Physical Therapy Intervention for Pelvic Organ Prolapses: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Physical Therapy Intervention for Pelvic Organ Prolapses (NCT06532292), a randomized na study. The primary outcome is POP Symptom Severity.

2. Clinical Question

The trial is described as a prospective, single-center randomized controlled pilot study, with a nested qualitative interview study. Its three parallel groups allow the interventions to be considered against usual care and against each other. The registry record does not report the actual allocation process beyond identifying the study as randomized, nor does it report results from the qualitative interviews. The central statistical question is therefore clear from the design, but its answer cannot be assessed from the posted registry results: no primary-outcome values or analyses are reported.

3. Trial Design

The registry describes a prospective, single-center, randomized controlled trial with a parallel-group model and three groups: HIFEM, biofeedback, and usual care. Masking is listed as none. The study status is completed. The recorded enrollment is 28, while the brief summary describes a plan to recruit 21 women; the record does not explain the difference between these figures.

The HIFEM and biofeedback groups were each described as receiving treatment twice a week for 8 weeks. For HIFEM, the summary describes sitting fully clothed in the center of an electromagnetic chair for 28 minutes. The biofeedback group received PFMT with biofeedback and/or electrostimulation from a skilled physical therapist. The usual-care group received care based on clinical judgment from an obstetrician or gynecologist, along with a lifestyle advice leaflet. Details beyond these descriptions are not reported in the registry record.

The primary outcome is POP symptom severity, assessed using the POP-SS at baseline and 8 weeks. The registry also lists secondary measures covering distress and impact related to pelvic floor dysfunction, pelvic floor muscle strength and endurance, urogenital hiatus diameter, and bladder-neck displacement. A nested qualitative interview study is mentioned, but its methods and findings are not reported in the registry record.

The study start date is 2024-08-05, and the primary completion date is 2025-06-06. The record lists the study as completed but does not include numerical primary-outcome results, a treatment-effect estimate, or an analysis. It also does not report protocol details such as the randomization procedure, allocation concealment, or the planned statistical model. These omissions prevent assessment of how the design was implemented and how the planned comparisons were conducted.

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

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as POP Symptom Severity, measured over absolute values at baseline and 8 weeks.

The primary endpoint is POP symptom severity measured by the Pelvic Organ Prolapse Symptom Score (POP-SS). The instrument comprises seven items addressing the frequency of prolapse symptoms. Each item uses a five-point Likert response scale scored from 0-4, and the total score ranges from 0 to 28. Higher scores indicate more pronounced symptom severity. The registry specifies absolute values at baseline and 8 weeks as the timeframe.

A symptom score is a patient-centered measure: it is intended to capture how frequently a person experiences symptoms, rather than measuring only an anatomical feature or a physical examination finding. This makes the outcome relevant to the study’s stated interest in symptoms and patient-centered outcomes. The other listed outcomes include measures of pelvic floor muscle function and pelvic anatomy, so they address different aspects of the condition.

For a randomized comparison, an important question would be how the symptom scores change or differ between groups over the specified timeframe. However, the registry record does not report score values, group-level summaries, an estimated difference, uncertainty around an estimate, or a statistical test. It also does not specify whether the planned analysis would compare follow-up scores, changes from baseline, or another formulation. Accordingly, the endpoint definition can be described, but the relative results for HIFEM, biofeedback, and usual care cannot be interpreted from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a continuous score, and the registry identifies the planned summary as a mean with standard deviation. A mean describes the center of a set of scores; a standard deviation describes how dispersed individual scores are around that mean. These summaries can help readers understand the average symptom burden and variation within a group. They do not, by themselves, show whether groups differ or whether a difference is estimated precisely. No group-level means or standard deviations are reported in the registry record.

What does a randomized comparison estimate?

In general, random assignment is intended to make groups comparable at the point of allocation, apart from chance variation. A treatment comparison then estimates how outcomes differed between assigned groups under the conditions of the study. The estimate depends on the outcome definition, the timepoint, the analysis population, and the statistical model. The registry identifies randomized allocation and a parallel model, but does not report the randomization procedure, the primary comparison model, or an estimated contrast.

Because there are three groups, the design allows more than one pairwise question: HIFEM versus biofeedback, HIFEM versus usual care, and biofeedback versus usual care. The record does not state which comparisons were designated as primary or how they were to be handled statistically. It also does not report whether baseline scores would be used as covariates, whether change from baseline would be analyzed, or whether follow-up values alone would be compared. These are distinct analytical choices and should not be inferred from the endpoint description.

How should uncertainty be assessed?

In general, a point estimate summarizes the size and direction of an observed contrast, while a confidence interval conveys its statistical uncertainty under the chosen method. A p-value addresses compatibility between the data and a specified null hypothesis, subject to the analysis assumptions. These measures answer different questions and are most informative when reported alongside group summaries and a clearly stated analysis. The registry record reports no contrast, confidence interval, or p-value for the primary endpoint, so neither effect magnitude nor inferential uncertainty can be assessed.

