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 Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure (NCT05900570), a na na study. The primary outcome is The Effect of Acute Peri-urethral Neurostimulation on Intra-urethral Pressure..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05900570 |
| Phase | NA |
| Condition | Stress Urinary Incontinence |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 3 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Corewell Health East |
| Results posted | Yes |
2. Clinical Question
Population
Women with stress urinary incontinence (SUI) were the intended population. The registry record reports enrollment of 3 participants, but does not provide further participant characteristics.
Intervention
Acute peri-urethral neurostimulation targeting the perineal branch of the pudendal nerve. The record describes stimulation needles or leads placed in the peri-urethral space, with settings adjusted using an external neurostimulator.
Comparator
Urodynamic testing without stimulation was the comparator condition. The record describes testing with and without stimulation in a single-group study, not a separate control group.
Primary question
How does intra-urethral pressure during acute peri-urethral neurostimulation compare with pressure without stimulation? No pressure measurements were obtained and recorded for analysis, so the primary comparison has no analyzable result.
The study was described as a prospective early feasibility investigation intended to gain an initial understanding of the acute pressure response. Its focus was measurement during a stimulation visit, rather than a longer-term clinical outcome. The registry lists the primary outcome timeframe as the stimulation visit, 1 day.
The record also lists safety and tolerability within one week of the stimulation visit and Valsalva leak point pressure (LLP) in response to stimulation compared with no stimulation as secondary outcomes. The posted record does not give analyzable results for those comparisons. The primary question therefore remains unanswered by the posted pressure data: the record reports that no pressure response was observed, but also states that pressure measurement data were not obtained or recorded for analysis.
3. Trial Design
This was a single-group study of urodynamic testing with and without pudendal nerve stimulation. The registry lists allocation as not applicable and masking as none. It does not describe a randomized allocation sequence or a separate control arm, so the stimulation and no-stimulation conditions should not be read as a randomized, parallel-group comparison. The record does not state the order in which the two conditions were tested.
The planned intervention was acute peri-urethral neurostimulation. Commercially available stimulation needles or leads were to be inserted into the peri-urethral space to target the perineal branch of the pudendal nerve; an external neurostimulator was to deliver stimulation after its settings were adjusted. Urodynamic testing was planned with and without stimulation. Further details about the stimulation settings, testing sequence, or procedural standardization are not reported in the registry record.
The record lists enrollment of 3 and identifies the population as women with stress urinary incontinence. It does not provide demographic or clinical characteristics that would describe who participated. The stated primary endpoint was the change in intra-urethral pressure with stimulation compared with pressure without stimulation, assessed at the stimulation visit, 1 day.
The study status is terminated. The registry lists a start date of 2024-02-26 and a primary completion date of 2025-12-11. Those record dates do not establish why the study ended. The reason for termination, recruitment experience, and any changes to the study procedures are not reported in the registry record. The record calls the investigation an early feasibility study, but a detailed protocol or sample-size justification is not reported.
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: All enrolled participants received the same testing.
Overall Study
| Stage | Urodynamic Testing and LLP With and Without Pudendal Nerve Stimulation |
|---|---|
| STARTED | 3 |
| COMPLETED | 3 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: No data was collected. No pressure response was observed in any of the patients; thus pressure measurement data was not obtained and recorded for analysis. No data will be collected in the future. This was not an effective method to collect this information.
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: Women with diagnosed with stress urinary incontinence
| Characteristic | Unit | Urodynamic Testing and LLP With and Without Pudendal Nerve Stimulation |
|---|---|---|
| Participants analysed | 3 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 3 |
6. Primary Endpoint
The registry lists the primary outcome as The Effect of Acute Peri-urethral Neurostimulation on Intra-urethral Pressure., measured over At stimulation visit, 1 day.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was intended to measure the change in intra-urethral pressure during acute peri-urethral neurostimulation compared with pressure without stimulation. Intra-urethral pressure is a physiologic measurement; in this study it was the direct measurement named in the primary question. The registry gives the timeframe as the stimulation visit, 1 day. It does not report a unit, a summary statistic, or a planned method for combining repeated measurements.
Such an endpoint can be used in an early feasibility study to examine whether a physiologic response can be measured during a procedure and to characterize that response under the tested conditions. That is a general description of the role of a physiologic endpoint, not evidence that the intervention produced a measurable change in this study.
