Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome (NCT02457182), a randomized na study. The primary outcome is Global Response Assessment (GRA).

2. Clinical Question

The study addresses whether response ratings differ between the two randomized groups. The GRA is a 7-point scale that spans worsening and improvement, from markedly, moderately or slightly worse to slightly, moderately or markedly improved. The registry record does not report a single comparison of those response categories, so it does not establish how the distributions differed between groups.

The registry also lists outcomes covering symptoms and problems, pain, health-related quality of life, sexual function, and pain self-efficacy. Those outcomes add relevant perspectives on participants’ experiences, but their results are not reported in the registry record. The clinical question is therefore clear from the planned comparison, while the posted information does not quantify the primary or secondary outcomes.

3. Trial Design

This was a randomized, parallel-group trial with no masking. Participants were assigned to MBSR or usual care. The enrollment recorded for the study is 20. The safety record lists 9 participants at risk in the MBSR group and 11 in the usual-care group; those group counts are the denominators shown for the adverse-event information.

The MBSR intervention is described as an 8 week class focused on meditation and other techniques. The comparator was usual medical therapy. The primary outcome was to be assessed within 2 weeks of the class ending. The record does not provide a corresponding outcome-assessment schedule for the secondary outcomes.

The study is marked completed. Its recorded start is 2014-11 and its primary completion is 2015-06. The phase is recorded as NA. The sponsor is the University of New Mexico. Details of the randomization sequence, allocation concealment, class attendance, treatment adherence, and use of other care are not reported in the registry record.

A parallel-group design compares outcomes between distinct groups assigned to different strategies. Random assignment is intended to support a fair comparison, but the registry record does not provide enough information to assess how assignment was generated or implemented. With no masking, participants and study personnel were not masked according to the record. That matters particularly for a participant-reported assessment such as the GRA, because expectations and awareness of group assignment may influence reported responses. The record does not describe any steps taken to address that possibility.

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 Global Response Assessment (GRA), measured over Within 2 weeks of 8-week class ending.

The primary endpoint is the Global Response Assessment (GRA), recorded in participants. It is a 7-point scale with categories ranging from markedly, moderately or slightly worse to slightly, moderately or markedly improved. The planned assessment time was within 2 weeks of the 8-week class ending.

The GRA is used in many types of research and is not specific to IC/BPS. A global assessment can capture a participant’s overall sense of change rather than one isolated symptom, making it useful when a condition may affect people in several ways. At the same time, its ordered categories are not interchangeable with a direct measurement of symptom severity or a count of symptoms. The interpretation depends on how the categories are analyzed and compared.

The registry record does not report how GRA categories were to be summarized for a primary comparison, nor does it provide category counts by group. It notes that the primary outcome has several categories or time points and was not reduced to one comparison. Therefore, the posted information does not support a numerical estimate of the difference in GRA response between MBSR and usual care. The outcome definition identifies what was to be measured, but it is not itself evidence of the result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Randomization and comparison. Randomization assigns participants to study groups by chance, with the aim of reducing systematic differences between groups at the point of assignment. This trial is recorded as randomized and parallel, comparing MBSR with usual care. General statistical interpretation: randomization supports a between-group comparison, but does not guarantee that groups will have identical characteristics, especially in a study with limited enrollment. The registry record does not describe the sequence-generation method, concealment of assignments, or any adjustment for baseline characteristics.

Outcome scale and analysis. The primary GRA is a 7-point scale with ordered categories spanning worse and improved responses. Such data preserve a ranking, but the distance between adjacent response categories is not necessarily equal. General statistical interpretation: analysts may compare the distribution across categories, use a prespecified summary, or apply a model appropriate for ordered outcomes. The choice affects the estimand and interpretation. The registry record does not report a primary analysis method or a single numerical comparison; it states that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, there is no posted estimate to interpret as a difference in response.

