The Urinary Incontinence Treatment Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Urinary Incontinence Treatment Study (NCT03057834), a non-randomized na study. The primary outcome is Number of Urinary Incontinence Episodes.

2. Clinical Question

The study concerns older women with urinary incontinence and whether physical-function status provides a useful way to describe differences in urinary incontinence and pelvic floor function. The registry record separates participants into functionally impaired and functionally normal groups. The impaired group is described as having a short physical performance battery score <9; the normal group is described as having a score > 10. The record does not explain how scores of 9 or 10 were handled.

The primary outcome is the number of urinary incontinence episodes measured at baseline using a three-day voiding diary. The registry lists the outcome as a mean with standard deviation. It also lists pelvic floor measures as secondary outcomes: power, endurance, repetition of contractions, and number of fast contractions. The study therefore frames a descriptive question about urinary incontinence and physical function, rather than a randomized test of a treatment against a control.

Pelvic floor muscle exercise is listed as a behavioral intervention, but the registry record does not report an intervention effect or provide results comparing exercise with another treatment. Its description instead emphasizes a prospective cohort design with recruitment adapted according to participants’ physical-function status, with the aim of recruiting similar numbers in the functionally impaired and functionally normal groups. Any conclusions about group differences, changes over time, or an exercise effect require results and analyses that are not reported in the registry record.

3. Trial Design

The registry describes a prospective cohort study with an adaptive recruitment approach based on physical-function status. The study was non-randomized, unmasked, and used a parallel model. The planned recruitment strategy was to track the number of women with physical-function impairment and those without functional impairment, aiming for similar numbers in each group. If recruitment produced unequal group sizes, recruitment strategies would be adapted according to a woman’s functional status.

The group descriptions use short physical performance battery scores: <9 for the functionally impaired group and > 10 for the functionally normal group. The registry does not describe the classification of scores 9 or 10. The groups are defined by observed functional status, not by randomized assignment. As a result, the contrast between them is not a like-for-like control comparison: characteristics associated with functional status could also be associated with urinary symptoms or pelvic floor function.

The registry lists pelvic floor muscle exercise as the behavioral intervention. It does not report enough detail to establish how the intervention was delivered, whether all participants received it, or what comparison was intended for evaluating it. Those details are not reported in the registry record.

The planned enrollment was 70, and the study status is completed. The registry lists a start date of 2017-03-01 and a primary completion date of 2020-01-29. It lists 24 outcome measures and no analyses. The primary outcome is a baseline mean number of urinary incontinence episodes, measured using a three-day voiding diary. No outcome estimates, group comparisons, or analysis results are reported in the registry record. The study description and planned enrollment therefore characterize the design, but do not establish what the study found.

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 Number of Urinary Incontinence Episodes, measured over Baseline.

The primary endpoint is the number of urinary incontinence episodes at baseline, recorded using a three-day voiding diary. The registry defines it as a continuous measure summarized by a mean and standard deviation. A diary records episodes over a specified observation period, offering a structured way to describe urinary symptoms rather than relying only on a general impression. The registry does not provide the diary entries, a mean, a standard deviation, or a comparison between groups.

Baseline measurement can describe the participants’ status at the start of observation. It does not, by itself, show change over time or an effect of pelvic floor muscle exercise. To interpret a change, results at more than one time point and a specified analysis would be needed; these are not reported in the registry record. Likewise, a difference between the functionally impaired and functionally normal groups would be an observational association, not a randomized treatment effect.

General: a mean gives the average value in a group, while a standard deviation describes how dispersed individual measurements are around that average. Both can help characterize a continuous outcome, but neither replaces the underlying result or its uncertainty. Because no endpoint estimates or interval estimates are reported, the registry record does not allow a quantitative assessment of the frequency of episodes or the precision of a group comparison.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a cohort design and outcome definitions, but it does not report the statistical analysis plan or any completed analyses. The concepts below are general explanations of how such information is usually interpreted; they should not be read as a description of methods used in this study unless the registry record states them.

What does a cohort comparison describe?

In a cohort study, participants are observed within groups defined by characteristics or exposures rather than being assigned randomly to groups. Here, the group descriptions are based on physical-function status. A comparison of urinary incontinence episodes between these groups would describe an association between group membership and the outcome. It would not, on its own, show that physical-function status caused a difference. Other characteristics may vary across groups and may also be related to the outcome.

Adaptive recruitment, as described in the record, means recruitment strategies could be adjusted to encourage similar numbers of women in the functional-status groups. This can support balanced group sizes, but equal or similar numbers do not ensure balance in other characteristics. The registry does not report whether the planned recruitment approach was carried out as described or what the final group sizes were for the primary outcome analysis.

What do the mean and standard deviation convey?

General: for a continuous outcome, a mean describes the group’s average measurement, while a standard deviation describes the spread of individual measurements around that mean. A mean can summarize a group’s level of urinary incontinence episodes during the diary period. The standard deviation helps show whether observations are relatively close to the mean or more dispersed. These summaries do not show the full distribution, and they do not by themselves quantify uncertainty in a comparison between groups.