The record states that no pressure response was observed in any of the patients and that pressure measurement data were not obtained and recorded for analysis. It further states that no data will be collected in the future and that this was not an effective method for collecting this information. Consequently, there is no recorded pressure value from which to estimate a change, quantify variability, or construct an uncertainty interval. The primary endpoint is therefore not estimable from the posted results. The record’s statement about the absence of an observed response should be read alongside its explicit statement that the measurement data were not obtained for analysis.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that the primary pressure comparison has no analyzable measurements in the registry record. The study asked whether intra-urethral pressure differed between acute stimulation and no stimulation, but the record says that pressure measurements were not obtained and recorded for analysis. There is therefore no estimated pressure change, no measure of its variability, and no interval or test result to quantify uncertainty about that comparison.
The registry also states that no pressure response was observed in any of the patients. That wording does not supply an analyzable pressure estimate: the same outcome description explains that pressure data were not obtained and recorded. It would be misleading to interpret the statement as a measured zero change or as evidence that the conditions were equivalent. Without recorded measurements, the magnitude and precision of any pressure difference cannot be assessed.
The posted record lists enrollment of 3. This describes enrollment, not the number of participants with usable primary endpoint measurements. The outcome text says that no pressure measurement data were obtained and recorded for analysis. The record does not give participant-level pressure values or an analysis population for this endpoint.
The study was single-group and unmasked, with testing described under both stimulation and no-stimulation conditions. This design does not include a separate randomized control group. In general, a within-study comparison can be affected by the order of conditions, measurement variability, and other changes during testing. The registry does not report the order or enough procedural details to assess those issues. More importantly, no pressure comparison can be estimated without the outcome data.
The record lists safety and tolerability within one week and LLP response as secondary outcomes. It reports no analyses, and the registry record does not give an analyzable LLP comparison or further safety outcome detail beyond the adverse-event counts. These entries do not fill the gap in the primary endpoint.
Overall, the posted results describe a feasibility problem with the planned pressure measurement. They do not provide a quantified estimate of the pressure response, and they do not establish the size, direction, or precision of a stimulation effect. The reason for study termination is not reported in the registry record, so termination should not be attributed to a particular statistical or clinical finding.
9. Statistical Methods Explained
The registry describes a single-group study with urodynamic testing both with and without pudendal nerve stimulation. Allocation is listed as not applicable, and masking is listed as none. This means the record does not describe random assignment to separate groups or masking of the intervention. The two testing conditions are part of one study group; they should not be portrayed as a randomized treatment-versus-control trial.
For a measured continuous endpoint, a comparison of conditions would generally begin with the observed pressure values under each condition and a clearly defined contrast, such as a within-participant change if that is the prespecified analysis. A statistical estimate would then describe the size and direction of the contrast. A standard error or confidence interval could describe its precision. These are general methods concepts; the registry record does not report a specific analysis method for the primary endpoint.
A confidence interval, in general, gives a range of values compatible with the data and the assumptions of the method. Its width reflects uncertainty: less precise data generally produce a wider interval, while more precise data generally produce a narrower one. A confidence interval is not available for the primary endpoint because the pressure values were not obtained and recorded for analysis. The registry also lists no analyses. No p-value or estimated pressure contrast is reported.
Why is the primary comparison not estimable?
Estimating a difference requires recorded outcome measurements for the conditions being compared. The outcome description says that no pressure response was observed, but also says that measurement data were not obtained and recorded. Without those data, neither a numeric change nor its sampling variability can be calculated from the posted record. Treating an unrecorded outcome as a measured value of zero would impose information that the record does not contain.
The study’s single-group structure matters for interpretation. In general, when the same group is assessed under two conditions, the measurements may be related within participants. A paired analysis can account for that relationship if paired observations are actually collected and if that analysis is appropriate to the protocol. The registry does not report a planned analysis for such paired data, and no pressure observations are available to carry it out. The testing order is also not reported, so potential order effects cannot be assessed from the record.
What do the planning assumptions mean?
Sample-size planning is a prospective exercise: it asks how much information a future study might need under stated assumptions. The registry’s planning description refers to 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. It also distinguishes planning quantities expressed per arm from time-to-event quantities expressed as total events. These are planning conventions, not observed trial results or evidence of achieved power.
