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 Neuromodulation for Accidental Bowel Leakage (NCT03278613), a randomized na study. The primary outcome is Change From Baseline St. Mark's (Vaizey) Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03278613 |
| Phase | NA |
| Condition | Fecal Incontinence, Bowel Incontinence |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 166 |
| Arms in the primary outcome | n/a |
| Lead sponsor | NICHD Pelvic Floor Disorders Network |
| Results posted | Yes |
2. Clinical Question
Population
Women with refractory accidental bowel leakage symptoms who had not achieved satisfactory symptom control with supervised pelvic muscle training and constipating medication. The registry describes an intent-to-treat analysis including eligible randomized participants who provided outcome data after baseline.
Intervention
Percutaneous tibial nerve stimulation, abbreviated PTNS. The registry describes treatment using a needle electrode directed toward the tibial nerve. The trial compared PTNS with a validated sham rather than with no treatment.
Comparator
A validated sham using a placebo needle at the same location as the PTNS needle electrode, along with an active gel surface electrode pad on the foot. The sham was intended to provide a comparison condition for the stimulation treatment.
Primary question
Whether the change from baseline in St. Mark’s (Vaizey) score after 12 weeks differed between women receiving PTNS and women receiving sham stimulation. Primary outcome estimates and the statistical comparison are not reported in the registry record.
The trial was designed around a comparison of change in a symptom score, not simply a comparison of scores at one follow-up visit. The registry describes assessments at 4, 8, and 12 weeks, while its stated primary question focuses on the 12-week change. A difference between groups would describe the contrast in average score changes, but the registry record does not report that contrast or its uncertainty.
The clinical question is limited to women with persistent symptoms after the stated first-line treatments. The registry does not establish that findings apply to people outside that described population. Nor does the question compare PTNS with every possible treatment or address outcomes beyond those specified in the record. The comparison can be interpreted only as PTNS versus the validated sham under the trial’s conditions; because the primary results are absent, the direction and size of any observed difference remain unknown.
3. Trial Design
The registry describes a multicenter, randomized clinical trial with a parallel-group model and single masking. The enrollment was 166. Participants were assigned to PTNS or a validated sham, and the study status is completed. The record gives the start date as 2018-02-09 and the primary completion date as 2020-03-09. It lists the phase as not applicable.
Random allocation is intended to make treatment assignment independent of participants’ characteristics, on average. It supports a fair comparison between groups, but it does not guarantee that every characteristic will be balanced in a particular trial. The registry does not report the allocation sequence method, allocation concealment details, or whether assignment used stratification or blocking. Those features should not be inferred from the fact that the study was randomized.
Single masking means one group involved in the study was masked, but the registry record does not identify which group or groups were masked. It also does not report how masking was assessed or whether participants could distinguish the active treatment from the sham. The sham is described as using a placebo needle and a surface electrode pad. This comparison can help address expectations and treatment-contact effects, but the registry alone does not establish how well masking worked.
The primary outcome was change from baseline in St. Mark’s (Vaizey) score, with the record listing assessments at 4, 8, and 12 weeks. The primary description identifies the 12-week assessment as the basis for comparing PTNS with sham. Several secondary outcomes are listed, including treatment response and changes in bowel-event measures. Although the registry lists 56 outcome measures, it does not report an analysis plan for them or identify which results were analyzed.
The registry does not report the planned sample-size justification, the target difference used in planning, an interim-analysis plan, or details of the statistical analysis strategy. Such details cannot be reconstructed from the enrollment total or the posted outcomes inventory. The record also does not report a trial flow, group-specific numbers randomized in the primary outcome analysis, or reasons outcome data may have been unavailable.
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 | Percutaneous Tibial Nerve Stimulation (PTNS) | Validated Sham |
|---|---|---|
| STARTED | 111 | 55 |
| COMPLETED | 108 | 54 |
| NOT COMPLETED | 3 | 1 |
Reasons for not completing this period:
| Reason | Percutaneous Tibial Nerve Stimulation (PTNS) | Validated Sham |
|---|---|---|
| Lost to Follow-up | 3 | 1 |
Analysis population for the primary outcome, as defined in the registry: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
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.
