Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study (NCT05128682), a na na study. The primary outcome is Pulse Amplitude Triggering Patient Sensation at First Verbally Reported Sensation..

2. Clinical Question

The study's stated purpose is to evaluate changes in stress-induced urethral leak point pressures and other urodynamic measurements in response to acute stimulation. The intervention description says urodynamic testing involves filling the bladder and observing for urinary leakage, with stimulation off and then on. The listed secondary outcomes concern the urethral pressure profile, maximum cystometric capacity, and post-void residual.

These details describe the question and planned measurements, not a demonstrated effect. The registry record does not report numerical leak point pressure results, the values for the primary outcome, or estimates for the secondary outcomes. It also does not report a statistical analysis of the conditions. The study can therefore be described as an exploration of acute measurements in a small group, but the registry record alone cannot establish the size, precision, or consistency of any change.

3. Trial Design

This is an early feasibility study registered as a single-group study, with no masking and no allocation specified. The registry record lists enrollment of 4 and a terminated status. It records a start date of 2022-05-24 and a primary completion date of 2022-07-27. The sponsor is Corewell Health East.

The intervention is urodynamic testing with and without pudendal nerve stimulation. The arm description states that settings on the implanted device would be adjusted to deliver acute stimulation. Testing is described with stimulation turned off and then turned on. This sequence means the record does not describe a randomized order or a parallel group that received no stimulation. Whether other procedures or measurements differed across participants is not reported in the registry record.

Because the conditions are assessed within a single group, the intended contrast is between measurements made under the two stimulation settings. Such a contrast can be informative about immediate changes in the measured variables, but it is not equivalent to a randomized comparison between independent groups. The fixed off-then-on sequence also leaves order and time effects as possible alternative explanations for a difference; whether the study addressed these issues is not reported in the registry record.

The record labels the study phase as not applicable and reports 8 outcome measures, with 0 analyses. It does not report a sample-size justification, a detailed statistical analysis plan, or reasons for termination. It also does not describe an interim-analysis plan. These omissions limit interpretation of how the study was intended to handle design choices and analysis decisions.

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: One subject did not have a pulse amplitude recorded.

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: Females with a neurostimulator implanted device

6. Primary Endpoint

The registry lists the primary outcome as Pulse Amplitude Triggering Patient Sensation at First Verbally Reported Sensation., measured over After Visit 2 activities are complete. An average of 30 days after enrollment..

The registry record lists the primary outcome as pulse amplitude at the first verbally reported sensation. Pulse amplitude is the amplitude of the electrical pulses delivered by the neuromodulation device, measured in mA. In this endpoint, the value is the device setting when a participant first verbally reports feeling a sensation. The record describes this as a device setting rather than a calculated measure.

This measure can characterize the stimulation level associated with a participant's first reported sensation during the study procedures. It is distinct from a direct measurement of urethral leak point pressure. Although the study's stated purpose includes evaluating leak point pressure, the listed primary outcome does not itself quantify leak point pressure or a change in pressure between stimulation conditions.

The endpoint timeframe is after Visit 2 activities are complete, described as an average of 30 days after enrollment. The registry record specifies a mean and standard deviation as the summary format, but does not report their values. It notes that one subject did not have a pulse amplitude recorded. The record does not explain why that value is missing or how the primary outcome was analyzed. Without the observed summary and a defined analysis, the endpoint's distribution and precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a continuous primary outcome summarized as a mean with a standard deviation. It does not report the observed mean or standard deviation, an analysis estimate, or inferential results. The record also lists 0 analyses. The concepts below explain how such methods are generally interpreted; they are not a description of analyses confirmed to have been conducted in this study.

What does a mean describe?

General explanation: a mean is the arithmetic average of the recorded values. It gives a compact description of the center of a set of continuous measurements, but can be affected by unusually high or low observations. A mean is most informative when read with a measure of variability and with details about the observations included. In this study, the primary outcome's planned summary is a mean and standard deviation. Its numerical values and the set of observations used to derive them are not reported in the registry record.

What does a standard deviation describe?

General explanation: a standard deviation describes the spread of individual observations around their mean. It is not the same as the uncertainty in the mean. The standard deviation concerns variation among the measured values, while the standard error and a confidence interval concern how precisely a population quantity is estimated under specified assumptions. Neither the primary outcome's standard deviation nor a confidence interval is reported in the registry record, so the amount of observed variation and the precision of a mean cannot be assessed.

How would the off-on comparison be analyzed?

General explanation: when the same participants are measured under two conditions, analysis often focuses on each participant's difference between conditions. The distribution of those differences, rather than treating all measurements as independent, is relevant to a paired comparison. Such an analysis depends on having usable paired observations and on suitable assumptions for the chosen method. The registry record describes testing with stimulation off and then on, but does not report paired outcome values, a paired analysis, or the assumptions used. It also does not report whether all participants completed both conditions.

