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 PTNS for Female Patients Suffering From Multiple Sclerosis (NCT05422625), a randomized na study. The primary outcome is The Overall Patient Reported Change of Bladder Overactivity (OAB) Symptoms in MS Patients as Reported on the Patient Global Impression of Improvement (PGI-I) Questionnaire.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05422625 |
| Phase | NA |
| Condition | Multiple Sclerosis, Overactive Bladder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 2 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Corewell Health East |
| Results posted | Yes |
2. Clinical Question
Population
Female patients with multiple sclerosis and bladder overactivity symptoms were the intended study population. The registry records 2 enrolled patients; only 1 completed the study and the primary outcome. The other participant withdrew before that outcome was collected.
Intervention
Active percutaneous tibial nerve stimulation (PTNS): weekly 30-minute treatments for 12 consecutive weeks.
Comparator
Sham PTNS, described as weekly 30-minute sham treatments for 12 consecutive weeks. The trial was randomized and sham-controlled, with single masking; which people were masked is not reported in the registry record.
Primary question
One week after completing all 12 treatments, what change in bladder overactivity symptoms did participants report on the Patient Global Impression of Improvement (PGI-I), and how did the reported results compare between active and sham PTNS?
The clinical question is framed as a comparison of patient-reported change, not simply as a count of urinary symptoms. The PGI-I asks participants to rate their urinary condition now compared with before treatment. A score of 4 means no change; lower scores indicate improvement and higher scores indicate worsening.
The record cannot answer the comparative part of the question: it reports a primary outcome score of 4 for the active PTNS arm, based on one participant, and no score for the sham arm, which had no participant completing the primary outcome. The result therefore describes one response and does not establish whether the response differed between treatment assignments.
3. Trial Design
This was a randomized, single-masked, parallel-group, sham-controlled pilot trial sponsored by Corewell Health East. It compared active PTNS with sham PTNS in female patients with multiple sclerosis and bladder overactivity. The study record lists a planned weekly treatment schedule of 30 minutes for 12 consecutive weeks in each arm. The record does not describe the method used to generate the random allocation sequence, how assignments were concealed, or who was masked.
The registry lists enrollment of 2 and study status as terminated. The recorded study start was 2023-01-09, and primary completion was 2023-04-10. One participant completed the primary outcome and one withdrew before it was measured. The reason for termination and the reason for withdrawal are not reported in the registry record.
The primary outcome was the PGI-I score, planned for assessment one week after the final treatment. Secondary outcomes concerned changes in urinary voids, urinary incontinence episodes, urinary urgency episodes, and overactive bladder symptoms measured with the Overactive Bladder Quality of Life Short Form Questionnaire. Although these outcomes are listed, results for them are not reported in the registry record.
The enrollment is too limited, and the outcome information too incomplete, for a meaningful comparison of the randomized arms. The registry record does not report a statistical analysis plan, sample-size justification, interim analyses, or a reason for choosing the recorded enrollment. It also does not provide enough information to determine whether the treatment schedule was completed as planned by the participant with a primary outcome score.
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
| Stage | Active PTNS | Sham PTNS |
|---|---|---|
| STARTED | 2 | 0 |
| COMPLETED | 1 | 0 |
| NOT COMPLETED | 1 | 0 |
Reasons for not completing this period:
| Reason | Active PTNS | Sham PTNS |
|---|---|---|
| Withdrawal by Subject | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Of the 2 patients enrolled, only 1 patient completed the study and the primary outcome measure. The other subject withdrew prior to the primary outcome measure.
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: There were zero patients randomized to the sham PTNS group.
| Characteristic | Unit | Active PTNS | Sham PTNS | Total |
|---|---|---|---|---|
| Participants analysed | 2 | 0 | 2 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 0 | 2 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 47 (SD 12) | — | 47 (SD 12) |
| Sex: Female, Male: Female | Participants | 2 | 0 | 2 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 2 | 0 | 2 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 2 | — | 2 |
6. Primary Endpoint
The registry lists the primary outcome as The Overall Patient Reported Change of Bladder Overactivity (OAB) Symptoms in MS Patients as Reported on the Patient Global Impression of Improvement (PGI-I) Questionnaire, measured over One week after completing all 12 treatments.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | score |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the overall patient-reported change in bladder overactivity symptoms, measured with the Patient Global Impression of Improvement (PGI-I). The registry describes it as a validated one-question measure. Participants compare their urinary condition at the time of assessment with their condition before starting treatment. The planned assessment was one week after completing all 12 treatments.
