Developing Rectal USPE Measures: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Developing Rectal USPE Measures (NCT02102867), a na na study. The primary outcome is User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means.

2. Clinical Question

3. Trial Design

This completed study was registered as “Developing Rectal USPE Measures,” with the official title “Evaluating User Perceptions and Experiences of Dual Compartment Microbicide Formulations. Project 5.1: Developing Rectal USPE Measures.” The sponsor was The Miriam Hospital. The registry lists the phase as NA, allocation as NA, masking as NONE, and the model as SINGLE GROUP. These entries describe a measure-development study without a randomized, masked treatment comparison.

The registry lists an enrollment of 18. The study dates are recorded as a start in 2014-04 and primary completion in 2015-03; its status is COMPLETED. Participants were recruited into male and female cohorts. The study’s purpose was to adapt existing vaginal User Sensory Perception and Experience items or instruments for rectal use, develop the scales using Gel, Cream, and Liquid formulations, and develop additional instruments for product use in the context of receptive anal intercourse.

The primary outcome is a continuous measure described as the mean of scale items, with standard deviation as the dispersion measure. Its timeframe is “3 web-based surveys over an average of 6-12 weeks.” The registry notes that the number analyzed for each scale may differ from the overall sample size because sex affects opportunity to evaluate some content, or because a scale may not be evaluable for a participant.

The registry record does not report a protocol-level allocation scheme, a control arm, masking beyond the entry NONE, or a detailed analysis plan. It also does not report numerical primary-outcome results. The record lists one outcome measure and zero analyses; that registry count does not establish whether analyses were or were not conducted outside the 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Before assignment: Three female participants were withdrawn from study and did not complete product evaluation. One had a positive pregnancy, two withdrew due to not being able to follow study guidelines.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Numbers analyzed for each scale may differ from overall sample size as a function of sex (and hence opportunity to evaluate) or a non-evaluable scale for a given participant.

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 User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means, measured over 3 web-based surveys over an average of 6-12 weeks.

The primary outcome is the User Sensory Perception and Experience (USPE; Perceptibility) Scale Item Means. It is described as the sum of averaged item means divided by the number of items, with a minimum and maximum of 1 and 5. The response anchors run from “Do not agree at all” at 1, through “Agree a little,” “Agree somewhat,” and “Agree a lot,” to “Agree completely” at 5. Higher scores indicate greater agreement about product characteristics.

The items address experiences and perceptions such as smoothness or lubricity at initial penetration, coating or lubrication, ease of stroke and product spread, awareness of product during sex, perceived wetness, stimulation, messiness, leakage, pre-coital leakage, naturalness, effort, pleasure, and noticeability. The registry describes these as characteristics of product use, not clinical outcomes such as infection or disease. The measure is relevant to the study’s stated objective of adapting and developing instruments for rectal compartment use and receptive anal intercourse.

A scale mean can provide a compact description of responses across its items, while the standard deviation describes variation among the measured scores. Those are general interpretations of the stated summary measures. The registry record does not report the scale means, standard deviations, numbers analyzed for each scale, or item-level results, so the direction and precision of observed responses cannot be assessed from the recorded outcome description alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the outcome as continuous and specifies a mean with standard deviation. General explanation: a mean describes the central level of a set of numerical observations, while a standard deviation describes how spread out those observations are around the mean. The mean does not show whether participants gave similar responses or whether responses varied considerably; the standard deviation is intended to help describe that variation. Neither statistic is reported numerically for the primary outcome in the registry record.

What does the scale score represent?

The described USPE score combines item responses using the stated sum of averaged item means divided by the number of items. Individual response anchors range from 1, “Do not agree at all,” to 5, “Agree completely.” The other anchors are “Agree a little,” “Agree somewhat,” and “Agree a lot.” The registry says that higher scores mean greater agreement about product characteristics. This direction refers to agreement with the scale items; it does not mean that a higher score is a clinical benefit or that one formulation is superior.

The listed domains cover multiple aspects of experience: smoothness or lubricity at initial penetration; coating or lubricating at initial lubrication; ease of stroke and product spread; product awareness during sex; perceived wetness; stimulation; messiness; leakage during or after sex and related cleanliness perceptions; pre-coital leakage; naturalness; lubricity; effort; pleasure; and noticeability. These descriptions indicate the range of content represented in the measure. The registry does not report item wording beyond the summarized descriptions, scoring rules for any separately named subscale, or evidence about reliability or validity.

Why does the analysis population matter?

The registry notes that numbers analyzed may differ by scale because some items depend on sex and the associated opportunity to evaluate a product-use experience, or because an individual scale may not be evaluable for a participant. General explanation: a denominator is the number of people contributing data to a particular estimate. If denominators differ across scales or formulations, their means may describe different subsets of the enrolled group. That can complicate direct comparisons, even when every estimate uses the same response anchors. The registry does not provide the scale-specific denominators, so the composition of the analysis population cannot be assessed.

