Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy (NCT01829425), a randomized na study. The primary outcome is Percent Change in Urgency Urinary Incontinence Episodes.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group trial listed as completed. The registry records an enrollment of 165 and identifies the condition as urinary urge incontinence. The record identifies the sponsor as the University of New Mexico. The listed start date is 2013-04-22, and the primary completion date is 2017-10-27. The phase is recorded as NA.

Participants were assigned to hypnotherapy or anticholinergic medication. The masking designation is single, but who was masked is not reported in the registry record. The intervention descriptions indicate that the treatment approaches were different: hypnotherapy involved sessions and home practice, while the medication arm involved a choice of long-acting anticholinergic medication and counseling. The registry does not describe any additional procedures intended to make the interventions indistinguishable.

The hypnotherapy program was described as approximately weekly sessions over 8 weeks, with digital recordings for home practice and encouragement to continue self-hypnosis or listening for 1 year. The medication arm used either long-acting tolterodine or extended-release oxybutynin, with counseling over 8 weeks and continued medication for 1 year. The record does not report the criteria for choosing a medication or the details of adherence assessment.

The primary endpoint used baseline and 2-month follow-up diary information. Although the brief study description refers to evaluations at months 2, 6 and 12, the registry record does not provide results for all those time points in the posted primary analysis. The study description also mentions validated questionnaires and other diary parameters as possible symptom or quality-of-life outcomes. The registry lists secondary outcomes, but the available results summarized in the record do not provide estimates for every listed outcome.

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: Patients required to keep 3 day voiding diary to confirm their eligibility for the study prior to randomization. Pts also underwent hypnotic susceptibility testing prior to randomization. Of those consented, 13 did not go on to randomization: 8 were excluded because they did not meet inclusion criteria and 5 were lost to further followup

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Randomized patients with primary outcome (diary information) 2 months. Hypnotherapy: 74 randomized; of those randomized 3 had withdrawn, 1 was lost=70 with primary outcome information for analysis. Medications: 78 randomized-- 4 withdrawn. 2 were missing diary information=72 with primary outcome information for analysis

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.

Population: analysis was performed on baseline of patients with primary outcome data; baseline analysis includes the 70 and 72 patients with 2 month data

6. Primary Endpoint

The registry lists the primary outcome as Percent Change in Urgency Urinary Incontinence Episodes, measured over Baseline and 2 month follow-up.

The primary endpoint is the percentage change in urgency urinary incontinence episodes from baseline to the 2-month follow-up. It is expressed as a percentage change in the median number of episodes, and the comparison is between the hypnotherapy and medication groups. The registry says the endpoint was based on diary information and describes the primary analysis population as randomized patients with primary outcome information at 2 months.

A diary-based episode measure addresses the symptom that the trial was designed to study: urgency urinary incontinence. Using change from baseline relates the follow-up measure to participants’ starting episode levels, while reporting the median describes the middle of the observed distribution rather than its arithmetic average. These are general statistical features of change measures and medians; the record does not state further reasons for selecting this endpoint or specify how diary entries were converted into each participant’s percentage change.

The posted arm values are median percentage changes of 73 for hypnotherapy and 88.6 for anticholinergic medications. Their reported confidence intervals are 60 to 88.9 and 78.6 to 100.0, respectively. The record identifies the intervals as 95% confidence intervals. The primary comparison is a non-inferiority analysis, but the non-inferiority margin and the exact direction convention for the percentage-change scale are not reported in the registry record. The arm values therefore describe the posted endpoint estimates, but by themselves do not establish the non-inferiority conclusion.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary comparison is described as an exact Mann Whitney analysis, with the endpoint expressed as percentage change in median urgency urinary incontinence episodes. In general, the Mann Whitney procedure compares the distributions of observations in two groups using their ranks rather than requiring the outcome to follow a normal distribution. An exact procedure calculates probabilities from the possible rank arrangements under its assumptions, rather than relying on a large-sample approximation. The registry does not report further details of the implementation, such as how ties or missing values were handled.

What does the median describe?

In general, the median is the central value after observations are ordered. It is less sensitive to extreme observations than an arithmetic mean. That can make it a useful summary when a measure is skewed, although the record does not provide the underlying episode-change distributions or explain why the median was selected. The posted arm summaries are medians, and the posted analysis is rank-based; these are related ways to characterize data but are not interchangeable descriptions of the same estimand.