The scale runs from 1 to 7. A score of 1 means very much better, 2 means much better, 3 means a little better, 4 means no change, 5 means a little worse, 6 means much worse, and 7 means very much worse. A higher score indicates a worse outcome. This direct patient report can capture a participant’s overall impression rather than limiting evaluation to a single symptom count.
The registry reports a score of 4 for the active PTNS arm, based on one participant. On the stated scale, that response corresponds to no change. No primary outcome score is reported for the sham PTNS arm. The registry notes that only one participant completed the primary outcome and that the other participant withdrew before its measurement. As a result, these endpoint data do not support a comparison of reported change between the two arms.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome is a PGI-I score of 4 in the active PTNS arm, with one participant contributing a score. The scale defines 4 as no change in the participant’s urinary condition compared with before treatment. This is a description of one person’s reported experience at the specified assessment, not an estimate of the typical response among participants.
No primary outcome value is available for the sham PTNS arm. With no reported outcome in that arm, a treatment contrast cannot be estimated from the posted results. The record also reports no analyses. There is no reported inferential test, confidence interval, or other estimate of uncertainty for a between-arm effect. The available information therefore does not quantify whether active and sham assignment were associated with different symptom reports.
A confidence interval, in general, expresses the precision of an estimate by showing a range of values compatible with the data and the statistical method. No such interval is reported for this primary endpoint. With one observed response and no sham outcome, a precise comparative estimate cannot be obtained from the registry results. The absence of an interval is not evidence that the arms are equivalent; equivalence would require an appropriate analysis and a sufficiently informative comparison, neither of which is reported.
The status is terminated, and the recorded enrollment is 2. The registry states that one participant withdrew before the primary outcome. Those features are important for interpreting the result: the posted score represents only the participant whose primary outcome was completed, while the missing sham result prevents the planned randomized comparison. The reason for termination, withdrawal, and the handling of the missing endpoint are not reported in the registry record.
Four secondary outcomes are listed, covering urinary voids, incontinence episodes, urgency episodes, and overactive bladder quality of life. Their results are not reported in the registry record. The record therefore offers no additional outcome data with which to assess symptom patterns, consistency across measures, or the impact of missing observations.
Overall, the registry reports a single active-arm response corresponding to no change on the PGI-I scale, but it does not report comparative evidence for active versus sham PTNS. This should be read as a highly incomplete account of a small terminated pilot trial, not as a reliable estimate of treatment effect or as evidence for or against an effect.
9. Statistical Methods Explained
The methods can be understood by separating the planned randomized comparison from the outcome information that was actually recorded. In a parallel-group randomized trial, participants are assigned to one of the treatment groups, and outcomes are compared across those groups. Randomization is intended to support a fair comparison by reducing systematic differences in group assignment. It cannot, by itself, overcome absent outcome data or make an estimate precise when very little information is available.
What does the posted endpoint represent?
The PGI-I is an ordinal rating: its response options have an order from very much better through no change to very much worse. The numerical labels identify categories, but the gaps between adjacent categories are not necessarily equal in meaning. A score of 4 has the specific interpretation no change under the registry’s definition. It is appropriate to report that response as a score and interpret it according to the stated scale, but one response does not describe the distribution of responses in an arm.
The registry lists the outcome parameter as a number and reports a value of 4 for the active PTNS arm, with one participant represented. It gives no spread or interval for that arm and no value for the sham arm. It would not be justified to infer an arm average, a variability estimate, or a treatment contrast from those entries. The record does not provide an analysis converting the PGI-I responses into another measure.
Why does the missing comparator result matter?
A comparative trial question requires information from both randomized groups. When one arm has no reported primary outcome, the observed active-arm score cannot show how that participant’s experience compares with the sham group. The missing comparator result also prevents estimation of the amount of uncertainty around a between-arm difference. General statistical principle: an estimate based on sparse observations is usually imprecise, and missing outcomes can further limit what a comparison says.
The registry identifies the sham arm as the control and reports no participant with a primary outcome there. The record does not say whether a sham-assigned participant withdrew, whether the sham arm had any participant assigned, or how the listed arm enrollment relates to the outcome completion information. Those details are not reported in the registry record, so the reason for the absent sham score should not be inferred.
What can randomization and masking contribute?
Randomization and masking are design features intended to limit bias. Randomization assigns participants by chance rather than by a systematic selection rule. Masking can reduce the influence of expectations on treatment delivery, outcome reporting, or assessment, depending on who is masked. Here, the record identifies the trial as randomized and single-masked, but does not report the randomization procedure or identify the masked party. These design labels do not substitute for outcome data, and they do not permit a reliable efficacy comparison when the primary endpoint is recorded for only one participant.
