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 Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder. (NCT03175029), a randomized phase 2 study. The primary outcome is Changes in the Mean BCI for Male From Baseline to Week 12.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03175029 |
| Phase | Phase 2 |
| Condition | Detrusor Underactivity, Overactive Bladder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 195 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Taiho Pharmaceutical Co., Ltd. |
| Results posted | Yes |
2. Clinical Question
Population
Patients with detrusor underactivity and overactive bladder were the study population. The primary outcome analysis was restricted to male patients in the PPS, as described in the registry record. Eligibility details beyond these conditions are not reported in the registry record.
Intervention
The intervention was TAC-302, identified as a drug. The arm description contains no further information about its use, dose, or schedule; those details are not reported in the registry record.
Comparator
The comparator was placebo, also identified as a drug. Further details about the placebo or its administration are not reported in the registry record.
Primary question
The primary outcome asked about changes in mean BCI for male patients from baseline to Week 12. BCI is an index used to assess detrusor contractility in men. The registry record does not report the numerical change in either arm or a numerical comparison between arms, so the direction and precision of any treatment contrast cannot be assessed from this record.
3. Trial Design
This was a randomized, parallel-group Phase 2 study of TAC-302 and placebo. The registry record identifies quadruple masking. It does not state which specific groups of people were masked, so the masking label alone cannot establish whether participants, clinical staff, outcome assessors, or analysts were masked in a particular way.
The study enrolled 195 participants. That is the overall enrollment recorded, not a reported count for the primary analysis. The primary outcome analysis used the PPS and was conducted only among male patients in that population. The registry record does not provide arm-specific enrollment or explain how the PPS was defined or formed.
The listed conditions were detrusor underactivity and overactive bladder. The study purpose was to evaluate the efficacy and safety of TAC-302 in patients with those conditions. TAC-302 and placebo were the listed interventions, but the arm descriptions are blank. Dose, treatment duration, adherence procedures, and concomitant-care details are not reported in the registry record.
The recorded study start was 2017-09-09, and primary completion was recorded as 2019-11-01. The study status is completed. Taiho Pharmaceutical Co., Ltd. is named as sponsor. These administrative details identify the study but do not provide evidence about the size or reliability of a treatment effect.
The primary outcome timeframe was baseline to Week 12. Secondary outcomes included BVE changes overall and in specified post-void residual subgroups, micturitions and urinary urgency episodes per 24 hours, OABSS total score, and adverse events and adverse drug reactions. The registry lists 14 outcome measures and 15 analyses. The reported record does not give numerical results for the primary outcome, and the existence of listed outcomes does not establish that their results are available in this 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.
Overall Study
| Stage | TAC-302 | Placebo |
|---|---|---|
| STARTED | 52 | 24 |
| COMPLETED | 49 | 23 |
| NOT COMPLETED | 3 | 1 |
Reasons for not completing this period:
| Reason | TAC-302 | Placebo |
|---|---|---|
| Withdrawal by Subject | 2 | 1 |
| Study treatment becomes impossible due to changing hospital or other reasons | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: PPS was used for the analysis. This analysis was conducted only in male patients in the PPS.
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: Per protocol set (PPS) was used for the analysis. PPS included all patients in the Full analysis set (FAS) with no inclusion/exclusion criteria violations, who were compliant for ≥ 80% of the treatment period, were not administered any prohibited concomitant medication or therapy during the study period, and had a week 12 evaluation of the primary endpoint. FAS included all patients who took the study drug at least once and had ≥ 1 efficacy measurement before and during the treatment period.
