Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding (NCT00496080), a na na study. The primary outcome is No Surgical Re-intervention.

2. Clinical Question

3. Trial Design

The registry describes a pivotal, single-group study of the Doppler-Guided Uterine Artery Occlusion Device. Its stated objective was to evaluate safety and effectiveness for reducing fibroid-associated bleeding. Enrollment was 87, the allocation field is NA, and the study model is single group. The registry lists no masking. These features mean that the posted design does not include a concurrent comparison arm, and it should not be interpreted as a randomized comparison between treatments.

The recorded study start was 2007-06, and primary completion was recorded as 2010-09. The current registry status is terminated. The reason for termination, and whether termination altered conduct or follow-up, are not reported in the registry record. The phase is listed as NA. No additional details about the planned schedule of visits, treatment delivery, follow-up duration, or protocol deviations are reported.

The primary outcome was assessed at study completion and concerned freedom from a subsequent surgical procedure intended to manage fibroid symptoms. The record identifies an ITT population for this outcome but notes missing data for 5 participants. It lists 7 outcome measures and 0 analyses. The record does not provide estimates or analysis records for the primary outcome or named secondary outcomes.

In a single-group design, an observed outcome describes what occurred among participants in the study, but there is no concurrent control group to distinguish an intervention-associated change from other influences. Changes over time, participant selection, follow-up, and decisions about further procedures can all affect interpretation. These are general design considerations, not claims about what occurred in this study. The registry record does not report a protocol rationale for choosing this design, a sample-size justification, or further details of the statistical plan.

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:

Analysis population for the primary outcome, as defined in the registry: ITT (Data missing for 5 participants)

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 No Surgical Re-intervention, measured over Study completion.

The primary endpoint, “No Surgical Re-intervention,” counts participants who had no subsequent surgical procedure intended to manage fibroid symptoms by study completion. The registry names possible procedures: surgical hysterectomy or dilatation and curettage for menorrhagia; uterine artery embolization or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy; or myolysis. The endpoint is reported as a number of participants, rather than as a continuous measurement.

This type of outcome can be useful because it captures whether participants proceeded to another procedure for symptom management during the specified follow-up. In general, a count is most interpretable when the outcome definition, follow-up period, and population are clear. Here, the timeframe is study completion, but the registry record does not give more detail about the timing of individual events or how follow-up differed among participants.

The primary population is described as ITT, with data missing for 5 participants. The registry record does not report the observed count without re-intervention, the complementary count with re-intervention, an estimate of uncertainty, or an inferential analysis. Accordingly, the endpoint definition is available, but the posted record does not permit a numerical assessment of the primary outcome.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a binary primary outcome expressed as a participant count. A binary outcome classifies each participant according to whether a defined event occurred. In this study, the endpoint is framed as having no subsequent surgical re-intervention by study completion. To estimate the proportion meeting a binary endpoint, an analysis generally needs both the number meeting the definition and the number assessed. The registry gives neither the primary outcome count nor an estimate based on it, so no primary proportion can be read from the record.

What a count can and cannot show

A count is a direct description of how many participants were recorded in a category. It does not, by itself, communicate uncertainty or permit comparison with a counterfactual outcome. In general, uncertainty can be represented with a confidence interval, which gives a range of values compatible with the data and the statistical method used. The registry record does not report a confidence interval for the primary outcome. No new interval can be constructed from the posted information because the endpoint result is absent.

For a binary outcome, an analysis may report a proportion and an interval around that proportion. The interpretation depends on how the denominator is defined, whether all enrolled participants have outcome information, and how the analysis treats missing observations. Here, the endpoint population is labeled ITT, with data missing for 5 participants. The record does not report the observed endpoint count, the denominator used in any calculation, or a method for missing data. Therefore, neither an endpoint proportion nor its precision is available.

Why design matters

This is a single-group study, with allocation listed as NA and masking listed as none. In general, an intervention study with a concurrent comparison group can estimate a contrast between groups, subject to its design and analysis assumptions. A single-group study instead describes outcomes among participants receiving the intervention. Without a concurrent control, differences between observed outcomes and what might otherwise have occurred cannot be separated using a randomized contrast. Other explanations, including changes over time or participant characteristics, can matter. These are general methodological considerations; the record does not report a comparative analysis.

The primary outcome’s timeframe is study completion. A fixed assessment time helps define what counts as an outcome, while differences in follow-up can complicate interpretation. The record does not provide individual follow-up times, event timing, or a time-to-event analysis. It would therefore be inappropriate to interpret this endpoint as a rate or as time until re-intervention. The registry describes a participant count, not a time-to-event result.

How to read the statistical planning illustration

The planning assumptions describe an illustration based on an observed effect, not the study’s own design. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. The record says that such sample-size illustrations are not the trial’s design. Since this trial is single group, those two-arm planning assumptions should not be mistaken for its allocation or for a prospective sample-size justification.