Effect estimates and uncertainty. A treatment-effect estimate describes the contrast between groups for a defined outcome and analysis. A confidence interval describes the range of values reasonably compatible with the data and the statistical method, under its assumptions. General statistical interpretation: a narrow interval indicates greater precision than a wide interval, while neither an estimate nor an interval alone establishes clinical importance. No primary-outcome estimate or confidence interval is reported in the registry record. The available information therefore cannot establish either the direction or precision of a primary comparison.

Significance testing. A p-value is a measure of how compatible observed data are with a specified null model, given the analysis assumptions; it is not the probability that a treatment works or that the null hypothesis is true. The registry record does not report a primary-outcome p-value or statistical test. The design information alone does not allow one to infer statistical significance.

Planning calculations. The record describes sample-size planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. General statistical interpretation: these are planning scenarios, not observed power, and their meaning depends on the assumed effect and analysis. Participants per arm for 80% power is a planning quantity, not a count of trial participants or a measure of what the completed study achieved. The registry record does not report the trial’s own sample-size justification. Because no single primary-outcome comparison is posted, planning values cannot replace an interpretable primary result.

Over-dispersion and count outcomes. The primary outcome is recorded in participants, but its response categories are not reported as a single binary event. General statistical interpretation: for count data, over-dispersion occurs when variation exceeds what a simple model assumes; accounting for it can be important because standard errors may otherwise be too small. That concept does not produce an analysis for this GRA outcome, and the registry record does not report a count model or dispersion estimate. No such model should be inferred from the outcome label alone.

Recalculation. A recalculated estimate, when available, is a simple unadjusted calculation from posted summary statistics; it is not a substitute for the sponsor’s own analysis. The registry record reports no primary summary statistics that permit a recalculation of the GRA comparison. No recalculated primary effect or uncertainty measure is therefore available from the posted information.

General limits of statistical summaries. A numerical comparison would need to identify the analyzed participants, the treatment contrast, the response categories or summary used, and the uncertainty around the estimate. Statistical methods can describe patterns in observed data, but they cannot resolve missing outcome reporting or establish details that are not documented. In this trial, the registry information identifies the study design and outcome but leaves the primary analysis and its result unreported.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 6 outcome measures: the primary GRA and five secondary measures. When several outcomes are assessed, repeated statistical testing can increase the chance of finding an apparently notable result by chance. General statistical interpretation: a prespecified hierarchy or an adjustment for multiple comparisons can help address that issue, but the appropriate approach depends on the study question and analysis plan. Multiplicity handling is not reported in the registry record.

The record reports 0 analyses. It does not provide outcome summaries, a primary comparison, or results for the listed secondary measures. Missingness and completeness of outcome data are also not reported in the registry record. There is no information on how many participants contributed data at each assessment, reasons for missing observations, or methods used to handle missing data.

Analysis populations are not reported in the registry record. It is therefore not possible to determine whether results were intended for all randomized participants, participants who attended the class, or another defined group. The record also does not describe an intention-to-treat analysis or a per-protocol analysis. These omissions limit assessment of whether the reported participants and methods would preserve the randomized comparison. They do not establish that data were missing or that any particular analysis population was used; those details are simply not reported in the registry record.

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.

The safety record lists 9 participants at risk in the MBSR group and 11 in the usual-care group. It reports 0 serious adverse events in each group and 0 other adverse events in each group. These are the posted counts among the participants listed as at risk. No serious adverse-event terms are listed.

Zero reported events in these records means that no events were entered in those categories for the listed groups; it does not establish that an event was impossible or that a larger study would observe none. General statistical interpretation: adverse-event counts are descriptive, and their interpretation depends on how events were collected, the length of follow-up, and whether all participants were assessed. Those details are not reported in the registry record.

Deaths are not reported in the registry record. The adverse-event information should be read as a limited accounting of recorded events, not as a comprehensive assessment of safety or a comparison capable of establishing differences between groups.

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

The registry record establishes that a randomized, parallel-group study compared an 8 week MBSR class with usual medical therapy for IC/BPS. It identifies the GRA as the primary outcome and gives its assessment window. The record also lists several secondary measures and provides counts for adverse events among participants at risk.