Those assumptions do not describe the study’s own documented design, which is single-group and has no analyzable primary pressure effect in the record. Because no observed pressure effect is available, planning calculations that depend on such an effect cannot be interpreted as being anchored to a measured primary outcome. The registry does not report a sample-size justification for this early feasibility study. Any planning illustration should be understood as hypothetical rather than as a finding about the enrolled participants.
What can be inferred from the adverse-event counts?
The registry reports serious adverse events and other adverse events separately for the listed study group, with participants at risk and affected counts. Such counts are descriptive. They do not estimate a comparative safety effect because no separate control group is listed. With a small enrolled group and no comparative analysis reported, the counts also cannot characterize uncommon events precisely. General statistical interpretation requires attention to both the number observed and the amount of follow-up; the registry states that the safety outcome concerned events within one week of the stimulation visit, but additional follow-up details are not reported.
In short, the statistical record supports a description of the design, the missing primary measurement, and the posted adverse-event counts. It does not support an inferential estimate of the primary pressure comparison. Analysis details such as a prespecified model, handling of repeated measurements, confidence intervals, missing-data procedures, or hypothesis-testing strategy are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures and identifies the pressure comparison as the primary outcome. The listed secondary outcomes concern safety and tolerability within one week of the stimulation visit and LLP in response to acute stimulation compared with no stimulation. The record does not report a multiplicity strategy, such as an adjustment to account for testing more than one outcome. It also does not report a hierarchy for interpreting secondary outcomes. Without those details and without posted analyses, the extent to which any outcome testing was planned or performed cannot be assessed.
For the primary outcome, the registry explicitly states that pressure measurement data were not obtained and recorded for analysis, and that no future data collection is planned. This is not a case where the record provides an analysis after excluding a stated number of participants with missing values; it does not give an analysis population or participant-level reasons for missing pressure values. The handling of missing data, if any, is not reported in the registry record.
The adverse-event figures are posted as counts for the listed group. The registry does not describe a broader analysis population for safety or provide an analysis of LLP. It also lists no statistical analyses. As a result, there are no reported estimates to evaluate for multiplicity-adjusted inference, and no analysis population details with which to assess selection into an analysis.
These omissions limit interpretation but should not be filled by assumptions. The registry does not report interim analyses, a missing-data plan, or the statistical plan used for any outcome. The status of the study is terminated; the record does not state whether the outcomes or analysis plans changed before termination.
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 |
|---|---|---|---|
| Urodynamic Testing and LLP With and Without Pudendal Nerve Stimulation | 0 | 3 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Urodynamic Testing and LLP With and Without Pudendal Nerve Stimulation | 0 of 3 |
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 |
|---|---|
| Urodynamic Testing and LLP With and Without Pudendal Nerve Stimulation | 0 of 3 |
For the listed study group, the registry reports 3 participants at risk for serious adverse events and 0 affected; it also reports 3 at risk for other adverse events and 0 affected. The record lists 0 deaths. The safety outcome description specifies that adverse events were assessed in relation to the incidence of events occurring within one week of the stimulation visit.
These are descriptive counts, not a comparison between stimulation and a separate control group. The study is listed as single-group, and no comparative safety analysis is reported. The counts indicate what the registry recorded for this group during the stated safety window; they do not establish that an event could not occur or characterize the frequency of rare events. In general, a zero count in a small study leaves substantial uncertainty about event risk beyond the observations recorded.
The registry does not provide details about event definitions, severity grading beyond the serious-versus-other categories, completeness of follow-up, or a participant-level listing. Those details are not reported in the registry record. The safety counts should therefore be read narrowly as reported event counts within the stated study group and timeframe, not as proof of safety or as evidence of a comparative effect.
12. What the Result Does, and Does Not, Mean
The record documents an early feasibility study of acute peri-urethral neurostimulation in women with stress urinary incontinence. The intended primary question concerned intra-urethral pressure during stimulation compared with no stimulation. The registry reports that no pressure response was observed, but also says that pressure measurements were not obtained and recorded for analysis. Accordingly, the posted record supplies no numeric primary endpoint estimate and no basis for judging its precision.
