Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics (NCT04090190), a na phase 4 study. The primary outcome is Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu..

2. Clinical Question

The study links two areas of measurement: the urinary inflammatory milieu and treatment for urgency urinary incontinence. Its stated objective is to better understand the urinary microbiome and inflammatory markers in blood and urine, and to assess how inflammation may relate to response to standard-of-care anticholinergic treatment. The primary outcome description focuses on inflammatory markers in urine; it does not give numerical findings for blood markers.

The question is about change over time within a treated group, rather than a difference between treatment and placebo or between anticholinergic treatment and another assigned therapy. A baseline-to-follow-up comparison can describe whether the measurements observed among returnees changed during the study interval. By itself, it cannot establish that treatment caused any change: without a concurrent comparison group, changes may also reflect other influences over time, measurement variability, or differences between participants who returned and those who did not.

The registry does not report a separate definition of treatment response or a numerical association between inflammatory measurements and symptom response. It also does not report which inflammatory markers were measured by name. Accordingly, the research question is clear at the broad level of urinary inflammation over the treatment period, but the posted record does not permit a marker-by-marker assessment of the findings.

3. Trial Design

NCT04090190 is listed as a completed phase 4 study sponsored by Brigham and Women's Hospital. The registry gives a start date of 2019-10-30 and a primary completion date of 2021-05-30. Enrollment is reported as 20. The study is classified as single-group, with no masking and no randomized allocation. The registry does not describe a separate control arm.

Participants were women presenting to a Urogynecology clinic with urgency urinary incontinence symptoms. The arm description says they received standard-of-care anticholinergic treatment and had their urinary microbiome evaluated before and after treatment. The listed intervention includes oxybutynin, solifenacin, tolterodine, trospium, or fesoterodine. The registry does not report how the clinician or participant selected among these medicines, treatment duration beyond the outcome's 6-week assessment point, or the number receiving each drug.

The primary outcome is urinary inflammatory markers measured with immunoenzyme assays at baseline and 6 weeks. The outcome is summarized using medians and inter-quartile ranges, with the stated unit pg/mL. The registry says statistical testing was used to assess differences between the baseline and 6-week visits. It does not specify the statistical test, the marker names, the numerical summaries, or the test results.

Follow-up was incomplete: 20 patients were involved in the study, while 13 returned for follow-up. The record does not explain why some participants did not return or how missing follow-up measurements were handled. It also does not specify a detailed analysis population, such as whether every enrolled participant contributed to each analysis.

The registry includes secondary outcomes concerning culture of aerobic bacteria and yeasts after DNA extraction and endpoint PCR for 16S rDNA genes, and baseline urinary symptoms assessed with the Urogenital Distress Inventory (UDI-6). Numerical results for these outcomes are not reported in the registry record. The study's single-group structure makes its before-and-after measurements descriptive of the participants assessed; it does not provide a like-for-like untreated 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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: 20 patients were involved in the study, however only 13 returned for follow-up, hence 13 patients involved in "follow-up" group.

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 Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu., measured over Baseline and 6 weeks.

The primary outcome is the concentration of inflammatory markers in urine, measured using immunoenzyme assays. The stated unit is pg/mL, and the outcome description specifies median and inter-quartile range summaries. Measurements are scheduled at baseline and 6 weeks. The registry says seven markers were selected for comparison, describing them as inflammatory markers present in urine, but does not name them individually.

Urinary inflammatory measurements are relevant to the study's stated aim of examining how inflammation and the urinary microbiome relate to anticholinergic treatment for urgency urinary incontinence. In general, measuring the same biological feature at baseline and follow-up can describe whether its distribution differs over the observation period. These measurements are not themselves a direct measure of symptom improvement unless a relationship to symptoms is evaluated and reported.

Using medians and inter-quartile ranges describes the centre and spread of the observed measurements without requiring a mean-based summary. In general, the median represents the middle of an ordered set of observations, while the inter-quartile range describes the central spread. These summaries can be useful for measurements whose distributions are asymmetric or contain extreme values. The registry does not report the actual median or inter-quartile range for any marker, so the size and direction of any observed change cannot be assessed from the posted results.