How should the confidence intervals be read?

In general, a confidence interval describes the uncertainty around an estimate using a stated method. The posted arm summaries are accompanied by 95% confidence intervals. For the group contrast, the record reports a lower bound but no upper bound. As a result, the interval does not provide the full span needed to assess the uncertainty in the reported contrast. The interval construction method for the arm medians is not reported in the registry record, and no additional method details are available for the contrast interval.

A confidence interval does not mean that the parameter has a 95% probability of lying within the particular interval after it has been calculated. In general, the stated confidence level describes the long-run performance of a procedure under its assumptions. For interpretation of this trial, the missing upper bound and the unreported non-inferiority margin are important: a non-inferiority assessment relies on comparing the uncertainty in the treatment contrast with a prespecified margin.

What is non-inferiority testing?

In general, a non-inferiority trial asks whether the outcome with one intervention is not worse than the comparator by more than a clinically acceptable margin. That margin should be specified before outcome analysis, and the result is interpreted in relation to the direction of the comparison and the interval for the treatment contrast. The registry labels the reported analysis as non-inferiority and states the hypothesis that hypnotherapy would be non-inferior to pharmacotherapy in diminishing episodes. It does not report the margin, the direction convention for the contrast, or a complete confidence interval. Those omissions prevent a full independent assessment of the stated non-inferiority question.

The p-value is reported as p < .025. In general, a p-value measures how incompatible the observed data are with a specified null model, conditional on the analysis assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. In a non-inferiority setting, the null hypothesis and decision threshold are tied to the margin. Since the margin and full contrast interval are not reported, the p-value alone cannot show how the reported result relates to the intended non-inferiority criterion.

What does the analysis population represent?

The record describes the primary analysis as randomized patients with diary information at the 2-month follow-up. It reports 70 participants with primary outcome information in the hypnotherapy group and 72 in the medication group. The record also details withdrawals, loss to follow-up, and missing diary information. This is an outcome-available analysis population rather than a clearly described analysis of every randomized participant. The registry does not report whether missing outcomes were imputed, whether sensitivity analyses were conducted, or whether an intention-to-treat analysis was performed.

In general, restricting an analysis to observed outcomes can affect comparability if outcome availability is related to treatment assignment or to the outcome itself. That is a general consideration, not evidence that such bias occurred in this trial. The registry does not provide enough information about reasons for missingness or missing-data methods to evaluate that possibility.

What does the registry report about planning?

The sample-size illustration is described as based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the original trial had a particular design justification. The registry does not report the trial’s own sample-size justification, the assumptions used when planning enrollment, or whether interim analyses were conducted. No inference about those design features should be drawn from a planning illustration based on the observed result.

The statistical plan beyond the named exact Mann Whitney method is not reported in the registry record. In particular, the record does not describe prespecified analysis procedures for the secondary outcomes, adjustment for multiple comparisons, handling of ties, or a complete missing-data strategy. These are limits on what can be independently evaluated from the posted statistical information.

10. Analyses Reported by the Sponsor

The registry’s reported primary comparison is an exact Mann Whitney non-inferiority analysis. It lists a between-group difference of 5, a 95% confidence interval with lower bound 5 and no reported upper bound, and p < .025. The registry also posts the arm-level medians and their 95% confidence intervals. No separate recalculated primary estimate is reported in the record, so there is no independent re-calculation to compare with the sponsor’s analysis.

The record does not flag a discrepancy between a sponsor analysis and a recalculation. The reported sponsor analysis therefore remains the relevant posted analysis; any recalculated values, if available, would be simple unadjusted calculations from posted summary statistics and would not replace the sponsor’s own analysis. The record does not provide enough detail to reproduce the rank-based test from the arm summaries alone.

Interpreting the sponsor’s result still requires information not present in the registry record. The non-inferiority margin, direction convention, and upper confidence bound for the contrast are not reported. The posted p-value should not be treated as a substitute for those details. The sponsor’s analysis is the source of the stated test result, while the incomplete interval and missing margin limit assessment of its non-inferiority interpretation.

