and the limits of causal interpretation.

The registry lists the study start as 2023-02-13 and primary completion as 2024-04-09. The reason for termination is not reported in the registry record. The listed phase is NA. No further details about clinic locations, recruitment, the timing or order of phases, or changes to the study plan are reported in the registry record.

The primary outcome timeframe is from baseline to 24 days. The endpoint compares leakage measures with and without device use, including a standardized pad test and a participant-controlled home phase. The record describes the home phase as requiring at least 7 days without device use and at least 7 days with device use. It does not report the exact sequence or whether every participant completed each phase.

The registry lists a secondary outcome of change in quality of life at baseline and 24 days. It reports two outcome measures and zero analyses. No numerical result for the primary endpoint or the secondary outcome is reported. The planned statistical methods, any protocol deviations, and the reason for the study’s termination 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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Effectiveness analyses were conducted on participants with evaluable paired outcome data obtained during both the control phase (without device use) and the intervention phase (with device use). Safety analyses include all enrolled participants who used the Pippa Fitness Pessary at least once, including participants who withdrew early or had incomplete data.

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 Proportion of Participants With Diagnosed Stress Urinary Incontinence (SUI) Who Achieved >50% Reduction of Urine Leakage With Intervention, measured over From baseline to 24 days.

The primary endpoint is the proportion of participants with diagnosed SUI who achieved >50% reduction in urine leakage with the intervention compared with the control phase without device use. Its timeframe is from baseline to 24 days. The endpoint is a composite with two components: >50% reduction in pad weight gain on the International Continence Society’s standardized 1-hour pad weight test, and/or >50% reduction in mean daily leak episodes during the participant-controlled home phase.

The pad test component compares a measurement made once without the device with a measurement made once with it. The home component compares mean daily leak episodes across at least 7 days without device use and at least 7 days with device use. The record uses “and/or,” so meeting either component could count toward the composite endpoint; it does not require both components to be met.

General statistical context: a threshold endpoint gives a clear rule for classifying whether an individual meets a response definition. A composite can encompass more than one way of measuring the same broad outcome, but its interpretation depends on the component definitions and on how often each component contributes to the result. The registry record does not report component-specific results or the overall proportion meeting the threshold. It therefore does not show how many participants met either component or the composite as a whole.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a single-group, open-label study in which participants served as their own controls. It does not report a detailed statistical analysis plan, the method used to analyze the paired outcome data, or the method used to calculate uncertainty. The record lists zero analyses. The following concepts explain how the design and endpoint are generally interpreted; they do not describe unreported analyses as if they had been performed.

What does a paired comparison mean?

General statistical context: in a paired design, each participant contributes measurements under both conditions, and the comparison is based on the within-participant contrast. This differs from comparing averages from separate groups, because the paired observations are linked to the same people. Pairing can account for stable differences between participants, but it does not automatically remove changes that occur over time or other influences that differ between phases.

For this study, the registry describes a control phase without device use and an intervention phase with device use. The order of those phases and the procedures for managing possible order effects are not reported in the registry record. Without those details and without the outcome data, it is not possible to assess whether the paired comparison was complete or how the observations were handled statistically.

What does the threshold endpoint capture?

The primary endpoint classifies participants according to whether they achieved >50% reduction in leakage using a composite definition. The pad test compares pad weight gain with and without the device; the home component compares mean daily leak episodes across the specified periods. The “and/or” wording means that either component may contribute to meeting the endpoint.

General statistical context: turning a continuous measure into a threshold response can make the outcome easier to describe as the proportion meeting a defined criterion. It also means the result does not convey the full distribution of individual changes. People with changes on different sides of the threshold may be classified differently even if their measured values are relatively close. Component-specific outcomes can help clarify what a composite response represents, but those results are not reported in the registry record.

What does open-label status imply?

The record lists masking as NONE and describes the study as open label. Participants and study personnel were therefore not described as masked to device use. General statistical context: awareness of the intervention may influence participant-reported outcomes, behavior during measurement, or study conduct. A standardized measurement procedure can help define what is measured, but it cannot by itself demonstrate that awareness had no influence. The registry record does not report procedures intended to assess or limit such influences.

The home component relies on participant-controlled periods and daily leak episodes. The record specifies at least 7 days in each condition, but it does not describe adherence checks, diary completeness, or the handling of days with missing reports. Those details matter when interpreting a home-based measure because the observed summary depends on which days were recorded and included.

What can be learned from the planning assumptions?

The registry describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also describes the effect to detect as a stated fraction of the observed effect. These are planning assumptions, not evidence that the study itself used a two-arm randomized design. The observed primary effect is not reported, and no planning outputs are included in the registry record details, so no sample-size result can be interpreted from the available information.

