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 Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms (NCT02865395), a randomized phase 4 study. The primary outcome is Post-operative Morphine Equivalent Dose.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02865395 |
| Phase | Phase 4 |
| Condition | Overactive Bladder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 23 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Campbell Grant |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing lithotripsy or cystoscopic/ureteroscopic procedures, in whom post-operative bladder spasms or urinary discomfort were the clinical concerns. The registry record lists overactive bladder as a condition, but does not report detailed eligibility criteria, participant characteristics, or the reasons for including or excluding patients.
Intervention
A belladonna and opium suppository placed in the rectum after anesthesia induction and before surgery. The study also examined timing after surgery: the post-operative suppository was placed while the patient remained under anesthesia, after the procedure.
Comparator
A rectal examination after the procedure while the patient remained under anesthesia, described in the registry record as serving as a placebo. The record describes a randomized, parallel-group comparison, but does not report the allocation procedure in further detail.
Primary question
The primary endpoint was post-operative morphine equivalent dose over 24 hours. The study’s broader objectives also concerned bladder spasms and urinary discomfort, as well as use of oral Ditropan and narcotic pain medication. The registry record reports no collected results for the primary endpoint and no posted analyses.
The central statistical question would have been whether outcomes differed among the timing strategies and the rectal-exam control. With no primary endpoint results or analyses reported, the registry record cannot establish the size, direction, or precision of any between-group difference. It also cannot answer the broader symptom and medication-use questions. The study is therefore best understood as a randomized comparison whose planned clinical questions remain unanswered in the posted results, rather than as evidence for or against any of the strategies.
3. Trial Design
The registry record describes a Phase 4, randomized, single-masked, parallel-group study. It lists enrollment of 23 and status as terminated. The study began in 2016-03, with primary completion recorded as 2017-06. The reason for termination is not reported in the registry record.
The three groups differed in the timing or type of rectal intervention. In the pre-operative group, the belladonna and opium suppository was placed after induction of anesthesia and before surgery. In the post-operative group, it was placed while the patient was still under anesthesia, after surgery. The control group received a rectal examination after the procedure while still under anesthesia; the registry describes this as a placebo. The record does not report further detail about how randomization was implemented, whether allocation was concealed, or what single masking meant in practice.
The official title refers to patients undergoing lithotripsy, while the study summary discusses cystoscopic and ureteroscopic procedures. The record does not give detailed information about the actual procedures performed by enrolled participants, their baseline characteristics, or the distribution of those characteristics across groups. It also does not state whether every enrolled participant completed follow-up.
The primary endpoint was post-operative morphine equivalent dose over 24 hours, but no results were collected for it. Post-operative pain is listed as a secondary outcome, but results are not reported. The registry record lists 0 analyses. It does not report a statistical analysis plan, a planned sample-size justification, or detailed analysis populations. These gaps limit assessment of how the trial was conducted and how its results would have been analyzed.
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 | Pre-operative Suppository | Post-operative Suppository | Rectal Exam |
|---|---|---|---|
| STARTED | 6 | 10 | 7 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 6 | 10 | 7 |
Reasons for not completing this period:
| Reason | Pre-operative Suppository | Post-operative Suppository | Rectal Exam |
|---|---|---|---|
| Physician Decision | 6 | 10 | 7 |
Analysis population for the primary outcome, as defined in the registry: Study terminated prior to results.
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: We did not collect the data on any of these patients. Therefore there is no data on ethnicity, age, or sex.
| Characteristic | Unit | Pre-operative Suppository | Post-operative Suppository | Rectal Exam | Total |
|---|---|---|---|---|---|
| Participants analysed | 0 | 0 | 0 | 0 | |
| Age, Categorical: <=18 years | — | — | — | — | |
| Age, Categorical: Between 18 and 65 years | — | — | — | — | |
| Age, Categorical: >=65 years | — | — | — | — | |
| Sex: Female, Male: Female | — | — | — | — | |
| Sex: Female, Male: Male | — | — | — | — |
6. Primary Endpoint
The registry lists the primary outcome as Post-operative Morphine Equivalent Dose, measured over 24 hours.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was post-operative morphine equivalent dose, with a timeframe of 24 hours. Morphine-equivalent dose is a way to express opioid medication amounts on a common scale, so that medication use can be represented as a single quantitative outcome rather than as separate drug-specific amounts. As a general statistical concept, such a measure can be useful when a study is interested in overall opioid use, provided that the medications and conversion approach are defined consistently.
