Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse (NCT00099372), a registered phase not stated study. The primary outcome is Number of Participants With Symptomatic Failure.

2. Clinical Question

The broader study description concerns longer-term success and complications after abdominal sacrocolpopexy, and whether adding Burch colposuspension affects urinary incontinence. The primary outcome listed for this record is narrower: a count of participants meeting a specified definition of symptomatic failure at 24 months. It is not itself a direct measure of urinary incontinence, nor does it encompass every possible aspect of surgical success or complication.

The arms describe different surgical procedures, but the allocation method is not stated. The record explicitly cautions that the arms are not a like-for-like control comparison. Therefore, a difference between arm counts, if reported, would not by itself establish that the added procedure caused a difference in outcomes. The registry record does not report a primary-outcome estimate or an inferential comparison, so the clinical question cannot be answered from the posted results.

3. Trial Design

E-CARE is described as a follow-up study of women who had participated in the CARE trial. The record says that recruitment into E-CARE was open only to women already enrolled in CARE, and that recruitment into CARE was closed. The listed enrollment is 215. The planned follow-up described in the summary was 10 years from surgery, with comparisons of success and complication rates between the groups.

The treatment arms are abdominal sacral colpopexy with Burch colposuspension and abdominal sacral colpopexy without Burch colposuspension. These descriptions identify the procedures but do not establish how participants came to receive them. Allocation is not stated in the registry record, and the record cautions that the arms are not a like-for-like control comparison. Randomization, allocation concealment, and other details of assignment are not reported in the registry record.

The record lists a start of 2004-05, primary completion of 2011-06, and status of terminated. It does not report why the study was terminated or how much of the intended follow-up was completed. The stated long-term aim and the primary endpoint’s 24-month timeframe are distinct: the planned follow-up was described as extending over 10 years, while the primary outcome is defined at 24 months.

The primary endpoint is a count of participants with symptomatic failure. Its stated analysis population includes randomized participants who completed the visit at the time point, or who were failures before that time point; prior dropouts who had not met failure criteria are excluded. Although the record uses the term “randomized participants” in describing this population, it does not state the allocation method for the arms in this study record. The analysis population should therefore be read as the record’s stated endpoint definition, not as evidence of a randomized comparison.

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.

Enrolled in Extended CARE Trial

Followed up 5 Years After Index Surgery

Followed up 7 Years After Index Surgery

Analysis population for the primary outcome, as defined in the registry: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

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 Number of Participants With Symptomatic Failure, measured over 24 months.

The primary endpoint is the number of participants with symptomatic failure at 24 months. Failure is defined as any of the following after the index surgery: a symptom of bulge on the Pelvic Floor Distress Inventory, interval prolapse surgery, or use of a pessary. The outcome is a participant count, not a continuous score or a time-to-event estimate.

This definition combines a reported symptom with subsequent clinical management. A symptom-based component can capture problems that matter to participants even when no additional procedure is undertaken. The surgery and pessary components capture further treatment for prolapse. Combining these elements gives the registry a practical way to count participants who meet the specified definition, but the combined count does not show which component was met by each participant or how severe a symptom was.

The endpoint is used to assess symptomatic failure after surgery, but it does not represent every dimension of effectiveness. It does not, by itself, describe urinary incontinence, all complications, quality of life, or the timing of failure. The endpoint’s stated timeframe is 24 months even though the study summary describes a longer follow-up aim. No count of participants meeting this endpoint or comparison estimate is reported in the registry record, so its observed frequency and precision cannot be assessed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is binary at the participant level: a participant either meets the stated symptomatic-failure definition by the time point or does not. The registry reports the outcome parameter as a count of participants. A count is descriptive; it does not, on its own, quantify uncertainty or establish whether groups differ. For interpretation, readers would ordinarily need the count and relevant denominator for each arm, along with an estimate of the contrast and its uncertainty. Those primary-outcome results are not reported in the registry record.

What does a confidence interval add?

In general, a confidence interval expresses the statistical uncertainty around an estimated effect. A narrow interval indicates greater precision under the assumptions of the method; a wide interval indicates less precision. The interval also helps readers assess which effect sizes remain compatible with the observed data. It does not measure every source of uncertainty: for example, it cannot correct for biased allocation, incomplete outcome ascertainment, or a mismatch between the analysis and the clinical question. No primary-outcome confidence interval is reported in this record, so the precision of the symptomatic-failure result cannot be evaluated.

What can an arm comparison establish?