| Characteristic | Unit | PTNS | Sham | Total |
|---|---|---|---|---|
| Participants analysed | 111 | 55 | 166 | |
| Age, Continuous | years | 63.5 (SD 12) | 63.8 (SD 11) | 63.6 (SD 12) |
| Sex/Gender, Customized: Female | Participants | 111 | 55 | 166 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 10 | 6 | 16 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 99 | 49 | 148 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Black or African American | Participants | 10 | 9 | 19 |
| Race (NIH/OMB): White | Participants | 95 | 39 | 134 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 | 4 | 7 |
| Body Mass Index | kg/m^2 | 29.2 (SD 7) | 29.7 (SD 6) | 29.4 (SD 7) |
| Current Smoker: Yes | Participants | 9 | 5 | 14 |
| Current Smoker: No | Participants | 102 | 50 | 152 |
| Ever Pregnant: Yes | Participants | 107 | 50 | 157 |
| Ever Pregnant: No | Participants | 4 | 5 | 9 |
| Number of Vaginal Deliveries | deliveries per participant | 2 (0 to 9) | 2 (0 to 7) | 2 (0 to 9) |
| Number of Cesarean Deliveries | deliveries per participant | 0 (0 to 4) | 0 (0 to 1) | 0 (0 to 4) |
| Menstrual Status: pre-menopausal | Participants | 11 | 4 | 15 |
| Menstrual Status: post-menopausal | Participants | 92 | 49 | 141 |
| Menstrual Status: not sure | Participants | 8 | 2 | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline St. Mark's (Vaizey) Score, measured over 4, 8, and 12 Weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in the St. Mark’s (Vaizey) score. The registry describes this as a mean change, expressed in units on a scale, and gives a 95% confidence interval as the dispersion measure. The score assesses fecal-incontinence symptoms. Its minimum is 0, described as perfect continence, and its maximum is 24, described as totally incontinent. The registry says the score was based on the Jorge-Wexner score and added items assessing constipating medication use and fecal urgency.
Change is defined as the score at a follow-up visit minus the baseline score. Under that definition, a negative change indicates a lower score at follow-up than at baseline, while a positive change indicates a higher score. That direction describes the arithmetic of the change measure; it does not establish whether a particular observed change is important to participants. The registry does not report a threshold for a clinically meaningful change.
A symptom score can combine information across several aspects of a condition into one measure. Using a mean allows a group-level comparison of average change, while the confidence interval conveys uncertainty about the estimated mean. The 12-week assessment is the stated focus of the primary comparison, although the record also lists 4- and 8-week assessments. Primary endpoint results are not reported in the registry record, so the mean changes, between-group contrast, and associated confidence interval cannot be described.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the question and endpoint but does not report numerical results for the primary outcome. It therefore does not establish the average change in St. Mark’s (Vaizey) score in either group, the difference between the groups, or the precision of that difference. No conclusion about the direction or size of the primary comparison can be drawn from the record.
The distinction between within-group change and a between-group contrast matters. A group may improve or worsen from its own baseline for many reasons, including changes that also occur under the sham condition. The trial’s primary question concerns whether average change differed between PTNS and sham. Without group estimates and a contrast, descriptions of improvement in one arm alone would not answer that question.
A 95% confidence interval is a measure of statistical uncertainty around an estimated quantity. In general, it gives a range of values compatible with the data and the statistical method, subject to the assumptions of that method. Its width conveys precision: a wider interval indicates less precise estimation than a narrower interval. The registry record lists this dispersion measure for the primary outcome but does not post the interval itself. Statistical significance, effect size, and clinical importance therefore cannot be evaluated from the posted results.
The registry lists assessments at 4, 8, and 12 weeks. Repeated assessments can describe how outcomes evolve over time, but they also raise questions about which time point is primary and how multiple comparisons are handled. The record identifies the 12-week change as the primary focus and includes multiple outcome measures, but it does not report how testing across time points or outcomes was controlled. No adjustment method should be assumed.
Enrollment was 166, but enrollment alone does not show how many participants contributed primary endpoint data, whether the groups retained similar numbers at follow-up, or how missing observations were handled. The described analysis population includes eligible randomized participants who provided outcome data after baseline. That wording makes availability of post-baseline data relevant to inclusion, but the number without such data and the reasons for missingness are not reported.
Safety counts are posted separately. The record reports serious adverse events among participants at risk in each group, as well as other adverse events and deaths. These counts describe events recorded in the registry; they do not replace the missing primary outcome estimates, and they should not be treated as a complete comparative safety analysis. The registry does not report the event-level context needed to determine relatedness, timing, or differences in exposure.
Overall, the record supports a description of the intended randomized comparison and its outcome definitions, but not an efficacy estimate. The absence of a posted primary result is not evidence that the groups were equal, that a difference was present, or that the study failed to detect one. Those interpretations require outcome estimates and their uncertainty, which are not reported in the registry record.