The outcome timeframe is 3 web-based surveys over an average of 6-12 weeks. That describes the survey schedule and overall observation period, but the registry does not explain how responses across surveys were combined, whether the same participants completed every survey, or how repeated responses were handled statistically. General explanation: repeated observations from the same participant are related rather than independent. An analysis that treats them as independent can misstate uncertainty; an analysis designed for repeated data accounts for that within-participant relationship. The registry record does not report which approach, if any, was used.

What can standard deviations and confidence intervals tell readers?

General explanation: a standard deviation describes the spread of observed values, whereas a confidence interval describes uncertainty around an estimated quantity under the assumptions of the analysis. A confidence interval is not a guarantee that the true value lies within its limits; it is a procedure for expressing estimation uncertainty. A narrow interval generally indicates more precise estimation than a wide interval, given the method and data. No confidence intervals are reported for the primary outcome, and the primary scale means and standard deviations are also not reported in the registry record. Consequently, neither the observed response level nor its precision can be evaluated from this record.

What does the design allow?

The study is listed as SINGLE GROUP, with allocation NA and masking NONE. General explanation: a single-group study can describe observations in the enrolled participants, but without a randomized comparator it cannot separate formulation-related differences from other explanations such as participant characteristics, order of exposure, or context. This is especially important when interpreting any apparent differences across products. The registry does not report whether formulation order was assigned or balanced, nor does it provide a comparative analysis plan. No causal or treatment-effect interpretation should be inferred from the outcome definition.

The record lists one outcome measure and zero analyses. Those are registry entries, not a statistical methods description. The statistical test, model, handling of repeated observations, covariate adjustments, and approach to uncertainty are not reported in the registry record. A normal approximation, a particular test, or a specific distributional assumption should not be attributed to the study without a reported plan.

What do the sample-size assumptions mean?

The record includes general assumptions for a planning illustration: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. It distinguishes total events for time-to-event illustrations from participants per arm for other illustrations. These assumptions describe a planning framework, not an observed result and not necessarily the study’s own design. The registry does not report numerical sample-size illustration results or an observed effect for this endpoint. In general, a planning sample size is conditional on its assumptions; it is not observed power and does not show that a study had a particular probability of detecting an effect.

The registry record does not report a sample-size justification for enrolling 18 participants, a pre-specified primary comparison, interim analyses, or a detailed statistical analysis plan. Those omissions limit reconstruction of how the investigators intended to interpret the scale scores. General methodological explanations can clarify what means, standard deviations, and repeated-measures analyses are designed to do, but they cannot fill in an unreported analysis or establish results that are absent from the record.

10. Multiplicity, Missing Data and Analysis Populations

The registry describes a broad set of USPE content areas, including lubrication, spreading, awareness, wetness, stimulation, messiness, leakage, naturalness, effort, pleasure, and noticeability. Evaluating many items or scales can raise a multiplicity issue: general explanation, when multiple statistical hypotheses are tested, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for the number and relationship of tests. The registry does not report a multiplicity adjustment, a hierarchy of outcomes, or which comparisons were intended to be primary. It also does not report numerical tests or results, so the consequences of multiple testing cannot be assessed.

Missing data are relevant because the registry explicitly says the number analyzed for each scale may differ from the overall sample size. The stated reasons include sex-related opportunity to evaluate a scale and whether a scale was evaluable for a participant. This is a measure-specific issue rather than evidence that all participants completed all items. The registry record does not report the number of missing responses, reasons for missingness by scale, imputation methods, or a sensitivity analysis. General explanation: results based on different subsets can be difficult to compare if the participants contributing to each estimate differ in meaningful ways.

The analysis population is not reported separately for each scale or formulation. The registry lists enrollment of 18, but that enrollment figure should not be treated as the denominator for every outcome estimate. The record also does not report whether all enrolled participants were included in any particular analysis, the handling of incomplete surveys, or whether analyses followed a pre-specified population definition. Since no numerical outcome estimates are reported, neither the extent of missing data nor its possible effect on the results can be quantified.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse-event counts separately for females and males. Among 7 females at risk, 0 serious adverse events are listed; among 8 males at risk, 0 serious adverse events are listed. For other adverse events, 1 is listed among females at risk and 0 among males at risk. No top serious adverse-event terms are listed. The death entries are null, which means death counts are not reported in the registry record.

These are counts in the registry’s safety categories and should not be read as rates or as a complete description of safety. General explanation: an adverse-event count depends on what was collected, the period of observation, the definitions used, and how events were attributed or entered. The registry does not report event descriptions for the other adverse event, its timing, severity, relatedness to a formulation, or follow-up duration for safety. It also does not state whether the listed at-risk groups represent every participant exposed to every formulation.

The reported zeros for serious adverse events are not evidence that no event could occur, nor do they establish comparative safety among Gel, Cream, and Liquid. The study is single-group and does not report a randomized safety comparison. The record supports only the listed counts and the limitations of the accompanying safety information.