A direct comparison of arm outcomes is most informative when the groups are comparable apart from the intervention being evaluated, and when allocation and analysis procedures support that interpretation. The registry does not state the allocation method and warns that the arms are not a like-for-like control comparison. For that reason, a difference between arm-specific counts, if available, would be descriptive unless the design and analysis justified a stronger interpretation. The record does not provide an adjusted analysis or other analysis details that could clarify this issue. The sponsor’s own analysis would take precedence over a simple recalculation from summary statistics if the two disagreed; no sponsor analysis is listed among the 0 analyses.

Why does the analysis population matter?

The endpoint description specifies that the outcome is analyzed among randomized participants who completed the visit at the time point, or who had already met failure criteria. Prior dropouts who had not met failure criteria are excluded. This rule means that the analysis is not simply described as including every enrolled participant regardless of follow-up. A participant who leaves follow-up without meeting the failure definition may contribute differently from a participant known to have failed before the time point. The record does not report how many participants completed the visit, how many were excluded as prior dropouts, or how missing outcome information was otherwise handled. Those details are important for judging how representative the analyzed group is of the enrolled group.

What does the sample-size planning describe?

The stated sample-size assumptions describe a planning illustration based on an observed effect, not the trial’s own design. They specify a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. For time-to-event tables, the planning quantity is the total number of events using the Schoenfeld approach; for other outcomes, it is participants per arm. These assumptions describe how a planning calculation is framed, not what was achieved in the study. The record does not report the original sample-size justification, and no outcome estimate is available to assess the observed effect underlying a planning illustration. A planning sample size is not observed power and does not show the probability that the completed study detected an effect.

Methods also depend on the outcome’s structure. This endpoint is a participant count, so an analysis would need to account for the binary outcome and the comparison being made. The registry does not report a specific model, test, adjustment strategy, or treatment of repeated observations. General methods for binary outcomes may estimate a difference or ratio between groups, but choosing among them requires design and analysis details that are not present in the record. No new effect estimate can be reconstructed from the safety counts, because those concern a different outcome category and do not provide the primary-outcome data.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 42 outcome measures and 0 analyses. It defines a primary endpoint, but does not describe how the remaining outcomes relate to it or how multiple statistical comparisons were handled. A multiplicity plan may specify which outcomes or comparisons are confirmatory and how the chance of false-positive findings is controlled when many hypotheses are examined. Such a plan is not reported in the registry record. Without it, readers cannot determine whether any unreported or later-reported secondary findings were planned as confirmatory, exploratory, or adjusted for multiple testing.

The endpoint description gives a rule for the analysis population: participants who completed the visit at the time point or had already met failure criteria are included, while earlier dropouts who had not met failure criteria are excluded. This is useful information, but it does not explain the amount or pattern of missing data. The numbers with completed visits, the reasons for dropout, and any sensitivity analyses are not reported in the registry record. No method for imputing missing outcomes or testing the effect of alternative missing-data assumptions is reported.

The record does not report whether analyses followed an intention-to-treat approach, how deviations from the assigned procedure were handled, or whether any subgroup analyses were planned. It also does not report interim analyses or stopping rules. These omissions do not prove that such procedures were absent; they mean that they are not described in the registry record. The status is terminated, but the record does not connect that status to any analysis decision. Readers therefore cannot assess whether termination affected outcome availability, multiplicity, or the analysis population.

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 serious adverse events separately from other adverse events. In the arm with Burch colposuspension, 0 participants are listed as affected by a serious adverse event among 104 at risk, and 0 deaths are listed. In the arm without Burch colposuspension, 0 participants are listed as affected by a serious adverse event among 111 at risk, and 0 deaths are listed. These entries describe what the registry reports; they do not establish that no serious events occurred outside the registry’s recorded ascertainment or reporting process.

For other adverse events, the record lists 12 affected among 104 at risk in the Burch arm and 15 affected among 111 at risk in the arm without Burch. These are participant counts, not a statistical comparison. No uncertainty estimates, definitions of the other-event category, event-level descriptions, or comparative safety analysis are reported in the registry record. The serious-event terms list is empty, so specific serious-event types are not described there.

Safety counts should be read separately from the symptomatic-failure endpoint. They do not describe the primary outcome and cannot establish a difference in overall safety between arms, particularly because allocation is not stated and the record cautions that the arms are not like-for-like controls. The registry status is terminated, but the reason and any implications for safety follow-up are not reported.

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

The registry record establishes that E-CARE was designed to follow women from CARE and describes procedures with and without Burch colposuspension. It defines symptomatic failure at 24 months through bulge symptoms, interval prolapse surgery, or pessary use after the index surgery. These details tell readers what clinical outcome the study intended to assess and which participant experiences counted toward it.