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 11 posted secondary outcomes and reports 12 outcome measures. Secondary outcomes include percent change in urgency urinary incontinence episodes, Overactive Bladder Questionnaire Short Form symptom bother, and Overactive Bladder Questionnaire Short Form quality of life. Several outcome labels appear more than once, and the registry lists 2 analyses. The record does not explain how the repeated outcome entries relate to distinct time points or analysis contrasts.

When many outcomes or comparisons are tested, the chance of obtaining at least one apparently unusual result can increase. In general, multiplicity procedures can control that risk, but the registry record does not report whether any adjustment was planned or applied. It also does not state a hierarchy for primary and secondary outcomes beyond identifying the primary endpoint. The posted primary non-inferiority p-value should therefore be interpreted as the reported test, without assuming a multiplicity adjustment or an unreported testing strategy.

For the primary outcome, the record describes randomized patients with diary information at the 2-month follow-up. In the hypnotherapy arm, 74 were randomized; 3 had withdrawn and 1 was lost, leaving 70 with primary outcome information for analysis. In the medication arm, 78 were randomized; 4 had withdrawn and 2 were missing diary information, leaving 72 with primary outcome information. These are the registry’s stated analysis counts and reasons; they should not be taken to establish why information was unavailable beyond the descriptions given.

The record does not report imputation, sensitivity analyses for missing outcomes, or an intention-to-treat analysis. It also does not describe whether the available-outcome population was prespecified. In general, estimates based only on participants with observed outcomes can be affected if missingness is related to treatment or outcome, but the registry does not establish that this occurred. The absence of a described missing-data strategy makes it difficult to judge how robust the primary comparison is to the unavailable diary information.

The detailed statistical analysis plan, including any interim analyses or the rationale for the planned sample size, is not reported in the registry record. No assumptions about those procedures can be made from the posted results or the planning illustration.

12. 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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: 1 inpatient hospitalization (1.4%), 1 inpatient hospitalization for observation (1.4%), 1 in-patient hospitalization (1.4%).

The adverse-event summary reports serious adverse events for 1 participant in the hypnotherapy group and 3 participants in the anticholinergic medication group. The respective serious-event risk sets are 70 and 72. The record reports no deaths in either group. It also reports other adverse events for 12 participants in the hypnotherapy group and 27 participants in the medication group, with the same respective risk sets.

These are descriptive counts from the registry record. They do not, by themselves, establish that one treatment caused more or fewer events. The record does not provide event-level timing, duration, severity classifications beyond the serious-event designation, or details about how events were collected. It also does not provide a statistical comparison of adverse events or explain whether participants could contribute more than one event to a category. Counts should therefore be read as posted rather than combined or interpreted as rates calculated from the group sizes.

The serious-event terms listed include inpatient hospitalization and hospitalization for observation, each shown as 1.4%, with minor wording differences across entries. The record does not clarify whether these labels refer to distinct cases or overlapping descriptions, so they should not be added or treated as separate categories. The safety summary offers a limited account of reported events, not a comprehensive estimate of comparative risk.

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

The posted primary findings describe median percentage change in urgency urinary incontinence episodes at the 2-month follow-up among participants with the required diary information. The registry reports arm medians of 73 for hypnotherapy and 88.6 for anticholinergic medications, along with 95% confidence intervals for each arm. It also reports an exact Mann Whitney non-inferiority analysis with a contrast of 5, a lower confidence bound of 5, no upper bound, and p < .025.

This result does not, on the registry information alone, establish that hypnotherapy is non-inferior to medication. A non-inferiority conclusion depends on the prespecified margin, the direction in which the contrast is defined, and the uncertainty interval relative to that margin. The margin and direction convention are not reported, and the contrast interval is incomplete. The result is therefore best described as a posted non-inferiority analysis whose full decision basis cannot be assessed from the record.

The findings also do not establish a comparison across every outcome mentioned in the study description. The registry lists symptom-bother and quality-of-life measures and refers to later follow-up assessments, but the primary result presented is limited to the episode endpoint at 2 months. The record does not provide a complete set of estimates for all those measures and time points.

Nor do these data establish how the interventions would perform in populations or settings beyond the trial’s described participants. The record identifies women with urgency urinary incontinence, but does not provide detailed participant characteristics, recruitment criteria, or the settings in which care was delivered. Generalization beyond the studied population therefore requires information not present in the registry record.

