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 Improving Care for Women With Urinary Incontinence (EMPOWER) (NCT05515198), a non-randomized na study. The primary outcome is Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05515198 |
| Phase | NA |
| Condition | Urinary Incontinence |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 400 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University Hospitals Cleveland Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Women with urinary incontinence. The registry record does not provide further eligibility details or a more specific description of the outcome population.
Intervention
Patient education was included in all arms. Nurse navigation was added in Arm 2, and a chatbot was added to patient education and nurse navigation in Arm 3.
Comparator
Arm 1 received patient education. The arms were assigned non-randomly, so they should not be treated as like-for-like randomized comparison groups.
Primary question
The primary outcome concerns change in urinary incontinence symptoms, measured with the ICIQ-UI SF at baseline and Months 2 and 6 after the intervention began in each wave. The registry record does not report the observed scores or changes by arm.
3. Trial Design
EMPOWER, registered as NCT05515198, is a completed, parallel-arm study sponsored by University Hospitals Cleveland Medical Center. The record lists an enrollment of 400 and identifies the condition as urinary incontinence. The listed start date is 2022-09-06, and primary completion is dated 2024-12-23. The phase is listed as NA.
The study has three arms: patient education; patient education plus nurse navigation; and patient education plus nurse navigation plus a chatbot. Allocation is listed as non-randomized, and masking as none. Thus, participants and providers were not described as masked, and the groups were not formed through random allocation. The registry explicitly cautions that the arms are not a like-for-like control comparison.
Because patient education is common to all arms, the design describes progressively added support components. However, non-random allocation means that differences between arms could reflect differences in who entered each arm, as well as differences in the added components. The record does not report the allocation process, baseline comparability, or methods used to address such differences.
The primary outcome is change in ICIQ-UI SF score from baseline to Months 2 and 6 after intervention start in each wave. The record also lists secondary measures related to urinary incontinence symptoms, self-efficacy for communication, patient empowerment, and overactive bladder symptom severity. The details of the waves and the statistical plan are not reported in the registry record.
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: The study design is parallel cluster randomization (i.e., each cluster was randomized to an intervention or control) implemented at different times (i.e., waves). The stepped design was initially considered but we moved away after discussions with funders and need to update the study design section of CT.gov. The medical office was randomized and every eligible patient at the medical office who was interested in participating was recruited. The medical office was assigned the intervention.
Overall Study
| Stage | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| STARTED | 158 | 139 | 103 |
| COMPLETED | 148 | 130 | 90 |
| NOT COMPLETED | 10 | 9 | 13 |
Reasons for not completing this period:
| Reason | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Lost to Follow-up | 8 | 5 | 10 |
| Withdrawal by Subject | 2 | 4 | 3 |
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: Baseline analysis was completed for participants enrolled in each Arm, not practices. Each participant was assigned an Arm with the following interventions: Arm 1: Patient Education, Arm 2: Patient Education + Nurse Navigation, and Arm 3: Patient Education + Nurse Navigation + ChatBot. Participants were analyzed by Arm.
| Characteristic | Unit | Arm 1 | Arm 2 | Arm 3 | Total |
|---|---|---|---|---|---|
| Participants analysed | 158 | 139 | 103 | 400 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 100 | 87 | 69 | 256 |
| Age, Categorical: >=65 years | Participants | 58 | 52 | 34 | 144 |
| Sex: Female, Male: Female | Participants | 158 | 139 | 103 | 400 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 8 | 6 | 4 | 18 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 142 | 131 | 96 | 369 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 8 | 2 | 3 | 13 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 3 | 0 | 4 |
| Race (NIH/OMB): Asian | Participants | 1 | 2 | 0 | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 32 | 18 | 25 | 75 |
| Race (NIH/OMB): White | Participants | 113 | 109 | 74 | 296 |
| Race (NIH/OMB): More than one race | Participants | 3 | 3 | 4 | 10 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 8 | 4 | 0 | 12 |
| BMI | kg/m^2 | 33 (SD 9) | 30 (SD 7) | 35 (SD 9) | 32 (SD 8) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), measured over Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each wave.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in patients’ urinary incontinence symptoms, measured using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, or ICIQ-UI SF. The registry describes this measure as assessing symptom frequency, severity, and impact on quality of life. Its composite score ranges from 0 to 21, with higher scores indicating more severe incontinence.