The record does not report the primary-outcome counts or a comparison between arms. It therefore does not show how often participants met the symptomatic-failure definition, whether the observed outcome differed between groups, or how precise an estimate might be. The absence of a reported result is not evidence that the procedures had identical outcomes, nor does it show that either procedure was superior or inferior.

The safety entries report 0 serious adverse events and 0 deaths in each arm, alongside other adverse-event counts of 12 and 15 affected participants. These entries are descriptive and lack a comparative analysis. They should not be expanded into claims about relative risk, overall safety, or the complete event experience, none of which can be determined from these entries alone.

The study’s long-term aim and its 24-month primary endpoint should also be kept distinct. The summary describes planned follow-up for 10 years, but the registry does not report the degree of follow-up achieved. The record is marked terminated, with no reason stated. It cannot establish from these details alone whether longer-term outcomes were fully collected or analyzed. In short, the record describes the research question, treatment arms, endpoint, and selected safety counts, but does not provide the primary efficacy results needed to resolve the stated comparison.

13. Why This Trial Matters Statistically

This trial record illustrates why an outcome definition and an outcome result are different kinds of information. The primary endpoint is described clearly enough to identify what counts as symptomatic failure and when it is assessed. But without the actual arm-specific counts and an estimate of the contrast, the central statistical question remains unanswered. A well-defined endpoint is necessary for interpretation; it cannot replace the evidence from observed outcomes.

The record also highlights the role of study design in interpreting comparisons. The arms represent different procedures, yet allocation is not stated and the record warns that the groups are not like-for-like controls. Statistical methods can quantify patterns in data, but they cannot by themselves remove bias arising from how participants entered each arm. Design information is therefore essential for deciding whether an observed contrast can be interpreted causally.

Follow-up and analysis-population definitions matter especially in a study that describes long-term observation. The endpoint includes participants who completed the relevant visit or had already failed, while excluding some prior dropouts. That definition makes missing follow-up relevant to interpretation. Without counts of completed visits, dropout reasons, and missing-data analyses, readers cannot judge how much outcome information is absent or how it may affect conclusions.

Finally, the registry distinguishes the primary outcome from safety reporting and sample-size planning. Safety counts are not substitutes for symptomatic-failure results, and a planning illustration is not evidence of achieved precision or observed power. Keeping these categories separate prevents descriptive counts, planned follow-up, and statistical assumptions from being mistaken for an analysis of the clinical question.

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.

Several limitations follow from what the registry record does and does not report. The primary endpoint is defined, but no primary-outcome count, effect estimate, confidence interval, or p-value is reported. The endpoint is a composite of bulge symptoms, interval prolapse surgery, and pessary use, and the record provides no component-specific results. As a result, neither the frequency of symptomatic failure nor the contribution of each component can be assessed.

The allocation method is not stated, and the registry explicitly cautions that the arms are not a like-for-like control comparison. This limits interpretation of any contrast as an effect of adding Burch colposuspension. Details of baseline comparability, deviations from the procedures, and adjusted analyses are not reported in the registry record.

The stated endpoint population excludes prior dropouts who had not met failure criteria. The record does not report the number completing the relevant visit, the number excluded, reasons for missingness, or sensitivity analyses. Thus, the extent to which missing outcome information could affect the result cannot be judged. The planned 10-year follow-up is described in the study summary, but the record does not report how much follow-up was achieved. The status is terminated, and the reason is not reported.

Although 42 outcome measures and safety entries are listed, the record lists 0 analyses. Statistical methods for the primary outcome, multiplicity handling, interim analyses, and the original sample-size justification are not reported in the registry record. The stated planning assumptions do not establish the completed study’s precision. These gaps constrain interpretation of both the intended clinical comparison and the posted safety counts.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse — NCT00099372.
• Registry record last updated 2021-03-22; status last verified 2020-12.
• Results first posted 2021-03-22.
• 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

E-CARE is described as a follow-up study of women who participated in CARE, comparing abdominal sacral colpopexy with and without Burch colposuspension. The registry lists enrollment of 215, a start of 2004-05, primary completion of 2011-06, and status of terminated. The summary describes intended follow-up for 10 years.

The primary outcome is the count of participants with symptomatic failure at 24 months, defined by bulge symptoms, interval prolapse surgery, or pessary use after the index surgery. The record lists 42 outcome measures and 0 analyses, but does not report primary-outcome results or an inferential comparison. Allocation is not stated, and the registry warns that the arms are not like-for-like controls.

Safety entries list 0 serious adverse events and 0 deaths in each arm. Other adverse events affected 12 participants among 104 at risk in the Burch arm and 15 among 111 at risk in the arm without Burch. The reason for termination and the extent of long-term follow-up are not reported in the registry record.