| Characteristic | Unit | TAC-302 | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 42 | 18 | 60 | |
| Age, Continuous | years | 71.0 (SD 10.7) | 70.4 (SD 9.1) | 70.8 (SD 10.2) |
| Age, Continuous | years | 74.0 (46 to 90) | 73.5 (44 to 84) | 74.0 (44 to 90) |
| Sex: Female, Male: Female | Participants | 15 | 7 | 22 |
| Sex: Female, Male: Male | Participants | 27 | 11 | 38 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 42 | 18 | 60 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Duration of lower urinary tract symptoms | months | 92.2 (SD 95.1) | 72.9 (SD 71.1) | 86.4 (SD 88.4) |
| Duration of lower urinary tract symptoms | months | 79.0 (4 to 483) | 45.5 (12 to 264) | 68.0 (4 to 483) |
| Bladder voiding efficiency (BVE) | % | 58.38 (SD 26.74) | 63.11 (SD 24.13) | 59.82 (SD 25.86) |
| Bladder voiding efficiency (BVE) | % | 65.15 (0.6 to 88.6) | 73.46 (11.7 to 89.6) | 69.18 (0.6 to 89.6) |
| Bladder contractility index (BCI) (Only Male) | Score on a scale | 64.604 (SD 16.569) | 61.339 (SD 16.629) | 63.659 (SD 16.428) |
| Bladder contractility index (BCI) (Only Male) | Score on a scale | 68.000 (13.77 to 98.00) | 60.000 (43.00 to 94.50) | 68.000 (13.77 to 98.00) |
| Projected isovolumetric pressure 1 (PIP1) (Only Female) | Score on a scale | 18.769 (SD 6.591) | 20.561 (SD 7.524) | 19.339 (SD 6.773) |
| Projected isovolumetric pressure 1 (PIP1) (Only Female) | Score on a scale | 17.000 (8.50 to 32.40) | 21.000 (10.60 to 30.10) | 17.875 (8.50 to 32.40) |
6. Primary Endpoint
The registry lists the primary outcome as Changes in the Mean BCI for Male From Baseline to Week 12, measured over Baseline to Week 12.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome is the change in mean BCI for male patients from baseline to Week 12. BCI is calculated from detrusor pressure at maximum urine flow, PdetQmax, and maximum flow rate, Qmax: PdetQmax + 5 × Qmax. The registry describes these as measures from a pressure-flow study. The index is used to assess detrusor contractility in men, with a higher value indicating greater contractility.
The registry gives interpretive categories for BCI: strong is > 150, normal is 100-150, and weak is < 100. It also states that the scale has no theoretical minimum or maximum. These categories help describe the index, but they do not specify what size of change would be important to patients or clinicians. Such a threshold is not reported in the registry record.
Assessing change from baseline focuses on how the mean score differs over the stated study period. For a randomized comparison, the central treatment question is whether the change differs between TAC-302 and placebo. A within-arm change alone would not answer that comparative question, because changes can occur in both groups for reasons unrelated to the intervention.
The record specifies a mean and standard deviation for this continuous outcome and says the analysis was in male patients in the PPS. It does not report the arm-level means, changes, comparative estimate, confidence interval, or p-value. The observed endpoint result and its precision therefore cannot be interpreted from the registry information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study record establishes the clinical question and the intended primary outcome: change in mean BCI among male patients in the PPS from baseline to Week 12. It does not report numerical primary outcome results. Without arm-level values and a between-group comparison, it is not possible to describe the direction or magnitude of the observed contrast, or how precisely it was estimated.
That absence matters because the primary outcome is a change measure. A change within the TAC-302 group, if reported alone, would not isolate the effect of treatment. Interpretation of a randomized trial generally relies on comparing outcomes between the randomized groups, while also considering uncertainty around the estimated difference. This is a general statistical principle, not a statement about an unreported result in this study.
The record identifies the outcome as a mean with standard deviation, but the numerical means and standard deviations are not reported in the registry record. No confidence interval or p-value for the primary comparison is reported either. A confidence interval, in general, describes uncertainty around an estimated effect and indicates which values are compatible with the data under the method used. Without an estimate and interval, precision cannot be assessed. A p-value, if available, would address compatibility with a specified null hypothesis under an analysis model; it would not by itself describe effect size or clinical importance.
The primary outcome applies to male patients in the PPS, not necessarily every enrolled participant. The registry does not report the size or composition of this analysis population, the definition of PPS, or how participants were handled if outcome measurements were unavailable. The primary estimate, if reported elsewhere, would need to be interpreted in relation to that analysis population and its data-handling methods.
The study also lists secondary outcomes, including BVE, micturitions, urgency episodes, OABSS, and adverse events. Their presence indicates that multiple outcomes were planned or recorded, but the numerical findings and the approach to interpreting multiple comparisons are not reported in the registry record. It would be inappropriate to infer a positive or negative result from outcome titles or from the study's completed status.
The serious adverse event counts are reported separately for the two groups: TAC-302 had 2 participants affected among 52 at risk, and placebo had 1 among 24 at risk. These are descriptive counts in the registry record. They do not establish a causal difference, and without additional information about event definitions, follow-up, and uncertainty, they should not be treated as a stand-alone comparison of safety. No deaths were reported in either group.
