This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence (NCT00996489), a na na study. The primary outcome is Incontinence Status as Assessed by Stamey Grade Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00996489 |
| Phase | NA |
| Condition | Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 459 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merz North America, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Women with female stress urinary incontinence due to intrinsic sphincter deficiency. The registry describes a full analysis set that included participants with a baseline and at least one post-baseline observed or imputed primary effectiveness value.
Intervention
Coaptite®, listed as a device intervention, in a post-approval study of treatment for female urinary incontinence.
Comparator
No concurrent comparator is recorded. The study is listed as a single-group study, with no random allocation or masking.
Primary question
How did the mean Stamey grade score, a measure of stress-incontinence severity, compare with baseline at the scheduled follow-up timepoints? Numeric outcome results are not reported in the registry record, so the amount or direction of any change cannot be assessed from this record.
The primary outcome was assessed at baseline and Months 6, 12, 18, 24, 30, and 36. The Stamey grade was derived from a 4-day voiding diary and used four grades from 0-3, with higher grades indicating more severe leakage. The registry also lists secondary outcomes covering injection counts, retreatment, alternative treatments, urge-incontinence medication status, quality-of-life scores, and injection characteristics. These describe additional aspects of treatment and follow-up, but their numeric results are not reported in the registry record. Because this is a single-group study, the clinical question concerns the course of outcomes among participants in the study; it does not provide a randomized comparison with another treatment or a control group.
3. Trial Design
The registry identifies NCT00996489 as a completed post-approval study of Coaptite® in the treatment of female urinary incontinence. The sponsor is Merz North America, Inc. The recorded study start date is 2008-01-08, the primary completion date is 2015-10-26, and enrollment is 459.
The design is listed as single group, with allocation marked NA and masking listed as none. Coaptite® is the recorded intervention, classified as a device. No comparator arm or randomization is recorded. Consequently, the study design does not support a like-for-like randomized comparison between Coaptite® and another intervention. Changes over follow-up, if reported, would describe observations within this enrolled group rather than an effect estimated against a concurrent control group.
The registry lists the primary measure as mean Stamey grade score with standard deviation at baseline and Months 6, 12, 18, 24, 30, and 36. Participants evaluable for the measure at a given timepoint were included in that timepoint’s category. The full analysis set is defined as participants with a baseline and at least one post-baseline observed or imputed primary effectiveness value. The registry does not explain the meaning of the abbreviation SES appearing in its full-analysis-set description.
The phase is recorded as NA. The protocol details, eligibility criteria beyond the listed condition, recruitment procedures, and statistical analysis plan are not reported in the registry record. The record also does not report numeric primary-outcome results or listed analyses. Completion status means the study is recorded as completed; it does not itself establish what the outcome estimates were or how complete follow-up was.
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.
Before assignment: A total of 459 participants were screened, enrolled and treated in the study. Of these, 298 participants completed the 36-month study.
Overall Study
| Stage | Coaptite |
|---|---|
| STARTED | 459 |
| COMPLETED | 298 |
| NOT COMPLETED | 161 |
Reasons for not completing this period:
| Reason | Coaptite |
|---|---|
| Device failure | 45 |
| Discontinued | 116 |
Analysis population for the primary outcome, as defined in the registry: The full analysis set (FAS) consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.
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: The safety evaluation set (SES) was the subset of all participants enrolled who were exposed to the study device at least once.
