Modern Urodynamics System Efficacy (MUSE) Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Modern Urodynamics System Efficacy (MUSE) Study (NCT05959655), a na na study. The primary outcome is Percentage of Participants With Insertion Success.

2. Clinical Question

3. Trial Design

The MUSE Study is a prospective clinical evaluation of the Glean Urodynamics System. The registry lists the model as single group, allocation as NA, and masking as none. It is marked completed. The listed start date is 2023-08-21 and the primary completion date is 2024-04-18. The phase is recorded as NA. Bright Uro is identified as the sponsor.

The planned sequence is important to interpreting the design. Participants were to undergo conventional urodynamics, after which the Glean Sensor would be inserted. Ambulatory urodynamics would then be performed with the sensor indwelling in the bladder, followed by sensor removal. The system is described as wireless and catheter-free. The study therefore evaluates use of a device in a procedural sequence, rather than comparing two separately assigned treatment groups.

The registry enrollment entry is 38. The primary endpoint description says that 33/34 participants who underwent conventional urodynamics underwent an insertion attempt with the system. These entries describe different aspects of the study population; the record does not reconcile them. It also does not report why some participants may not have entered the endpoint population, or whether the endpoint denominator reflects all enrolled participants, all who underwent the conventional examination, or another analysis population.

This is not a randomized comparison, and the registry specifically notes that the arms are not a like-for-like control comparison. Consequently, the design can describe experience with the device in the enrolled study context, but it does not by itself establish a comparative effect against a randomized control. Further details about recruitment, eligibility criteria, study sites, protocol deviations, and the statistical analysis 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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: 33/34 participants who underwent conventional urodynamics underwent an insertion attempt with the Glean Urodynamics System.

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: Participants enrolled in the study

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants With Insertion Success, measured over during the insertion procedure of a device.

The primary endpoint is titled Percentage of Participants With Insertion Success. It is intended to represent whether insertion of the Glean sensor was successful during the insertion procedure. The outcome description refers to insertion attempts deemed successful, while the listed unit is participants. This distinction matters: a participant-level count describes how many people experienced success, whereas an attempt-level percentage would require a clear definition of the attempt denominator and how unsuccessful or repeated attempts are handled. The registry record does not explain those operational details.

Insertion success is a feasibility measure because it addresses whether the device can be placed as intended in the study setting. It is not, by itself, a measure of the accuracy of pressure readings, the quality of ambulatory recordings, patient comfort, or safety. Those are separate questions. A secondary outcome concerns the percentage of participants rating overall comfort as comfortable or extremely comfortable, while the study summary also names efficacy and safety as aims.

The endpoint description states that 33/34 participants who underwent conventional urodynamics underwent an insertion attempt. However, the record does not state how many insertions succeeded. It also provides no primary estimate, confidence interval, or analysis result. The endpoint therefore identifies what the study intended to measure, but the posted registry information does not establish the observed level of insertion success or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the endpoint count?

The primary outcome is described as the percentage of participants with insertion success, and its unit is participants. Its description also refers to the percentage of insertion attempts deemed successful. These formulations may coincide when each participant has one attempt, but the registry record does not specify whether repeat attempts were possible or how they would be counted. It says 33/34 participants who underwent conventional urodynamics underwent an insertion attempt. It does not state the number of successful insertions, the rule used to classify success, or whether an attempted insertion could be classified as indeterminate. Those details are needed to reproduce the endpoint from participant-level records.

General statistical context: a binary endpoint records whether a defined event occurred for each eligible unit. A proportion is the event count divided by the relevant denominator. The denominator should match the question: participants, attempts, or another unit. When the unit and analysis population are not fully specified, the result can be difficult to interpret even if a numerator is posted.

What would an uncertainty interval add?

The registry record does not report an insertion-success estimate or confidence interval. General statistical context: an interval estimate expresses the range of values reasonably compatible with the observed data under a stated statistical model. It reflects sampling uncertainty, not every possible source of bias. A narrow interval generally indicates greater precision than a wide interval, but neither interval width nor an estimate can be recovered without the relevant outcome data and analysis method. The record also does not report a test of a prespecified threshold for success.

For binary outcomes, methods commonly model the probability of the event. Such methods rely on a clearly defined denominator and appropriate assumptions about the observations. If each participant contributes one independent result, a participant-level approach may be suitable. If a participant can contribute multiple attempts, treating all attempts as independent could understate uncertainty because attempts from the same person may be related. The registry record does not describe repeated attempts or a method for accounting for within-participant dependence, so no such method should be presumed.

How should the single-group design be understood?

The record lists a single-group model, no masking, and allocation as NA. General statistical context: in a single-group study, outcome descriptions are based on participants receiving or undergoing the studied procedure. Without a randomized concurrent control group, observed outcomes cannot separate the device experience from other influences such as participant selection, procedural context, or how outcomes were assessed. This does not make descriptive results unusable; it limits the kinds of comparisons and causal interpretations they support.