Standard deviations are useful for describing variation in continuous outcomes, but a mean-based analysis may depend on assumptions about the distribution of scores and model residuals. General statistical practice considers whether those assumptions are reasonable and whether the analysis is robust to departures from them. The registry does not report diagnostics, transformations, a nonparametric alternative, or another approach to distributional concerns. It would therefore be inappropriate to claim that any particular method was used.

What does over-dispersion mean in general?

Over-dispersion is a general concern for outcomes whose variability is greater than a statistical model expects. It is especially relevant to count outcomes, where a simple model may underestimate variation and produce overly narrow uncertainty estimates if the data are more variable than assumed. The primary endpoint in this record is described as a continuous symptom score, not as a count outcome. The registry does not report a model or evidence of over-dispersion, so this concept should not be treated as a specific finding from the trial.

The listed secondary outcomes are heterogeneous: some concern distress or impact, some concern muscle strength or endurance, and others concern anatomical measurements. Different types of outcomes may require different summaries and models. The registry does not describe their measurement scales, analysis methods, or numerical results in enough detail to evaluate those choices. Nor does it report whether the secondary outcomes were confirmatory or exploratory.

What can the sample-size assumptions tell readers?

The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. Such calculations are planning illustrations, not observations of trial performance and not evidence that a particular effect was detected. The record does not report a trial-specific sample-size justification, and no calculated planning quantities are available in the registry record for interpretation. The illustration should not be described as observed power.

In general, a sample-size calculation depends on assumptions about the target effect, variability, allocation, significance level, and analysis. If those assumptions differ from what occurs in the study, the calculation may not describe the precision achieved. The stated illustration concerns two arms, whereas this trial has three groups; its assumptions do not establish how the three-arm trial was planned. No further design rationale or sample-size calculation is reported.

What is not established by the record?

The registry does not report an analysis plan, model specification, handling of baseline values, missing-data method, analysis population, or multiplicity adjustment. These omissions mean that readers cannot reproduce or evaluate an efficacy analysis. They also prevent assessment of whether the statistical methods followed a prespecified plan. General statistical principles can explain why these choices matter, but cannot establish which choices were made in this trial.

10. Multiplicity, Missing Data and Analysis Populations

The trial has a three-group design and lists one primary outcome alongside multiple secondary outcomes. In general, testing several comparisons or outcomes can increase the chance of observing a nominally unusual result by chance. A prespecified testing strategy can clarify which comparisons are confirmatory, how the family of tests is defined, and whether an adjustment or hierarchy is used. The registry record does not report a multiplicity strategy, a hierarchy among comparisons, or a statistical analysis plan.

The primary outcome is specified at baseline and 8 weeks, but the record does not describe the planned analysis of those measurements. It does not state whether baseline adjustment, change scores, or another method was intended. No primary or secondary analyses are reported, so there are no results from which to assess the impact of multiplicity or to distinguish confirmatory from exploratory findings.

Missing-data handling is not reported in the registry record. The record does not state whether all randomized participants completed the 8-week assessment, how missing scores would be handled, or whether any sensitivity analysis was planned. The enrollment figure does not establish how many participants contributed outcome data. Likewise, the analysis population is not reported: there is no statement about whether analyses would follow randomized assignment, include only participants who completed treatment, or use another definition.

These details affect interpretation because exclusions and missing outcomes can change the analyzed population and the assumptions needed to interpret a comparison. Their absence does not establish that data were missing or that a particular analysis was biased; it means the registry record does not allow readers to assess these issues. Numerical results and the accompanying analysis plan would be needed for a fuller statistical appraisal.

11. 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 2% reporting threshold.

The registry lists safety counts for the HIFEM, biofeedback, and usual-care groups. For each listed group, the number at risk for serious adverse events matches the corresponding number at risk for other adverse events: 10 for HIFEM, 9 for biofeedback, and 9 for usual care. The posted counts are zero serious adverse events, zero other adverse events, and zero deaths in each group.

These figures describe the events recorded in the registry. They do not, on their own, establish how safety events were defined, how they were solicited, the period during which they were monitored, or whether all randomized participants contributed to safety follow-up. Those details are not reported in the registry record. The figures also do not provide an estimate of comparative risk or its uncertainty.

A zero count should therefore be read as no events reported in that category for the listed group, rather than as proof that the intervention has no safety risks. The record does not include serious-event terms, and no further event descriptions are available. The safety counts are limited to the categories and denominators posted in the registry.

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

The registry record establishes that a completed, randomized, three-group pilot study was designed to assess POP symptom severity and other patient-centered, functional, and anatomical outcomes. It identifies HIFEM, biofeedback-based PFMT, and usual care as the study groups and specifies the POP-SS at baseline and 8 weeks as the primary outcome. These design details explain the intended comparison; they do not provide the comparison’s result.

