Dexamethasone for Post Uterine Artery Embolization Pain: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Dexamethasone for Post Uterine Artery Embolization Pain (NCT04655144), a randomized phase 3 study. The primary outcome is Pain Scores Using the VAS Questionnaire.

2. Clinical Question

The clinical question concerns pain after uterine artery embolization, a procedure described in the registry summary as a nonsurgical treatment for uterine fibroids that blocks their blood supply. The trial also set out to investigate post-procedure nausea, vomiting, and a general feeling of weakness. Its listed secondary outcomes cover severity of post-embolization syndrome symptoms, change in symptoms, and change in quality of life.

The central comparison is between an anti-inflammatory medication delivered directly into the uterine arteries before embolization and saline delivered by the same route. Because the saline volume was specified to match the total volume delivered in the dexamethasone arm, the comparison was designed to distinguish the medication strategy from the saline procedure. The record does not provide further details about how the treatments were prepared or whether participants and staff could identify them.

The primary question is not answerable from the posted outcome information: no Day 7 arm-specific mean, standard deviation, treatment contrast, confidence interval, or test result is reported. The trial’s stated aim and design identify what was intended to be assessed, but they do not establish what the observed pain scores were or how precisely any difference was estimated.

3. Trial Design

The registry identifies NCT04655144 as a Phase 3, randomized, double-masked, parallel-group trial sponsored by the University of Miami. Its listed condition is leiomyoma, and its enrollment is 42. The record gives a start date of 2021-01-25, a primary completion date of 2024-12-04, and a status of completed. These details describe the registered study; they do not supply an outcome analysis.

Participants were assigned to a dexamethasone arm or a saline arm. In the dexamethasone arm, 5mg was to be administered into each uterine artery, for 10mg total, before uterine artery embolization. In the saline arm, normal saline of a volume equal to the total volume delivered in the dexamethasone arm was to be administered into each uterine artery before the procedure. The registry labels allocation randomized, masking double, and the model parallel.

Random allocation is intended to make treatment assignment independent of participants’ baseline characteristics, on average. It does not guarantee that the groups will be similar in every characteristic in a particular trial. Masking is intended to reduce the influence of treatment knowledge on care, reporting, or assessment, depending on who is masked. The registry gives the masking label but does not report which roles were masked or whether masking was maintained.

A parallel design assigns participants to an arm and compares outcomes between arms, rather than having each participant receive both study treatments. The record does not report the randomization method, allocation concealment procedures, stratification factors, treatment adherence, or withdrawals. It also does not describe a sample-size justification or a prespecified statistical analysis plan. Those details are not reported in the registry record.

The primary completion date and completed status indicate that the registry marks the trial as completed. Completion does not, by itself, demonstrate that results for every listed outcome were entered or analyzed. In particular, the record lists no analyses for the outcome information addressed. The registered design supports understanding the intended comparison, while the absence of posted outcome estimates limits conclusions about its observed results.

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 Pain Scores Using the VAS Questionnaire, measured over Day 7.

The primary endpoint is pain measured with a modified Visual Analogue Score (VAS) on Day 7. The registry describes the scale as ranging from 0, meaning no pain at all, to 10, meaning worst pain, and identifies the endpoint summary as a mean with standard deviation. A scale of this kind converts a participant’s reported pain intensity into a value that can be summarized and compared across randomized arms.

A mean describes the average score in a group. The standard deviation describes how spread out individual scores are around that group average; it is not the same as the uncertainty in the estimated mean. Together, these summaries can show both the typical score and the variability among participants, if the results are reported.

A Day 7 assessment provides a defined time point for the primary pain measure. The registry record does not state why this time point was selected, and it does not report the arm-specific means or standard deviations. It also does not report a treatment contrast, confidence interval, or statistical test for this endpoint. Therefore, the endpoint’s definition and measurement scale can be described, but the posted record does not show the observed pain results or their precision.

In general, a patient-reported pain scale captures the experience reported by the participant rather than an objective measurement of tissue or procedure characteristics. Interpretation depends on how the question is administered, how missing responses are handled, and whether the scale is applied consistently. Further details about these procedures are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean and standard deviation describe?

The primary endpoint is identified as a mean pain score with standard deviation. The mean is the arithmetic average of recorded scores in an arm. It provides a concise description of the group’s average reported pain, but it does not describe every participant’s experience. The standard deviation describes variation among individual scores around the mean. A larger spread means observations are less concentrated around the average; it is not a measure of the uncertainty in the treatment comparison.

To compare randomized arms, an analysis commonly estimates a difference between their average scores. That estimate would describe the observed separation between group means, and a confidence interval would describe uncertainty around it under the model used. The registry record does not report the arm means, standard deviations, contrast, confidence interval, or inferential test for Day 7 pain. No such comparison can be reconstructed from the endpoint definition alone.

Why does randomization matter?