In general, a sample-size calculation asks how much information a hypothetical design would need to detect a specified effect under chosen assumptions. Its output is a planning quantity, not evidence that a study actually had a particular probability of success after completion. The registry record does not report the trial’s own sample-size justification, target enrollment rationale, or planned power. The illustrations should not be described as observed power, and they do not substitute for an outcome estimate or its uncertainty.

What an inferential analysis would require

Statistical inference for a binary endpoint typically depends on an explicit estimand, a defined analysis population, outcome ascertainment, and a method consistent with the design. A confidence interval or test would also rely on assumptions about the sampling process and missing data. The registry lists 0 analyses, and no primary estimate or test is reported. This does not establish what analyses may have been conducted outside the registry; it means that inferential results are not reported in the registry record.

For a comparative trial, an effect measure might contrast groups. For a single-group study, a descriptive proportion can characterize observed outcomes, but a benchmark or causal interpretation would require additional context that is not reported. No comparator value is listed, and no threshold or external reference is given. Consequently, the record does not support an estimate of a treatment contrast or a conclusion based on a prespecified performance target.

Multiplicity and secondary outcomes

Multiple outcomes can raise a multiplicity concern when several statistical claims are tested. In general, testing more hypotheses can increase the chance of at least one apparently notable result if no adjustment or prespecified hierarchy is used. The registry lists 7 outcome measures and names secondary measures covering quality of life, menses, satisfaction, fibroid bulk, and symptom severity. It does not report an outcome hierarchy, a multiplicity adjustment, or analyses for these endpoints. Without reported results and a statistical plan, the extent to which multiplicity was addressed cannot be determined.

Some listed secondary outcomes are measurements or scores rather than binary counts. Their interpretation would depend on the scale, assessment time, baseline values, and analysis method. Those details and results are not reported in the registry record. General statistical principles cannot fill in those missing study-specific details. In particular, no change score, variability estimate, confidence interval, or test result should be inferred from the outcome names alone.

The adverse-event data are likewise descriptive counts. The registry reports serious and other event counts for the DUAO Device group, with 87 participants at risk in each category. In general, an adverse-event count does not describe comparative risk unless a comparison and suitable analysis are available. The record does not list a control group or comparative safety estimate. Event-term percentages identify listed terms, but the registry does not describe their overlap or provide a complete event-level analysis.

Overall, the statistical record is limited to design descriptions, outcome definitions, enrollment, and adverse-event counts. The absence of analysis results leaves the precision and inferential interpretation of the primary and secondary outcomes unresolved. General statistical explanations clarify what kinds of evidence would ordinarily be useful, but they do not provide missing results for this study.

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("DUAO Device")
n      <- c(82)
events <- c(74)
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  DUAO Device  82  74  90.2  81.7  95.7  81.9  95.0  81.9  94.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 7 outcome measures, including a primary endpoint and named secondary outcomes related to health-related quality of life, maintenance of menses, procedural satisfaction, fibroid bulk, and UFS-QOL symptom severity. It lists 0 analyses. Results for the secondary outcomes, and any multiplicity strategy for interpreting multiple outcomes, are not reported in the registry record.

In general, multiplicity is relevant when several outcomes or hypotheses are examined, because repeated testing can increase the chance of observing at least one apparently unusual result. A prespecified hierarchy, adjustment, or clear distinction between confirmatory and exploratory outcomes can help frame interpretation. The registry record does not report such a hierarchy or adjustment. With no posted outcome analyses, it is not possible to assess how multiplicity affected conclusions.

The primary endpoint population is identified as ITT, with data missing for 5 participants. The registry does not describe the missing-data mechanism, the handling method, or sensitivity analyses. General approaches can include assumptions about the missing outcomes or analyses that examine how conclusions change under alternative assumptions. No such approach is reported. It is therefore not possible to determine how the missing data affected the primary endpoint.

The record does not provide analysis populations for the secondary endpoints or say whether participants were excluded from particular analyses. The primary population label alone does not establish how all outcomes were analyzed. Although enrollment was 87, the missing-data note should not be used to infer an unreported analysis denominator or an outcome count.

12. Safety Results

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

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: urinary retention (2.3%), diverticulitis (1.1%), medication error (1.1%), dysfunctional uterine bleeding (1.1%).

The DUAO Device group lists 4 serious adverse events among 87 participants at risk and 37 other adverse events among 87 participants at risk. These are the posted event counts; the registry does not provide a concurrent group for comparison or a comparative estimate of safety. The counts should be read descriptively rather than as evidence of a difference between treatments.

The listed serious adverse-event terms are urinary retention at 2.3%, diverticulitis at 1.1%, medication error at 1.1%, and dysfunctional uterine bleeding at 1.1%. These term-specific percentages should not be added together to infer a total: the registry does not state whether participants could appear under more than one term, or provide the detail needed to establish overlap. The record does not describe the event-term coding or the basis for each term percentage beyond listing them.

Deaths are not reported in the registry record. The record also does not provide event timing, duration, severity detail beyond the serious classification, or a causal assessment. In general, an adverse event recorded during a study is not necessarily caused by the intervention. These posted counts alone cannot establish causation, comparative risk, or the probability of an event in a different setting.