9. Statistical Methods Explained
The registry identifies the primary outcome as a mean change in a continuous score and names a 95% confidence interval as its dispersion measure. These choices describe the kind of summary intended for the outcome; they do not reveal the numerical result. The primary estimates and their interval are not reported in the registry record.
What does a mean change represent?
A mean is an average across participants with observed outcome data. For this endpoint, each participant’s follow-up score is compared with that participant’s baseline score, and the group mean summarizes those changes. The registry defines change as the follow-up score minus the baseline score. This differs from comparing only the average follow-up scores, because change incorporates each participant’s baseline value into the outcome being summarized.
A mean is useful for a continuous scale because it retains the magnitude of score changes. However, it may not describe the full distribution: participants can have different changes even when the group average is similar. The registry does not report additional distributional summaries for the primary score, so its variability, skewness, and participant-level pattern cannot be assessed from the record.
What does the confidence interval add?
A confidence interval expresses uncertainty in an estimate under a statistical method and its assumptions. In general, a narrower interval indicates a more precise estimate, while a wider interval indicates greater uncertainty. A confidence interval is not a guarantee that the true value lies within the particular interval, nor is it a measure of clinical importance. To interpret the primary comparison, the group contrast and its interval would be needed. The record specifies a 95% confidence interval for the primary outcome but does not post its limits.
When comparing randomized groups, the most direct estimate for the stated question is the between-group difference in mean change. The difference estimates how much the average score change in one group differs from the average change in the other. Its uncertainty depends on the observed data and analysis method. The registry does not report the contrast, its standard error, its confidence interval, or a test result; these quantities should not be inferred from the group assignment or enrollment.
Why does the analysis population matter?
The record describes an intent-to-treat analysis that included eligible participants who were randomized and provided outcome data after baseline. Intent-to-treat commonly refers to analyzing participants according to their randomized assignment, regardless of treatment received. In this record, however, inclusion is also described as requiring post-baseline outcome data. It is therefore important not to assume that every randomized participant contributed to the primary analysis. The number included, the number missing post-baseline data, and any methods used to address missing outcomes are not reported.
Missing outcomes can affect a comparison when the likelihood of missingness or the unobserved outcomes differ across participants or groups. General methods may include explicit assumptions about the missing-data process, imputation, or sensitivity analyses. The registry record does not state which approach, if any, was used. It also does not report whether the main analysis was accompanied by analyses testing alternative missing-data assumptions.
How should repeated time points be understood?
The primary outcome description gives 4, 8, and 12 weeks as assessment times, while identifying the 12-week change as the primary comparison. Repeated observations on the same participant are related rather than independent. A statistical model for repeated measures can account for that dependence, but the record does not report whether such a model was used. Nor does it specify whether the 4- and 8-week assessments were analyzed separately or as part of a longitudinal model.
Testing several time points or outcomes can increase the chance of at least one apparently notable result when each is examined independently. General approaches to multiplicity include pre-specifying a primary comparison, adjusting significance thresholds, or interpreting secondary findings as exploratory. The record identifies a primary outcome and lists numerous other outcomes, but a multiplicity strategy is not reported. It is not possible to determine from the record whether secondary analyses were adjusted or how they were prioritized.
What can planning calculations say?
Sample-size calculations are planning tools that describe the number of participants needed under specified assumptions about the effect to detect, variability, allocation, and statistical method. They are not observed treatment effects and do not show the probability that a trial result is true. The registry’s planning description refers to a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects expressed as fractions of an observed effect. It characterizes such calculations as planning illustrations based on the observed effect, not as the trial’s own design justification. The numerical planning results and the trial’s own sample-size justification are not reported in the registry record.
These planning assumptions cannot substitute for the trial’s observed estimate. A calculation based on an observed effect is conditional on that effect and on the stated assumptions; it does not recover the missing primary endpoint result. Nor should a planning illustration be described as observed power. The record does not provide the quantities needed to evaluate the original design rationale or to reproduce a primary outcome analysis.
10. Multiplicity, Missing Data and Analysis Populations
The record identifies change in St. Mark’s (Vaizey) score as the primary outcome and gives assessment times of 4, 8, and 12 weeks, with the primary description focused on 12 weeks. It also lists several secondary outcomes, including treatment response and changes in fecal-incontinence events, urge events, bowel movements, and days without episodes. Multiple time points and outcomes create a multiplicity issue: examining many comparisons can make chance findings more likely. The registry record does not report a multiplicity adjustment, a hierarchy for secondary outcomes, or a statistical plan describing how these comparisons were interpreted.
