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 Disposable Stress Urinary Incontinence Pessary Device Study (NCT03323723), a na na study. The primary outcome is Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03323723 |
| Phase | NA |
| Condition | Stress Urinary Incontinence |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 73 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Rinovum Women's Health, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with stress urinary incontinence were enrolled in a single-group study. The primary outcome population is described as the mITT Population, but the registry record does not define how that population was determined or how it differed from the enrolled group.
Intervention
Participants used the SUI Device. The study summary describes an initial baseline period with preweighed pads worn for 7 consecutive days, followed by 14 consecutive days using the device and preweighed pads at the same time. Both periods involved pad wear for 12 hours.
Comparator
The comparison was within the single study group: a baseline control period without the device versus a treatment period with the device. This was not a comparison between randomized groups or a concurrent control group.
Primary question
Did mean pad weight gain per hour decline by more than 50% during treatment compared with baseline? The endpoint is a percentage reduction in mean pad weight gain per hour, with the primary description specifying a 98.33% confidence interval. The registry record does not report the estimated reduction, the interval limits, or the result of a statistical test.
Pad weight gain per hour was intended to quantify urine leakage using the weight of returned pads, adjusted for the hours each pad was worn. The primary outcome compares an average from the baseline phase with an average from treatment. The treatment average uses the last 7 days of the treatment phase, rather than all days in that phase. This gives the stated question a measurable endpoint, but it does not by itself establish that observed changes were caused by device use. With no parallel control group, the contrast is between periods in the same study and remains open to other explanations for change over time.
3. Trial Design
The registry record identifies this as an interventional, single-group, multi-center study of a device for stress urinary incontinence. Allocation is listed as not applicable, masking as none, and the model as single group. The record lists enrollment of 73 and describes study sites in the northeastern United States. It gives the study status as completed, with a start date of 2017-10-16 and primary completion date of 2018-05-01.
The study summary describes a baseline control period followed by a treatment period. During baseline, participants wore preweighed pads for 12 hours on each of 7 consecutive days without the device. Participants then used the device and wore preweighed pads simultaneously for 12 hours over 14 consecutive days. For the primary endpoint, the baseline average uses the 7 days of baseline, while the treatment average uses the last 7 days of the treatment phase.
The registry summary says the sample size would consist of approximately 50 participants, while the enrollment field lists 73. The registry record does not explain this difference. It also does not report the number of sites, the extent of participant follow-up beyond the described periods, or the operational details of device fitting and use. The planned assessment is a within-participant comparison across study periods, not a randomized comparison of device and no-device groups. Consequently, the design can describe changes during the study but cannot separate the effect of the device from other changes that might occur between baseline and treatment. Allocation procedures beyond the single-group description 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.
Screening
| Stage | RS-2 SUI Device |
|---|---|
| STARTED | 73 |
| COMPLETED | 64 |
| NOT COMPLETED | 9 |
Baseline Phase
| Stage | RS-2 SUI Device |
|---|---|
| STARTED | 64 |
| COMPLETED | 60 |
| NOT COMPLETED | 4 |
Treatment Phase
| Stage | RS-2 SUI Device |
|---|---|
| STARTED | 60 |
| COMPLETED | 51 |
| NOT COMPLETED | 9 |
Analysis population for the primary outcome, as defined in the registry: mITT Population
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: Analysis conducted on mITT population.
| Characteristic | Unit | RS-2 SUI Device |
|---|---|---|
| Participants analysed | 73 | |
| Age, Customized: Average Age | years | 53.4 (SD 12.04) |
| Sex/Gender, Customized: Sex, Female | Participants | 73 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 43 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 73 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase., measured over 7 days of the baseline phase and 7 days of treatment phase.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 98.33% Confidence Interval |
| Unit | percent change |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the percentage reduction in mean pad weight gain per hour during treatment compared with baseline. To derive pad weight gain per hour, the weight of a returned pad is reduced by its pre-use weight, and the resulting leakage weight is divided by the number of hours the pad was worn. The baseline value is the average of these daily measurements over the baseline phase. The treatment value is the average over the last 7 days of treatment.
This measure uses an objective physical quantity rather than relying only on a participant rating. It also accounts for the amount of time a pad was worn, which matters when wear duration varies. As general statistical context, measurements recorded repeatedly within a participant can capture variation across days, while an average can make the comparison less dependent on any one day. An average, however, can conceal day-to-day changes and depends on the completeness and quality of the underlying measurements.