General statistical context: a sample-size calculation estimates the number of participants that a hypothetical design would plan for under specified assumptions. It is not a measure of the probability that the completed study found an effect, and it is not “observed power.” When a planning illustration uses a two-arm allocation but the actual study is single-group with participants serving as their own controls, the illustration should be understood as a planning scenario rather than as a description of the trial’s observed design. The assumptions and the design being planned need to match the question for the calculation to be directly relevant.

The record notes that time-to-event planning tables give total events, while other planning results give participants per arm. The primary outcome described for this study is a proportion, not a time-to-event endpoint. No time-to-event primary outcome is reported.

What is over-dispersion, and is it relevant?

General statistical context: over-dispersion occurs when count data vary more than a model’s assumptions would predict. It can make standard errors too small if the extra variability is ignored. The primary endpoint is defined as a proportion of participants meeting a binary threshold, while one component uses daily leak episodes. The registry record does not report a count-data model, an over-dispersion assessment, or any model-based analysis, so no claim can be made about whether over-dispersion was assessed or affected the findings.

More generally, statistical methods should be read alongside the outcome definition, analysis population, missing-data handling, and design. For this study, the record identifies the endpoint and an effectiveness population based on paired data, but does not report the analysis procedure, uncertainty estimates, or missing-data methods. Those omissions prevent a detailed evaluation of the statistical analysis.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Pippa Fitness Pessary")
n      <- c(4)
events <- c(0)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Pippa Fitness Pessary  4  0  0.0  0.0  60.2  0.0  49.0  0.5  52.2

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and identifies a primary endpoint and a secondary outcome of change in quality of life at baseline and 24 days. The record does not report results for either outcome and lists zero analyses. It also does not report whether any statistical adjustment for multiple outcomes, endpoint components, or comparisons was planned or used. The statistical plan is not reported in the registry record.

The primary endpoint itself is composite, with a pad-test component and a home leak-episode component joined by “and/or.” Component-specific results are not reported. It is therefore not possible to tell how each component contributed to the composite result or whether separate component-level tests were conducted.

General statistical context: when many outcomes or comparisons are examined, the chance of finding an apparently notable result by chance can increase. Adjustment methods and a prespecified hierarchy can address aspects of that issue, but the appropriate approach depends on the study’s plan and aims. Since the registry record does not report a multiplicity strategy, no adjustment should be assumed.

For effectiveness, the registry defines the analysis population as participants with evaluable paired outcome data from both phases. The number with complete paired data, the number excluded from that analysis, reasons for missing data, and any imputation or other missing-data method are not reported in the registry record. These omissions make it impossible to evaluate whether missing observations could affect the primary result.

The safety definition is different: safety analyses include enrolled participants who used the device at least once. The adverse-event figures report 7 at risk. The record does not provide further detail about missing safety follow-up or how incomplete safety observations were handled.

12. 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 registry reports 0 participants affected by serious adverse events among 7 at risk in the Pippa Fitness Pessary group. It reports 3 participants affected by other adverse events among 7 at risk. Deaths are reported as 0. No serious adverse-event terms are listed.

These figures are counts, not a complete description of the events. The registry record does not provide event descriptions, timing, severity details beyond the category, or information about whether an event was considered related to device use. The distinction between the serious and other adverse-event categories should be read as the registry records them; the figures alone do not establish causation.

The record describes the safety population as enrolled participants who used the Pippa Fitness Pessary at least once. It reports 7 at risk for both serious and other adverse events, but does not provide additional detail about follow-up duration or completeness. With no serious events reported in this record, that observation should not be interpreted as proof that serious events cannot occur. The safety figures describe what is recorded for this study and do not establish the safety profile beyond it.

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

The primary clinical question concerns the proportion of participants who achieved >50% reduction in urine leakage with device use compared with the control phase. The registry record does not report that proportion, the underlying outcome counts, or an estimate of uncertainty. It therefore does not show whether the endpoint was met by participants or how precisely any observed effect was estimated.

The study was single group and open label, with each participant serving as her own control. That structure defines a paired comparison but does not provide a randomized parallel-group comparison. The record does not report phase order or the detailed analysis method. These design and reporting features limit what can be inferred about the source of any change, even if a numerical before-and-after result were available.

The composite endpoint includes a standardized pad test and participant-controlled home reporting. Since separate component results are not reported, the record cannot show whether the measurement approaches agreed or which one contributed to any composite response. The secondary quality-of-life outcome is listed, but its result is not reported in the registry record.

