Feasibility Study of the Reia Vaginal Pessary: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feasibility Study of the Reia Vaginal Pessary (NCT04508335), a na na study. The primary outcome is Pelvic Floor Distress Inventory-20 (PFDI-20).

2. Clinical Question

The central statistical question is about change in reported symptom burden over time in one group, alongside feasibility and safety observations. It is not a randomized test of the Reia device against a concurrent control group. Participants’ experience with their existing pessary gives a practical reference point, but changes between the baseline and follow-up assessments may reflect factors other than the device itself.

3. Trial Design

This completed study is listed as a single-group device study with no masking. The registry reports 78 enrolled participants and identifies pelvic organ prolapse as the condition under study. Participants were to have Stage II prolapse or greater and already use a Gellhorn or ring style pessary. The study’s stated aim was to collect preliminary data on effectiveness, safety, function, comfort, and satisfaction with the Reia vaginal pessary among people who had chosen non-surgical management.

The study plan began with a 1-month washout period during which participants continued using their current pessary. Subjective and objective baseline data were collected during this period. Participants were then fitted with the Reia device and entered a 3-month treatment phase. The registry describes comparative assessments at the conclusion of the study. The primary endpoint schedule is stated as enrollment [Week 0] and post treatment [Week 16]. The registry does not explain the relationship between these time labels and the washout and treatment periods in further detail.

Because there was no random allocation and no masking, the design does not protect against expectations or changes over time in the way a blinded randomized comparison can. The current-pessary observations provide context for participants’ assessments, but they are not equivalent to outcomes in a separate, concurrently randomized group. The registry lists 12 outcome measures and 2 analyses. It does not report a protocol-level account of the statistical plan or explain the scope of those analyses.

The record lists the study as completed, with enrollment beginning on 2021-11-21 and primary completion on 2023-06-16. Those dates describe the registered study timeline; they do not indicate when an outcome was measured for any particular participant.

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: All subjects treated with the Reia pessary were included in the analysis. Those subjects who withdrew after being treated with the Reia pessary (n = 14) were conservatively considered treatment failures and assigned the upper equivalence limit of 18.3 for the mean different (Reia Pessary - Current Pessary).

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: Demographic information recorded on all enrolled subjects, even those who dropped out before receiving treatment.

6. Primary Endpoint

The registry lists the primary outcome as Pelvic Floor Distress Inventory-20 (PFDI-20), measured over At enrollment [Week 0] and post treatment [Week 16].

The primary endpoint is the Pelvic Floor Distress Inventory-20 (PFDI-20), a 20-item questionnaire intended to measure the presence and bother of symptoms associated with pelvic-floor disorders and their impact on health-related quality of life in women. It is the short form of the 46-question PFDI and includes three subscales: the Urinary Distress Inventory 6, the Colorectal-Anal Distress Inventory 8, and the Pelvic Organ Prolapse Distress Inventory 6.

The overall score ranges from 0 to 300. A higher score indicates greater perceived impact of pelvic-floor dysfunction on a participant’s life. A patient-reported measure can capture symptom burden that may not be represented by an objective examination alone, which is relevant to a study assessing comfort and perceived experience as well as support of prolapse.

The registry defines the endpoint as a mean with standard deviation and gives the measurement times as enrollment [Week 0] and post treatment [Week 16]. It also states that a change of between 13.5 and 18.3 points is the minimal important change for women choosing conservative management of prolapse. This threshold provides context for judging the possible importance of a score change; it is not a study result. The registry record does not report the observed PFDI-20 means, standard deviations, change estimate, or uncertainty interval.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean score describe?

General statistical explanation: A mean is an average across the observations included in an analysis. For a continuous questionnaire score such as the PFDI-20, it gives a summary of the group’s reported score, but it does not show how individual participants’ scores are distributed. The registry specifies a mean and standard deviation for the primary endpoint. The standard deviation describes variation among observations; it is not the same as the uncertainty in the estimated mean.

The record gives two measurement times: enrollment [Week 0] and post treatment [Week 16]. A within-participant analysis can focus on how each person’s score changes across those occasions, then summarize those changes. That approach accounts for the fact that two scores from one participant are related. The registry record does not fully describe the primary statistical calculation, so the precise analysis method should not be inferred from the endpoint schedule alone.

How should a confidence interval be read?

General statistical explanation: A confidence interval gives a range of values compatible with the data and the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval. It does not show that every participant experienced a change within that range, and it does not remove design limitations such as the absence of a randomized comparison. No confidence interval for the primary PFDI-20 result is reported in the registry record.

What is the role of the minimal important change?

The registry states that the minimal important change in PFDI-20 for women choosing conservative management is between 13.5 and 18.3 points. General statistical explanation: A minimal important change is a benchmark for interpreting whether a measured change may be meaningful in context; it is distinct from a test of whether an estimated change differs from zero. It should be considered alongside the estimated change and its uncertainty, and it does not substitute for reporting those results. The registry does not report an observed primary score change to compare with this benchmark.