The stated objective was to show a reduction greater than 50%. The primary description specifies a mean and a 98.33% confidence interval, and identifies the mITT Population. The registry record does not report the observed percentage reduction, confidence interval limits, or how missing daily pad measurements were handled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record states the primary question and analysis population but does not report the primary efficacy estimate. In particular, it gives no observed percentage reduction in mean pad weight gain per hour, no confidence interval limits, and no p-value or other test result. The objective of demonstrating a reduction greater than 50% is therefore a stated target, not evidence that the target was met. The endpoint definition alone cannot establish the direction, magnitude, or precision of the observed change.
The reported confidence-interval type is 98.33%. A confidence interval expresses uncertainty around an estimated quantity under the assumptions of the analysis; it is not a guarantee that the true value falls within the particular interval. Without the estimate and interval limits, readers cannot assess whether the data are compatible with a reduction below, at, or above the stated 50% threshold, nor how precisely the reduction was estimated. The statistical test result is also not reported in the registry record, so no conclusion about a test decision can be drawn from the stated hypothesis.
The comparison uses a baseline period and a later treatment period in the same group. This arrangement can describe within-study change, but it does not provide a contemporaneous group that remains untreated. Changes in symptoms, behavior, measurement conditions, or other influences over time could contribute to a difference between periods. These are general considerations for before-and-after designs, not findings about what occurred in this study.
The record lists 73 participants as enrolled and reports safety figures for 73 at risk in the device group. Those enrollment and safety counts do not supply the missing efficacy estimate. They also do not establish how many participants contributed complete data to the primary analysis: the definition of the mITT Population and the analysis denominator are not reported in the registry record. The posted efficacy data therefore do not permit an independent reading of the size or precision of the primary effect. Any planning illustrations based on an observed effect should not be mistaken for an observed-power result or for a substitute for the missing endpoint estimate.
9. Statistical Methods Explained
The primary outcome is a continuous measurement summarized as a mean: pad weight gain per hour, expressed as a percentage reduction from baseline to treatment. The registry description explains how daily pad weight gain per hour is formed and how averages are made across the baseline and treatment periods. These definitions clarify what the endpoint is intended to represent. They do not reveal the distribution of measurements, the amount of variability, or the number of observations used in the final calculation.
What does a confidence interval communicate?
A confidence interval gives a range of values compatible with an estimate under the statistical procedure and its assumptions. A narrower interval generally indicates greater precision than a wider interval, while the interval's position relative to a clinically or scientifically relevant threshold can inform interpretation. Here, the registry record identifies a 98.33% confidence interval but does not provide its limits or the estimate it accompanies. Its reported confidence level therefore cannot be used to judge whether the stated threshold was exceeded. The registry record also does not explain the interval construction or the assumptions used to obtain it.
How does the threshold relate to the hypothesis?
The primary description states that the objective was a reduction greater than 50%, with the null hypothesis that the mean reduction is 50% or less and the alternative that it is greater than 50%. This makes the target more specific than a general question about whether the treatment-period average differs from baseline: the stated question concerns whether the reduction passes a threshold. The registry record does not report a test statistic, p-value, or decision for that hypothesis. The confidence-interval limits are also absent, so readers cannot independently assess the threshold comparison from the posted results.
What does the single-group comparison estimate?
Because this is a single-group study, the primary contrast compares measurements from the same study population at different times. A within-participant comparison can account for some stable differences between individuals, since each participant contributes measurements in both periods. That feature does not control for time-related influences shared by participants, changes in measurement behavior, or other differences between periods. These are general design considerations, not evidence that any particular influence occurred. A randomized concurrent comparator would address a different question by contrasting groups observed over the same period; such a comparison is not described in this record.
Why can repeated measurements vary?
Pad weight gain can vary from day to day, and recorded values may also depend on pad wear time and completeness of returned pads. The registry description accounts for wear time by expressing leakage per hour and uses averages across specified days. As general statistical context, repeated measurements from one participant are related rather than independent observations. Analysis methods should account for that dependence if daily measurements are modeled individually. If the analysis instead reduces each participant's measurements to period averages, the comparison is based on those averages. The registry record does not say which participant-level analysis procedure was used or how within-participant variation was represented.
As general statistical context, unusually variable or skewed measurements can affect how well a simple model describes uncertainty. Methods that assume a particular distribution may give unreliable intervals if their assumptions are poorly matched to the data. The registry record does not report distributional checks, transformations, robust methods, or sensitivity analyses. It is therefore not possible to assess whether the chosen approach was appropriate for the observed measurements.
What can planning calculations tell readers?
