Early Feasibility Study of the Reia Vaginal Pessary: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Early Feasibility Study of the Reia Vaginal Pessary (NCT04275089), a na na study. The primary outcome is The Ability of the Study Device to be Retained During Valsalva Compared to the Ability of the Subject's Current Pessary to be Retained During Valsalva (Change in Distance Between Current Pessary and Study Pessary to Leading Edge to the Hymen).

2. Clinical Question

The study’s stated purpose was to obtain preliminary information about the function and effectiveness of a novel pessary and inform future design modifications. The primary outcome focuses on retention during Valsalva, using the distance between the pessary’s leading edge and the hymen as the measurement. The comparison was made after the participant’s current pessary was assessed and then replaced by the study device. The current device was returned at the end of the visit.

This clinical question is about device performance during a short, controlled assessment. It is not a randomized comparison of treatment strategies or a test of longer-term outcomes. The registry record describes additional assessments of pessary shape or orientation, insertion and removal discomfort, and global comfort. Their results are not reported in the registry record. Nor are numerical results for the primary comparison reported in the registry record. Consequently, the record establishes what the study set out to assess, but does not show the observed comparison or its precision.

3. Trial Design

The registry identifies this as an early feasibility, prospective, open-label, non-randomized, single-group study of the Reia Vaginal Pessary. Allocation is recorded as NA, masking as none, and the model as single group. The record lists 15 participants enrolled. It describes recruitment of women with Stage II pelvic organ prolapse or greater who already used a legally marketed pessary.

The assessment took place during a single visit. First, the participant’s current pessary was assessed for performance and comfort. With that device in place, the participant was asked to Valsalva and the distance from the leading edge of the pessary to the hymen was measured in centimeters. The current pessary was then removed, the study pessary was placed, and the Valsalva assessment and measurement were repeated. The registry describes the study pessary’s function as being assessed under controlled circumstances. At the conclusion of the visit, the participant’s current pessary was replaced.

Because the same participant’s current device and study device were assessed in sequence, the comparison is paired in concept: the two measurements come from one participant rather than from independent randomized groups. However, the registry record does not report the order of all assessments beyond the sequence described, nor whether repeated assessments were made. The study was open-label, so masking is not part of its design as recorded.

The record lists the study as completed, with a start date of 2020-11-05 and primary completion date of 2021-01-20. It does not report a randomized control group, a comparative allocation scheme, or a longer-term follow-up period. These design features frame the intended scope: an early assessment of device function and comfort, rather than a controlled estimate of longer-term treatment effects.

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

Reasons for not completing this period:

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 The Ability of the Study Device to be Retained During Valsalva Compared to the Ability of the Subject's Current Pessary to be Retained During Valsalva (Change in Distance Between Current Pessary and Study Pessary to Leading Edge to the Hymen), measured over During treatment - within 1 hour.

The primary endpoint compares the distance from the leading edge of the current pessary and the study pessary to the hymen during Valsalva. The measurement unit is centimeters, and the timeframe is during treatment, within 1 hour. The participant performs the maneuver with each device in place, and the distances are compared to assess the study device’s ability to function and be retained.

This measure is used to capture device position during a maneuver that challenges retention. It offers a measured, anatomical outcome rather than relying only on a verbal description of comfort or function. Comparing the two devices within the same participant can account for some stable differences between participants, because each person serves as their own comparator. That design feature does not eliminate possible influences from measurement variability, the sequence of assessments, or differences in how the devices fit.

The registry specifies the parameter as median and the dispersion as standard deviation. These are different summaries: the median describes the middle of an ordered set of values, while standard deviation describes spread around the mean. The registry record does not report the observed distances, the comparison estimate, a confidence interval, or a test result. It also does not specify how the comparison was calculated or how the direction of a favorable difference was defined. Therefore, the endpoint’s purpose and measurement can be described, but its observed result and precision cannot be interpreted from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation begins with the design and the outcome definition. This study is recorded as a single-group, open-label, non-randomized assessment. Each participant’s current pessary was measured and then compared with the study pessary in the same participant. That makes the comparison paired in concept. The relevant information would be the within-participant differences or another clearly defined comparison of the two measurements. The registry record does not report the analysis used to make that comparison.

What does a paired comparison mean?

In a paired design, two observations are linked because they come from the same person. A statistical analysis can use that link rather than treating observations as if they came from unrelated groups. This can help separate differences between devices from stable differences between participants. It does not remove all sources of uncertainty. Measurement error, changes between assessments, the sequence in which devices are tested, and variation in how a device is positioned can still matter. The record describes the assessment sequence but does not report analyses of these possible influences.

The registered primary outcome is distance from the leading edge of a pessary to the hymen during Valsalva, measured in centimeters. The registry lists median as the parameter and standard deviation as the dispersion. In general, a median is the central value after observations are ordered; standard deviation describes the spread of observations around their mean. These summaries convey different aspects of a distribution. The registry record does not explain whether the median and standard deviation refer to each device’s measurements, to a change score, or to another summary. It also does not give a specific statistical method for comparing the devices.