The measure is scheduled at baseline, immediately before the intervention starts, and at Months 2 and 6 after intervention start in each wave. A change score is intended to describe how a participant’s measured symptom level differs from their baseline level over follow-up. Reporting change at follow-up can therefore help describe whether symptom scores shifted after the intervention began, while the score’s direction is interpretable because higher values indicate more severe symptoms.
These measurements do not, by themselves, establish that an intervention caused a change. In a non-randomized study, group differences may also reflect differences between participants or other factors. The registry record does not report the arm-level scores, changes, uncertainty estimates, or tests for this primary outcome, so the magnitude and precision of any observed change cannot be assessed from the recorded results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically interpretable primary measure: ICIQ-UI SF score, which ranges from 0 to 21, with higher scores indicating more severe urinary incontinence. It specifies baseline measurement and follow-up at Months 2 and 6 after intervention start in each wave. However, it does not report the observed primary outcome values by arm, the mean changes, a between-arm estimate, confidence intervals, or a p-value. The direction, size, and statistical precision of the primary outcome findings are therefore not reported in the registry record.
The study is non-randomized, and the record warns that its arms are not a like-for-like control comparison. Consequently, even if arm-level outcome results were available, a raw difference would not automatically isolate the effect of adding nurse navigation or a chatbot. Differences could also arise from characteristics that influenced which arm participants entered. The record does not report whether or how such differences were adjusted for.
There are 21 outcome measures and 2 analyses listed, but the registry record does not explain how those analyses correspond to specific outcomes or time points. It also does not report a statistical analysis plan, model specifications, or multiplicity procedures. No inference about statistical significance or the handling of multiple comparisons can be made from the outcome listings alone.
The record lists 400 as enrollment, but this does not establish how many participants contributed data to each outcome or follow-up. Outcome-specific denominators and missing-data details are not reported in the registry record. Accordingly, the completeness and representativeness of the observed symptom measurements cannot be assessed.
Safety entries report serious adverse events affecting 2 participants in Arm 1, 3 in Arm 2, and 5 in Arm 3; deaths are reported as 0 in each arm. These are descriptive counts, not a randomized comparison. The numbers at risk differ across arms, and the record does not provide enough information to determine whether differences reflect exposure, follow-up, participant characteristics, or chance. The counts should not be interpreted as evidence that one intervention caused more or fewer events.
9. Statistical Methods Explained
General statistical context: The primary measure is continuous: it is a numerical score rather than a count of events or a yes-or-no outcome. The registry specifies that the primary parameter is the mean and that dispersion is described by the standard deviation. A mean summarizes the central level of scores, while a standard deviation describes how spread out individual scores are around that mean. The record does not report the actual means or standard deviations for the primary outcome.
What does a change score describe?
General statistical context: A change score compares a follow-up measurement with a baseline measurement for the same participant. It can describe whether scores tend to move over time, but an average change within an arm is not the same as an estimate of the effect of that arm relative to another. A between-arm estimate compares outcomes across groups and requires an analysis that defines the comparison and how participant differences are handled. The registry identifies baseline and follow-up times but does not report the change estimates or the analysis used to produce them.
The stated time points are baseline, immediately before intervention start, and Months 2 and 6 after intervention start in each wave. Measurements over time can be analyzed in different ways, including comparisons of change or models that account for repeated measurements from the same participant. These approaches make different assumptions and produce different estimates. Which approach was used is not reported in the registry record.
Why does allocation matter?
General statistical context: Random allocation is intended to make comparison groups similar on average with respect to measured and unmeasured characteristics. This trial is listed as non-randomized, and the record cautions that arms are not like-for-like controls. As a result, observed differences between arms may reflect the intervention components, differences in participants, or both. Statistical adjustment can sometimes address measured differences, but it cannot necessarily remove bias from factors that were not measured or were not appropriately modeled. Whether any adjustment was conducted is not reported in the registry record.