Masking can reduce the influence of knowledge about the intervention on some assessments. The registry lists masking as none. The record does not state whether insertion success was assessed by an independent reviewer or whether any outcome assessors were unaware of other study information. Those safeguards should not be assumed. General statistical context: subjective outcomes, such as a comfort rating, can be especially sensitive to how questions are asked and to participants' awareness of the device being evaluated.

What does the planning information mean?

The registry record describes sample-size calculations as planning illustrations based on the observed effect, not as the study's own design. It states that 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 stated fraction of the observed effect. These are planning assumptions, not a description of the single-group study design. The calculation convention for time-to-event outcomes is a total number of events; other illustrations are expressed as participants per arm.

General statistical context: a sample-size illustration asks how much information a hypothetical design might require under specified assumptions. It is not a report of the study's achieved statistical power, and it does not show that the study was adequately powered for its actual objectives. An illustration based on an observed effect is also dependent on that effect estimate, which can be uncertain. The posted registry record does not describe a prospective sample-size justification for this trial. The illustration should therefore be interpreted as a planning aid rather than an observed trial finding.

Over-dispersion is a general concern when outcomes vary more than a statistical model expects. In a binary endpoint with repeated observations per participant, for example, correlated observations can carry less independent information than the same number of unrelated observations. The record does not identify repeated endpoint observations or an over-dispersion model. This is a general methodological consideration, not a finding about this trial.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Glean Urodynamics System")
n      <- c(33)
events <- c(32)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Glean Urodynamics System  33  32  97.0  84.2  99.9  84.7  99.5  84.7  99.3

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists four outcome measures and no analysis records. It names insertion success as the primary endpoint and lists a secondary comfort outcome: the percentage of participants rating overall comfort as comfortable or extremely comfortable. The record does not supply results for the comfort outcome or describe the other outcome measures in enough detail to assess their statistical roles.

Multiplicity arises when several outcomes, comparisons, or time points are tested. Repeated testing can increase the chance of obtaining a seemingly noteworthy result by chance unless the analysis plan accounts for the family of tests. General statistical context: approaches can include prespecifying a primary outcome, adjusting significance thresholds, or presenting outcomes as exploratory. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or a plan for interpreting multiple tests. Since no analysis records are listed, no correction method or testing hierarchy can be inferred.

Missing-data handling is also not reported in the registry record. The enrollment entry is 38, while the primary endpoint population description says 33/34 participants who underwent conventional urodynamics underwent an insertion attempt. The record does not explain this difference, identify reasons for nonparticipation in the endpoint, or state how missing or unevaluable outcomes were handled. It does not specify whether the primary analysis included all enrolled participants, only those who underwent the conventional examination, only those with an attempted insertion, or another population.

General statistical context: excluding participants with unavailable outcomes can change the composition of the analyzed group, especially if missingness is related to the outcome or to participant characteristics. An analysis population should be defined before results are interpreted. Without a reported population definition and missing-data method, readers cannot judge whether the endpoint summary, if reported elsewhere, would represent all enrolled participants or a selected subset.

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.

Most frequent non-serious adverse event terms

The registry lists safety counts for All Participants and for Glean Urodynamics System. In the All Participants group, 0 serious events are listed among 38 at risk, 12 participants with other events among 38 at risk, and 0 deaths. In the Glean Urodynamics System group, 0 serious events are listed among 32 at risk, 7 participants with other events among 32 at risk, and 0 deaths. These counts should be read with their own group labels and denominators.

The entries do not establish that the groups are independent or mutually exclusive. The record does not explain why the at-risk counts differ, how the device group relates to the all-participants group, or whether event follow-up was identical across groups. The figures should therefore not be added, subtracted, or interpreted as a direct comparison. The listing of 0 serious events means that no serious events are recorded in those entries; it does not establish that no event of any kind occurred. The separate other-event counts are nonzero.

The registry does not provide the specific terms for the listed non-serious events in these entries, their timing, duration, severity, or relationship to the device. A count of participants with an event is not a rate over person-time. General statistical context: safety summaries are easier to interpret when the event definition, observation period, attribution method, and population are clear. Those details are not reported in the registry record, so these counts are descriptive and should not be treated as evidence of comparative safety.

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

The study addresses a useful measurement and feasibility question: whether a wireless, catheter-free system can be incorporated into a clinical urodynamics sequence, including insertion and subsequent ambulatory data collection. The registry describes the intended procedure and identifies insertion success as the primary endpoint. It also identifies comfort as a secondary outcome and includes safety counts. These elements indicate the domains the study was designed to examine.