| Characteristic | Unit | Coaptite |
|---|---|---|
| Participants analysed | 459 | |
| Age, Continuous | years | 66.4 (SD 12.9) |
| Sex: Female, Male: Female | Participants | 459 |
| Sex: Female, Male: Male | Participants | 0 |
| Race/Ethnicity, Customized: Native American | Participants | 1 |
| Race/Ethnicity, Customized: Asian | Participants | 9 |
| Race/Ethnicity, Customized: Black | Participants | 8 |
| Race/Ethnicity, Customized: Caucasian | Participants | 406 |
| Race/Ethnicity, Customized: Hispanic | Participants | 33 |
| Race/Ethnicity, Customized: Other | Participants | 2 |
| Region of Enrollment: United States | Participants | 459 |
6. Primary Endpoint
The registry lists the primary outcome as Incontinence Status as Assessed by Stamey Grade Score, measured over Baseline and Months 6, 12, 18, 24, 30, and 36.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is incontinence status assessed using the Stamey grade score. The registry describes the scale as four grades from 0-3, calculated from a 4-day voiding diary. Grade 0 represents controlled urination; Grade 1 represents accidents with vigorous activity, such as lifting weights, coughing, or sneezing; Grade 2 represents accidents with minimal activity, such as walking or standing up; and Grade 3 represents accidents regardless of activity or position that cannot be attributed to a specific activity. Higher grades indicate more severe leakage.
The final grade was based on an average across 4 days and rounded up when needed; the record gives 2.5 rounded to Grade 3 as an example. The outcome is summarized as a mean with standard deviation at baseline and scheduled follow-up timepoints. In general, a repeated measure can help describe how a symptom measure changes during follow-up, while the standard deviation describes variation among the measured scores. Here, numeric values for the mean and standard deviation at the listed timepoints are not reported in the registry record. The direction, size, and precision of any change therefore cannot be evaluated from the record.
Stamey grade is an ordered severity scale, so a one-grade step represents movement between defined categories rather than a directly measured physical quantity. Reporting a mean can provide a group-level summary, but interpretation should retain the scale’s category-based meaning. The registry’s definition explains the measure and its collection schedule; it does not establish that any observed score change occurred.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the intended primary outcome and its follow-up schedule, but it does not report numeric Stamey grade results. There is therefore no basis in this record for describing whether the mean grade rose, fell, or remained similar over time, or for quantifying the precision of any estimated change. No confidence intervals, standard deviations by timepoint, test statistics, or p-values are reported in the registry record. The absence of these results is different from evidence that there was no change.
The design also shapes what any eventual outcome estimates could mean. This is a single-group study with no randomized comparator recorded. An observed change from baseline would describe the participants’ outcomes over follow-up, but by itself would not separate the intervention’s contribution from other influences on symptoms or measurement. Without a concurrent comparison group, the registry record cannot establish how outcomes would have differed under another treatment or without the intervention.
The primary measure uses an ordered four-grade scale derived from a 4-day diary. A group mean compresses the distribution of participants across grades into one summary. The standard deviation, if reported, would describe spread around that mean, but it would not show how many participants moved between particular grades or whether the distribution was concentrated in a few categories. The registry record does not provide the category counts or numeric mean and standard deviation values.
The analysis population is described as participants with a baseline and at least one post-baseline observed or imputed primary effectiveness value. This definition does not mean that every participant contributed data at every follow-up timepoint. The record says participants evaluable at a given timepoint were included for that category, but timepoint-specific denominators are not reported in the registry record. The method used to impute missing values is also not reported, so the influence of missing observations cannot be assessed.
The record lists 12 outcome measures and no analyses. It does not report how multiplicity across outcomes or timepoints was addressed, or whether any adjustment was planned. Thus, even if individual estimates were available, the registry entry would not establish how to interpret them in relation to a prespecified testing strategy. The key statistical conclusion is limited: the design and outcome definition are recorded, but the numeric primary results and analysis details needed to judge magnitude, uncertainty, and robustness are not reported in the registry record.
9. Statistical Methods Explained
The primary outcome is a continuous summary in the registry’s analysis description: mean Stamey grade score, with standard deviation. The underlying grades are ordered categories from 0-3, with higher grades representing more severe leakage. In general, a mean summarizes the average score in a group, while the standard deviation describes how dispersed individual scores are around that average. Neither statistic is reported numerically for the primary outcome in the registry record, so the group’s observed scores and their variability cannot be evaluated.
What does a repeated outcome measure?