What does the withdrawal handling imply?

The primary-outcome description says that all subjects treated with the Reia pessary were included in the analysis. It also says 14 participants who withdrew after treatment were conservatively considered treatment failures and assigned the upper equivalence limit of 18.3 for the mean difference. The rest of the analysis description is not reported in the registry record. This assignment is a stated handling rule, not an observed score for those participants. It can affect the resulting estimate, so interpretation would depend on the full outcome definition, the treatment-failure rule, and how the remaining observations were handled. Those further details are not reported in the registry record.

Why does the study structure matter?

General statistical explanation: In a single-group before-and-after study, the observed change combines any effect associated with the intervention and other changes that occur over time. Without random allocation to a concurrent comparison group, those influences cannot be separated as cleanly as they can in a randomized trial. No masking is listed, so participant reports may also be affected by awareness of the device being used. These design features do not make descriptive results unusable; they limit what causal claims those results can support.

The registry describes current-pessary observations as a reference and identifies the overall model as single group. Although some outcome assessments compare the study pessary with the current pessary, that comparison is not a randomized arm-to-arm estimate. The registry does not report a statistical adjustment that would make the two periods equivalent to randomized groups.

How should planning illustrations be interpreted?

General statistical explanation: Sample-size planning illustrations based on an observed effect ask how many participants per arm would be needed under stated assumptions to detect a specified fraction of that effect. They are planning exercises, not evidence about the study’s achieved power, and they do not replace an analysis of the observed data. The registry’s stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a fraction of the observed effect. No resulting participant counts or effect values are reported in the record details, and this study itself is listed as single group rather than an equal-allocation two-arm trial.

More generally, power calculations depend on the assumed effect, variability, allocation, and analysis. If those assumptions do not match a study’s actual design or data, the calculation may not describe that study. Sample-size illustrations should not be interpreted as observed power or as proof that a result is reliable.

What can be said about event comparisons?

General statistical explanation: Event counts and the number of participants at risk are useful descriptive summaries. They do not by themselves establish a difference in risk, especially when groups are not randomized or comparable by design. A formal comparison would require a clearly defined analysis, an estimate of the contrast, and an assessment of uncertainty. The registry record does not report such a comparative safety estimate. The adverse-event figures should therefore be read as counts recorded for the listed groups, not as evidence of a causal safety difference.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Reia Pessary", "Current Pessary")
n   <- c(48, 62)
m   <- c(49.46, 62.75)
sp  <- c(43.2, 42.3)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Reia Pessary  48  49.460  43.200  36.916  62.004
CARM  Current Pessary  62  62.750  42.300  52.008  73.492

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 12 outcome measures and 2 analyses. It does not report a multiplicity adjustment, a hierarchy for interpreting outcomes, or a full statistical analysis plan. When several outcomes or analyses are examined, the chance of finding an apparently notable result by chance can increase. General statistical explanation: A prespecified hierarchy or multiplicity procedure can help control how confirmatory results are interpreted. Whether such procedures were used is not reported in the registry record, so their use should not be assumed.

The record provides a specific missing-data rule for the primary outcome: 14 participants who withdrew after treatment were conservatively considered treatment failures and assigned 18.3 for the mean difference. It also states that all subjects treated with the Reia pessary were included in the analysis. The complete description of this rule and any handling of missing observations at other time points or for other outcomes is not reported in the registry record.

General statistical explanation: Missing-data assumptions matter because people with unavailable follow-up measurements may differ from people whose measurements are observed. Assigning a value to withdrawals makes an analysis possible under a specified rule, but does not reveal what their unobserved measurements would have been. The assigned value should not be read as an observed score or as proof that every withdrawal had the same experience.

The registry does not report whether there were additional analysis populations, sensitivity analyses, or approaches to evaluate alternative missing-data assumptions. It also does not report enough detail to determine how the analysis accounted for the paired measurement schedule. These omissions limit independent appraisal of the primary estimate and its robustness.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: symptomatic coronary artery disease (1.6%).

The adverse-event record lists 62 participants at risk in each of three groups. In the Reia Pessary group, 1 participant was affected by a serious adverse event, 51 were affected by other adverse events, and 1 death was recorded. In the Current Pessary group, the corresponding counts were 0, 55, and 0. In the Persisting Across Pessary Type group, the counts were also 0, 55, and 0. The serious event term listed is symptomatic coronary artery disease, reported at 1.6%.

These figures describe events recorded in the registry. The one death in the Reia Pessary group does not establish that the death was caused by the device; the record does not report a causal attribution. Likewise, the absence of a recorded serious event or death in the other groups does not establish that their risks were zero. The groups are not a randomized, like-for-like control comparison, and the record does not report a comparative safety estimate or uncertainty interval.

Counts of participants affected by other adverse events summarize whether events were recorded, not their severity, duration, or relationship to the device. Those details are not reported in the registry record. Safety interpretation should distinguish the recorded counts from conclusions about causation or comparative risk.