However, the registry record does not report the primary endpoint result. Although it states that 33/34 participants who underwent conventional urodynamics underwent an insertion attempt, it does not give the number of successful insertions or an estimate of the percentage. It also does not report a confidence interval or analysis result. The posted information therefore cannot establish the observed insertion-success level or how precisely it was estimated.

The safety entries record 0 serious events and 0 deaths in each listed group, alongside other-event counts of 12 among 38 at risk in All Participants and 7 among 32 at risk in Glean Urodynamics System. These descriptive figures do not establish that the device caused or prevented events. The registry does not describe the relationship between the groups or provide detailed event terms and follow-up context.

The single-group, unmasked design also limits comparative interpretation. There is no randomized control group in the record, and the conventional urodynamics examination is part of the planned sequence rather than a parallel randomized comparator. The study description does not establish a comparative advantage, equivalence, or non-inferiority claim. Nor does a feasibility endpoint by itself establish the accuracy or clinical utility of pressure measurements.

Overall, the registry record explains the intended evaluation and provides limited safety counts, but it does not post the primary efficacy or feasibility result. The appropriate conclusion is about the limits of the available registry information, not a claim that the system succeeded or failed.

14. Why This Trial Matters Statistically

This trial is statistically notable because the main question is framed around a practical binary outcome: successful insertion. Feasibility studies often need a clear operational definition of success, a clearly specified analysis population, and an explicit denominator. Here, the record identifies the outcome and gives a count of participants who underwent an insertion attempt, but does not report the successful count. That gap illustrates why endpoint registration and outcome reporting are separate parts of a statistical record.

The difference between enrollment and the endpoint population also matters. The registry lists enrollment as 38 and describes 33/34 participants who underwent conventional urodynamics as undergoing an insertion attempt. Without an explanation of the denominator, readers cannot tell which participants contribute to the primary endpoint or why the entries differ. A well-defined participant flow supports transparent interpretation and helps readers assess potential selection effects.

The study also illustrates the limits of single-group evidence. A single-group design can describe whether a procedure was completed and what events were recorded in the study context. It cannot provide the same protection against confounding as randomized allocation to a concurrent comparison group. The record explicitly cautions that the arms are not a like-for-like control comparison. Statistical summaries must match that design rather than imply a controlled effect.

Finally, the registry contains safety counts but limited context about event types and follow-up. Counts without detailed definitions, exposure context, and clear relationships among groups are useful as a basic record, but they cannot answer every safety question. The study is therefore a reminder that precision, transparency, and design all shape what an estimate can mean—not just the numerical result itself.

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 trial-specific limitations affect interpretation of the registry record. First, the primary endpoint result is not reported. The record gives the endpoint definition and says that 33/34 participants who underwent conventional urodynamics underwent an insertion attempt, but it does not list successful insertions, an estimate, or an uncertainty interval. The central feasibility result therefore cannot be evaluated from the registry information.

Second, the record does not reconcile the enrollment entry of 38 with the endpoint population description. It does not explain the participant flow from enrollment through conventional urodynamics and insertion attempt, or identify reasons for any difference. The primary analysis population and missing-data handling are not reported in the registry record.

Third, the single-group model, lack of masking, and absence of a randomized control arm constrain comparative conclusions. The registry does not describe an independent outcome assessor or a prespecified comparison. The conventional examination is part of the procedure sequence, not a stated randomized control group.

Fourth, safety reporting is limited. The record lists serious events, other events, and deaths with group-specific denominators, but does not give event terms, timing, severity details, attribution, or an explanation of how the two group entries relate. Follow-up duration for safety events is not reported in the registry record.

Finally, the registry does not report a statistical analysis plan, the methods used for endpoint estimation, multiplicity handling, or a prospective sample-size justification. It lists four outcome measures but no analysis records. These omissions prevent assessment of whether the reported outcomes, analysis population, and statistical procedures followed a prespecified plan.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Modern Urodynamics System Efficacy (MUSE) Study — NCT05959655.
• Registry record last updated 2025-12-18; status last verified 2025-12.
• Results first posted 2025-12-18.
• 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 MUSE Study is a completed, prospective, single-group evaluation of the Glean Urodynamics System, sponsored by Bright Uro. It enrolled 38 participants and was designed to assess feasibility, efficacy, and safety of collecting vesical pressure data in adults with lower urinary tract symptoms. The planned sequence included conventional urodynamics, sensor insertion, ambulatory urodynamics with the sensor in the bladder, and sensor removal.

The primary endpoint is insertion success during the insertion procedure. The registry states that 33/34 participants who underwent conventional urodynamics underwent an insertion attempt, but does not report the number of successful insertions or a primary estimate. Safety entries list 0 serious events and 0 deaths in both labeled groups, with other-event counts of 12 among 38 at risk for All Participants and 7 among 32 at risk for Glean Urodynamics System. The registry does not report a statistical analysis plan, missing-data methods, or a multiplicity strategy.