The record also does not report assay details beyond the general method, marker-specific measurement limits, or whether values below any assay limit occurred. These omissions limit interpretation of the outcome's measurement properties. The intended endpoint is a laboratory measurement at two visits; the posted record does not establish that a change in a marker corresponds to a clinical benefit or to an individual participant's treatment response.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a median and inter-quartile range communicate?

The primary outcome is described using medians and inter-quartile ranges. In general, a median is the centre of ordered measurements: half the observations lie at or below it and half at or above it. The inter-quartile range describes the spread of the central portion of the observations. Together, these summaries give readers information about a measurement's typical value and variability without assuming that the data are symmetrically distributed.

Inflammatory marker concentrations can have distributions that are uneven or include unusually high measurements. For data of that kind, a median may represent the centre more appropriately than an arithmetic mean, and an inter-quartile range can show how dispersed the central observations are. This is a general statistical rationale, not a report of the actual distribution in this study. The registry does not give the marker-specific medians, inter-quartile ranges, or distributions, so it is not possible to tell whether the measurements were skewed or whether these summaries were well matched to the observed data.

What does a baseline-to-follow-up comparison estimate?

The stated outcome compares baseline with the 6-week visit. In general, a within-person analysis evaluates change by comparing measurements from the same participant across visits. This differs from comparing unrelated groups because each participant can serve as their own reference for stable characteristics. A paired analysis can therefore be useful when the scientific question concerns change over time in the same people.

The record says statistical testing was used to determine whether there was a difference between the visits, but the test itself is not reported in the registry record. It is therefore unknown whether the analysis was paired, which assumptions were used, whether marker distributions influenced test selection, or whether covariate adjustment was performed. The fact that the outcome was collected at baseline and follow-up does not establish which analytic method was used.

In general, a confidence interval expresses the uncertainty around an estimated quantity, such as a median change or difference. It helps distinguish a relatively precise estimate from one compatible with a broad range of values. No confidence intervals or numerical estimates are reported in the registry record. A p-value, if reported, would address compatibility with a specified statistical null model under the chosen analysis; it would not by itself show the size, importance, or cause of a difference. The registry does not report p-values for the marker comparisons.

Why does variation matter?

Biological measurements vary among participants and can also vary within a participant across visits. General statistical methods account for this variation when estimating a centre, a difference, or uncertainty. If a marker's values are highly dispersed, a small study may yield an imprecise estimate even when the median appears to change. Conversely, a statistically detectable difference would not automatically establish that the difference is clinically meaningful. Interpretation depends on the estimated magnitude, its uncertainty, the measurement context, and a clear connection to outcomes that matter to participants.

Over-dispersion is a general issue in statistical modeling: it occurs when the variability in observed data is greater than the model assumes. If a model underestimates variation, its uncertainty estimates can be too narrow. The registry does not identify a particular model for the primary outcome, so there is no basis to say whether over-dispersion was assessed or relevant to the actual analysis.

How should the planning illustrations be distinguished from the study design?

The record includes assumptions for planning illustrations based on an observed effect, rather than the trial's own design. Those illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For time-to-event illustrations, the total number of events is the planning quantity; other illustrations describe participants per arm. These assumptions do not describe the actual single-group study, which has no two-arm randomized comparison. No numerical planning illustration is discussed in this discussion.

Such illustrations are planning aids, not evidence that a study had a particular probability of finding a result. In general, power calculations depend on assumptions about effect size, variability, significance level, allocation, and analysis. A calculation using an effect observed in the study is especially distinct from a prospective justification of the original enrollment target. The registry does not report a sample-size justification for the study's enrollment of 20, and the planning assumptions should not be mistaken for the trial's protocol or for observed power.

What is the role of multiple testing?

The primary outcome description states that seven urinary inflammatory markers were chosen and compared. In general, testing multiple markers creates a multiplicity issue: the chance of observing at least one apparently unusual result can increase as the number of tests increases, even if no true differences exist. A statistical plan may address this through an adjustment, a hierarchy of outcomes, or a clearly exploratory interpretation. The registry does not report whether any multiplicity procedure was used, what threshold governed interpretation, or how results across markers were handled.