Overall, the record documents a randomized Phase 2 study and specifies a clinically interpretable primary measure, but does not provide the primary numerical results needed to judge the observed treatment contrast. The information supports describing the design and outcome definitions, not drawing conclusions about efficacy or safety.
9. Statistical Methods Explained
The registry identifies randomization, quadruple masking, and a parallel-group model. Randomization is intended, in general, to make treatment assignment independent of measured and unmeasured prognostic factors at the point of assignment. It supports a fair comparison when allocation is implemented appropriately, but it does not guarantee that the groups will be identical or that all later sources of bias are prevented. Details of sequence generation and allocation concealment are not reported in the registry record.
What does masking mean?
Masking is intended to limit the influence of knowledge about treatment assignment on participant experience, care, outcome assessment, or analysis. The registry gives the label quadruple, but does not identify the people or processes covered by that label. The arm descriptions are blank, and practical details about masking are not reported. The label should therefore be read as a design description, not as a complete account of how masking was implemented or maintained.
What does the mean represent?
The primary endpoint is a continuous measure summarized as a mean. A mean describes the arithmetic center of observed values, while the standard deviation describes how spread out individual values are around that mean. These summaries do not show the full distribution. In general, distributions with unusual shapes or influential extreme values can make the mean and standard deviation less representative of typical observations. The registry does not report outcome distributions or diagnostic checks, so their form cannot be assessed.
The endpoint is a change from baseline to Week 12. For a randomized comparison, analysts may compare changes between groups or use a model that accounts for baseline outcome values. Those approaches can differ in assumptions and precision. The registry record does not report the specific model, covariates, or method used for the primary comparison. It is therefore not possible to say whether the analysis used a change-score comparison, baseline adjustment, or another approach.
How should a confidence interval be read?
In general, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the statistical procedure. A narrower interval indicates greater precision than a wider interval for the same measure and method. The interval does not express the probability that a particular fixed effect lies within its bounds. No primary confidence interval is reported in the registry record, so the precision of the treatment contrast is unknown.
A p-value, in general, measures how incompatible the observed data are with a specified null hypothesis under a statistical model. It is not the probability that the null hypothesis is true, and it does not measure the clinical importance of a result. The registry record does not report a primary p-value or the testing procedure used. Statistical significance therefore cannot be assessed from this information, and even a reported p-value would need to be considered alongside the effect estimate and its uncertainty.
What do the planning illustrations mean?
The registry's sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These assumptions describe the illustration, not necessarily the design decisions used for the trial. The registry record does not report the trial's own sample-size justification or planning assumptions.
Sample-size illustrations based on an observed effect are sensitive to that effect estimate. If the estimate is uncertain, an illustration derived from it inherits that uncertainty. Such calculations are planning aids, not observed power and not evidence that the trial had a particular probability of detecting an effect. The record does not provide enough numerical detail to interpret particular illustrated sample sizes, and no new values should be inferred.
Why can event counts need different methods?
For continuous outcomes, analysis often concerns a difference in means or a model-based estimate. Adverse events are counts of participants or events and have different statistical properties. In general, event counts may be sparse, may vary more than a simple model expects, and may depend on how long participants are followed. Over-dispersion means the observed variability exceeds what a model assumes; if ignored, uncertainty can be understated. The registry record does not report an inferential model for the safety outcomes, exposure-adjusted rates, or follow-up duration by group.
The record lists 14 outcome measures and 15 analyses. Multiple outcomes and analyses can create multiplicity: when many hypotheses are tested, the chance of at least one apparently unusual result can increase. General approaches include prespecifying a primary hypothesis, adjusting significance thresholds, or treating secondary findings as exploratory. The registry record does not report a multiplicity strategy, so it is not possible to determine how the listed analyses were governed or interpreted.
Finally, the primary analysis population is described as PPS, and the record says the analysis was restricted to male patients in that population. A per-protocol population generally refers to participants meeting defined protocol-related criteria, but the registry does not define PPS in this study. The exact eligibility rules for analysis, exclusions, missing-data procedures, and sensitivity analyses are not reported. Those details affect which participants and measurements contribute to an estimate and how robust it may be.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 14 outcome measures and 15 analyses. The primary outcome is identified as change in mean BCI for male patients from baseline to Week 12. The record also names secondary outcomes covering BVE, micturitions, urgency episodes, OABSS, adverse events, and adverse drug reactions. A list of outcomes alone does not reveal which analyses were confirmatory, how hypotheses were ordered, or whether any adjustment was made for multiple testing.