What would an uncertainty interval add?

In general, a confidence interval gives a range of estimates compatible with the observed data and the method used to calculate it. It helps readers assess precision, rather than focusing only on a single estimate. A wide interval indicates less precision than a narrow interval, though interpretation also depends on the outcome and study context. The registry record does not report a confidence interval for the primary comparison. It also does not report a p-value or a prespecified hypothesis test for that endpoint. Without an estimate and its uncertainty, statistical evidence for a difference cannot be evaluated from this record.

How should the planning illustration be understood?

The record describes sample-size assumptions as a planning illustration based on an observed effect, not as the study’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. The record distinguishes illustrations for participants per arm from a total-event approach for time-to-event outcomes. These assumptions do not describe the actual single-group, within-participant design of this trial. The record does not provide the illustration’s calculated sample sizes or the observed effect on which such planning might be based. A planning illustration is not observed power and cannot substitute for an analysis of the trial’s results.

More generally, sample-size calculations are conditional on assumptions about the outcome, variability, target effect, statistical method, and design. If those assumptions differ from the eventual data or study design, a planning figure may not describe the precision achieved. The record does not report a sample-size justification for the trial itself, so the reason for the enrollment target and any design calculations are not reported in the registry record.

Why does the absence of an analysis plan matter?

A statistical analysis plan can specify the outcome definition, analysis population, handling of missing measurements, summary measures, and methods for estimating uncertainty. Those choices influence how results should be interpreted. The registry record does not report a detailed statistical analysis plan, an interim-analysis plan, or a method for handling missing data. It also does not report whether any analyses were adjusted for other variables. These elements should not be inferred from the stated median and standard deviation.

The registry lists secondary assessments that include pessary shape during expulsion if the device cannot be retained, stem orientation after regular activity, insertion and removal discomfort differences, and global comfort. Some are descriptive or verbal assessments, while others are described using a change in VAS. The record does not report numerical results or analysis methods for these outcomes. General statistical principles still apply: outcome definitions, scale direction, completeness, and uncertainty all matter. For example, a positive discomfort score is defined in the registry as indicating lower discomfort with the study pessary, but no score is reported to interpret.

Finally, the study is open-label and the assessment occurs in a controlled, short-term setting. In general, awareness of which device is being assessed can influence subjective reports, and findings from a brief assessment do not by themselves establish performance during longer use. These are considerations for interpretation, not evidence that any particular bias occurred. The registry record’s absence of outcome results means that the statistical methods can be discussed only in relation to the planned measurement and general principles, not applied to a reported estimate.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists seven outcome measures and zero analyses. The primary outcome concerns distance from the pessary’s leading edge to the hymen during Valsalva. Listed secondary outcomes concern the shape of the study pessary during expulsion if it cannot be retained, stem orientation after regular activity, discomfort with removal and insertion compared with the current pessary, and global comfort. Numerical results for these outcomes are not reported in the registry record.

When a study assesses multiple outcomes, multiplicity can arise if several statistical tests are conducted and interpreted together. General approaches may define one primary outcome, adjust inference across a family of tests, or treat secondary assessments as exploratory. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or tests for these outcomes. It is not possible to determine from the record whether any adjustment was planned or performed.

The record does not report how missing measurements were handled, whether any participants were excluded from an analysis, or how analysis populations were defined. Although enrollment is listed as 15, the number of participants with primary or secondary outcome data is not reported in the registry record. The registry also does not report the amount or reasons for missingness, or whether any imputation or sensitivity analysis was used. These omissions limit assessment of completeness and potential bias.

The analysis population, missing-data approach, and multiplicity decisions are part of the context needed to evaluate estimates and their uncertainty. In their absence, no conclusions about those aspects of the statistical analysis can be drawn from the registry record.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry lists 15 participants at risk for serious adverse events and zero participants with serious adverse events in the Reia Vaginal Pessary group. It also lists 15 participants at risk for other adverse events and zero participants with other adverse events. The listed number of deaths is zero, and no top serious adverse-event terms are listed.

These figures describe what the registry record reports for the study group; they do not establish that no adverse events of any kind occurred outside the categories or reporting captured in the record. The record does not give event-level details, an observation period for safety reporting, or information about the completeness of adverse-event ascertainment. It also does not describe how events were solicited or classified. The enrollment of 15 should not be taken as confirmation that every participant completed the same duration of safety follow-up, because that detail is not reported in the registry record.

Safety counts from a small early feasibility study are descriptive. With no reported serious or other adverse events in the listed group, the registry does not provide an event frequency estimate beyond those counts or a comparative safety assessment. There is no separate control group in this single-group study. The figures should therefore be read as the recorded safety counts, not as proof that risk is absent or as evidence comparing the device with another treatment.