Planning illustrations are not trial results. The stated assumptions for the illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Those assumptions describe a hypothetical two-arm planning exercise, whereas the registered study is single group. The illustrations should not be read as the study's actual design, as evidence of an observed treatment effect, or as observed power. A sample-size calculation is a planning aid based on chosen assumptions; it does not establish the precision or validity of an analysis after data are collected. The registry record does not report the trial's own sample-size justification or other design calculations.
The record gives a 98.33% confidence-interval label, but the exact inferential procedure is not reported. It does not specify whether the analysis used a parametric model, a nonparametric method, or a particular variance estimate. It also does not describe handling of missing data, deviations from the measurement schedule, or the influence of extreme observations. Those details matter because they can change the estimated uncertainty and the population to which the result applies.
For a complete statistical reading, the primary estimate, interval limits, analysis denominator, and analysis method would be needed alongside the endpoint definition. Without them, the registry supports a description of the intended measurement and hypothesis, but not an independent assessment of the numerical efficacy result or its precision.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists the primary pad-weight endpoint and three secondary outcome topics: change in mean stress urinary incontinence episodes, change in quality of life, and adverse events and laboratory evaluations for safety. It lists 4 outcome measures and 0 analyses. The names of the secondary outcomes do not provide their numerical results or analysis details.
When a study examines multiple outcomes or makes multiple statistical comparisons, the chance of at least one apparently notable result can increase. As general statistical context, a prespecified hierarchy or multiplicity adjustment can help explain how multiple findings should be interpreted. The registry record does not report a multiplicity strategy, a hierarchy among secondary endpoints, or which comparisons were intended to support formal statistical claims. It is therefore not possible to determine how any secondary findings were treated relative to the primary hypothesis.
The primary analysis population is called the mITT Population, but its inclusion and exclusion rules are not reported in the registry record. The record also does not define how participants with incomplete pad records, missing follow-up, or protocol deviations were handled. No missing-data method, imputation procedure, or sensitivity analysis is reported. The number of participants contributing to the primary efficacy calculation is not stated, and the listed enrollment does not establish that every enrolled participant had analyzable endpoint data.
These omissions limit reproducibility and make it difficult to assess whether the analysis population and handling of missing values could affect the primary estimate. They do not show that data were missing or that a particular analysis choice was made; those matters are simply not reported in the registry record.
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 |
|---|---|---|---|
| RS-2 SUI Device | 0 | 73 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| RS-2 SUI Device | 0 of 73 |
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 |
|---|---|
| RS-2 SUI Device | 22 of 73 |
Most frequent non-serious adverse event terms
| Event term | Organ system | RS-2 SUI Device |
|---|---|---|
| Vaginal Pain | Reproductive system and breast disorders | 6 of 73 |
| Uterine Pain | Reproductive system and breast disorders | 4 of 73 |
| Vaginal Hemorrhage (Spotting) | Reproductive system and breast disorders | 4 of 73 |
| Pain of Skin | Skin and subcutaneous tissue disorders | 3 of 73 |
| Urinary Incontinence | Renal and urinary disorders | 2 of 73 |
| Urinary Retention | Renal and urinary disorders | 2 of 73 |
| Vaginal Discharge | Reproductive system and breast disorders | 2 of 73 |
| General Disorders and Administration Site Conidtions - Other, Specify | General disorders | 1 of 73 |
| Urinary Tract Infection | Infections and infestations | 1 of 73 |
| Back Pain | Musculoskeletal and connective tissue disorders | 1 of 73 |
The registry record reports 0 serious adverse events among 73 at risk in the RS-2 SUI Device group, and 0 deaths. It reports 22 participants affected in the other-adverse-event category among 73 at risk. These figures are separate from the primary efficacy endpoint and do not establish whether pad weight gain changed.
A zero count for serious events means none were recorded in this group during the safety reporting captured by the registry; it does not prove that the risk of a rare event is zero. The registry record does not report the observation period for these safety counts, event timing, severity details for the other category, or whether events were considered related to the device. It also does not provide a breakdown of the 22 other adverse events by type or participant. The top serious-event terms are not listed.
As general statistical context, adverse-event counts need to be interpreted alongside the number at risk, duration of observation, event definitions, and completeness of reporting. The registry figures alone cannot establish comparative safety because this study has no concurrent control group. They describe the recorded safety experience in the single study group, not a controlled estimate of excess risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed to compare pad weight gain per hour during a baseline period without the device with measurements during a later period of device use. It also specifies a target of a reduction greater than 50% and identifies a 98.33% confidence interval as the measure of uncertainty. These details explain the intended primary question. They do not answer it: the primary estimate, interval limits, and test result are not reported in the registry record.