The recorded order matters. General explanation: if one condition always occurs after another, changes associated with time, repeated testing, or procedure order may coincide with the condition change. Randomizing or counterbalancing order can help distinguish those influences from a condition effect, but whether either approach was used is not reported in the registry record. This is a design consideration, not evidence that an order effect occurred.

Why do confidence intervals matter?

General explanation: a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, but neither width nor location can be evaluated without the reported estimate and interval. A confidence interval does not guarantee that the analysis assumptions are correct, and it does not establish clinical importance by itself. No interval estimates for the registered outcomes are reported in the registry record.

How should planning illustrations be read?

General explanation: sample-size illustrations based on an observed effect use assumptions to show how a hypothetical future comparison might be planned. They are not the number of participants observed, and they are not observed power. The stated planning assumptions describe 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 record also distinguishes participant counts per arm for non-time-to-event outcomes from total event counts for time-to-event outcomes. These are planning conventions, not a description of this single-group study's actual design.

The planning assumptions refer to an observed effect, but numerical effect estimates are not reported in the registry record. The values of any planning illustrations therefore cannot be interpreted as evidence about the study's outcomes or as a sample-size justification for the registered trial. The record does not report a protocol-based sample-size calculation. It also does not report that these hypothetical two-arm assumptions governed enrollment or analysis.

What can be concluded from the methods information?

The record establishes the intended summary type for the primary outcome and provides a general description of testing conditions. It does not provide enough information to reproduce an analysis, evaluate assumptions, or quantify uncertainty. Details such as the handling of missing values, outcome-specific analysis populations, and adjustment for multiple outcomes are not reported in the registry record. The 0 analyses listed reinforce that no statistical outcome analysis is posted in the registry record. Consequently, statistical-method concepts can clarify what an analysis would mean, but they cannot substitute for estimates and analysis details that are absent.

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("Urodynamic Testing With and Without Pudendal Nerve")
n   <- c(3)
m   <- c(0.76)
sp  <- c(0.45)
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  Urodynamic Testing With and Without Pudendal Nerve  3  0.760  0.450  -0.358  1.878

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 8 outcome measures. It identifies a primary outcome concerning pulse amplitude at first verbally reported sensation and names secondary outcomes concerning the urethral pressure profile, maximum cystometric capacity, and post-void residual. The details of the remaining outcome measures are not reported in the registry record. It also lists 0 analyses, so no outcome-specific estimates or tests are available for interpretation.

When a study evaluates multiple outcomes, general statistical reasoning recognizes that examining many results can increase the chance of finding an apparently notable result by chance. Analysis plans may specify a hierarchy, adjustment method, or limited set of confirmatory comparisons. The registry record does not report a multiplicity strategy or explain how the primary and secondary outcomes would be interpreted together. It is therefore not possible to determine whether any planned adjustment or prioritization was used.

The record notes that one subject did not have a pulse amplitude recorded. It does not report the reason, whether the missing value arose from a measurement issue or another cause, or how the missing value was handled. Missingness information for the other outcomes is not reported in the registry record. There is no reported imputation method, complete-case rule, or sensitivity analysis.

The enrolled group comprises 4 participants, but the number contributing data to each outcome is not reported in the registry record. The record does not define an analysis population or state whether analyses were intended to include every enrolled participant, only participants with complete measurements, or another group. Since no analyses are listed, there is no posted analysis population to evaluate. These omissions prevent assessment of how missing data and multiple outcomes might affect any reported conclusions.

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.

The registry record lists 4 participants at risk for serious adverse events and 4 at risk for other adverse events. It records 0 serious adverse events, 0 other adverse events, and 0 deaths. No serious adverse event terms are listed. These are counts recorded for the study, not estimates of the probability of an event.

A zero count in a small study does not show that an event is impossible or that a risk is absent. General statistical explanation: when few participants are observed, the data provide limited information about uncommon events, and the plausible range of risk may remain broad even when no event is recorded. No risk interval or further safety analysis is reported in the registry record.

The record does not describe the duration or completeness of safety follow-up, definitions used for adverse events, or how events were collected. It also does not explain the study's terminated status. The event counts should therefore be read as the registry's reported observations for this group, not as a comprehensive assessment of safety or as a comparison with another treatment or control group.

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

The record documents an early feasibility investigation of acute pudendal nerve stimulation during urodynamic testing in women with a pre-existing implanted urological neurostimulator. It describes testing with stimulation off and then on, lists 4 participants enrolled, and records a terminated status. It also names the outcomes the study intended to assess. These registry entries establish the study's scope, but they do not provide numerical outcome findings.