Randomization uses an assignment process intended to prevent treatment choice from depending on participant characteristics. In expectation, this supports a fair comparison of the assigned groups, including for characteristics that were not measured. It does not ensure exact balance in a particular study, especially when enrollment is limited. The registry identifies the trial as randomized, but does not report its sequence-generation method, allocation concealment, or any adjustment variables used in analysis.

Masking can reduce bias when knowledge of treatment assignment could affect participant reports, clinical management, or outcome assessment. The record labels the study double-masked, but does not identify who was masked, how masking was maintained, or whether it was assessed. The label alone cannot establish that expectations had no influence on reporting or care.

What can a p-value or confidence interval add?

In general, a p-value assesses how compatible data are with a specified null hypothesis under the assumptions of the test. It is not the probability that the null hypothesis is true, nor does it describe the clinical size of an effect. A confidence interval is usually more informative about the range of effect estimates compatible with the data and analysis assumptions. Neither can be interpreted without a reported estimate and the analysis context. The registry record does not report a p-value or confidence interval for the primary endpoint.

Even if a test result were reported, interpretation would need to consider the estimated effect, its precision, the scale’s meaning, and the analysis population. A statistical test does not replace those elements. Here, the absence of the primary endpoint estimate means there is no basis in the posted record for a numerical assessment of the treatment comparison.

What does over-dispersion mean for a continuous outcome?

For a continuous score, variation among participants is summarized by the standard deviation. General statistical models rely on assumptions about how outcomes vary and how observations relate to one another. If the actual variability is greater than the model assumes, uncertainty estimates may be too small and tests may appear more decisive than warranted. Researchers can address model fit through appropriate methods, but the registry record does not report the analysis model, diagnostics, or any variance adjustments. No claim about over-dispersion in this trial can be made from the posted information.

How should sample-size planning be read?

Sample-size planning concerns how much information a future or planned study might need to detect a defined effect under stated assumptions. The registry record does not report the trial’s own sample-size justification, so its enrollment should not be treated as evidence that the study had a particular level of power. Planning illustrations are not observed power: they are calculations based on assumptions about an effect, significance level, allocation, and statistical approximation.

The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect expressed as a fraction of an observed effect. Those assumptions do not substitute for a protocol justification. Since the registry record does not report the primary outcome comparison, it does not provide the observed effect needed to interpret effect-based planning illustrations in relation to the trial’s own results. Any sample-size values should therefore be read as planning illustrations, not as observed evidence or proof that the study was adequately powered.

What analysis details are missing?

The record does not list an analysis for the primary endpoint. It also does not report whether the comparison was adjusted, how repeated or incomplete observations were handled, which participants were included in each analysis, or whether the planned analysis differed from the one ultimately used. These details affect the meaning of an estimate and its uncertainty. Without posted methods and results, the endpoint can be described but the numerical analysis cannot be independently assessed.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary pain endpoint and secondary outcomes concerning symptom severity, change in symptoms, and change in quality of life. When a study examines several outcomes or time points, the chance of obtaining at least one apparently notable result can increase if each is tested independently without a suitable plan. General approaches to this issue include designating a primary outcome in advance, adjusting for multiple comparisons, or interpreting secondary findings as exploratory. The registry record does not report a multiplicity strategy, a testing hierarchy, or how any secondary outcomes were to be interpreted.

The record identifies Day 7 as the primary pain assessment but does not provide the results or analyses. It also indicates that the primary outcome has several categories or time points and is not reduced to one comparison. This means the posted information does not support a single outcome contrast for interpretation. The analysis details behind the different categories or time points are not reported in the registry record.

Missing-data handling is also not described. The record does not report the number of missing primary outcome assessments, reasons for missingness, imputation methods, or sensitivity analyses. In general, missing outcome data can affect a comparison if the probability of missingness is related to participants’ outcomes or treatment assignment. Without details on completeness and handling, the effect of missingness cannot be assessed.

The analysis population is not specified in the posted results. The record does not say whether participants were analyzed according to randomized assignment, treatment received, or another defined set. It also does not provide participant flow or outcome-specific denominators. These omissions limit assessment of whether the comparison preserves the benefits of randomization and how broadly the results would apply, even if an estimate were available.

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.

Most frequent non-serious adverse event terms

The registry lists 0 participants with serious adverse events among 21 at risk in the dexamethasone arm, and 0 participants with serious adverse events among 21 at risk in the saline arm. It also lists 0 deaths in each arm. These are the serious-event figures recorded for the study; they should be read as reported counts, not as proof that serious harms were impossible or that every possible event was captured.

The record lists 1 participant with other adverse events in each arm. It does not give event descriptions or clarify the types of events represented by this category in the information available for interpretation. The registry also does not provide detailed collection procedures, follow-up duration for adverse events, or an analysis comparing safety outcomes.

In general, safety counts are most useful when considered alongside how events were defined, how long participants were monitored, and whether collection was systematic. Small or unreported counts do not by themselves establish equivalence between treatments. The registry’s figures describe what was posted, while the missing event details and methods limit a fuller safety assessment.