Patient education is included in all three arms. The other arms add nurse navigation, and Arm 3 also adds a chatbot. This structure describes comparisons of support packages, not a comparison of each component in isolation under random assignment. The registry record does not explain how participants were allocated or whether the analysis was designed to estimate the separate contribution of each component.
How should uncertainty be understood?
General statistical context: A confidence interval expresses the uncertainty around an estimated quantity under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates less precision. It does not by itself resolve bias caused by non-random allocation or other design limitations. No confidence interval for the primary outcome is reported in the registry record.
A p-value, when reported, describes how compatible observed data are with a specified null model and its assumptions. It does not measure the size or importance of an effect. The registry record does not report a primary outcome p-value or enough information to reconstruct the test used. Thus, statistical significance cannot be assessed from the registry entries.
What do the sample-size illustrations mean?
General statistical context: The stated planning framework uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. Any sample-size figures based on that framework are planning illustrations, not observed power and not evidence that the trial was designed around those assumptions. The record explicitly distinguishes the illustration from the trial’s own design. The particular effect estimates and sample-size values are not reported in the registry record.
Such illustrations depend on their assumptions, including the chosen effect and the variability of the outcome. They do not establish that the trial had adequate precision for its primary endpoint, especially when the allocation is non-randomized and the outcome data and analysis details are unavailable. The registry record does not report a sample-size justification for the study’s own design.
What does the safety count represent?
General statistical context: Counts of participants affected by adverse events are descriptive safety summaries. Their interpretation depends on the number of people observed, duration and completeness of follow-up, and how events were collected and classified. The registry lists participants at risk and affected in each arm, but does not report further details about follow-up duration or event ascertainment. With non-randomized arms, unadjusted differences in counts cannot be attributed to the intervention components alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 21 outcome measures and 2 analyses. It names secondary outcomes concerning urinary incontinence symptoms, self-efficacy for communication about urinary incontinence, patient empowerment, and overactive bladder symptom severity. Several entries refer to measurements or changes at different time points. The record does not specify which outcomes were included in each analysis, which comparisons were prespecified, or how the primary and secondary measures were prioritized beyond identifying the primary outcome.
When multiple outcomes, time points, or group comparisons are examined, the chance of obtaining at least one apparently notable result may increase. Statistical procedures can account for multiplicity, but the choice depends on the analysis plan and inferential goals. Whether any adjustment was planned or applied is not reported in the registry record. The record also does not report the threshold used for interpreting statistical tests or whether analyses were confirmatory or exploratory.
Missing-data information is not reported in the registry record. The enrollment entry of 400 does not establish the number with a baseline measure, the number completing each follow-up, or the number included in any analysis. The record does not describe reasons for missing measurements, methods for handling missing values, or sensitivity analyses. Those details matter because incomplete follow-up can affect both the precision and interpretation of estimated changes.
Analysis populations are also not described. The registry record does not specify whether all enrolled participants, only participants who began an intervention, or another defined group contributed to each outcome analysis. Without these details, the analyzed population and the potential impact of exclusions cannot be assessed.