The study summary says that one objective was to determine whether peri-operative suppositories reduced the need for narcotic pain medications. A dose endpoint can address medication consumption over a defined period, but it does not directly measure bladder spasms, urinary discomfort, or pain intensity. Those are related but distinct outcomes, and the registry lists post-operative pain as a secondary outcome.
The registry record gives no unit, calculation details, or results for the primary endpoint. It explicitly states that no results were collected for post-operative morphine equivalent dose because the study terminated prior to results. Consequently, there is no posted group estimate, measure of variability, confidence interval, or test of a between-group difference to interpret. The record also does not report how medication doses would have been converted or how the endpoint would have been summarized. Without those details and collected data, the primary endpoint’s comparative result cannot be evaluated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The key interpretive fact is that the primary outcome has no collected results. Although the study was designed to compare the timing of belladonna and opium suppositories with a rectal-exam control, the registry record does not provide a post-operative morphine-equivalent dose for any group. It therefore supplies no estimate of how much medication was used, no comparison among groups, and no measure of uncertainty around a treatment contrast.
The enrollment is reported as 23, and the study status is terminated. These registry entries describe the registry record, but they do not reveal why the study stopped or whether all participants contributed complete follow-up data. The reason for termination and details about the participant flow are not reported in the registry record. Enrollment alone is not a result and cannot indicate whether the intended clinical questions were answered.
There are also no posted analyses. The registry lists post-operative pain as a secondary outcome, but gives no result for it. The study summary identifies bladder spasms, urinary discomfort, oral Ditropan use, and narcotic medication use as objectives; results for those questions are not reported in the registry record. Thus, no claim about symptom frequency, pain, medication use, or differences between the groups can be supported by the posted data.
A confidence interval, in general, describes the uncertainty around an estimate under the assumptions of the analysis. Here there is no reported primary estimate or interval to assess. Likewise, a p-value would quantify how compatible observed data are with a specified null hypothesis under a statistical model; no such test result is posted. Neither statistical significance nor lack of statistical significance can be inferred from the absence of results.
The registry’s adverse-event figures list no serious adverse events, other adverse events, or deaths in the reported groups. Those are descriptive counts, not evidence that the interventions are free of risk. The groups are small, and the registry does not provide definitions, follow-up details, or a fuller safety analysis. The figures should be read as the events recorded in the registry, not as a guarantee about possible outcomes.
Overall, the trial record documents a randomized comparison and its intended endpoint, but not comparative outcome evidence. The trial’s clinical questions remain unresolved in the posted results. The record does not support conclusions about benefit, lack of benefit, or comparative safety.
9. Statistical Methods Explained
What does randomization contribute?
In general, randomization assigns participants to study groups by chance. Its statistical purpose is to reduce systematic differences between groups at the time of assignment, so that later outcome comparisons are less confounded by known or unknown baseline characteristics. Randomization does not guarantee that groups will be alike in every respect, particularly in a small study. The registry record states that allocation was randomized, but does not report the sequence-generation method, allocation concealment, or other implementation details. Those omissions prevent a detailed assessment of how randomization was carried out.
How should the parallel design be understood?
In a parallel-group design, each participant is assigned to a group and is followed under that group’s intervention. The record describes pre-operative suppository, post-operative suppository, and rectal-exam groups. The main statistical comparisons would concern outcomes across those groups, but the registry does not report an analysis plan specifying which comparisons were primary, how group differences would be estimated, or how outcomes would be handled. No analysis results are posted, so the planned comparisons cannot be reconstructed from outcome data.