Accordingly, the posted results do not support a numerical conclusion about the magnitude or precision of change in the primary endpoint. The stated target is part of the study hypothesis, not a reported finding. The absent efficacy result should not be interpreted as either evidence for or evidence against that target. The registry record also does not give enough detail to reconstruct the analysis or determine how the mITT Population was formed.
The study design further limits causal interpretation. Baseline and treatment measurements were taken in the same group at different times, without a randomized concurrent comparison group. Any observed difference could reflect the device, but a before-and-after contrast alone cannot rule out other changes over time or measurement-related influences. This is a general limitation of the design, not a claim that another explanation caused a change in this study.
The safety information is descriptive: 0 serious adverse events, 0 deaths, and 22 participants affected by other adverse events are recorded for the group. Without event details, duration, or a comparator, these counts cannot establish comparative safety or characterize the full range of possible harms. The registry record is most informative about the planned endpoint, study structure, enrollment, and recorded safety counts; it is not sufficient to independently evaluate the primary efficacy result.
13. Why This Trial Matters Statistically
This trial is statistically notable for the contrast it was designed to make: a threshold-based change in an objective pad-weight measure within one group, from a baseline period to a later treatment period. The outcome definition links measured pad weight to wear duration, and the stated hypothesis asks whether the mean reduction is greater than 50%. That structure illustrates why an endpoint definition and a numerical result are both necessary. A well-described measurement tells readers what was intended to be estimated; without the estimate and its uncertainty, it cannot show what the data indicate.
The design also illustrates the distinction between observing change and attributing change to an intervention. Repeated measurements within participants may describe how values differ between periods, but a single-group comparison does not include a concurrent untreated group to account for changes over time. Statistical interpretation must therefore take account of the design, not only the endpoint formula or any single estimate.
Finally, the registry record separates several kinds of evidence that should not be conflated: the primary efficacy question, the safety counts, and planning illustrations. Safety counts do not answer the efficacy hypothesis, and a hypothetical sample-size calculation does not replace the observed estimate. Here, the record identifies the methods and reports selected safety counts, while leaving the primary numerical result and important analysis details unreported. That combination makes clear why transparent reporting of estimates, uncertainty, analysis populations, and missing-data methods is essential for clinical 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.
Several limitations specific to this study affect interpretation. It is a single-group, unmasked study with a baseline period followed by treatment, rather than a randomized comparison with a concurrent control group. The within-group timing means that observed period differences cannot be attributed to device use alone. The registry record does not report whether participants or outcome assessors were blinded to measurements; masking is listed as none.
The primary efficacy estimate and 98.33% confidence interval limits are not reported in the registry record. The test result is also absent. The endpoint description identifies the mITT Population, but does not define it or state how many participants contributed to the analysis. Methods for missing measurements, protocol deviations, and sensitivity analyses are not reported. These gaps prevent an independent assessment of the primary result's size, precision, and robustness.
The record describes approximately 50 participants in the study summary and lists enrollment of 73, without explaining the difference. It does not report a sample-size justification for the trial. The planning assumptions described for sample-size illustrations use a hypothetical two-arm framework, which is not the registered single-group design; such calculations are not evidence of observed power.
Safety reporting is also limited in detail. The registry lists serious-event and death counts, as well as a count in the other-adverse-event category, but does not provide event types, timing, duration of observation, or attribution. No concurrent group is available for a comparative safety estimate. The record does not report the sites' number or detailed procedures for measurement quality control.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Disposable Stress Urinary Incontinence Pessary Device Study — NCT03323723.
- Registry record last updated 2019-05-16; status last verified 2019-05.
- Results first posted 2019-05-16.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed, multi-center, single-group device study in participants with stress urinary incontinence. It lists enrollment of 73 and identifies the primary endpoint as percentage reduction in mean pad weight gain per hour during treatment compared with baseline. The study summary describes 7 days of baseline pad use without the device, followed by 14 days of device use with pads; the primary treatment average uses the last 7 days of treatment.
The stated primary objective was a reduction greater than 50%, and the endpoint description specifies a 98.33% confidence interval. The registry record does not report the primary estimate, interval limits, or test result. It identifies the mITT Population without defining it. Safety figures list 0 serious adverse events, 0 deaths, and 22 participants affected by other adverse events among 73 at risk. Further details on analysis methods, missing data, and event characteristics are not reported in the registry record.