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 Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse (NCT01648751), a randomized na study. The primary outcome is Patient Global Impression of Improvement.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01648751 |
| Phase | NA |
| Condition | Pelvic Organ Prolapse |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 21 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Pamela Moalli |
| Results posted | Yes |
2. Clinical Question
Population
Women with symptomatic mild pelvic organ prolapse who were undergoing pelvic floor physical therapy. The primary outcome population is described as participants who completed surveys 6 months after starting vaginal cream.
Intervention
Vaginal estrogen cream given as part of a combined approach with pelvic floor physical therapy. The registry describes the study as evaluating whether adding vaginal estrogen to physical therapy improves clinical outcomes and anatomical support.
Comparator
Placebo vaginal cream alongside pelvic floor physical therapy. The randomized, parallel-group design compares this group with the vaginal-estrogen group.
Primary question
At 6 months after starting vaginal cream, how did participants rate their overall improvement on the Patient Global Impression of Improvement scale? Lower scores indicate more improvement. The registry also lists pelvic floor symptoms, general quality of life, prolapse stage, collagenase activity, and sexual function as secondary outcomes.
The trial’s stated clinical question concerns a combined treatment approach. Both groups were undergoing pelvic floor physical therapy, while the assigned cream differed: vaginal estrogen or placebo. The registry’s description gives the investigators’ prediction that combining physical therapy with vaginal estrogen would reduce pelvic floor symptoms and improve anatomical support, with biomarker data providing corroboration. That prediction is a statement of the research question, not evidence that the anticipated outcomes occurred.
The primary outcome is a global rating of perceived change rather than a direct measurement of anatomical support or a specific symptom. The posted values describe the ratings of participants who completed the six-month survey. They do not provide a complete account of all clinical outcomes named in the trial description, nor do they establish how outcomes changed from each participant’s starting point. The registry record lists secondary outcomes but does not report analyses for them.
3. Trial Design
The registry describes a randomized, triple-masked, parallel-group trial. Participants were assigned to vaginal estrogen cream or placebo cream while undergoing pelvic floor physical therapy. The record labels the study phase as not applicable. It lists an enrollment of 21 and a status of terminated. The reason for termination is not reported in the registry record.
The registry record gives a start date of 2012-05 and a primary completion date of 2023-03-02. The primary outcome timeframe is 6 months after starting vaginal cream. The population specified for that outcome consists of participants who completed surveys at that time. The posted outcome counts are 7 for vaginal estrogen and 7 for placebo cream. These counts describe the primary outcome results, not necessarily every participant enrolled or every analysis population.
Triple masking indicates that the record classifies the study as masked at three levels, but which people or study roles were masked is not reported in the registry record. The physical therapy procedures, cream dosing, treatment adherence, and details of how random assignment was generated or concealed are also not reported in the registry record. The label “randomized” identifies the study’s allocation design but does not by itself supply those procedural details.
The primary measure is the Patient Global Impression of Improvement (PGI-I), recorded as a score on a scale and summarized with a mean and full range. The record gives six outcome measures in total and names five secondary outcomes: pelvic floor symptoms, general quality of life, pelvic organ prolapse stage, collagenase activity, and sexual function. It reports no analyses. No explanation of the termination, the planned analysis population, or the trial’s original sample-size justification is reported in the registry record.
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: One subject was ineligible prior to randomization.
Overall Study
| Stage | Vaginal Estrogen | Placebo Cream |
|---|---|---|
| STARTED | 9 | 11 |
| COMPLETED | 7 | 8 |
| NOT COMPLETED | 2 | 3 |
Reasons for not completing this period:
| Reason | Vaginal Estrogen | Placebo Cream |
|---|---|---|
| Withdrawal by Subject | 2 | 3 |
Analysis population for the primary outcome, as defined in the registry: Subjects who completed surveys at 6 months post treatment.
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 | Vaginal Estrogen | Placebo Cream | Total |
|---|---|---|---|---|
| Participants analysed | 9 | 11 | 20 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 8 | 9 | 17 |
| Age, Categorical: >=65 years | Participants | 1 | 2 | 3 |
| Sex: Female, Male: Female | Participants | 9 | 11 | 20 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: United States | participants | 9 | 11 | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Patient Global Impression of Improvement, measured over 6 months after starting vaginal cream.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the Patient Global Impression of Improvement (PGI-I), measured 6 months after starting vaginal cream. The record describes it as a global index for rating a condition’s response to therapy and as a transition scale. Its response options range from “Very Much Better” to “Very Much Worse”; lower scores indicate more improvement. The posted results are mean scores with the full range for each group.