The registry describes the study as parallel-group and sham-controlled. It lists active and sham schedules of weekly 30-minute sessions for 12 consecutive weeks. Whether the completed participant received all scheduled treatments is not reported in the registry record. The record also does not report adherence, protocol deviations, or details of treatment delivery beyond the arm descriptions.
How should precision be understood?
Precision concerns how narrowly the data identify an effect or response pattern. A confidence interval is a general statistical tool for expressing uncertainty around an estimate. None is reported for the primary outcome, and the registry records zero analyses. No p-value or model-based estimate is reported. These omissions mean the reader cannot evaluate inferential precision from a reported comparative analysis.
Over-dispersion is a general issue for count outcomes: it occurs when variability exceeds what a simple statistical model expects, and can make standard errors and tests misleading if ignored. It is not possible to assess over-dispersion from the posted primary endpoint, which is a single ordinal patient rating, or from the secondary outcomes, whose results are not reported. The registry does not report a statistical model for the secondary count measures.
What do planning calculations mean?
Sample-size planning is generally based on a target effect, variability assumptions, significance level, and desired power. A planning illustration is not an observed trial result or a measure of the probability that the completed study detected an effect. The registry record describes assumptions for a planning illustration, including a two-sided significance level of 0.05, equal allocation, and a normal approximation, but no resulting participant targets are reported in the record. The trial’s own sample-size justification is not reported in the registry record. No planning value should be treated as a property of the participants who enrolled.
In general, planning for a fraction of an observed effect means asking how many participants might be needed to detect a smaller target effect under specified assumptions. Such a calculation depends on the observed effect and cannot be interpreted without its assumptions. No usable observed between-arm effect is reported for this trial, so a comparative planning target cannot be inferred from the posted primary outcome.
The registry’s results support a narrow descriptive statement: one active-arm participant reported a PGI-I score of 4. They do not support a statistical conclusion about the difference between active and sham PTNS.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary PGI-I outcome and four secondary outcomes. The secondary measures concern changes in urinary voids, urinary incontinence episodes, urinary urgency episodes, and overactive bladder symptoms assessed with the Overactive Bladder Quality of Life Short Form Questionnaire. Results for those secondary measures are not reported in the registry record. The record reports zero analyses.
Multiplicity arises when several outcomes or statistical tests are examined. In general, testing many hypotheses can increase the chance of finding an apparently notable result by chance, so a statistical plan may specify how to interpret or adjust for multiple comparisons. The registry record does not report a multiplicity adjustment or a plan for selecting among outcomes. Since no analyses are reported, there are no posted inferential results to assess for multiplicity.
The primary outcome is missing for the participant who withdrew before its measurement, and the sham arm has no primary outcome score recorded. The record states that one participant completed the study and primary outcome, while the other withdrew before the primary outcome. It does not report an imputation method, a missing-data sensitivity analysis, or the reason for withdrawal. It also does not report an analysis population definition, such as whether results were intended to include all randomized participants or only participants who completed treatment.
These gaps matter because missing outcomes can affect both the amount of information available and the interpretation of a comparison. No assumption about the unobserved outcome should be treated as a registry result. The available record does not show how the withdrawal or missing sham outcome was handled analytically.
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 |
|---|---|---|---|
| Active PTNS | 0 | 2 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Active PTNS | 0 of 2 |
| Sham PTNS | 0 of 0 |
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 |
|---|---|
| Active PTNS | 0 of 2 |
| Sham PTNS | 0 of 0 |
The safety entries report zero serious adverse events among the 2 participants listed as at risk in the active PTNS group. The sham PTNS group is listed with zero participants at risk and zero serious adverse events. The registry also reports zero other adverse events in the active group among 2 participants at risk, and zero in the sham group among zero participants at risk. Deaths are recorded as zero in both groups. No serious adverse event terms are listed.
These entries are counts as recorded in the registry; they are not estimates of comparative safety. In particular, the sham group’s zero at-risk count means its zero-event entry does not provide an observed safety comparison among participants at risk. The registry does not describe the adverse-event collection period, definitions, severity grading, or relationship assessment in the information available for this trial.
Zero reported events does not establish that an intervention has no risk. It means that no events are recorded in the stated categories for the listed at-risk groups in this record. The small enrollment and incomplete study make the safety information especially limited. These entries should not be interpreted as evidence that the arms have equal safety profiles.
12. What the Result Does, and Does Not, Mean
The result documents one participant’s report after active PTNS: a PGI-I score of 4, defined by the registry as no change. It does not provide a result for the sham arm. The registry therefore does not estimate a difference between active and sham PTNS, nor does it report a statistical test or confidence interval for such a difference.