The result does not give a complete account of adverse-event risk. It provides group counts and a short list of serious-event terms, but not detailed event descriptions or a comparative safety analysis. The absence of reported deaths and the listed adverse-event counts should be interpreted as registry summaries, not as evidence that unreported events did not occur.

14. Why This Trial Matters Statistically

This trial raises a useful statistical question about how to assess a non-inferiority claim when the primary outcome is summarized by medians and the posted inferential result is rank-based. Medians can describe the center of a distribution without assuming that observations are symmetrically distributed. The Mann Whitney approach provides a way to compare the groups using ranks, but interpreting its result still depends on a clearly defined estimand and contrast.

The registry illustrates why a p-value should not carry a non-inferiority conclusion on its own. The analysis is labeled non-inferiority and reports p < .025, yet the non-inferiority margin is not reported, and the contrast interval has no upper bound. Without a margin and a complete interval, readers cannot determine how the uncertainty in the estimate relates to the decision criterion. Reporting the underlying design choices is essential to make a non-inferiority result interpretable and reproducible.

The outcome-available analysis also makes missing-data reporting important. The registry gives withdrawals, loss to follow-up, and missing diary information, and it states the number with primary outcome information in each arm. It does not describe imputation, sensitivity analyses, or an intention-to-treat analysis. Readers can see that the primary comparison uses available diary information, but cannot assess from the record how the missing outcomes might affect the result.

Finally, the trial combines a symptom-based primary endpoint with secondary measures of symptom bother and quality of life. Those domains may provide different kinds of information, but the registry’s incomplete outcome results and unreported multiplicity strategy limit the conclusions that can be drawn across them. The record is a reminder that a trial result is most informative when estimates, uncertainty, analysis populations, and decision rules are all clearly documented.

15. 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 registry does not report the non-inferiority margin, the direction convention for the treatment contrast, or the upper confidence bound for the reported contrast. Those omissions constrain interpretation of the primary test. The p-value is posted, but the available information does not show how the test result compares with the intended non-inferiority criterion.

The primary outcome analysis is based on participants with diary information at the 2-month follow-up. Although the record gives counts of withdrawals, loss to follow-up, and missing diary information, it does not report how missing outcomes were handled statistically. Imputation methods, sensitivity analyses, and an intention-to-treat analysis are not reported in the registry record. The effects of missing outcome information therefore cannot be evaluated from the posted data.

The registry provides limited detail about the endpoint calculation and inferential methods. It does not explain how individual diary data were converted into percentage change, how ties were handled in the exact Mann Whitney analysis, or how the arm-level confidence intervals were constructed. It also does not provide the underlying outcome distributions. These details would be needed for an independent reconstruction of the primary analysis.

The record lists multiple secondary outcome entries and 2 analyses, but does not explain the repeated labels, the role of each analysis, or whether multiplicity was addressed. The brief description mentions follow-up at months 2, 6 and 12, whereas the posted primary outcome is at 2 months; complete results for all stated assessment times are not reported in the registry record.

Participant characteristics, recruitment and setting details, the masking roles, the medication selection process, and adherence information are not reported. The record also does not provide the trial’s sample-size justification or a full statistical plan. These limitations are specific to the information available for this trial and restrict evaluation of generalizability, implementation, and analysis choices.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy — NCT01829425.
• Registry record last updated 2019-04-23; status last verified 2019-04.
• Results first posted 2019-04-01.
• 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.

19. Record Summary

The registry describes a completed randomized parallel-group trial of hypnotherapy versus anticholinergic medication for urgency urinary incontinence. Enrollment is recorded as 165, and the primary completion date is 2017-10-27. The primary endpoint is percentage change in median urgency urinary incontinence episodes from baseline to the 2-month follow-up.

The posted arm medians are 73 for hypnotherapy and 88.6 for medication, with reported 95% confidence intervals of 60 to 88.9 and 78.6 to 100.0. The exact Mann Whitney non-inferiority analysis reports a contrast of 5, a lower confidence bound of 5, no upper bound, and p < .025. The registry does not report the non-inferiority margin or direction convention.

The primary analysis uses participants with diary information at the follow-up. Adverse-event counts are reported by group, with no deaths listed. Missing-data methods, multiplicity procedures, and a full statistical plan are not reported in the registry record.