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 |
|---|---|---|---|
| Arm 1 | 2 | 158 | 1.3% |
| Arm 2 | 3 | 139 | 2.2% |
| Arm 3 | 5 | 103 | 4.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm 1 | 0 of 158 |
| Arm 2 | 0 of 139 |
| Arm 3 | 0 of 103 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Arm 1 | 11 of 158 |
| Arm 2 | 9 of 139 |
| Arm 3 | 9 of 103 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|---|
| Incarcerated umbilical hernia | Gastrointestinal disorders | 1 of 158 | 0 of 139 | 0 of 103 |
| gastric ulcers | Gastrointestinal disorders | 1 of 158 | 0 of 139 | 0 of 103 |
| Suicide Attempt | Psychiatric disorders | 0 of 158 | 1 of 139 | 0 of 103 |
| Cerebrovascular accident (CVA) | Vascular disorders | 0 of 158 | 1 of 139 | 0 of 103 |
| Cholecystitis | Gastrointestinal disorders | 0 of 158 | 1 of 139 | 0 of 103 |
| Chest pain | Cardiac disorders | 0 of 158 | 0 of 139 | 1 of 103 |
| Pyelonephritis of right kidney | Renal and urinary disorders | 0 of 158 | 0 of 139 | 1 of 103 |
| Small bowel obstruction | Gastrointestinal disorders | 0 of 158 | 0 of 139 | 1 of 103 |
| Fall | Injury, poisoning and procedural complications | 0 of 158 | 0 of 139 | 1 of 103 |
| Pericardial Effusion | Cardiac disorders | 0 of 158 | 0 of 139 | 1 of 103 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|---|
| general musculoskeletal pain | Musculoskeletal and connective tissue disorders | 2 of 158 | 3 of 139 | 2 of 103 |
| Abdominal pain | General disorders | 2 of 158 | 0 of 139 | 1 of 103 |
| Syncope | Metabolism and nutrition disorders | 0 of 158 | 2 of 139 | 1 of 103 |
| Gastroenteritis | Gastrointestinal disorders | 1 of 158 | 1 of 139 | 0 of 103 |
| Urinary tract infection | Renal and urinary disorders | 0 of 158 | 0 of 139 | 2 of 103 |
| Hemoptysis | Gastrointestinal disorders | 1 of 158 | 0 of 139 | 0 of 103 |
| Leg swelling | General disorders | 1 of 158 | 0 of 139 | 0 of 103 |
| Right hip pain | General disorders | 1 of 158 | 0 of 139 | 0 of 103 |
| Total hip replacement | Musculoskeletal and connective tissue disorders | 1 of 158 | 0 of 139 | 0 of 103 |
| Thyroid cancer recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 158 | 0 of 139 | 0 of 103 |
Serious events with the highest arm-level rate: chest pain (1.0%), pyelonephritis of right kidney (1.0%), small bowel obstruction (1.0%), fall (1.0%), pericardial effusion (1.0%).
The registry reports serious adverse events affecting 2 participants in Arm 1, 3 in Arm 2, and 5 in Arm 3. The corresponding numbers at risk are 158, 139, and 103. Deaths are reported as 0 in each arm. These are descriptive registry counts; the record does not provide an inferential comparison of safety between arms.
The registry also lists serious adverse event terms including Chest pain, Pyelonephritis of right kidney, Small bowel obstruction, Fall, Pericardial Effusion, and hematoma with non-occlusive DVT. Each listed term is accompanied by 1.0%. The record does not assign these terms to particular arms in the information, so they should not be attributed to a specific intervention group.
The groups were not randomized and differ in the numbers at risk. Counts alone do not account for how long participants were followed, their characteristics, or how events were sought and classified. The registry record does not report those details. The figures therefore describe reported safety events, but do not establish that any component caused or prevented an event, or that the arms differ in underlying safety risk.
12. What the Result Does, and Does Not, Mean
The registry describes a completed, non-randomized study of three support packages for women with urinary incontinence. Its primary outcome is change in ICIQ-UI SF score from baseline to Months 2 and 6 after intervention start in each wave. The score measures symptom frequency, severity, and quality-of-life impact, with higher scores indicating more severe incontinence on a scale from 0 to 21.
The registry record does not report the primary outcome results. There are no arm-level score summaries, mean changes, between-arm estimates, confidence intervals, or p-values in the record details. It is therefore not possible to describe whether scores changed, how large any change was, or how precisely a comparison was estimated. Completion status indicates that the study is listed as completed; it does not supply the missing outcome estimates.
The design can describe outcomes across groups receiving patient education, patient education with nurse navigation, and patient education with nurse navigation and a chatbot. Because allocation was non-randomized, differences between these groups would not by themselves establish that an added component caused a difference. The registry also warns that the arms are not a like-for-like control comparison. The allocation process and any methods for addressing group differences are not reported.