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

The registry record documents an early feasibility assessment of the Reia Vaginal Pessary in women with pelvic organ prolapse who were already using a legally marketed pessary. It describes a single-visit, open-label procedure in which the current pessary and study pessary were assessed in sequence, including a Valsalva measurement of distance to the hymen. It also lists comfort and device-position assessments. The record therefore clarifies the question the study was designed to explore.

It does not report numerical results for the primary outcome or the listed secondary outcomes. There is no reported estimate of the comparison, confidence interval, or p-value. As a result, the registry record cannot establish whether the study device was retained similarly to, better than, or less well than participants’ current pessaries according to the registered distance measure. It also cannot quantify how variable the measurements were or how precise a comparison might be.

The study design is not a randomized comparison between separate groups. Each participant’s own pessary serves as the comparator in a sequential within-visit assessment. This provides a direct device comparison for those assessed, but it does not create a blinded or randomized contrast. The setting and timeframe described are short and controlled; longer-term use and outcomes are not reported in the registry record.

The listed adverse-event counts are zero for serious events and zero for other events among 15 participants at risk in each category. These are descriptive registry counts, not proof of absence of risk and not a comparison with another device. Taken together, the record supports understanding of the study’s design, measurements, and recorded safety counts. It does not support a conclusion about the primary result, effectiveness, or comparative safety because outcome estimates and fuller reporting are absent.

13. Why This Trial Matters Statistically

Early feasibility studies address questions that arise before a larger or more definitive evaluation: can a device be assessed in the intended setting, what measurements may be informative, and what design changes might be considered? This study’s registry description is statistically relevant because it specifies a direct, within-participant comparison of a novel pessary with the participant’s current device. It also identifies a measurable primary outcome rather than relying solely on a general impression of function.

The study design matters when interpreting any comparison. Pairing measurements within participants can account for stable individual differences, but the open-label, sequential assessment does not provide the same basis for inference as a randomized, masked comparison. The setting is a single visit, and the primary outcome is measured during Valsalva within 1 hour. These features define the context to which any reported result would apply.

The record also illustrates why outcome reporting is essential to statistical interpretation. A carefully described endpoint does not reveal its observed value. Without the primary comparison, uncertainty interval, analysis population, and missing-data information, readers cannot judge the magnitude, precision, or robustness of the findings. Enrollment and study completion status alone do not answer those questions.

Finally, a planning illustration should not be confused with evidence from the study. The record describes assumptions for an illustration based on an observed effect, but those assumptions do not change the trial’s single-group design and do not supply a result. Statistical importance lies in distinguishing the planned clinical question from what the registry actually reports. The design and endpoint are documented; the outcome estimates needed to answer the comparison question are not.

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.

A central limitation of interpretation is that the registry record does not report numerical results for the primary endpoint or secondary outcomes. The number of participants contributing data to each outcome is also not reported in the registry record. Without these details, the planned comparison cannot be evaluated for magnitude, variability, precision, or completeness.

The primary endpoint title describes a change in distance between the current and study pessary measurements, but the record does not specify the calculation’s sign convention. It lists median and standard deviation without explaining precisely which values each summary describes. No analysis method, confidence interval, or hypothesis test is reported. These omissions prevent a full statistical reading of the endpoint even apart from the absence of results.

The comparison was open-label and sequential within a single visit. The record does not describe masking, randomization of device order, repeated measurements, or assessment of measurement reliability. The procedure establishes the order in which the current pessary and study pessary were assessed, so the record does not report a design that separates possible order effects from device differences.

The population is described as women with Stage II pelvic organ prolapse or greater who were current users of a legally marketed pessary. The record does not report further eligibility details or participant characteristics. It therefore does not allow assessment of how representative the enrolled participants were of other populations. The assessment timeframe is within 1 hour; longer-term use and follow-up outcomes are not reported in the registry record.

Lastly, the registry does not report a trial-specific sample-size justification, a detailed analysis plan, missing-data procedures, or a multiplicity strategy. These limitations should be considered alongside the early feasibility purpose when interpreting what the record can establish.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Early Feasibility Study of the Reia Vaginal Pessary — NCT04275089.
• Registry record last updated 2023-07-28; status last verified 2022-09.
• Results first posted 2023-07-28.
• 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

NCT04275089 is recorded as a completed, prospective, open-label, non-randomized, single-group early feasibility study of the Reia Vaginal Pessary. The registry lists 15 participants enrolled, with a start date of 2020-11-05 and primary completion date of 2021-01-20. The study population was described as women with Stage II pelvic organ prolapse or greater who were current users of a legally marketed vaginal pessary.

During a single visit, participants were assessed with their current pessary and then with the study pessary. The primary outcome compared the distance from each pessary’s leading edge to the hymen during Valsalva, measured in centimeters within 1 hour. Secondary assessments included device position and comfort.

The registry reports zero serious adverse events, zero other adverse events, and zero deaths in the listed group. It does not report numerical results for the primary or secondary outcomes, analysis methods, or the number contributing data to each outcome. The record therefore describes the study question and design but does not provide estimates with which to interpret the device comparison.