What does single masking establish?
The record labels the study single-masked. In general, masking means that one or more parties involved in a trial are not told which intervention assignment applies. It can reduce the influence of expectations on care, reporting, or outcome assessment. The term alone does not establish who was masked, how masking was maintained, or whether participants and assessors could distinguish the interventions. Those details are not reported in the registry record. The rectal-exam control is described as serving as a placebo, but the record does not explain whether it was intended to mimic the suppository procedure in other ways.
What does the endpoint measure?
The primary outcome is post-operative morphine equivalent dose over 24 hours. In general, a continuous dose outcome may be summarized by a measure of central tendency and a measure of variability, then compared across study groups. The appropriate summary and model depend on the data distribution and on the analysis plan. Morphine-equivalent conversion rules and endpoint units matter because they define how medication records become the analyzed value. The registry record reports neither the conversion details nor endpoint results, and it does not specify the statistical model or summary measure.
For a quantitative outcome, a confidence interval would ordinarily give a range of values compatible with the data and the stated method. It helps distinguish an estimate that is precise from one that is uncertain. A hypothesis test can also assess compatibility with a null hypothesis, but a p-value alone would not describe the magnitude or precision of an effect. None of these quantities is reported for the primary endpoint in this study.
What can the planning note tell us?
The registry’s planning note describes illustrative assumptions: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial used those settings in its design or analysis. The registry record does not report the study’s own sample-size justification. The primary endpoint has no collected results, so the record supplies no observed primary effect from which to assess such an illustration. Any sample-size figures should be understood as planning illustrations, not observed power or a description of what the trial actually achieved.
In general, planning calculations depend on an assumed effect size, variability, significance threshold, allocation, and analysis method. Changing assumptions changes the resulting planned sample size. Those calculations do not establish that a study is adequately powered after the fact, and they cannot substitute for observed outcomes. The record’s note also distinguishes participants per arm for outcomes other than time-to-event outcomes, for which it describes total events. This study’s primary endpoint is a dose measure, not a time-to-event endpoint, but no trial-specific calculation is reported.
Why do distribution and model choices matter?
As a general statistical point, dose data can be unevenly distributed, with some observations much larger than others. Over-dispersion means the observed variability is greater than a model assumes; if ignored, standard errors and uncertainty estimates can be misleading. Choice of summary and model should follow the endpoint’s distribution and the design. The registry does not report the observed data, a distributional assessment, or a method for handling unusual values. No particular model or distribution can therefore be attributed to this study.
With no posted analysis, it is not possible to evaluate model assumptions, covariate adjustment, missing-data handling, or whether the analysis followed a prespecified plan. The record lists 0 analyses. The absence of these details does not establish that a particular method was inappropriate; it means the registry record does not permit readers to assess the method or its results.
10. Multiplicity, Missing Data and Analysis Populations
The study lists several intended questions: effects on bladder spasms and urinary discomfort, use of post-operative oral Ditropan, use of narcotic pain medication, and post-operative pain. The primary endpoint is post-operative morphine equivalent dose over 24 hours. The registry record does not report a statistical plan identifying the hierarchy among these outcomes, specifying which comparisons were confirmatory, or explaining whether adjustments for multiple testing were planned.
Multiplicity is a general concern when several outcomes or group comparisons are tested. Conducting many tests can increase the chance of finding an apparently notable result by chance. Statistical approaches can control that risk, but the appropriate approach depends on the prespecified questions and analysis plan. Because the registry record gives no analyses and no detailed plan, it is not possible to determine how multiplicity was addressed. No result should be treated as a confirmed finding on the basis of the listed objectives alone.
Missing-data details are also not reported in the registry record. It does not describe participant-level follow-up, missing outcome values, reasons for missingness, or a method for handling incomplete data. The statement that no primary outcome results were collected because the study terminated prior to results is not a report of how missing observations within an analyzed sample were treated; no such analysis is posted.