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

The record establishes the intended clinical comparison: intra-arterial dexamethasone versus saline before uterine artery embolization, with Day 7 pain measured using a modified VAS as the primary endpoint. It also documents randomized allocation, double masking, a parallel design, and the trial’s completed status. These registry entries help explain how the study was structured and what question it aimed to address.

The record does not, however, report the primary pain scores or a statistical comparison between arms. It therefore does not establish whether the observed scores differed, which arm had a higher or lower mean, how large any difference was, or how precisely an effect was estimated. The same limitation applies to the listed secondary outcomes: their results are not reported in the information available for interpretation.

General statistical interpretation requires separating an estimate from its uncertainty and from its clinical meaning. A treatment contrast can be small or large, and uncertainty can be narrow or wide; without a reported contrast and interval, neither can be judged. A p-value, if available, would not by itself convey the size or importance of a difference. No p-value or confidence interval is reported for the primary endpoint.

The serious adverse event counts and deaths recorded in the registry are limited safety summaries. They do not provide a complete account of all possible events, event severity, timing, or follow-up. The equal listing of other adverse events in the arms likewise does not establish that the overall safety profiles were equivalent.

Thus, the trial design and outcome definitions are informative, but the registry record does not support a conclusion about the primary outcome or the comparative safety of the study treatments. The absence of posted results is not evidence that the treatments produced the same outcomes, nor does it indicate that either treatment did or did not alter pain or post-embolization symptoms.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of why a registered question and a reported result are different kinds of evidence. The record sets out a randomized, double-masked, parallel comparison and defines a patient-reported primary endpoint. Those features identify the intended estimand in broad terms: a comparison of Day 7 pain scores between treatment assignments. But without endpoint values and an analysis, the effect itself cannot be estimated from the registry record.

That distinction matters for readers who may otherwise infer results from the trial’s status, phase, or design. A completed randomized trial can still have incomplete outcome reporting in a registry. Design quality can reduce some risks of bias, but it cannot replace the observed data, analysis methods, and uncertainty estimates needed to interpret an effect.

The record also illustrates the value of transparent analysis reporting. Participant flow, outcome-specific denominators, handling of missing responses, analysis populations, and multiplicity plans all help readers assess whether a comparison is complete and appropriately interpreted. Those details are not reported in the registry record.

Finally, the safety counts are interpretable only within the limits of their definitions and ascertainment. Reporting a count without the event descriptions and monitoring context leaves uncertainty about what was captured. For clinical researchers and biostatisticians, the central statistical lesson is that conclusions should track the information actually reported: in this case, the trial’s design is documented, but its primary outcome comparison is 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.

The main limitation for interpreting this specific trial is the absence of posted results for the primary endpoint. The registry describes Day 7 pain on a modified VAS but does not report arm-specific means, standard deviations, an effect estimate, confidence interval, or test result. Without these, neither the direction nor precision of a treatment contrast can be assessed.

The registry also does not report participant flow, the number of completed outcome assessments, reasons for missing data, or the analysis population. It is therefore not possible to assess whether the primary comparison included all randomized participants, how incomplete responses were handled, or whether the groups contributing to the endpoint remained comparable.

Important design and analysis details are not reported in the registry record, including randomization procedures, allocation concealment, the identities of those masked, the analysis model, any covariate adjustment, and the statistical plan. The record does not give a sample-size justification. These omissions prevent a detailed appraisal of the safeguards against bias, the assumptions underlying any analysis, or whether the study was planned around a specified clinically relevant effect.

The record lists secondary outcomes but does not report their results or explain how multiplicity was addressed. It does not give further details about the population, eligibility criteria, baseline characteristics, or outcome measurement procedures beyond the primary scale description. These gaps limit assessment of generalizability and of how consistently symptoms and quality of life were measured.

Safety reporting is limited to summarized counts. Event descriptions, ascertainment methods, and monitoring details are not reported. The registry record supports a description of the registered design and posted safety figures, but not a complete efficacy or safety evaluation.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Dexamethasone for Post Uterine Artery Embolization Pain — NCT04655144.
• Registry record last updated 2026-01-07; status last verified 2025-08.
• Results first posted 2025-09-12.
• 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

NCT04655144 is a completed, randomized, double-masked, parallel Phase 3 trial sponsored by the University of Miami. It enrolled 42 participants with leiomyoma and compared dexamethasone delivered into each uterine artery before uterine artery embolization with a volume-matched saline administration.

The primary endpoint was mean pain on a modified VAS at Day 7, with scores ranging from 0 to 10. The registry lists secondary outcomes related to post-embolization syndrome symptoms and quality of life. It does not report the primary outcome results, a between-arm analysis, or results for the listed secondary outcomes. Serious adverse event figures were 0 among 21 at risk in each arm, and deaths were 0 in each arm. The posted information documents the study question and design but does not permit an estimate of the primary treatment effect.