No numerical primary-outcome values, group contrasts, uncertainty estimates, or statistical tests are reported. As a result, the posted record does not establish whether one group had higher or lower symptom scores, how large any difference might have been, or how precisely a difference was estimated. It also does not report results for the listed secondary outcomes or the nested qualitative interview study.

In general, an observed difference in a pilot trial would need to be considered alongside its uncertainty, the analysis plan, completeness of follow-up, and the study’s design. A finding from one outcome would not automatically establish a similar pattern for muscle function, anatomy, or other patient-centered measures. Here, those outcome results are not reported, so no cross-outcome interpretation is possible.

The registry lists zero adverse events in the posted serious and other event categories and zero deaths for each group. This is a report of the recorded counts, not a comprehensive characterization of safety: event definitions, monitoring procedures, and follow-up details are not reported. The available information therefore supports a description of the trial and its posted safety counts, but does not support a conclusion about comparative effectiveness or risk.

The study is described as a pilot, and the record does not report a trial-specific sample-size justification. The enrollment figure and the recruitment target described in the summary also differ, without an explanation in the record. Readers should not treat the enrollment count alone as evidence of precision, nor infer a treatment effect from the fact that the study is marked completed.

13. Why This Trial Matters Statistically

This trial is statistically notable for asking a three-group question about a symptom score while also collecting measures spanning distress, impact, muscle function, and anatomy. Such a design can address different dimensions of pelvic organ prolapse, but each outcome answers a distinct question. Clear outcome definitions and a prespecified analysis strategy are important when several groups and outcomes are involved.

The registry identifies a randomized, parallel-group pilot and records that masking was none. Those features help readers understand the planned structure, but are not substitutes for results. Interpretation of a completed trial depends on posted group summaries and comparisons, uncertainty estimates, analysis populations, and information about missing data. Those elements are not reported for the primary outcome in this record.

The record also illustrates why enrollment and analysis are different concepts. It lists enrollment of 28, while the brief summary describes recruiting 21 women. Neither figure establishes how many participants completed follow-up or contributed to the primary analysis, because outcome-level participation and analyses are not reported. Likewise, a planning illustration based on an observed effect is not an account of the study’s original sample-size justification or evidence of observed power.

Finally, the zero posted adverse-event counts require the same attention to definitions and follow-up as any other safety result. The figures are useful as registry-reported counts, but do not supply the detail needed for a full safety comparison. The statistical importance of this record is therefore as much about the limits of the reported information as about the intended design: the question is described, but comparative outcome evidence is not posted.

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 consequential limitation for statistical interpretation is that the registry record contains no primary-outcome values or analyses. Without group summaries and a comparison estimate, there is no basis for assessing the direction, magnitude, or precision of differences in POP symptom severity. Secondary-outcome results and findings from the nested qualitative interview study are also not reported.

The record describes enrollment of 28, while the brief summary says 21 women would be recruited. It does not explain the difference or state how many participants were randomized, completed the 8-week assessment, or contributed data to an analysis. The event denominators are posted, but they do not resolve the number included in efficacy analyses.

Other design and analysis details are absent. The registry record does not report the randomization procedure, allocation concealment, a statistical analysis plan, methods for missing data, analysis populations, or an approach to multiple comparisons. It also does not state how the primary endpoint would be analyzed across baseline and 8 weeks. These omissions prevent assessment of whether the final analysis matched a prespecified plan.

The record identifies a single-center pilot study and lists no masking. It does not report the rationale for the sample size or the intended role of the pilot, and the posted planning illustration is not a substitute for that rationale. Intervention descriptions are limited, and the registry does not provide detailed adherence or treatment-exposure data. Safety-event definitions and monitoring details are not reported. These limitations describe what cannot be evaluated from the registry record; they do not establish that a particular problem occurred during the trial.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Physical Therapy Intervention for Pelvic Organ Prolapses — NCT06532292.
• Registry record last updated 2026-06-12; status last verified 2025-07.
• Results first posted 2026-06-12.
• 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.

18. Record Summary

The registry record describes NCT06532292, a completed prospective, single-center, randomized, parallel-group pilot study of HIFEM, biofeedback-based PFMT, and usual care for pelvic organ prolapse. Masking is listed as none. The study start date is 2024-08-05, the primary completion date is 2025-06-06, and recorded enrollment is 28. The brief summary describes a planned recruitment of 21 women.

The primary outcome is POP symptom severity on the POP-SS, with absolute values at baseline and 8 weeks. Listed secondary outcomes include distress and impact, pelvic floor muscle strength and endurance, urogenital hiatus diameter, and bladder-neck displacement. The registry record does not report outcome values or analyses. Safety counts list zero serious adverse events, zero other adverse events, and zero deaths in each group’s reported at-risk population.