It does not provide a primary-outcome result. In particular, there are no posted GRA response counts by group and no single comparison across the response categories. The registry record also does not report results for the secondary measures. Thus, the posted information cannot quantify whether response ratings differed, how large any difference was, or how precise an estimate might be.

This absence of a reported result is not the same as a finding of no difference. Nor does it support a conclusion that one approach performed better. A statistically meaningful interpretation would require an outcome estimate and its uncertainty, together with enough detail about the analysis to understand the comparison. Those elements are not reported in the registry record.

The sample-size illustrations are planning calculations, not observed power and not evidence about the study’s findings. Likewise, the recorded adverse-event counts are descriptive and do not replace the missing efficacy outcomes. The registry information is therefore most informative about what the trial set out to compare and what measures it listed; it is not sufficient to answer the comparative clinical question from results.

These limits concern what can be concluded from the registry record. They do not determine what may have been collected or analyzed outside the record. Any interpretation of unreported results would require information not reported in the registry record.

13. Why This Trial Matters Statistically

This trial illustrates why a defined outcome and a reported result are different things. The registry identifies the GRA, its range of response categories, and the planned timing. But a multi-category outcome needs a clearly reported comparison to show how the groups’ responses relate. Without category counts or a summary estimate, readers cannot assess direction, magnitude, or precision.

The enrollment of 20 also makes precision an important statistical consideration. General statistical interpretation: smaller studies often have less information for estimating group differences, and uncertainty can remain substantial even when the observed estimate appears notable. In this record, no primary effect estimate or confidence interval is reported, so the actual precision cannot be evaluated.

The study’s open-label design is another relevant feature because the primary measure is a participant assessment of overall response. Awareness of assignment can influence reports in some settings. That is a general methodological concern, not evidence that responses in this trial were biased. The registry record does not describe procedures to address this issue.

Finally, the record includes multiple secondary measures as well as the primary outcome. When several outcomes are examined, transparent reporting of the analysis plan and multiplicity approach helps readers interpret the evidence. Those details are not reported in the registry record. The statistical lesson is that design information, outcome definitions, analysis methods, and numerical results are all needed for a complete appraisal; the record supplies some of these elements but not the primary comparison.

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 interpretation is that no primary-outcome comparison is reported. The GRA includes several categories, and the registry record notes that it was not reduced to one comparison. Without response counts or an effect estimate, the result cannot be quantified. Results for the five listed secondary measures are also not reported in the registry record.

The recorded enrollment is 20, and the safety denominators are 9 and 11. This limits the amount of information available for precise group comparisons, although precision cannot be calculated without outcome estimates and uncertainty measures. The record does not report baseline characteristics, so the groups’ starting comparability cannot be assessed from this information.

The trial was unmasked. Since the primary measure is a participant-reported global assessment, awareness of assignment is a possible source of measurement influence in general; the record does not indicate whether this occurred. It also does not report adherence, attendance, concurrent treatment details, or the procedures used to implement randomization.

Further limitations include the absence of a reported statistical analysis plan, analysis populations, missing-data methods, and multiplicity handling. The GRA is used in many types of research and is not specific to IC/BPS, as the record notes. The assessment was planned within 2 weeks of the 8-week class ending; longer-term outcomes are not reported in the registry record. These gaps restrict interpretation of both the primary question and the broader outcome profile.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome — NCT02457182.
• Registry record last updated 2018-10-09; status last verified 2018-01.
• Results first posted 2018-10-09.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT02457182, sponsored by the University of New Mexico, is a completed randomized, unmasked, parallel-group trial of MBSR versus usual medical therapy for IC/BPS. The recorded enrollment is 20; the safety record lists 9 participants at risk in the MBSR group and 11 in usual care. The MBSR intervention is described as an 8 week class.

The primary outcome was the Global Response Assessment within 2 weeks of the class ending. Five secondary outcomes are listed. No analysis is reported, and the primary outcome is not reduced to a single comparison. The record lists 0 serious and 0 other adverse events in each group; deaths are not reported in the registry record. The study start is recorded as 2014-11 and primary completion as 2015-06.