The registry describes an intent-to-treat analysis including eligible randomized participants who provided outcome data after baseline. The description therefore does not establish that all randomized participants were included in the primary outcome analysis. The number with available baseline and follow-up scores, the amount of missing data by group, reasons for missingness, and methods used to handle missing observations are not reported in the registry record.
Missing-data assumptions matter because observed outcomes may not represent participants without recorded follow-up data. General statistical approaches can make different assumptions about those missing outcomes, and sensitivity analyses can examine how conclusions depend on those assumptions. The record does not state whether missing-data methods or sensitivity analyses were used.
The registry lists 56 outcome measures, but the analysis entries are not reported. It is therefore unclear which outcomes were analyzed, whether all planned comparisons were conducted, and whether the reported outcome list reflects the complete analysis plan. The protocol, analysis plan, interim-analysis procedures, and sample-size justification are not reported in the registry record. No claims about prespecification or analytical choices beyond the stated endpoint description should be made.
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 |
|---|---|---|---|
| PTNS | 4 | 111 | 3.6% |
| Sham | 2 | 55 | 3.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| PTNS | 1 of 111 |
| Sham | 0 of 55 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0.00% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| PTNS | 72 of 111 |
| Sham | 30 of 55 |
Most frequent serious adverse event terms
| Event term | Organ system | PTNS | Sham |
|---|---|---|---|
| Myocardial infarction | Cardiac disorders | 1 of 111 | 0 of 55 |
| Colitis | Gastrointestinal disorders | 0 of 111 | 1 of 55 |
| Hiatus hernia | Gastrointestinal disorders | 1 of 111 | 0 of 55 |
| Death | General disorders | 1 of 111 | 0 of 55 |
| Localised infection | Infections and infestations | 0 of 111 | 1 of 55 |
| Femur fracture | Injury, poisoning and procedural complications | 1 of 111 | 0 of 55 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 1 of 111 | 0 of 55 |
Most frequent non-serious adverse event terms
| Event term | Organ system | PTNS | Sham |
|---|---|---|---|
| Urinary tract infection | Infections and infestations | 14 of 111 | 4 of 55 |
| Paraesthesia | Nervous system disorders | 11 of 111 | 2 of 55 |
| Medical device site haemorrhage | General disorders | 9 of 111 | 0 of 55 |
| Nasopharyngitis | Infections and infestations | 7 of 111 | 2 of 55 |
| Diarrhoea | Gastrointestinal disorders | 6 of 111 | 1 of 55 |
| Fall | Injury, poisoning and procedural complications | 6 of 111 | 1 of 55 |
| Constipation | Gastrointestinal disorders | 4 of 111 | 2 of 55 |
| Bronchitis | Infections and infestations | 4 of 111 | 1 of 55 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 3 of 111 | 2 of 55 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 5 of 111 | 0 of 55 |
Serious events with the highest arm-level rate: colitis (1.8%), localised infection (1.8%), myocardial infarction (0.9%), hiatus hernia (0.9%), death (0.9%).
The registry reports serious adverse events among 111 participants at risk in the PTNS group and 55 at risk in the sham group. It records 4 serious adverse events in the PTNS group and 2 in the sham group. Other adverse events are reported for 72 participants at risk in the PTNS group and 30 at risk in the sham group. The record also reports 1 death in the PTNS group and 0 in the sham group.
These are descriptive counts from the registry. They do not by themselves establish that an event was caused by a treatment, and they do not convey event timing, duration, severity beyond the serious-event classification, or participant-level exposure. The registry does not report an adjusted comparison, a confidence interval for a safety contrast, or the relationship of each event to treatment. The counts should therefore not be interpreted as proof of a difference or no difference in safety.
The listed serious-event terms include colitis and localised infection at 1.8% each, and myocardial infarction, hiatus hernia, death, and femur fracture at 0.9% each. The record does not provide enough context in this listing to attribute these terms to a particular arm or to assess causality. These figures describe reported entries, not a complete account of the clinical circumstances.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group comparison of PTNS and a validated sham was conducted in women with refractory accidental bowel leakage symptoms. It identifies a primary measure, describes how change was defined, and gives the assessment schedule. It also reports enrollment and selected adverse-event counts. These registry entries describe the trial’s setting and intended comparison, but they do not provide the primary treatment-effect estimate.
Because the primary outcome values are not reported in the registry record, it is not possible to determine whether mean score change favored either group, how large any difference was, or how precisely it was estimated. The record does not support a conclusion that PTNS was effective, ineffective, equivalent to sham, or associated with a particular degree of benefit. Absence of a posted result is not evidence of no effect.