A global impression measure is used to capture a participant’s overall sense of change, rather than limiting the assessment to one symptom or one anatomical finding. This can be useful when an intervention is intended to affect multiple aspects of experience. It also means the score is a broad rating: it does not identify which symptom or aspect of prolapse influenced a participant’s response. General statistical context: a mean summarizes the central level of scores, while a range describes the lowest and highest recorded scores. A range does not show how densely scores fall within those endpoints.
The endpoint population is defined as participants who completed surveys at 6 months post treatment. In the vaginal-estrogen group, the mean was 2.3, with a full range from 1.0 to 3.0; in the placebo-cream group, the mean was 3.0, with a full range from 1.0 to 5.0. The registry does not post a standard deviation, confidence interval, or inferential comparison for this endpoint. Consequently, the displayed group summaries describe observed ratings but do not establish the precision of a treatment-group contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the primary outcome, the registry posts a mean PGI-I score of 2.3 in the vaginal-estrogen group and 3.0 in the placebo-cream group. Since lower PGI-I scores indicate more improvement, the observed mean in the vaginal-estrogen group is in the direction associated with greater reported improvement. The full ranges are 1.0 to 3.0 and 1.0 to 5.0, respectively. Both groups include the lowest scale value, and the placebo group’s range extends to a higher score. These descriptions do not reveal how individual scores are distributed across the ranges.
The endpoint results are based on 7 participants in each group who completed surveys at the specified time. They are descriptive summaries, not a reported test of the randomized comparison. The registry record lists no analyses, and it does not post a confidence interval, standard error, standard deviation, or p-value for the primary endpoint. The size and precision of an underlying treatment contrast therefore cannot be determined from the posted summaries. In particular, the means should not be treated as evidence of a statistically reliable difference.
The record states that the trial enrolled 21 participants, while the primary endpoint population is described by the survey completers and its group counts. The record does not explain why the number represented in the endpoint differs from enrollment, or what happened to participants not represented in that outcome. No reason for termination is reported. These omissions limit interpretation of how representative the posted outcome summaries are of all randomized participants.
The registry names several additional outcomes, including pelvic floor symptoms, quality of life, prolapse stage, collagenase activity, and sexual function. Although it lists six outcome measures overall, it posts no analyses. The primary results therefore do not answer whether any of those secondary outcomes differed between groups. Nor do the PGI-I means directly report anatomical support or biomarker change.
General statistical context: a confidence interval would communicate the range of effect estimates compatible with the data under a specified analysis, while reflecting sampling uncertainty. Without an interval or another inferential result, the reader cannot assess precision beyond the limited information in the endpoint counts, means, and ranges. This uncertainty is especially relevant when interpreting a small posted outcome population. No conclusion about treatment efficacy follows from the descriptive summaries alone.
9. Statistical Methods Explained
The registry identifies a randomized, parallel-group design with vaginal estrogen and placebo cream as the two assigned interventions. Randomization is intended, in general, to make treatment groups comparable at allocation with respect to measured and unmeasured factors. In a small trial, however, chance differences can remain, and the design label alone does not show whether groups were balanced on particular characteristics. Baseline characteristics and the randomization procedure are not reported in the registry record.
The study is labelled triple-masked. In general, masking can reduce the influence of treatment knowledge on participants’ responses, clinical care, or outcome assessment. The registry does not specify which roles were masked, how masking was maintained, or whether it was assessed. Those details should not be inferred from the label alone. The parallel model means the registry describes distinct groups assigned to the two cream conditions rather than a crossover comparison.
The primary endpoint is a mean score on the PGI-I scale, accompanied by the full range. The registry’s outcome description identifies the PGI-I as a transition scale, with lower values denoting more improvement. General statistical context: a mean is a summary of the values in a group, whereas the full range gives the smallest and largest values. A range is sensitive to extreme observations and does not describe the shape of the distribution or the variability around the mean as fully as measures such as a standard deviation would. The record does not post such a dispersion measure for this endpoint.
The endpoint counts are 7 per group. For small groups, individual observations can have a substantial influence on a mean, and estimates of group differences can be imprecise. This general point is not a calculation of an effect or its uncertainty in this trial. No confidence interval or formal comparison is posted, so the precision of the treatment-group contrast is not quantified in the registry record.
The study record lists six outcome measures, including the primary PGI-I and five named secondary outcomes. It reports zero analyses. This means the registry record does not provide an inferential analysis for the primary endpoint or the secondary outcomes. It does not specify a statistical model, a test, covariate adjustments, or rules for handling repeated observations. These elements are not reported in the registry record and cannot be reconstructed from the group means and ranges.
The sample-size assumptions describe planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. For non-time-to-event outcomes, those illustrations are expressed as participants per arm, and the detectable effect is described as a stated fraction of the observed effect. These are planning illustrations, not observed power and not the trial’s own design justification. The registry does not report the original sample-size rationale. No numerical illustration values are stated in the record summarized by these results, so none can be interpreted as a recommended or achieved enrollment target.