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

The study addresses an important measurement question: how to describe sensory perceptions and product-use experiences for rectal formulations, including use in the context of receptive anal intercourse. It aimed to adapt existing vaginal USPE items, develop scales using Gel, Cream, and Liquid, and create novel instruments for product use in male and female cohorts. The described domains make clear that the focus was on subjective experiences such as lubrication, product awareness, leakage, effort, and pleasure.

The record does not report numerical results for the primary scale outcome. It therefore does not establish the average ratings for any formulation, how variable the ratings were, whether ratings differed between formulations, or how precise any estimates might be. The scale’s response anchors and direction explain what a score is intended to mean, but they are not a substitute for observed scale values.

Nor does the record establish that the instruments are reliable, valid, or suitable for every intended context. Such conclusions would generally require evidence about measurement properties and the way the items perform in the relevant population. The registry does not report those analyses. The study’s stated purpose is measure development, but the existence of that purpose alone is not evidence that a final or validated instrument resulted.

Because there was no randomized comparison recorded, the study should not be interpreted as estimating a causal effect of one formulation versus another. The record also does not report clinical outcomes that would support conclusions about prevention, treatment, or health benefit. The figures available for safety are limited to the registry’s adverse-event counts, with deaths not reported.

In general, a study can contribute useful descriptive or developmental evidence without answering a treatment-effect question. For this record, the appropriate interpretation is bounded by its stated measurement-development aims and the absence of numerical primary-outcome findings. Claims about comparative acceptability, product performance, or clinical effectiveness are not supported by the results reported in the registry record.

13. Why This Trial Matters Statistically

Clinical measures need to capture experiences that matter in the setting where a product is used. This study’s stated aim was to adapt vaginal USPE content for rectal compartment use and to develop measures for the context of receptive anal intercourse. Its focus on lubrication, spreading, awareness, wetness, leakage, naturalness, effort, and other perceptions reflects the complexity of describing product use through participant reports rather than through a single clinical event.

Statistically, the study illustrates why defining the measurement target comes before interpreting a score. A scale mean is meaningful only in relation to the items included, response anchors, population contributing responses, and scoring approach. The registry gives a broad score description and identifies a 1-to-5 response range, while also noting that scale-specific analysis numbers may vary. Those details matter because estimates from distinct sets of participants or items may not be directly comparable.

The record also highlights the difference between a measurement-development objective and a randomized treatment comparison. A single-group design can support a descriptive or developmental purpose, but it does not by itself isolate causal differences between products. The design classification, absence of allocation, and lack of reported comparative analyses should guide interpretation more strongly than the presence of several named formulations.

Finally, transparent reporting of the scale-specific results, analysis populations, missing responses, and measurement properties would be needed to assess what the study established. Those details are not reported in the registry record. The value of the record is therefore its account of the question and outcome concept, while the strength and precision of any empirical conclusions remain unavailable.

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 outcome is that numerical scale results are not reported in the registry record. Means, standard deviations, confidence intervals, scale-specific denominators, and item-level findings are unavailable. Without them, readers cannot assess response levels, between-participant variation, or precision.

The record identifies a single-group design and no randomized allocation. It does not report a control group or a formal comparison between Gel, Cream, and Liquid. Thus, any descriptive variation across formulations would not, on the information recorded, establish a causal formulation effect. The registry also does not report product order, exposure details, or whether every participant evaluated each formulation.

Scale-specific analysis populations may differ because of sex-related opportunity to evaluate particular content or because a scale may be non-evaluable. However, the registry does not provide the numbers analyzed by scale, item completion, missing-data reasons, or methods for handling incomplete responses. This limits assessment of whether results would represent the enrolled participants or a selected subset.

The outcome description gives broad domains and scoring direction, but the registry does not report detailed psychometric analyses, reliability, validity, or evidence that the adapted and novel instruments function as intended. Nor does it report a detailed statistical analysis plan, hypothesis tests, multiplicity procedures, or a sample-size justification. The listed planning assumptions do not establish the study’s own design basis or observed power.

Safety reporting is also limited: event details and attribution are not reported, and death entries are null. These limitations are specific to the information in the registry record and do not establish what may have been documented elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Developing Rectal USPE Measures — NCT02102867.
• Registry record last updated 2026-02-05; status last verified 2026-01.
• Results first posted 2026-02-05.
• 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

NCT02102867 is a completed single-group study sponsored by The Miriam Hospital, with enrollment of 18 and a focus on developing and evaluating USPE measures for rectal-use microbicide formulations. The registry lists Gel, Cream, and Liquid and describes 3 web-based surveys over an average of 6-12 weeks. The primary outcome is a continuous scale score with responses from 1 to 5, where higher scores indicate greater agreement about product characteristics.

The record lists one outcome measure and zero analyses, but does not report numerical primary-outcome results, scale-specific analysis counts, or detailed statistical methods. The study is not recorded as a randomized comparison. Safety entries list 0 serious adverse events for the female and male groups, 1 other adverse event among females, and 0 among males; death counts are not reported in the registry record. Interpretation is therefore limited to the study’s measurement-development purpose and the information recorded.