The record reports 7 analyses, but it does not describe their exact relationship to the outcome measures or provide the analysis specifications. It would therefore be inappropriate to infer that each analysis corresponds to a particular marker or that a particular adjustment was applied. Without marker-level estimates and analysis details, the strength and consistency of evidence across the measurements cannot be evaluated.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome description identifies seven urinary inflammatory markers for comparison. Testing multiple markers raises a general multiplicity concern because conducting several tests can increase the chance that at least one result appears notable by chance. The registry does not report whether the analyses used a multiplicity adjustment, whether the markers were ordered by priority, or whether the comparisons were considered exploratory. It also does not report marker-specific p-values or estimates that would allow readers to evaluate consistency across the outcomes.

There is incomplete follow-up: 20 patients were involved in the study, and 13 returned for follow-up. The reasons for non-return are not reported in the registry record. Nor does the record state whether missing measurements were excluded, imputed, or handled through another method; whether analyses were restricted to participants with both visits; or whether participants without follow-up contributed to any analyses. The number with complete data for each marker is not reported.

In general, missing follow-up can affect interpretation if the participants who return differ systematically from those who do not. The available counts alone cannot establish whether such differences occurred or whether missingness changed the results. A comparison of baseline characteristics by follow-up status, a description of missingness, and sensitivity analyses can help assess these issues, but those details are not reported in the registry record.

The analysis population and statistical plan are also not described in sufficient detail to determine how the reported tests were chosen or applied. The record does not specify a prespecified analysis population, the handling of outliers or assay values outside measurement limits, or whether any adjustment for participant characteristics was used. These absences limit assessment of the robustness and reproducibility of the analysis. They do not establish that a method was or was not used; the relevant details are not reported in the registry record.

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.

The registry lists 20 participants at risk for serious adverse events and 0 participants affected. It also lists 20 participants at risk for other adverse events and 0 participants affected. Deaths are reported as 0, and no top serious adverse event terms are listed. These figures describe the event counts posted for the standard-of-care anticholinergic treatment group.

A zero count means that no affected participants were recorded in that category in the registry entry. It does not demonstrate that an event is impossible or establish a precise rate for a broader population. The record does not provide event-level details, observation time for safety reporting, or a comparative group, so it cannot support a comparison of adverse event risk between treatments.

Safety counts should also be read alongside the study's follow-up information. The registry reports that 13 of the 20 patients returned for follow-up, but does not explain how return status relates to adverse event ascertainment. It does not state whether safety information was collected from participants who did not return. The posted counts are therefore best understood as the registry's reported figures, not as proof that all possible events were captured or that no risk exists.

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

The record establishes that a single-group study examined urinary inflammatory markers at baseline and 6 weeks among women receiving standard-of-care anticholinergic treatment for urgency urinary incontinence. It also reports the number enrolled and the number returning for follow-up. These registry entries describe the study's design and assessment plan, but they do not reveal the observed marker findings.

Numerical results for the seven urinary markers are not reported in the registry record. There are no posted marker-specific medians, inter-quartile ranges, changes, confidence intervals, or p-values in the available information. Consequently, the direction and magnitude of any observed difference, and its statistical precision, cannot be evaluated. The record's statement that statistical testing was used does not substitute for results of those tests.

Even if a before-and-after marker change were available, its interpretation would be constrained by the single-group design. A temporal change among treated participants would not alone show that medication caused the change. The study does not include a concurrent control group, and the registry does not report an analysis that separates treatment effects from other changes over time. The record also does not report a quantified link between a marker change and urinary symptoms or treatment response.

The follow-up count is another important qualification. There were 20 patients involved in the study, while 13 returned for follow-up. The record does not explain why others did not return or how their missing measurements were handled. If follow-up participants differed from those without follow-up, the available measurements might not represent all enrolled participants; the posted information does not allow that possibility to be assessed.

The study therefore contributes a defined biomarker question and a baseline-to-follow-up measurement framework, but the registry entry does not permit conclusions about whether inflammation changed, how large any change was, or whether it was related to symptoms or medication response. It should not be read as evidence that a treatment does or does not work. It is a report of a completed study's design and limited posted results, with the numerical primary findings not reported in the registry record.