General statistical context: a planning calculation asks how much information a future study might need to detect an effect under specified assumptions. Its output depends on the assumed effect, variability, significance threshold, and allocation. If assumptions are based on an observed effect from a small study, that effect may itself be uncertain. A planning illustration is therefore not evidence that the present study had adequate power, nor does it establish that a finding is real or absent.
For a count or score outcome, over-dispersion means that variability is greater than expected under a particular statistical model. In general, failing to account for over-dispersion can make uncertainty estimates too small. The registry does not state that over-dispersion was assessed or that a model requiring such an assessment was used. This is a general methodological consideration, not a feature established for this trial.
The posted summaries do not allow an independent recalculation of an adjusted treatment effect or its uncertainty. The record contains means and ranges, but no standard deviations or participant-level values, and no analyses. A simple unadjusted recalculation may be possible only when the necessary summary statistics are available; it cannot replace the sponsor’s analysis when the registry reports one. No sponsor analysis is posted for this endpoint, and the discrepancy indicator is false. The absence of a posted analysis should be distinguished from a finding of no difference: it leaves the inferential question unanswered in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures, consisting of the primary PGI-I and five secondary outcomes. It does not report analyses for these outcomes. No statistical plan for prioritizing outcomes, controlling multiplicity, or interpreting several outcome tests is reported in the registry record. Thus, it is not possible to tell whether the secondary outcomes were intended to support confirmatory claims, how multiple comparisons would have been handled, or whether any outcomes were omitted from the posted results.
General statistical context: when several outcomes or comparisons are tested, the chance of at least one apparently unusual result can increase if each is considered separately. A prespecified multiplicity strategy can help define how evidence across tests is interpreted. This general concern does not establish that any particular multiplicity procedure was planned or needed in this trial; the registry record does not report one.
The primary endpoint population is described as participants who completed surveys at 6 months after starting vaginal cream, with 7 in each group. The record does not state how many participants were randomized to each group, whether participants discontinued treatment or follow-up, or how missing survey values were handled. It also does not report an intention-to-treat analysis population, a per-protocol population, imputation, or sensitivity analyses. The reasons that some enrolled participants may not be represented in the endpoint summaries are not reported in the registry record.
These gaps matter because analyses limited to completed surveys can differ from analyses that include all randomized participants, especially if outcome availability is related to treatment or response. That is a general methodological issue; the registry does not give enough information to determine whether such a bias occurred. The result should therefore be read as a summary for the stated survey-completer population, not assumed to represent every enrolled participant.
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 |
|---|---|---|---|
| Vaginal Estrogen | 0 | 9 | 0.0% |
| Placebo Cream | 0 | 11 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Vaginal Estrogen | 0 of 9 |
| Placebo Cream | 0 of 11 |
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 |
|---|---|
| Vaginal Estrogen | 0 of 9 |
| Placebo Cream | 0 of 11 |
The serious adverse event figures are reported for 9 participants at risk in the vaginal-estrogen group and 11 in the placebo-cream group. The registry records 0 serious adverse events in each group and 0 deaths in each group. It also records 0 other adverse events in each group, using those same at-risk counts. No serious adverse event terms are listed.
These entries describe the safety counts in the registry record. They do not establish that no adverse events could occur, and they do not by themselves show that safety was equivalent between groups. The at-risk groups and the primary endpoint survey-completer groups are reported separately; the record does not explain the relationship between those populations. The duration and completeness of adverse-event monitoring, definitions used, and methods for collecting events are not reported in the registry record.
General statistical context: a zero count in a limited group does not mean the underlying risk is zero. Rare events may not appear in a small study, and event counts are interpreted in light of the number monitored and the monitoring period. No rate or comparative safety estimate is posted, so one should not infer a quantitative difference between the groups from these counts alone. The figures are best read as the events recorded for the stated at-risk groups, rather than as proof of an absence of risk.
12. What the Result Does, and Does Not, Mean
The registry reports a primary endpoint mean of 2.3 for vaginal estrogen and 3.0 for placebo cream, with lower PGI-I scores indicating more improvement. The full range was 1.0 to 3.0 in the vaginal-estrogen group and 1.0 to 5.0 in the placebo group. These are descriptive findings among participants who completed surveys at 6 months after starting vaginal cream. They show the recorded group summaries, but do not quantify uncertainty around a treatment contrast.
The result does not establish that vaginal estrogen caused better outcomes. The record posts no analysis, confidence interval, or p-value for the primary comparison. It also does not establish that there was no difference. Without an inferential result and information about missing outcomes, the strength and precision of a comparison cannot be assessed from the posted endpoint summaries.
