Clinical Evaluation of Ajust™ in Stress Urinary Incontinence: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (NCT01290796), a na na study. The primary outcome is Percentage of Patients Free of Stress Urinary Incontinence.

2. Clinical Question

3. Trial Design

The registry record describes the Clinical Evaluation of Ajust™ in Stress Urinary Incontinence, also identified by the official title Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe). It is a single-group study of the Ajust Adjustable Single-Incision Sling. The listed allocation is NA, and masking is listed as NONE. There is no separate comparison arm described, so the design does not support a randomized, between-group treatment contrast.

Enrollment was 153. The study status is COMPLETED, with a start date of 2011-01 and a primary completion date of 2013-06. The phase is listed as NA. C. R. Bard is identified as the sponsor. The record describes the intervention as a device and the arm as a urinary incontinence sling.

The primary endpoint was assessed at 12-months post surgical procedure. The stated measure is the percentage of patients free of stress urinary incontinence, using a negative Cough Stress Test and no surgical retreatment as the criteria. The registry record also lists secondary outcomes concerning operative, perioperative, and longer-term complications; post-operative pain; self-reported symptoms; the Incontinent Impact Questionnaire; and patients’ impression of improvement. Some named outcomes include assessments at 12 or 36 months.

The record lists 11 outcome measures, but no analyses are reported in the registry record. Details such as eligibility requirements, recruitment procedures, visit schedules beyond the named outcome timeframes, and the statistical analysis plan are not reported in the registry record. The available design information establishes the single-group structure and endpoint definition, but does not establish how every outcome was analyzed or how missing observations were handled.

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 Percentage of Patients Free of Stress Urinary Incontinence, measured over 12-months post surgical procedure.

The primary endpoint is the percentage of participants free of stress urinary incontinence at 12-months post surgical procedure. The registry definition requires both a negative Cough Stress Test (CST) and no surgical retreatment at the 12 month study visit. It is therefore a combined classification: a participant must meet the stated test criterion and the stated retreatment criterion to count as free of stress urinary incontinence under this endpoint.

A percentage is useful for describing how common a defined outcome was among the participants included in an analysis. Here, the endpoint is intended to express the frequency of the specified outcome at a particular follow-up visit. The CST provides a test-based component, while the no-retreatment condition adds a further criterion relevant to how the endpoint classifies participants. The registry record does not report the observed percentage, the number assessed at the visit, or the 95% Confidence Interval.

As a general statistical point, a confidence interval communicates uncertainty around an estimated quantity. Its width depends on factors including the amount of information available and the variability in the data. Without the estimate and interval, the endpoint definition alone cannot show the observed frequency or how precisely it was estimated. The record also does not report the details needed to determine how participants without an assessment at the visit were treated in the endpoint analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies the primary outcome as a percentage and lists a 95% Confidence Interval as its dispersion measure. It does not report the statistical method used to calculate the percentage or interval. The distinctions below explain the general statistical ideas relevant to interpreting such an endpoint; they do not describe an analysis method confirmed for this study.

What does a percentage represent?

For a binary outcome, each participant is classified into one of two categories for the endpoint being analyzed. A percentage describes the share in the category of interest among the participants included in the calculation. In this study’s endpoint definition, the category of interest is being free of stress urinary incontinence at the specified visit. The definition requires both a negative CST and no surgical retreatment. A participant who does not meet the complete definition would not be counted in that category, although the registry record does not give further rules for handling unavailable or ambiguous assessments.

To interpret a percentage, the numerator and denominator matter. The numerator represents participants classified as meeting the endpoint; the denominator represents the participants included in the analysis. The record reports enrollment of 153 but does not report the number with an evaluable 12-month endpoint or the endpoint numerator. Enrollment should not be assumed to equal the analysis denominator.

What does a confidence interval add?

A confidence interval is a statistical way to express uncertainty around an estimated quantity. A point estimate alone gives a single value; an interval gives a range of values compatible with the data under the method’s assumptions. The interval is not a guarantee that the true value lies within its endpoints, nor does it address every source of uncertainty. Its interpretation depends on the analysis method and the data used.

The registry names a 95% Confidence Interval for the primary outcome, but does not report the calculated interval or its associated estimate. It also does not identify the interval method. Without the reported values, the uncertainty around the primary percentage cannot be assessed. Even when an interval is available, its width is not a measure of clinical importance and does not resolve the absence of a comparator.

Why does the single-group design matter?

A single-group study can describe outcomes observed among participants who received the intervention. A randomized comparison has a different purpose: it estimates a contrast between groups assigned to different study conditions. Because this record describes a single group and no control arm, there is no randomized contrast to interpret. A favorable-looking percentage, if one were reported, would not on its own establish what would have happened to comparable participants under another approach.