The outcome is scheduled at baseline and Months 6, 12, 18, 24, 30, and 36. Repeated measurements allow a study to describe outcomes at multiple times during follow-up. Measurements from the same participant are generally related rather than independent, because each person contributes observations at more than one timepoint. General statistical methods for longitudinal data can account for this relationship, but the registry record does not identify a model or method used to analyze repeated measurements. It would be inappropriate to infer a particular method from the schedule alone.
The record states that participants evaluable for the measure at a given timepoint were included in that timepoint’s category. This indicates that the number contributing to a summary could depend on the timepoint, but the actual denominators are not reported in the registry record. It is also not clear from the entry whether summaries were calculated from observed values, imputed values, or a combination at each specific timepoint.
How should the Stamey score be understood?
The scale represents ordered severity categories, not a physical measurement with an established equal distance between every pair of grades. The registry nevertheless specifies a mean and standard deviation. As a general point, summaries of ordered scores can be convenient for comparing group-level patterns, but a mean does not reveal the full distribution across categories. Category counts or transition summaries would help show how many participants were in each grade and how individual scores changed; those results are not reported in the registry record.
The recorded score was calculated from a 4-day voiding diary. The registry says the average of 4 days for the final grade was recorded and rounded up if needed, giving 2.5 rounded to Grade 3 as an example. This rule affects how the score is assigned at the participant level. The record does not provide further details about diary completion, adjudication, or handling of incomplete diary entries.
What can uncertainty estimates add?
In general, a confidence interval expresses the range of values compatible with an estimate under a specified statistical procedure and its assumptions. It helps readers distinguish an estimate’s central value from its uncertainty. A standard deviation instead describes variation among observations; it is not itself a confidence interval for the mean. The registry record lists standard deviation as the measure of dispersion, but does not report numeric standard deviations or confidence intervals for the primary outcome. The precision of the mean estimates therefore cannot be judged from the record.
What analysis plan is recorded?
The record lists no analyses. It does not specify a statistical test, longitudinal model, covariate adjustment, confidence-interval procedure, or decision rule for the primary outcome. These details are not reported in the registry record and should not be inferred from the endpoint definition. The absence of an analysis listing also means that the record does not establish whether the primary comparison was intended to be a change from baseline, a comparison between timepoints, or another summary of the repeated measurements.
The registry lists 12 outcome measures. In general, evaluating multiple outcomes or timepoints can raise multiplicity concerns: the more questions considered, the more important it is to know which analyses were prespecified and how interpretation was controlled. The record does not describe a multiplicity strategy, so it is not possible to determine whether or how such concerns were addressed.
How should planning calculations be read?
The sample-size assumptions describe planning illustrations 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 hypothetical arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For time-to-event calculations, the stated output is a total number of events using the Schoenfeld approach; other calculations are expressed as participants per arm. These assumptions do not change the recorded single-group design, which has no randomized comparison arm.
Such illustrations are hypothetical planning exercises rather than evidence about the study’s achieved power. In general, observed power is not a substitute for reporting an estimate and its uncertainty. No calculated sample-size outputs or observed-effect value are reported in the registry record, so no planning total can be interpreted from this information. The registry also does not report the trial’s own sample-size justification or whether such a calculation informed the enrollment target.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 12 outcome measures, including the primary Stamey grade score and secondary measures related to injections, retreatment, alternative treatments, medication status, quality of life, and treatment characteristics. It lists no analyses. A multiplicity plan—such as a prespecified hierarchy, adjustment, or distinction between confirmatory and exploratory analyses—is not reported in the registry record. Without that information, the record does not explain how results across outcomes or follow-up timepoints would be interpreted together.
The primary analysis population is defined as the full analysis set: participants with a baseline and at least one post-baseline observed or imputed primary effectiveness value. The record says participants evaluable for the measure at a given timepoint were included in that timepoint’s category. This does not establish that all enrolled participants contributed at all scheduled visits. Timepoint-specific participant counts and reasons for missing observations are not reported in the registry record.