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

This study addresses a practical question: whether a novel pessary can be evaluated in people who already use a pessary and have chosen non-surgical management of pelvic organ prolapse. Its planned assessment combines a validated patient-reported symptom measure with secondary outcomes covering quality of life, sexual function, objective support, satisfaction, and pain associated with insertion and removal. That breadth reflects the study’s stated feasibility focus on effectiveness, safety, function, comfort, and satisfaction.

The record does not report numerical results for the primary PFDI-20 endpoint. It therefore does not show the average score at either time point, the magnitude of change, or the precision of an estimate. The stated minimal important change of between 13.5 and 18.3 points is a benchmark for interpretation, not a result demonstrating that the benchmark was met.

The single-group, unmasked design can describe participants’ experience over the study period, but it cannot by itself establish that any change was caused by the Reia pessary. Participants’ current-pessary experience may offer a reference for subjective and objective comparisons, but it is not a randomized control group. Changes over time, expectations, and other influences remain possible explanations for observed differences.

The adverse-event counts provide a descriptive account of what was recorded among participants at risk in the listed groups. They do not establish causality or comparative safety. Taken together, the registry record describes the study question, design, outcomes, and selected safety counts, but it does not provide the primary outcome estimate needed to judge the size or precision of symptom change.

14. Why This Trial Matters Statistically

Feasibility studies can be statistically informative even when they are not designed as definitive randomized comparisons. They can show how a device is assessed in practice, identify which outcomes matter to participants, and make clear what evidence would be needed for a more conclusive estimate. This study’s stated focus includes patient-reported symptoms, objective support, comfort, satisfaction, and safety, rather than relying on one type of measurement alone.

The PFDI-20 is particularly relevant to interpretation because it captures perceived presence and bother of symptoms and gives a defined score range, with higher values representing greater impact. The registry also states a minimal important change benchmark for conservative management. Together, these details provide an interpretive framework for a future reported estimate, though they cannot replace the missing observed scores and uncertainty.

The statistical structure matters as much as the choice of outcome. A single-group design can characterize change across the study period, while the lack of random allocation and masking limits causal interpretation. The stated conservative handling of withdrawals is also important because assumptions about missing outcomes can influence an estimate. Reporting the complete analysis method and sensitivity to those assumptions would help readers judge how robust a result is.

For this registry record, the key statistical point is a distinction between a defined study question and a reported study result. The intervention, schedule, population, endpoint, and selected safety counts are described, but numerical primary-outcome findings are not reported in the registry record. Without those estimates, readers cannot assess the magnitude or precision of change against the stated clinical benchmark. The record therefore supports an account of how the study was organized, not a quantitative conclusion about the primary endpoint.

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 principal interpretive limitation is that numerical results for the primary PFDI-20 endpoint are not reported in the registry record. There are no posted enrollment or post-treatment means, standard deviations, change estimates, or uncertainty intervals. As a result, the endpoint’s observed magnitude, precision, and relation to the stated minimal important change cannot be assessed.

The study is listed as a single-group study with no masking and no random allocation. The before-and-after schedule can describe change among participants, but does not provide a randomized control condition that would separate device-associated change from other changes over time. The current pessary provides a within-study reference, not a like-for-like randomized arm.

The record’s primary-outcome description includes a conservative treatment-failure assignment for 14 participants who withdrew after treatment, using 18.3 for the mean difference. Further detail about the full analysis rule, other missing observations, and sensitivity analyses is not reported in the registry record. The record also does not report whether multiplicity procedures or a complete prespecified statistical plan were used.

The adverse-event figures are descriptive and do not include a reported comparative safety estimate or causal attribution. The groups should not be treated as randomized comparisons. The registry lists 12 outcome measures and 2 analyses, but the full results for those measures are not reported in the registry record for this record. These limitations restrict assessment of both the completeness of outcome reporting and the robustness of any conclusions.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Feasibility Study of the Reia Vaginal Pessary — NCT04508335.
• Registry record last updated 2024-11-27; status last verified 2024-11.
• Results first posted 2024-11-27.
• 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

The registry record describes a completed, single-group study of the Reia vaginal pessary in women with pelvic organ prolapse who had already chosen non-surgical management and used a Gellhorn or ring style pessary. The study enrolled 78 participants, used no masking, and planned a 1-month period continuing the current pessary followed by a 3-month treatment phase with the study device.

The primary endpoint is the PFDI-20 score at enrollment [Week 0] and post treatment [Week 16]. The registry explains the score’s meaning and gives a minimal important change benchmark of between 13.5 and 18.3 points. It describes a conservative treatment-failure assignment for 14 post-treatment withdrawals. Numerical primary-endpoint results are not reported in the registry record.

Safety figures include one serious adverse event and one death in the Reia Pessary group, with no serious events or deaths recorded in the other listed groups. These are descriptive counts and do not establish causation or comparative risk.