Masking is listed as NONE. Masking can, in general, reduce the influence of knowledge of treatment assignment on some assessments or decisions. Its relevance depends on the outcome and study procedures. The registry record does not give additional details about assessment procedures, so the implications of the listed masking status for the CST or other outcomes cannot be determined from this information.

What can safety counts show?

Counts of serious and other adverse events describe reported events or affected participants as categorized in the registry record. Their interpretation depends on the record’s definitions, reporting period, method of collection, and whether counts refer to events or people. The registry record does not provide all those details. The listed counts should be read as descriptive safety information, not as a comparative estimate, because no control group is listed. A count also does not by itself establish whether an event was caused by the intervention.

What do the planning illustrations mean?

The sample-size material is described as a planning illustration computed from the observed effect, not as the trial’s own design. Its stated assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. Such illustrations ask how many participants per arm might be needed under specified assumptions for a future two-arm comparison. They are not the number enrolled in this single-group study, do not establish that the study was designed around those assumptions, and are never observed power.

In general, a planning calculation depends on the effect targeted, the variability or event frequency assumed, the significance level, the desired power, and the allocation scheme. A calculation based on an observed effect is especially dependent on that effect estimate and should be treated as an illustration. The registry record does not report the study’s own sample-size justification, so the planning illustration cannot be taken as evidence about the original enrollment rationale.

Why can over-dispersion matter?

As a general concept, over-dispersion occurs when observed variability exceeds what a statistical model assumes. It can make standard errors and confidence intervals too small if the model does not account for the extra variability. This concept is most relevant to particular kinds of repeated, clustered, or count data. The primary endpoint is described as a percentage, but the registry record does not report a model or indicate that over-dispersion was assessed. It would therefore be inappropriate to claim that it affected this study’s analysis.

These general methods explain what kinds of information are needed for a statistical interpretation. For this study, the registry record does not report the primary estimate, the confidence interval, the analysis method, or the analysis denominator. Those omissions limit what can be inferred from the endpoint definition and enrollment total alone.

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("Ajust Adjustable Single-Incision Sling")
n      <- c(153)
events <- c(142)
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  Ajust Adjustable Single-Incision Sling  153  142  92.8  87.5  96.4  87.6  95.9  87.6  95.9

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 11 outcome measures, including the primary endpoint and secondary outcomes that address complications, pain, symptoms, questionnaire change, and impressions of improvement. Several listed outcomes refer to different follow-up times. Considering multiple outcomes or timepoints can create multiplicity: the more statistical questions examined, the greater the chance that some results may appear notable by chance if each is interpreted separately. This is a general statistical concern, not a statement that a particular false-positive result occurred in this study.

The registry record does not report a multiplicity strategy, such as a hierarchy of outcomes or an adjustment to account for multiple tests. It also does not report analyses for the listed outcomes. Accordingly, the relationship among the primary and secondary analyses and any control of the overall error rate are not reported in the registry record. The endpoint listings alone cannot establish which outcomes were analyzed or how their results were interpreted.

Missing-data handling and analysis populations are also not reported in the registry record. Although enrollment was 153, the number of participants with data at each endpoint and the rules for including them are not stated. The record does not describe whether missing assessments were excluded, imputed, or handled by another method. It does not report whether analyses used all enrolled participants or a defined subset. These details are important for interpreting a percentage and judging how well it represents the enrolled group. No assumptions about missing observations or analysis populations should be inferred from the enrollment total or the completion status.

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: anuria (0.7%), implant site pain (0.7%), medical device complication (0.7%).

The registry record lists 153 at risk for the Ajust Adjustable Single-Incision Sling group, with a serious-event count of 2 and an other-event count of 16. These are descriptive counts as presented in the record. The listed serious terms are Anuria, Implant Site Pain, and Medical device complication, each reported as 0.7%.

The record does not report deaths; the death entry is not reported in the registry record. It also does not provide, in the information available, definitions and collection details sufficient to establish whether counts refer to unique participants or events, or how events were attributed. The counts should not be interpreted as evidence that the device caused the listed events.

Because the study is single-group and no comparator is listed, these figures cannot establish whether event frequency was higher or lower than it would have been under another treatment or no intervention. They do not provide a comparative risk estimate. The registry’s named safety outcomes include complications during the procedure, perioperatively, and through 36 months, but the timing and detailed results for those outcomes are not reported in the registry record. The listed counts therefore provide limited descriptive information and do not substitute for a complete account of safety analyses.

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

The registry record establishes that a completed single-group study evaluated the Ajust Adjustable Single-Incision Sling in female stress urinary incontinence and defined a primary 12-month endpoint. That endpoint classified participants as free of stress urinary incontinence only when the CST was negative and no surgical retreatment had occurred at the study visit. These details make the intended outcome interpretable in principle.