For a contrast between group means, an interval estimate can communicate both the estimated difference and its precision. General: a confidence interval is a range calculated by a statistical procedure to reflect uncertainty in an estimate under its assumptions. A narrower interval indicates greater precision than a wider interval, though the interval’s interpretation depends on the method and study design. No confidence interval or group mean is reported in the registry record, so no numerical statement about the size or precision of a group contrast can be made.

Why does non-random allocation matter?

Random allocation, when used, can help make groups comparable on average with respect to measured and unmeasured characteristics. This study is listed as non-randomized, so that protection against systematic group differences is not part of the design. Adjustment for measured characteristics can sometimes address some observed differences, but it cannot guarantee removal of confounding, especially from factors that were not measured or not included in an analysis. The registry record does not report an adjustment strategy, covariates, or model specifications.

The functional-status categories also require attention to their stated definitions. The impaired group is described using a score <9, and the normal group using a score > 10. The record does not say how scores of 9 or 10 were classified. That missing detail limits a complete understanding of how group eligibility and assignment to the descriptive categories operated.

How should a planning illustration be read?

General: sample-size calculations estimate the number of participants needed to detect a specified effect under selected assumptions. They are planning illustrations, not evidence that an effect occurred and not a measure of the study’s observed power. The registry’s planning assumptions specify a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. The planning description says that non-time-to-event calculations are expressed as participants per arm; time-to-event calculations are expressed as total events. The record does not report a numerical observed effect or the planning output estimates, so no particular planning target can be interpreted from it.

General: over-dispersion refers to variability greater than a statistical model expects. When a model underestimates variability, standard errors and uncertainty intervals may be too small, potentially making evidence appear more precise than it is. Whether over-dispersion is relevant depends on the outcome and model. The registry does not report a model, diagnostics, or an over-dispersion assessment, so it is not possible to say whether this issue was evaluated for the trial.

What can the posted statistical record establish?

The registry lists 24 outcome measures and 0 analyses. The endpoint descriptions identify what was intended to be measured, but they do not reveal how observations were summarized, how missing measurements were handled, which comparisons were conducted, or whether models were adjusted. Those methods are not reported in the registry record. Without analyses and estimates, statistical significance, effect magnitude, and precision cannot be assessed. The completed status describes the study’s status, not the availability or direction of results.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Functionally Impaired", "Functionally Normal")
n   <- c(33, 37)
m   <- c(4.3, 2.7)
sp  <- c(0.6, 0.6)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Functionally Impaired  33  4.300  0.600  4.087  4.513
CARM  Functionally Normal  37  2.700  0.600  2.500  2.900

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 24 outcome measures and 0 analyses. It identifies a primary outcome and names secondary outcomes, but the record does not report a statistical analysis plan, a hierarchy among the outcome measures, or a procedure for addressing multiple comparisons. Multiplicity arises when several outcomes or tests are examined: the more questions considered, the greater the chance that some findings may appear notable by chance alone. General: prespecifying a primary question and controlling or clearly interpreting multiple comparisons can help readers distinguish confirmatory findings from exploratory ones. The registry record does not say how multiplicity was handled.

Missing-data methods are also not reported. The record does not provide the number of participants with available baseline diaries, indicate whether any observations were missing, or describe imputation, exclusion, or sensitivity analyses. General: missingness can affect interpretation when participants with recorded measurements differ systematically from those without them. The consequences depend on the amount and pattern of missingness and on the assumptions used in an analysis. No such assessment can be made from the posted information.

The analysis populations are not described. The registry does not say which participants were included in any endpoint analysis, whether participants were analyzed according to a specified population definition, or whether the primary endpoint was analyzed separately by functional-status group. Since no analyses are listed, results based on any particular population cannot be evaluated. These gaps limit reproducibility and make it important not to infer analysis decisions from the study design or outcome names alone.

12. 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.

For the functionally impaired group, the registry lists 33 participants at risk for serious adverse events, 0 serious events, 33 at risk for other adverse events, 0 other events, and 0 deaths. For the functionally normal group, it lists 37 participants at risk for serious adverse events, 0 serious events, 37 at risk for other adverse events, 0 other events, and 0 deaths.

These are posted event counts within the listed groups. They do not establish that no adverse experiences occurred outside the registry’s event definitions or collection period, and the record does not describe the monitoring process or follow-up duration for safety. The figures also do not provide a comparative risk estimate or an uncertainty interval. Since the study is non-randomized, the group counts should not be read as a randomized safety comparison.

The appropriate interpretation is limited: the registry reports 0 serious adverse events, 0 other adverse events, and 0 deaths in each group. It does not provide enough detail to assess the completeness of reporting or to draw broader conclusions about safety.