The definition allows observed or imputed values, but the imputation method, assumptions, and sensitivity analyses are not reported in the registry record. In general, missing-data methods rely on assumptions about why measurements are unavailable and how the missing values relate to recorded information. Those assumptions matter because different approaches can yield different estimates. Without method details and results under alternative assumptions, the effect of missing data on the primary summary cannot be assessed.
The registry does not explain the abbreviation SES used in the full-analysis-set description. It also does not report a separate intention-to-treat definition or a per-protocol analysis population. These details limit assessment of who contributed to each analysis and how departures from follow-up were handled.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Coaptite | 163 | 459 | 35.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Coaptite | 10 of 459 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Coaptite | 246 of 459 |
Most frequent serious adverse event terms
| Event term | Organ system | Coaptite |
|---|---|---|
| Urinary tract infection | Infections and infestations | 114 of 459 |
| Urinary retention | Renal and urinary disorders | 63 of 459 |
| Urge incontinence | Renal and urinary disorders | 27 of 459 |
| Fungal infection | Infections and infestations | 5 of 459 |
| Cystitis | Infections and infestations | 4 of 459 |
| Micturition urgency | Renal and urinary disorders | 4 of 459 |
| Pollakiuria | Renal and urinary disorders | 4 of 459 |
| Haematuria | Renal and urinary disorders | 3 of 459 |
| Vulvovaginal mycotic infection | Infections and infestations | 2 of 459 |
| Nocturia | Renal and urinary disorders | 2 of 459 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Coaptite |
|---|---|---|
| Urinary tract infection | Infections and infestations | 136 of 459 |
| Urge incontinence | Renal and urinary disorders | 109 of 459 |
| Urinary retention | Renal and urinary disorders | 66 of 459 |
| Micturition urgency | Renal and urinary disorders | 29 of 459 |
Serious events with the highest arm-level rate: urinary tract infection (24.8%), urinary retention (13.7%), urge incontinence (5.9%), fungal infection (1.1%), cystitis (0.9%).
The registry lists 459 participants at risk for serious adverse events and 163 affected. It also lists 459 at risk for other adverse events and 246 affected. These are separate categories in the record; they should not be added together because the record does not indicate whether participants could appear in both categories. The registry also records 10 deaths. The timing, causes, and relationship of deaths or adverse events to the intervention are not reported in the registry record.
The serious adverse event terms listed most often are urinary tract infection at 24.8%, urinary retention at 13.7%, urge incontinence at 5.9%, fungal infection at 1.1%, cystitis at 0.9%, and micturition urgency at 0.9%. The denominator and counting method for these percentages are not reported in the registry record, so they should be read as registry-listed percentages rather than recalculated participant risks. The record does not provide event-level detail, severity grades beyond the serious-event classification, or a comparison group.
These figures describe recorded safety events in a single-group study. Without a control group, they do not establish how event frequency compares with another treatment or with background occurrence. Nor do the counts alone establish causation. The registry’s safety information is therefore descriptive; the context needed for comparative or causal interpretation is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed, single-group post-approval study of Coaptite® enrolled 459 participants and specified Stamey grade score as its primary outcome. The measure was scheduled at baseline and Months 6, 12, 18, 24, 30, and 36, and the registry describes how grades were derived from a 4-day voiding diary. It also records secondary outcome topics and adverse-event counts.
However, the numeric primary-outcome results are not reported in the registry record. This means the record does not establish the average score at each timepoint, the size or direction of a change, or how variable the scores were. No reported uncertainty estimates are available to show how precisely an outcome was estimated. The lack of reported results should not be interpreted as a finding of no change, and it does not support a claim that the intervention did or did not produce a particular outcome.
The study has no randomized comparator recorded. Any observed before-and-after pattern would be a description of participants over time, not a randomized estimate separating the intervention from other possible explanations. The registry also does not report analysis methods, imputation details, timepoint-specific denominators, or a multiplicity strategy. These omissions prevent a full assessment of statistical robustness.