The primary outcome result itself is not reported in the registry record. Neither the observed percentage nor its 95% Confidence Interval is available in the record. As a result, the size of the endpoint estimate, its precision, and the number of participants contributing to it cannot be assessed. The endpoint definition should not be mistaken for evidence about the outcome observed.

The single-group design also limits what any outcome percentage could establish. Without a listed comparison group, an outcome among participants receiving the sling cannot be interpreted as a randomized difference from another approach. The registry record does not establish how outcomes would have differed in the absence of the intervention or under an alternative. This limitation applies independently of whether a single-group percentage is large or small.

The secondary outcomes show that the registry intended to address several aspects of outcomes and safety, including complications, pain, symptoms, and questionnaire measures. Their names are not results, and the record does not report analyses for them. The adverse-event counts provide some descriptive information, but do not establish causation or comparative safety.

Overall, the registry information supports conclusions about the study’s design, stated endpoint, enrollment, and limited reported safety counts. It does not support a numerical conclusion about the primary endpoint, its precision, or a treatment comparison. Missing analysis details, including endpoint denominators and missing-data procedures, further constrain interpretation. These boundaries distinguish what the registry record describes from questions it does not answer.

14. Why This Trial Matters Statistically

This trial is statistically notable for the contrast between a specific endpoint definition and the limited outcome information reported in the registry record. The primary measure has a defined timepoint and explicit criteria: a negative CST and no surgical retreatment at the 12 month study visit. Such definitions are important because they establish what a reported percentage would count. Yet without the observed percentage, interval, or analysis denominator, the definition cannot be translated into an estimate of outcome frequency or precision.

The single-group design is another central statistical feature. It can describe outcomes in the group studied, but it does not provide a randomized control contrast. This distinction matters because readers may otherwise interpret a percentage as evidence about a comparative effect. The record does not describe a control arm or allocation between groups.

The registry lists 11 outcome measures spanning several domains and timeframes. Multiple outcomes can support a broad assessment, but they also raise questions about which outcomes were prioritized and how multiple statistical tests were handled. The multiplicity strategy and analyses are not reported in the registry record. Missing-data handling and analysis populations are also not reported, making it difficult to assess how endpoint estimates would relate to all enrolled participants.

The planning material is explicitly an illustration based on an observed effect and assumptions for a two-arm calculation. It is not the study’s own design justification or observed power. Keeping planning calculations separate from trial results prevents a common statistical misunderstanding: a hypothetical sample-size requirement does not show whether an actual study detected an effect or how precise its estimate was.

These features make the record useful for understanding the structure and intended measurements of the study, while also defining clear limits on what can be concluded from the reported information.

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.

Several trial-specific limitations follow directly from the registry record. The study is identified as single-group, with allocation listed as NA and no masking. No comparator group is described, so the design does not furnish a randomized contrast. The record’s endpoint and safety information therefore cannot be used to make a direct between-group comparison.

The primary endpoint is defined, but its observed result and 95% Confidence Interval are not reported in the registry record. The number of participants assessed at 12 months and the analysis denominator are also not reported. Although enrollment was 153, the registry does not establish how many participants contributed to the primary endpoint.

The record lists 11 outcome measures, including outcomes assessed at different times, but does not report analyses or a multiplicity strategy. Missing-data methods, analysis populations, and the statistical analysis plan are not reported in the registry record. The sample-size justification for the study is also not reported; the described sample-size calculations are planning illustrations rather than the trial’s own design rationale.

Eligibility criteria, participant characteristics, and additional procedural or follow-up details are not reported in the registry record. The available adverse-event information includes counts and serious-event terms, but does not establish the event definitions, attribution process, or comparative rates. These omissions limit assessment of representativeness, precision, and the completeness of outcome and safety reporting.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Clinical Evaluation of Ajust™ in Stress Urinary Incontinence — NCT01290796.
• Registry record last updated 2017-03-27; status last verified 2017-02.
• Results first posted 2014-05-12.
• 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.

19. Record Summary

The registry record describes a completed, single-group device study of the Ajust Adjustable Single-Incision Sling for female stress urinary incontinence. Enrollment was 153; the start date was 2011-01 and the primary completion date was 2013-06. Masking is listed as NONE, and allocation and phase are listed as NA.

The primary endpoint is the percentage of participants free of stress urinary incontinence at 12-months post surgical procedure, defined by a negative CST and no surgical retreatment at the 12 month study visit. The observed endpoint result and 95% Confidence Interval are not reported in the registry record. The record lists 11 outcome measures and descriptive adverse-event counts, but analyses, missing-data methods, and the multiplicity strategy are not reported.