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

The study is statistically informative as a description of a planned cohort design, its functional-status group definitions, and the outcomes selected for measurement. Its primary outcome is the baseline mean number of urinary incontinence episodes from a three-day voiding diary. The record also identifies secondary pelvic floor measures and describes an adaptive recruitment approach intended to seek similar numbers of women in the two functional-status groups. These design details clarify the questions the investigators intended to examine.

The record does not, however, report outcome estimates or analyses. It does not establish the level of urinary incontinence in either group, whether the groups differed, or how precisely any difference was estimated. It also does not report an intervention effect for pelvic floor muscle exercise. An intervention name in a registry entry is not evidence of an observed benefit or harm, and a completed study status is not a substitute for posted results.

Any group comparison would need to be interpreted as observational because functional status, rather than random assignment, defines the groups. Similar recruitment numbers would not remove the possibility that groups differed in other relevant characteristics. The registry does not report participant characteristics, covariate adjustment, or other analysis choices that could clarify this issue.

General: statistical evidence is most useful when an effect estimate is considered alongside its uncertainty, the design that generated it, and the assumptions used to analyze the data. Here, the estimate and its uncertainty are not reported in the registry record. The planning assumptions concern hypothetical sample-size illustrations and do not constitute observed evidence. They cannot be used to infer what the study found or whether the study had adequate precision for any particular result.

Accordingly, the record supports neither a claim that functional status is associated with a particular episode frequency nor a claim about the effectiveness of exercise. It documents a completed observational study with defined outcomes and posted safety counts, while leaving the main statistical findings unavailable.

14. Why This Trial Matters Statistically

This trial matters statistically because it illustrates the distinction between a study’s design record and its results. The registry describes a prospective cohort, functional-status categories, a baseline diary outcome, and a recruitment strategy. These details help readers understand the intended research question. But without posted estimates and analyses, the record cannot answer that question quantitatively. Design information is essential, yet it is not a substitute for effect estimates and their precision.

The non-randomized grouping is also important. Functional impairment is used to define the cohorts, and the registry’s adaptive recruitment approach sought similar numbers in each. Similar group sizes can make descriptive summaries easier to compare, but they do not make participants otherwise comparable. If results were available, interpretation would need to consider possible differences between groups and the analysis methods used to address them. The record does not report those methods or results.

The outcome definition reinforces another useful statistical distinction: a baseline measurement describes status at a point in the study, whereas a treatment effect requires an interpretable comparison of outcomes across relevant conditions or times. The primary endpoint is explicitly baseline, and the registry does not provide later measurements or a treatment comparison. Thus the intervention listing cannot be read as a test of exercise efficacy.

Finally, the registry identifies many outcome measures but lists no analyses. This makes transparent reporting of outcome-specific estimates, uncertainty, missing-data handling, and multiplicity decisions especially important for interpreting the study. The posted record conveys what was planned and how certain outcomes were defined, but not what the data demonstrated.

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 limitations follow directly from the registry record. It is non-randomized, and participants are grouped according to functional status. Any observed group association would therefore be vulnerable to differences between groups that are not explained by the group definition. The record does not report participant characteristics, adjustment variables, or an analytical approach that might help readers assess confounding.

The primary endpoint is specified at baseline. The registry record does not report outcome values, later measurements, or a comparison of change over time. Consequently, it does not support conclusions about change in urinary incontinence or an effect of pelvic floor muscle exercise. Although the intervention is listed, delivery details and the relationship between the intervention and the cohort comparison are not reported.

The group definitions use scores <9 and > 10. The registry does not explain how a score of 9 or 10 was handled. It also does not report the final number with an evaluable primary outcome in each group, even though planned enrollment is listed. No analysis results are posted, so the precision of estimates and the handling of missing measurements cannot be assessed.

The registry lists 24 outcome measures and 0 analyses, without reporting how multiplicity was addressed or which populations were used for analysis. The safety record reports zero events in the listed categories, but does not explain event definitions, observation duration, or completeness of ascertainment. These limitations mean that the available record is useful for understanding study structure, but insufficient for evaluating its outcome findings.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: The Urinary Incontinence Treatment Study — NCT03057834.
• Registry record last updated 2025-11-10; status last verified 2021-01.
• Results first posted 2025-11-10.
• 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 Urinary Incontinence Treatment Study (NCT03057834) is listed as completed, with planned enrollment of 70. It is a non-randomized, unmasked, parallel prospective cohort study. Recruitment was intended to adapt to physical-function status, with similar numbers sought in the functionally impaired and functionally normal groups.

The primary outcome is the baseline mean number of urinary incontinence episodes, measured using a three-day voiding diary. Pelvic floor muscle exercise is listed as a behavioral intervention, and secondary outcomes include measures of contraction power, endurance, repetition, and fast contractions. The registry lists 24 outcome measures and 0 analyses.

The record reports 0 serious adverse events, 0 other adverse events, and 0 deaths in each group. It does not report outcome estimates, group comparisons, confidence intervals, missing-data methods, or an analysis plan. The design and outcomes are described, but the study’s statistical findings are not reported in the registry record.