This result does not show that stimulation produced a pressure change of a particular size, nor does it show that the pressure conditions were equivalent. A lack of recorded measurements is different from a measured value indicating no change. The primary comparison cannot be resolved statistically from the registry information.
The adverse-event figures describe zero serious and zero other adverse events recorded among the listed participants at risk during the registry’s stated one-week safety window. Those counts are limited to the study group and do not provide a controlled estimate of safety. They should not be generalized beyond the observations in the record.
The record does indicate a practical limitation: it says the method was not effective for collecting the pressure information and that no future data will be collected. This is relevant to feasibility of the measurement approach as recorded, but it does not explain why the method failed or establish whether another approach would work. The reason for termination is not reported in the registry record.
Overall, the study record is informative about the planned question and the absence of an analyzable pressure dataset, but it does not provide evidence that quantifies an acute pressure effect. Its findings should be interpreted as an incomplete measurement result, rather than a definitive estimate of the physiologic response or a comparative assessment of benefit or harm.
13. Why This Trial Matters Statistically
Early feasibility studies can be statistically informative even when they do not produce an efficacy estimate. They can reveal whether a planned measurement can be collected under the study procedures and whether the intended endpoint is available for analysis. In this record, the primary measurement was not obtained and recorded, and the outcome description states that the method was not effective for collecting the information. That is important because an endpoint must be measured before its effect or uncertainty can be estimated.
The distinction between an absent response and absent data is central. If a measurement were recorded and showed little or no change, that value could contribute to an estimate, with uncertainty determined by the data and design. Here, the registry says no pressure response was observed but also explains that pressure data were not obtained for analysis. The record therefore cannot support a numeric interpretation of the primary question.
The study also illustrates why design details matter. Testing was planned with and without stimulation in a single group, without masking, and the registry does not report the order of conditions or an analysis plan. These details would help readers understand how a future comparison might be interpreted. In this record, they cannot overcome the lack of endpoint measurements.
Finally, the registry reports adverse-event counts and a terminated status, while leaving the reason for termination and several analysis details unreported. Keeping those known details separate from what remains unknown helps prevent overinterpretation. The statistical value of the record lies chiefly in documenting that the intended pressure endpoint was not successfully captured for analysis, rather than in providing an estimate of the stimulation response.
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 primary limitation is the lack of recorded intra-urethral pressure measurements. The outcome description says no pressure response was observed, but explicitly states that measurement data were not obtained and recorded for analysis. This prevents estimation of the primary change and its uncertainty.
The registry lists enrollment of 3, but does not report participant characteristics, pressure values, or an analysis population. The study is single-group and unmasked, and the record does not state the order of stimulation and no-stimulation testing. It also does not report enough procedural detail to evaluate measurement repeatability or the reasons the planned measurement method did not work.
The record lists secondary outcomes, but does not provide an analyzable LLP comparison or an inferential analysis. It reports adverse-event counts for the group, but does not give additional details about event ascertainment or completeness of follow-up. The safety window is described as within one week of the stimulation visit.
The registry does not report a statistical analysis plan, missing-data methods, multiplicity handling, interim analyses, or a sample-size justification. The status is terminated, but the reason for termination is not reported in the registry record. These omissions mean that readers cannot determine whether the posted record captures all planned analyses or why the study ended. They should not be replaced with assumptions about the protocol or the cause of the missing endpoint.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure — NCT05900570.
- Registry record last updated 2026-07-22; status last verified 2026-06.
- Results first posted 2026-07-22.
- 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
NCT05900570 is a terminated, single-group early feasibility study sponsored by Corewell Health East. It concerned acute peri-urethral neurostimulation in women with stress urinary incontinence, with urodynamic testing planned with and without stimulation. The record lists enrollment of 3, a start date of 2024-02-26, and a primary completion date of 2025-12-11.
The primary outcome was the change in intra-urethral pressure at the stimulation visit, 1 day. The registry states that no pressure response was observed, but that pressure measurement data were not obtained or recorded for analysis; no future data collection is planned. No analyses are listed. Safety and LLP were listed as secondary outcomes. The registry reports 0 serious adverse events, 0 other adverse events, and 0 deaths in the listed group, with the safety outcome concerning events within one week of the stimulation visit. The reason for termination and further statistical analysis details are not reported in the registry record.