The safety counts and listed serious-event terms provide descriptive information, but they do not by themselves establish whether events were caused by the intervention or how they compare with another group. The record’s sample-size assumptions describe planning illustrations, not the observed power of this study. Overall, the registry entry documents the study framework and selected safety information, but it does not contain the primary outcome estimates needed to assess the observed course of incontinence severity.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between a documented study design and a reported treatment effect. The registry records a single-group post-approval study, a defined primary measure, and a schedule of repeated follow-up. Those details clarify what investigators intended to measure. They are not substitutes for numeric outcome estimates or a transparent analysis description.
The Stamey grade combines diary-based observations into an ordered severity score. This makes the endpoint interpretable in terms of leakage categories, while also reminding readers that a mean can conceal the distribution of grades. Reporting category-level results alongside a mean would help readers understand whether group summaries reflect small shifts across many participants or larger changes among a subset. Such results are not reported in the registry record.
The repeated-measure structure raises questions about how observations from the same participant were handled and how incomplete follow-up was addressed. The full-analysis-set definition allows observed or imputed values and requires baseline plus at least one post-baseline primary value, but does not supply the imputation method or timepoint-specific counts. Those details matter for judging who contributes to each estimate and how sensitive results may be to missing data.
The single-group design also sets an important boundary on interpretation. It can describe participant outcomes over time, but it does not create a randomized counterfactual for estimating what would have happened under a different condition. The registry record’s lack of numeric primary results makes this limitation especially consequential: the reader has neither comparative results nor a numerical within-group trajectory to evaluate. The entry therefore illustrates why outcome definitions, analysis methods, missing-data handling, and complete results are all needed for statistical interpretation.
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 specific to this record is that numeric results for the primary Stamey grade outcome are not reported in the registry record. Although the measure, summary type, and follow-up schedule are described, the timepoint means and standard deviations are absent. The record therefore does not support an estimate of change or an assessment of its precision.
The study is listed as single group, with no comparator, no random allocation, and no masking. It cannot provide a randomized comparison with another treatment. The registry entry does not report whether other factors that might influence symptom scores were measured or accounted for, and it does not describe an adjusted analysis.
The full-analysis-set definition includes participants with baseline and at least one post-baseline observed or imputed primary value, while the record says participants evaluable at a given timepoint were included in that category. It does not report the number evaluable at each timepoint, reasons for missing data, imputation method, or sensitivity analyses. The abbreviation SES in the population description is not explained.
The record lists 12 outcome measures but no analyses. It does not report a statistical analysis plan, multiplicity handling, or details of any hypothesis tests. It also does not report a sample-size justification for the study itself. Planning assumptions are described separately, but the calculated outputs and observed effect used for those illustrations are not reported in the registry record.
For safety, event counts and selected percentages are recorded, but the percentage denominators, event-level details, causal assessments, and comparative context are not reported. The registry record thus offers limited context for evaluating safety patterns or attributing events to the intervention.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence — NCT00996489.
- Registry record last updated 2019-07-23; status last verified 2019-01.
- Results first posted 2019-07-23.
- 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.
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18. Record Summary
NCT00996489 is recorded as a completed post-approval study of Coaptite® for female urinary incontinence due to intrinsic sphincter deficiency. It is a single-group study with no masking and enrollment of 459. The recorded start date is 2008-01-08 and the primary completion date is 2015-10-26.
The primary outcome is mean Stamey grade score with standard deviation, assessed at baseline and Months 6, 12, 18, 24, 30, and 36. The full analysis set is defined as participants with baseline and at least one post-baseline observed or imputed primary effectiveness value. Numeric primary-outcome results and analyses are not reported in the registry record.
The registry lists 12 outcome measures, including secondary outcomes related to retreatment, alternative treatments, medication status, quality of life, and injection details. It records serious and other adverse-event counts, 10 deaths, and selected serious-event terms. No randomized comparator, statistical analysis plan, multiplicity approach, or imputation method is reported in the registry record.