The study's stated purpose refers to stress-induced urethral leak point pressure and other urodynamic measurements. However, the registered primary outcome is pulse amplitude at the first verbally reported sensation. The distinction matters: a sensory threshold recorded as a device setting does not directly quantify leak point pressure. The registry record does not report values for either the primary outcome or leak point pressure, so it cannot show the magnitude or direction of a change in those measures.

The record also does not establish whether any observed difference, if measured, would be precise, reproducible, or attributable to stimulation rather than order or time effects. No outcome analyses or uncertainty estimates are listed. Statistical concepts such as paired comparisons and confidence intervals can describe how results might be evaluated, but they cannot recover findings that are not reported.

The event record shows no serious adverse events, other adverse events, or deaths among the participants recorded as at risk. This is a limited observation, not proof that adverse events cannot occur. The small group and absence of detailed safety follow-up information constrain what can be learned about risk.

Accordingly, the registry record supports a description of an exploratory study and its recorded safety counts. It does not support a conclusion about whether stimulation changes leak point pressure, whether it changes other urodynamic outcomes, or how large or reliable any such change might be. It also does not provide an explanation for termination.

14. Why This Trial Matters Statistically

This study is statistically notable because its central scientific aim and its registered primary outcome are not the same measurement. The stated purpose emphasizes leak point pressure and other urodynamic measurements, while the primary outcome is pulse amplitude when a participant first reports sensation. Keeping these endpoints distinct is essential: conclusions about one measure cannot be substituted for findings on another.

The design also illustrates how a within-participant condition contrast differs from a conventional parallel-group comparison. Measurements with stimulation off and then on can potentially make each participant their own reference, but a fixed sequence can leave condition changes entangled with time or order. Whether those issues were addressed is not reported in the registry record. This is especially relevant when interpreting acute measurements, for which the timing and sequence of testing are part of the measurement context.

The listed enrollment of 4 and the absence of reported outcome analyses mean that the record offers no estimate of an effect or its uncertainty. A study can be informative as an early feasibility effort without yielding a precise estimate of an outcome effect. However, feasibility status should not be taken as a substitute for numerical results or an inferential analysis.

The record also makes clear why planning illustrations must be separated from trial findings. Hypothetical assumptions for a two-arm design do not describe the actual single-group study, and a planning calculation is not observed power. With no posted outcome estimate, such illustrations cannot be treated as evidence that an effect was observed. The main statistical lesson is to distinguish study purpose, endpoint definition, design, planning assumptions, and reported results rather than blending them into one claim.

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.

The registry record is sparse for assessing outcomes. It lists 4 participants enrolled and 0 analyses, but does not report numerical results for the primary outcome, leak point pressure, or the secondary outcomes. Without estimates, variability, or confidence intervals, the magnitude and precision of any change cannot be evaluated.

The registered primary outcome is pulse amplitude at first verbally reported sensation, whereas the stated study purpose emphasizes leak point pressure and other urodynamic measurements. This difference limits direct interpretation of the primary endpoint as evidence about the title's pressure question. One subject did not have a pulse amplitude recorded, and the reason and handling of that missing value are not reported in the registry record.

The design is a single group, with urodynamic testing described first with stimulation off and then with stimulation on. There is no separate control group or allocation specified. The record does not report whether the order was varied, whether measurements were repeated, or how within-participant data were analyzed. Potential time, order, and measurement effects therefore cannot be assessed.

The record does not report a sample-size justification, a statistical analysis plan, a multiplicity strategy, or an analysis population. It lists 8 outcome measures but provides limited detail on the outcomes beyond the named primary and secondary measures. Reasons for the terminated status and the completeness of follow-up are not reported in the registry record. Safety information is limited to event counts and does not include further event-collection or follow-up details.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study — NCT05128682.
• Registry record last updated 2023-05-16; status last verified 2023-05.
• Results first posted 2023-05-16.
• 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.

19. Record Summary

The registry record describes an early feasibility, single-group study of acute pudendal nerve stimulation during urodynamic testing in women with urinary incontinence and a pre-existing implanted urological neurostimulator. Enrollment was 4; the study is listed as terminated. Testing was described with stimulation off and then on.

The stated purpose concerns stress-induced urethral leak point pressure and other urodynamic measurements. The registered primary outcome is pulse amplitude at first verbally reported sensation, measured in mA. One subject did not have this measure recorded. The record lists 8 outcome measures and 0 analyses; numerical outcome estimates are not reported in the registry record.

The adverse-event record lists 0 serious adverse events, 0 other adverse events, and 0 deaths among 4 participants at risk. The record does not report why the study was terminated, a sample-size justification, or a detailed statistical analysis plan.