The PGI-I is a global perception-of-change measure. Its values do not directly demonstrate improved anatomical support, changes in collagenase activity, or changes in the other outcomes named in the registry. Those are separate outcomes, and the record reports no analyses for them. The investigators’ prediction about symptoms, anatomical support, and biomarkers remains a research hypothesis rather than a finding established by the posted primary result.
The study is listed as terminated, with enrollment of 21 and primary completion on 2023-03-02. The reason for termination is not reported in the registry record. The primary result is based on 7 participants per group, and the record does not explain why the endpoint population does not represent the full enrollment. This limits assessment of how well the posted summaries reflect the randomized cohort.
General statistical context: statistical evidence depends not only on the direction of a summary but also on its uncertainty, the analysis population, and the prespecified comparison. A difference in descriptive means can be compatible with a range of underlying effects. The registry record does not provide the information needed to characterize that range. The responsible interpretation is therefore limited to the scores and ranges posted, without a claim that either cream produces a benefit or lacks one.
13. Why This Trial Matters Statistically
This trial presents a useful statistical distinction between a planned clinical question and an answer supported by posted analyses. The registry describes a randomized comparison of vaginal estrogen cream with placebo cream, both alongside pelvic floor physical therapy, and identifies a global improvement score at 6 months as the primary outcome. The posted values allow readers to understand the direction of the observed mean scores, but they do not provide an inferential comparison or a measure of precision.
The primary endpoint population is small, with 7 survey completers per group. General statistical context: in small groups, estimates can be sensitive to a small number of observations, and uncertainty can be substantial. Reporting the full range is informative about the endpoints observed, but does not substitute for a standard deviation or confidence interval. The absence of those measures makes it difficult to judge how precise the group summaries are.
The record also illustrates why enrollment, outcome completion, and analysis populations should be distinguished. It lists enrollment of 21, but the primary endpoint is based on survey completers and the record does not explain the difference. Without a participant flow or missing-data account, readers cannot determine how the endpoint results relate to all randomized participants.
The trial is listed as terminated, and the reason is not reported. Its record names several secondary outcomes but posts no analyses. These features make transparent reporting of the endpoint population, analysis plan, missing data, and termination especially important for interpretation. The registry entries do not establish that the study was poorly conducted; they define what can and cannot be concluded from the posted record.
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 principal limitation for interpreting the primary result is that the record reports descriptive summaries without a treatment-comparison analysis. No confidence interval, p-value, standard deviation, or model-based estimate is posted. The observed means and ranges therefore do not quantify the uncertainty in a group contrast.
The endpoint summaries cover 7 survey completers in each group. Although enrollment is listed as 21, the registry does not describe participant flow, group-specific randomized totals, reasons for missing surveys, or how missing outcome data were handled. It is consequently unclear how the endpoint sample relates to the full randomized population. The reason the trial was terminated is also not reported.
The registry identifies the study as randomized, triple-masked, and parallel-group, but does not report details of random sequence generation, allocation concealment, the roles masked, or the procedures used to maintain masking. Treatment adherence, physical therapy content, cream dosing, baseline characteristics, and the timing or completeness of adverse-event monitoring are not reported in the registry record.
The record lists five secondary outcomes but no analyses. It does not describe a multiplicity strategy or specify which analysis populations or statistical models were planned. The PGI-I is a global rating, so its summary does not directly answer questions about anatomical support, biomarkers, or each listed symptom and quality-of-life outcome. These limitations concern the completeness of the registry record and the scope of the posted results; they do not establish the direction or validity of unreported findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse — NCT01648751.
- Registry record last updated 2024-09-19; status last verified 2024-09.
- Results first posted 2024-09-19.
- 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
The registry describes a randomized, triple-masked, parallel-group trial of vaginal estrogen cream versus placebo cream in women with symptomatic mild pelvic organ prolapse undergoing pelvic floor physical therapy. Enrollment is listed as 21, and the study status is terminated. The reason for termination is not reported in the registry record.
The primary outcome is the PGI-I score at 6 months after starting vaginal cream, with lower scores indicating more improvement. Among survey completers, the vaginal-estrogen group had a mean of 2.3 and a full range of 1.0 to 3.0; the placebo-cream group had a mean of 3.0 and a full range of 1.0 to 5.0. Each group had 7 participants represented in this outcome. The registry posts no analysis for the primary outcome or the named secondary outcomes.
Serious adverse events and deaths are recorded as 0 in each group. These counts are reported for 9 participants at risk in the vaginal-estrogen group and 11 in the placebo-cream group. The record does not provide enough analysis or missing-data detail to establish the precision or interpretation of a treatment comparison.