General statistical context: a study result, its precision, and its causal interpretation are separate questions. An effect estimate would describe the observed result; an uncertainty interval would show how imprecise that estimate may be; and design details would inform how confidently the difference could be attributed to the intervention. Here, the registry record does not provide the primary estimate or its precision, and the single-group open-label design limits causal interpretation.

The reported safety counts are descriptive. They record 0 serious adverse events among 7 at risk, 3 affected by other adverse events among 7 at risk, and 0 deaths. These counts do not establish whether events were caused by the device, and the record provides no detailed event descriptions. The study status is TERMINATED, but the reason is not reported in the registry record. None of these registry entries can substitute for the missing primary effectiveness result.

14. Why This Trial Matters Statistically

This study raises statistical issues that are common in clinical research: how to interpret a participant-as-own-control design, how a composite endpoint defines response, and how to judge results when outcome estimates and analysis details are absent. The distinction between a paired comparison and a comparison of independent treatment groups is important because the study’s design determines what the data can support.

The endpoint combines a standardized pad-weight measure with daily leak episodes recorded during participant-controlled periods. Those measures represent different ways of assessing leakage. Reporting the composite alone would describe whether participants crossed the threshold, while component-specific results would help readers understand what supported that classification. The registry record does not report either the composite result or component-specific results.

The record also illustrates why an enrollment figure and a design description are not enough to assess statistical evidence. Effectiveness analyses were defined around evaluable paired data, but the number in that analysis population and the outcome counts are not reported. Without them, readers cannot assess the observed response proportion or its precision. No analysis methods or multiplicity strategy are reported either.

There is a further distinction between the trial’s actual design and the described sample-size planning assumptions. The study is recorded as a single-group within-participant comparison, while the planning assumptions describe equal allocation between two arms. A planning illustration is not a report of how participants were assigned or evidence of the study’s power. The observed effect used for planning is not reported in the registry record.

These details matter because statistical interpretation depends on transparent reporting of the outcome, analysis population, methods, and uncertainty—not just on the endpoint label. The record identifies a clinically interpretable question but does not provide the numerical result needed to answer it.

15. 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 small enrollment recorded in the registry, 7, limits the amount of information available from this study. More importantly for interpretation, the number of participants with evaluable paired outcomes is not reported, so the effectiveness analysis denominator cannot be confirmed from the record. The primary estimate and its uncertainty are also not reported.

The single-group, open-label design does not include a randomized parallel-group comparison. Participants served as their own controls, but the record does not report the order of the control and intervention phases or how possible time and order effects were addressed. The absence of masking may also be relevant to participant-controlled home reporting. The registry record does not describe procedures to evaluate these influences.

The composite endpoint combines pad-test and home leak-episode criteria. Without component-specific counts or results, it is not possible to assess which measure contributed to the composite or whether the components yielded consistent findings. The listed quality-of-life outcome has no reported result. The registry also lists zero analyses and does not report the statistical methods, missing-data approach, or multiplicity strategy.

The study is marked TERMINATED, but the reason for termination is not reported in the registry record. No protocol, recruitment-flow detail, or explanation of whether termination affected planned analyses is reported. These absences should not be filled by assuming a reason or an effect on the results.

General statistical context: limited sample information and missing outcome reporting reduce the ability to assess precision and generalizability. The available record supports a description of the design and reported safety counts, but it does not support a numerical estimate of effectiveness or a broad conclusion beyond the recorded participants and study conditions.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Pippa Pessary Study (Clinical Trial) — NCT05611970.
• Registry record last updated 2026-03-13; status last verified 2026-01.
• Results first posted 2026-03-13.
• 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.

19. Record Summary

NCT05611970, the Pippa Pessary Study (Clinical Trial), is listed as an interventional, open-label, single-group, multi-clinic study of the Pippa Fitness Pessary device for stress urinary incontinence. Each participant served as her own control, comparing a phase without device use with a phase using the vaginal pessary. Enrollment is recorded as 7. The study status is TERMINATED; the reason is not reported in the registry record.

The primary endpoint was the proportion achieving >50% reduction in urine leakage from baseline to 24 days, using a composite of pad-test and home leak-episode criteria. The primary result, its uncertainty, and the secondary quality-of-life result are not reported. The registry lists two outcome measures and zero analyses. Safety figures report 0 serious adverse events among 7 at risk, 3 affected by other adverse events among 7 at risk, and 0 deaths. These counts do not establish causation.

The study start is listed as 2023-02-13 and primary completion as 2024-04-09. Allocation is listed as NA, masking as NONE, and phase as NA.