Multiplicity is a general concern when many comparisons are examined. Without a stated strategy, a reader cannot tell whether reported p-values, if available, were adjusted, whether secondary findings were considered exploratory, or how the primary outcome was prioritized in analysis. The multiplicity approach is not reported in the registry record.
The primary outcome analysis used the PPS and was conducted only among male patients in that population. The PPS definition and the number of participants contributing to the primary analysis are not reported in the registry record. The overall enrollment was 195, but this does not establish how many participants were included in the male PPS analysis or how many had complete endpoint measurements.
Missing-data handling is not reported in the registry record. The record does not specify how unavailable Week 12 measurements were treated, whether any imputation was used, or whether sensitivity analyses assessed the effect of missingness. In general, missing-data methods rely on assumptions about why measurements are absent. If those assumptions are not stated, readers cannot fully evaluate how missing observations may affect the estimate.
The study is described as randomized, but the record does not provide enough information to assess whether the analysis followed the randomized groups or how protocol deviations were handled. These gaps do not show that a particular method was or was not used; they mean the relevant details are not reported in the registry record.
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 |
|---|---|---|---|
| TAC-302 | 2 | 52 | 3.8% |
| Placebo | 1 | 24 | 4.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| TAC-302 | 0 of 52 |
| Placebo | 0 of 24 |
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 |
|---|---|
| TAC-302 | 24 of 52 |
| Placebo | 9 of 24 |
Most frequent serious adverse event terms
| Event term | Organ system | TAC-302 | Placebo |
|---|---|---|---|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | 0 of 52 | 1 of 24 |
| Subdural haematoma | Injury, poisoning and procedural complications | 1 of 52 | 0 of 24 |
| Prostatitis | Reproductive system and breast disorders | 1 of 52 | 0 of 24 |
Most frequent non-serious adverse event terms
| Event term | Organ system | TAC-302 | Placebo |
|---|---|---|---|
| Constipation | Gastrointestinal disorders | 1 of 52 | 2 of 24 |
| Nasopharyngitis | Infections and infestations | 2 of 52 | 1 of 24 |
| Diarrhoea | Gastrointestinal disorders | 2 of 52 | 0 of 24 |
| Pyrexia | General disorders | 2 of 52 | 0 of 24 |
| Bronchitis | Infections and infestations | 1 of 52 | 1 of 24 |
| Cystitis | Infections and infestations | 1 of 52 | 1 of 24 |
| Pharyngitis | Infections and infestations | 1 of 52 | 1 of 24 |
| Pyuria | Infections and infestations | 2 of 52 | 0 of 24 |
| Enteritis infectious | Infections and infestations | 2 of 52 | 0 of 24 |
| Back pain | Musculoskeletal and connective tissue disorders | 2 of 52 | 0 of 24 |
Serious events with the highest arm-level rate: diverticulum intestinal haemorrhagic (4.2%), subdural haematoma (1.9%), prostatitis (1.9%).
The registry reports serious adverse events using counts of participants at risk and participants affected. For TAC-302, 52 were listed as at risk and 2 as affected. For placebo, 24 were listed as at risk and 1 as affected. The registry reports 0 deaths in each group. These are descriptive safety figures; they do not by themselves establish whether the groups differ in risk.
Other adverse events were reported for 24 participants at risk in the TAC-302 group and 9 in the placebo group. The record also lists the serious adverse event terms “Diverticulum intestinal haemorrhagic” at 4.2%, “Subdural haematoma” at 1.9%, and “Prostatitis” at 1.9%. The registry record does not specify a group for each listed term in this summary, so those percentages should not be assigned to an arm based on this information alone.
In general, safety counts depend on event definitions, observation time, and whether the unit is participants or events. The registry provides participant counts for the group summaries, but does not report detailed event timing, exposure-adjusted rates, or an inferential comparison. The counts should therefore be read as reported descriptions, not as proof of a treatment-related effect or its absence.
12. What the Result Does, and Does Not, Mean
This study addresses TAC-302 in patients with detrusor underactivity and overactive bladder, with placebo as the comparator. Its primary outcome is a male-specific change in mean BCI from baseline to Week 12. The registry identifies a randomized, quadruple-masked, parallel-group Phase 2 design. These details establish the question and broad study structure.
They do not establish what the study found. Numerical results for the primary outcome are not reported in the registry record. Without an estimate comparing groups, readers cannot determine the observed direction or size of the primary contrast. Without an interval or other uncertainty measure, they cannot assess its precision. Without a reported inferential method, they cannot evaluate the statistical analysis in detail.