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

The registry record establishes that this was a single-group device study enrolling 87 participants and that its primary question concerned avoiding a subsequent surgical procedure intended to manage fibroid symptoms. It also records a primary completion date of 2010-09 and a current status of terminated. Those details describe the study record, but they do not supply the primary outcome result.

The central limitation for interpreting effectiveness is that the number of participants without re-intervention is not reported. No estimate of the primary outcome, confidence interval, or analysis result is listed. The record therefore does not show how many participants met the endpoint or how precisely that outcome was estimated. It also does not provide results for the listed secondary outcomes.

Even if a primary count were available, a single-group result would describe the participants observed in this study rather than provide a randomized comparison. In general, attributing an outcome to an intervention requires attention to alternative explanations and to the design used to estimate a counterfactual. The registry does not report a concurrent control group or a benchmark for interpreting the outcome.

The adverse-event counts and listed terms contribute descriptive safety information. They do not determine whether the device caused an event, nor do they show how event counts compare with another treatment. The record gives no deaths data, and does not report comparative safety analyses.

The results that can be stated are consequently limited: enrollment was 87; the primary endpoint was defined as no surgical re-intervention by study completion; data were missing for 5 participants in the stated ITT population; and adverse-event counts and selected serious-event terms were listed. The reason for termination, outcome estimates, missing-data handling, and statistical analysis details are not reported in the registry record. No conclusion about benefit or lack of benefit follows from the absence of posted outcome results.

14. Why This Trial Matters Statistically

This study is statistically instructive because its primary endpoint is clearly described while its observed result is not reported in the registry record. A well-defined outcome tells readers what the investigators intended to count; it does not by itself show how often the outcome occurred. Keeping the distinction between outcome definition and outcome result explicit prevents readers from treating the study objective as evidence of an observed effect.

The single-group design also highlights the difference between describing an outcome and estimating a comparative effect. A participant count can characterize study experience, but the absence of a concurrent comparator limits what can be attributed to the intervention. This distinction is important whenever a study’s stated aim uses language such as safety or effectiveness but its posted design does not provide a like-for-like comparison.

Missing information matters for both estimation and precision. The primary population is labeled ITT, with data missing for 5 participants, yet the record does not state how those data were handled or report the endpoint count. Readers cannot establish the denominator used for an analysis, assess the impact of missingness, or judge uncertainty from the posted information.

The registry also lists several outcomes but no analyses. This makes multiplicity and endpoint hierarchy relevant questions, while leaving them unanswered. The safety counts offer another useful lesson: descriptive event counts and listed term percentages are not the same as comparative risk estimates or causal conclusions. Overall, the record illustrates why statistical interpretation requires results, denominators, uncertainty, and design context—not merely an objective and a list of outcomes.

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 primary limitation for interpreting this particular trial is that the registry record does not report the primary endpoint result. It defines freedom from surgical re-intervention through study completion, but gives no count of participants meeting the definition, estimate, or uncertainty interval. The record lists 0 analyses, and does not provide posted statistical results for the named secondary outcomes.

The single-group design lacks a concurrent control arm. The allocation field is NA and masking is listed as none. As a result, the record does not provide a randomized comparison or a basis for estimating a between-group contrast. The registry also does not report a benchmark against which the primary outcome might be interpreted.

The ITT population description notes missing data for 5 participants. The record does not explain the reason for missingness, how these observations were handled, or whether sensitivity analyses were performed. It does not report participant-level follow-up or the timing of potential re-interventions, so interpretation of outcome ascertainment over the study period is limited.

The registry lists 7 outcome measures but does not report an analysis plan, hierarchy among outcomes, or multiplicity procedure. It does not provide further details on eligibility, treatment delivery, protocol deviations, or the reason the study was terminated. These absences do not establish that such information was never collected; they mean it is not reported in the registry record.

Safety information is limited to the posted counts and selected serious-event terms. The record does not report deaths, event timing, causal assessments, or comparative analyses. Thus, it cannot establish comparative safety from these counts alone.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding — NCT00496080.
• Registry record last updated 2012-09-10; status last verified 2012-09.
• Results first posted 2012-07-24.
• 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

NCT00496080 is a single-group device study of Doppler-guided uterine artery occlusion for fibroid-associated bleeding. The registry lists 87 enrolled participants, no masking, a phase of NA, and a current status of terminated. The recorded start was 2007-06, and primary completion was 2010-09.

The primary endpoint was the number of participants without subsequent surgery intended to manage fibroid symptoms by study completion. Its population is labeled ITT, with data missing for 5 participants. The observed endpoint result and statistical analyses are not reported in the registry record. Seven outcome measures are listed, alongside 0 analyses.

The DUAO Device group lists 4 serious adverse events and 37 other adverse events, with 87 participants at risk in each category. The record lists selected serious-event terms and percentages but provides no concurrent comparison. The reason for termination, missing-data methods, and detailed statistical plan are not reported in the registry record.