13. Why This Trial Matters Statistically

This study is statistically interesting because it connects repeated biological measurements with a clinical treatment setting. Measuring urinary inflammatory markers at baseline and 6 weeks poses a within-person question: how do measurements among observed participants compare across visits? That question differs from asking whether one treatment outperforms another, and the distinction matters when interpreting estimates or planning analyses.

The study also illustrates how follow-up affects the information available for a repeated-measures question. Although 20 patients were involved, 13 returned for follow-up. The number with paired, usable measurements is central to the precision and representativeness of any change estimate, yet marker-specific analysis counts and missing-data handling are not reported in the registry record. Readers cannot assess how much information contributes to each comparison or whether returnees differ from those not observed at follow-up.

Another statistical issue is the set of seven markers. Multiple outcomes can be scientifically useful when inflammation is being explored, but they require transparent reporting of which outcomes were analyzed, how multiplicity was addressed, and what estimates and uncertainties were observed. The registry identifies seven markers but does not provide their numerical results or the relevant analysis details. This limits both reproducibility and interpretation across outcomes.

Finally, the lack of a control group separates description from causal inference. A within-group change can be informative about patterns in the observed cohort, but it cannot by itself identify the effect of treatment. This distinction is especially important when the study's objective refers to response to medication while the posted primary outcome is a laboratory measure. The record leaves open how marker measurements related to clinical response.

The statistical value of the record is therefore in clarifying the study structure and the questions that its design can address, while also showing why numerical estimates, uncertainty, missing-data reporting, and analysis methods are needed before the biomarker findings can be interpreted.

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 registry record does not report the numerical results for the primary outcome. Marker-specific medians and inter-quartile ranges, estimates of change, confidence intervals, p-values, and directions of change are absent. The names of the seven urinary inflammatory markers are also not reported, limiting clinical and laboratory interpretation.

The follow-up group is smaller than the group involved in the study: 20 patients were involved, and 13 returned. Reasons for missing follow-up, the amount of usable data per marker, and the method for handling missing measurements are not reported in the registry record. It is therefore not possible to determine whether the analysis represents all enrolled participants or only those with follow-up data, or to assess the possible effects of selective return.

The single-group design has no concurrent control group and no randomized treatment comparison. Any change between baseline and 6 weeks, if numerical findings were available, could not be attributed to treatment on the basis of this design alone. The record also does not give the number of participants receiving each listed medication, the method for choosing a medication, or a quantified definition of treatment response.

Analysis details are limited. The registry does not specify the statistical test, whether the comparison was paired, whether any covariates were included, how multiple marker comparisons were handled, or whether assay limits and unusual values were addressed. It does not report the sample-size justification for the enrollment target. The planning assumptions described for illustrative calculations are not a substitute for a study-specific statistical plan.

These limitations concern what can be learned from the registry entry; they do not establish that unreported methods or analyses were not performed. The methods, marker-level results, and follow-up details needed to evaluate them are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics — NCT04090190.
• Registry record last updated 2022-11-15; status last verified 2022-10.
• Results first posted 2022-10-03.
• 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

NCT04090190 is a completed phase 4, single-group study sponsored by Brigham and Women's Hospital. The registry lists a start date of 2019-10-30, a primary completion date of 2021-05-30, and enrollment of 20. Women presenting with urgency urinary incontinence symptoms received standard-of-care anticholinergic treatment. Listed medications are oxybutynin, solifenacin, tolterodine, trospium, or fesoterodine.

The primary outcome concerns urinary inflammatory markers measured by immunoenzyme assays at baseline and 6 weeks, summarized by medians and inter-quartile ranges in pg/mL. The record says seven markers were compared and statistical testing was used. It reports that 13 patients returned for follow-up, but numerical marker results, test details, and missing-data methods are not reported in the registry record.

The study has no separate control group. The registry lists 0 affected participants among 20 at risk for serious adverse events, 0 affected among 20 at risk for other adverse events, and 0 deaths. These counts do not provide a comparative safety estimate. The record describes the study question and design but does not report the numerical primary findings needed to evaluate changes in urinary inflammatory markers.