This is not evidence that the treatments are equivalent, and it is not a reliable estimate of the frequency or size of a response in the intended population. A single response cannot characterize how varied participant experiences might be. The absence of a sham score leaves the central comparative question unanswered. The result also cannot establish what would have happened to the active-arm participant without active treatment.
The record includes a withdrawal before the primary outcome, a terminated status, and no reported results for the listed secondary outcomes. It does not state why the study terminated or why the participant withdrew. Those missing details limit interpretation of the study’s progress and the reasons outcome information is incomplete. The planned schedule is described, but completion of that schedule by the participant with an outcome is not reported.
What can be concluded is descriptive and narrow: the registry records a no-change response from one active-arm participant, while a sham-arm primary response is absent. The safety entries likewise describe only the events recorded for the listed at-risk groups and do not provide a balanced comparative safety assessment.
In general, randomized evidence is interpreted through the comparison created by random assignment, adequate outcome measurement, and an analysis that reflects the study design. The record does not contain enough outcome information to carry out that comparison. Its results should therefore be treated as incomplete pilot-trial data, not as a treatment recommendation or a definitive assessment of PTNS.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it illustrates the difference between a randomized design and an informative randomized comparison. Randomization can help protect against systematic differences between treatment groups, but it does not guarantee that enough outcomes will be observed to estimate a treatment contrast. Here, the primary endpoint is recorded for one participant in the active arm and is absent for the sham arm.
The PGI-I value has a clear individual interpretation: a score of 4 means no change. That clarity does not make it a group-level estimate. Statistical interpretation must distinguish a participant’s observed response from an estimate of what might be expected across a population or from the difference between randomized treatments. The registry does not report the latter.
The record also shows why trial status, withdrawals, and missing outcomes belong in a statistical reading. A terminated study with a withdrawal before endpoint measurement can leave a planned comparison incomplete. Without the reason for termination, missing-data handling, or secondary outcome results, readers cannot assess whether the available endpoint reflects the study’s intended analysis.
Finally, the safety entries demonstrate the need to read event counts together with the number at risk. A zero-event entry in a group with zero participants at risk is not the same kind of evidence as observing no events among participants under follow-up. These distinctions matter when interpreting small studies, where every missing observation changes how much information is available.
The statistical value of this record is therefore chiefly educational: it makes clear why design labels alone do not establish an effect, and why effect estimation depends on complete, interpretable data from both groups.
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 main trial-specific limitation is the very limited primary outcome information: the registry reports one score in the active PTNS arm and none in the sham PTNS arm. The lone score cannot characterize a group response, and the missing comparator score prevents a between-arm estimate. The other participant withdrew before the primary outcome was collected.
The registry lists the trial as terminated but does not report the reason for termination or the reason for withdrawal. It does not describe how missing outcomes were handled, define the analysis population, or report a statistical analysis plan. The method of randomization and the identity of the person or people masked are also not reported in the registry record.
Although four secondary outcomes are listed, their results are not reported. No analyses are reported, and no inferential estimates, confidence intervals, or p-values are available. The record does not report adherence, protocol deviations, or whether the participant with a primary outcome completed the planned treatment schedule.
The safety record is limited as well. The sham group is listed with no participants at risk, so its zero-event counts do not offer a meaningful arm-to-arm safety comparison. The registry information does not describe the event-collection period or other details needed to interpret ascertainment.
These limitations mean that the posted results are not sufficient to assess comparative efficacy, precision, consistency across outcomes, or relative safety. They are specific to the incomplete outcome record and should not be filled in with assumptions about what happened during the study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: PTNS for Female Patients Suffering From Multiple Sclerosis — NCT05422625.
- Registry record last updated 2024-10-09; status last verified 2024-09.
- Results first posted 2024-10-09.
- 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
NCT05422625 is a randomized, single-masked, parallel, sham-controlled pilot trial of PTNS for female patients with multiple sclerosis and bladder overactivity symptoms. Corewell Health East is listed as sponsor. The record describes weekly 30-minute active or sham treatments for 12 consecutive weeks. Study status is terminated; the recorded start was 2023-01-09 and primary completion was 2023-04-10.
The primary endpoint was PGI-I score one week after completing treatment. One active-arm participant had a reported score of 4, meaning no change; the other participant withdrew before the primary outcome. No sham-arm primary score or secondary outcome results are reported. The registry records zero analyses. It does not report a comparative effect estimate, statistical uncertainty, the reason for termination, or the handling of missing outcomes.