The BCI is an index of detrusor contractility in men, and the registry states that higher values indicate greater contractility. That interpretation describes the measure; it does not show that a particular observed change occurred or that a change would matter clinically. A threshold for a clinically important change is not reported in the registry record.
The listed secondary outcomes broaden the questions the study could address, but their titles are not results. Their numerical findings and the approach to multiplicity are not reported in the information. Similarly, the reported adverse event counts provide descriptive safety information, but do not establish causation or a comparative safety conclusion.
The record's completed status means the study is recorded as completed; it is not itself evidence of a favorable, unfavorable, or conclusive result. The overall enrollment of 195 does not tell readers how many participants contributed to each outcome analysis. The primary analysis was restricted to male patients in the PPS, whose definition and size are not reported.
Accordingly, the statistical meaning of the available record is limited to the design, outcome definitions, analysis-population description, and reported safety counts. It does not support a conclusion about whether TAC-302 changed BCI relative to placebo, how large such a change was, or how precise an estimate might be.
13. Why This Trial Matters Statistically
The study is statistically notable for pairing a randomized comparison with a clearly defined continuous primary measure: change in mean BCI from baseline to Week 12. Randomization can support a comparative interpretation when implemented and analyzed appropriately. The parallel-group structure also identifies the intended comparison between TAC-302 and placebo. The registry record does not, however, include the numerical primary result needed to evaluate that comparison.
The primary outcome is restricted to male patients in the PPS, even though the overall study population is described as patients with detrusor underactivity and overactive bladder. This makes the analysis population important to interpretation. The record does not define the PPS or report its size, so readers cannot fully assess how it relates to overall enrollment or who contributed to the endpoint analysis.
The study also records a range of secondary outcomes, including symptom measures and safety outcomes. Such breadth can be useful for describing different aspects of a trial, but it creates a need for clear prioritization and transparent handling of multiple analyses. The registry record lists 14 outcome measures and 15 analyses, while a multiplicity strategy is not reported.
Finally, the record offers a useful example of the distinction between a study's design and its results. Randomization, masking, an endpoint definition, and a completed status do not substitute for an effect estimate and its uncertainty. The serious adverse event counts add descriptive information, but are not enough on their own to establish comparative safety. Statistical interpretation depends on both the design and the actual analyzed results, and the latter are not reported for the primary endpoint in this 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 this study record is that numerical results for the primary outcome are not reported. The record identifies the outcome, timeframe, summary measure, and analysis population, but does not give arm-level values, a between-group estimate, a confidence interval, or a p-value. The observed primary contrast and its precision therefore cannot be evaluated.
The primary analysis is described as using the PPS and as being limited to male patients in that population. The registry record does not define the PPS, report its size, or explain how participants were selected for it. Overall enrollment was 195, but that figure does not establish the analysis denominator for the primary endpoint.
Important methodological details are also not reported in the registry record, including the statistical model, handling of missing outcome data, protocol-deviation rules, and sensitivity analyses. The masking label is given without identifying who was masked or how masking was maintained. The arm descriptions do not provide treatment dose or schedule.
The record lists many outcome measures and analyses, but does not report the multiplicity strategy or distinguish confirmatory from exploratory analyses. The serious adverse event summary gives participant counts and selected terms, but does not provide event timing, detailed group assignment for each listed term, or an inferential safety analysis. These reporting gaps limit assessment of both efficacy and safety; they do not establish that an unreported method or analysis was not performed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder. — NCT03175029.
- Registry record last updated 2025-01-20; status last verified 2024-12.
- Results first posted 2025-01-20.
- 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.
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18. Record Summary
NCT03175029 is a completed randomized, quadruple-masked, parallel-group Phase 2 study sponsored by Taiho Pharmaceutical Co., Ltd. It enrolled 195 participants with detrusor underactivity and overactive bladder and compared TAC-302 with placebo. The recorded study start was 2017-09-09, and primary completion was 2019-11-01.
The primary outcome was change in mean BCI for male patients from baseline to Week 12, analyzed in the PPS. The registry lists 14 outcome measures and 15 analyses. It reports serious adverse events affecting 2 participants in the TAC-302 group and 1 in the placebo group, with 0 deaths in each group. Numerical primary outcome results, the PPS definition, missing-data methods, and multiplicity procedures are not reported in the registry record.