The safety counts provide a descriptive account of reported serious adverse events and deaths by arm. They are not a causal comparison, and differences in counts should not be interpreted as treatment effects. The record does not report enough detail about follow-up or event ascertainment to further characterize these comparisons.
Overall, the registry record identifies the study question, outcome measure, design, and some safety counts, but does not report the primary efficacy results or key analysis details. Conclusions about the size, precision, or causal interpretation of symptom changes cannot be drawn from the recorded information.
13. Why This Trial Matters Statistically
EMPOWER has a useful statistical structure to examine: its arms share patient education and add nurse navigation and a chatbot in different combinations. This makes clear why the allocation method matters. In a randomized comparison, group assignment is designed to support causal contrasts; in this non-randomized study, differences between groups may also reflect who entered each arm. The registry itself cautions that the arms are not like-for-like control groups.
The primary measure also captures more than a simple symptom count. The ICIQ-UI SF assesses frequency, severity, and quality-of-life impact, and its score has a defined range and direction. Measuring it at baseline and follow-up can describe change over time. To understand what that change means statistically, readers also need the estimated changes, between-arm contrasts, and their uncertainty. Those results are not reported in the registry record.
The record lists 21 outcome measures and 2 analyses, which makes transparent reporting of outcome definitions, analysis choices, missing data, and multiplicity procedures especially relevant. Without those details, readers cannot tell how the listed measurements were combined into analyses or how the results should be interpreted across outcomes and time points.
The study therefore illustrates a broader statistical distinction: a well-defined clinical question and a completed study record are not the same as a fully interpretable treatment-effect estimate. Clear reporting of the group allocation process, outcome data, analysis methods, and uncertainty is essential for evaluating what the observed data can support.
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 principal limitation for interpretation is that the registry record does not report the primary outcome results. Arm-specific ICIQ-UI SF values, changes, between-arm estimates, confidence intervals, and p-values are not reported in the registry record. Consequently, the primary endpoint’s magnitude and precision cannot be assessed.
The allocation is non-randomized, and the record states that the arms are not a like-for-like control comparison. The allocation process, baseline characteristics, and any adjustment for differences between groups are not reported. This limits causal interpretation of any possible difference between the support packages.
The record identifies 21 outcome measures and 2 analyses but does not describe how the analyses map to outcomes, time points, or group comparisons. A statistical analysis plan and multiplicity procedures are not reported in the registry record. Nor are outcome-specific sample sizes, missing-data patterns, analysis populations, or methods for handling missing measurements.
Although the study is listed as completed and enrollment is 400, these entries do not show how many participants contributed data at each follow-up. Follow-up completeness and the representativeness of analyzed participants therefore cannot be assessed. The record also does not detail the study waves beyond specifying that the outcome time points apply in each wave.
For safety, the registry reports affected participants, numbers at risk, and deaths, but does not provide further information about event ascertainment or follow-up duration. These limitations prevent a detailed comparison of safety across the non-randomized arms.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Improving Care for Women With Urinary Incontinence (EMPOWER) — NCT05515198.
- Registry record last updated 2026-05-05; status last verified 2025-01.
- Results first posted 2026-05-05.
- 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
EMPOWER is a completed, parallel-arm, non-randomized study sponsored by University Hospitals Cleveland Medical Center. The registry lists urinary incontinence as the condition, enrollment of 400, a start date of 2022-09-06, and primary completion on 2024-12-23. Masking is listed as none.
The three arms received patient education; patient education plus nurse navigation; or patient education plus nurse navigation and a chatbot. The primary outcome is change in ICIQ-UI SF score, measured at baseline and Months 2 and 6 after intervention start in each wave. The score ranges from 0 to 21, with higher scores indicating more severe incontinence.
The record lists 21 outcome measures and 2 analyses, along with serious adverse event counts and 0 deaths in each arm. Primary outcome estimates and key analysis details are not reported in the registry record. The registry cautions that the non-randomized arms are not like-for-like control groups.