Even when an outcome difference is available, statistical evidence and clinical meaning are distinct. A confidence interval can communicate uncertainty around the estimated contrast, while clinical interpretation also depends on whether the magnitude is meaningful to participants and how the endpoint behaves. The registry does not report a threshold for clinically meaningful change, so that criterion cannot be applied.
The results also cannot be generalized automatically beyond the population described in the record. The trial concerned women with refractory symptoms after the specified first-line treatments and compared PTNS with a particular validated sham. It does not answer questions about other populations, other comparators, or outcomes not reported in the record.
Safety counts provide a limited description of reported events, not a causal assessment. The counts do not show whether events were treatment-related, and the record does not report a statistical safety comparison. A complete interpretation would require the outcome estimates, their uncertainty, information about missing data and analysis methods, and fuller context for adverse events. Those details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically relevant because it uses random allocation and a sham comparison to address a question about a symptom-focused intervention. Randomization can support a causal comparison when the analysis preserves the assigned groups and outcome data are handled appropriately. The registry describes an intent-to-treat analysis, but its eligibility wording requires post-baseline outcome data. Without the participant flow and missing-data details, the extent to which the analysis retained the benefits of randomization cannot be assessed.
The endpoint also illustrates the importance of distinguishing a within-group change from a randomized between-group contrast. Improvement from baseline in either group would not, by itself, show that the active intervention changed outcomes more than the sham. The primary scientific quantity is the difference in average change, accompanied by an uncertainty estimate. Neither is reported in the registry record.
Repeated assessment times and a broad set of listed outcomes make prespecification and multiplicity important. A clearly stated primary comparison helps focus interpretation, while transparent reporting of secondary analyses helps readers distinguish confirmatory findings from exploratory ones. Here, the registry identifies the primary endpoint but does not report the analysis plan or multiplicity approach. The absence of analysis entries further limits reconstruction of which comparisons were conducted.
The record also shows why enrollment is not a substitute for an outcome report. An enrollment total cannot reveal the observed effect, the variability of scores, the number with follow-up data, or the precision of a group contrast. Planning calculations likewise cannot stand in for observed results. Without posted primary estimates and confidence intervals, readers cannot judge the statistical evidence or its precision.
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 most important limitation of the registry record for interpretation is that it does not report primary outcome results. There are no posted group mean changes, between-group estimate, confidence interval, or test result for the St. Mark’s (Vaizey) score. The record therefore permits description of the planned comparison but not assessment of its observed effect.
The analysis population is described as eligible randomized participants who provided outcome data after baseline. The number of participants contributing data at each assessment, the reasons for missing outcomes, and the handling of missingness are not reported. This leaves uncertainty about follow-up completeness and the assumptions underlying the analysis.
The record lists multiple assessment times and numerous outcome measures, but does not report the statistical analysis plan, multiplicity strategy, or which outcomes were analyzed. It also does not provide the sample-size justification, interim-analysis plan, or enough detail to assess whether the posted outcome descriptions match a prespecified analysis plan. These omissions prevent a full evaluation of selective reporting and analytical choices.
Important design details are also not stated, including the allocation procedure and which parties were masked. The registry describes the study as single masked but does not identify the masked group or report whether masking was maintained. It does not report a treatment-adherence summary or details of participant flow that would help characterize implementation.
Finally, the adverse-event counts lack reported information about timing, treatment relationship, exposure, and comparative uncertainty. The listed serious-event terms and percentages do not provide enough context to attribute events or assess causal differences. These limitations concern what can be learned from the registry record; they do not establish that the underlying trial lacked these analyses or information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Neuromodulation for Accidental Bowel Leakage — NCT03278613.
- Registry record last updated 2025-06-03; status last verified 2025-05.
- Results first posted 2021-05-14.
- 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
The registry describes NCT03278613, titled “Neuromodulation for Accidental Bowel Leakage,” as a completed, multicenter, randomized, single-masked, parallel-group trial with enrollment of 166. It compared percutaneous tibial nerve stimulation with a validated sham in women with refractory accidental bowel leakage symptoms after unsuccessful symptom control with the stated first-line treatments.
The primary outcome was change from baseline in St. Mark’s (Vaizey) score, with assessments at 4, 8, and 12 weeks and the primary comparison focused on 12 weeks. The record describes a mean outcome and a 95% confidence interval, but the primary estimates are not reported in the registry record. It lists secondary outcomes and selected adverse-event counts, but does not report the analysis plan, multiplicity handling, missing-data methods, or the trial’s sample-size justification.