The record does not define an intention-to-treat, per-protocol, or safety analysis population, and it does not report who was included in any analysis. Without those details, the enrollment count cannot be treated as the analyzed sample for a clinical outcome. These gaps limit reproducibility and prevent assessment of whether all randomized participants were represented in any comparison.
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 |
|---|---|---|---|
| Pre-operative Suppository | 0 | 6 | 0.0% |
| Post-operative Suppository | 0 | 10 | 0.0% |
| Rectal Exam | 0 | 7 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Pre-operative Suppository | 0 of 6 |
| Post-operative Suppository | 0 of 10 |
| Rectal Exam | 0 of 7 |
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 |
|---|---|
| Pre-operative Suppository | 0 of 6 |
| Post-operative Suppository | 0 of 10 |
| Rectal Exam | 0 of 7 |
The registry lists three groups: pre-operative suppository, post-operative suppository, and rectal exam. For serious adverse events, the posted figures are 0 among 6 at risk, 0 among 10 at risk, and 0 among 7 at risk, respectively. For other adverse events, the figures are also 0 in each group, with the same reported numbers at risk. Deaths are recorded as 0 in all groups.
These entries mean that the registry reports no events in those categories for the listed groups. They should not be interpreted as proving that no adverse effects are possible, or that the groups have equivalent safety. Small group sizes provide limited information about uncommon events, and the record does not give adverse-event definitions, collection procedures, or additional details about follow-up. The event counts are descriptive; no comparative safety analysis or uncertainty estimate is reported.
The registry’s safety figures should also be kept distinct from the missing efficacy outcomes. They do not provide a substitute for the uncollected post-operative morphine-equivalent endpoint or the unreported symptom and medication-use results. The reason for termination and its relationship, if any, to safety monitoring are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, single-masked, parallel-group study compared two timings of a belladonna and opium suppository with a rectal-exam control. It also documents the primary question: post-operative morphine equivalent dose over 24 hours. These details describe the trial’s design and intended measurement, not its comparative outcome.
The primary outcome was not collected because the study terminated prior to results. No analyses are listed, and results for the secondary outcome of post-operative pain are not reported. The registry record therefore does not show whether the groups differed in medication use, pain, bladder spasms, urinary discomfort, or use of oral Ditropan. It does not give an estimate of effect or its precision.
That absence should not be read as evidence that the strategies had identical outcomes, nor as evidence that one strategy was better. A null finding would require observed data and an analysis; none is posted for the primary endpoint. Likewise, the record does not establish that the intended effects were absent. The comparative clinical questions remain unanswered by the registry results.
The safety entries record zero serious events, zero other events, and zero deaths in each group as listed. Those descriptive counts do not establish that the interventions have no risks, and they do not permit a robust comparative safety conclusion. The registry does not report the reason for termination or detailed safety follow-up.
In short, the trial record is informative about the design and the planned endpoint, but not about treatment effects. The enrollment count and the fact of randomization cannot replace measured outcomes. Interpretation should remain limited to what the registry actually records: a terminated study, an uncollected primary endpoint, no posted analyses, and descriptive adverse-event counts.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the distinction between a study design and evidence from outcomes. Random allocation can support a fair comparison in principle, but a randomized label alone does not provide an effect estimate. Without collected primary endpoint data and a reported analysis, there is no basis for estimating the size or precision of a difference among the groups.
The record also shows why a clearly specified endpoint is important. Post-operative morphine equivalent dose over 24 hours is the stated primary outcome, while the study’s broader objectives include symptoms and medication use. These measures address related but different questions. A dose outcome cannot by itself stand in for symptom severity, and a symptom outcome cannot be assumed from a medication-use measure. The registry record does not report results for these outcomes.
Study termination can leave a clinical question unresolved even when the design and objectives are documented. Enrollment is not equivalent to completion, and completion is not equivalent to an analyzed result. The registry lists enrollment of 23, but does not provide participant flow or the reason for termination. Such information would help readers understand what data were obtained and why the planned comparison did not yield posted results.
The record also highlights the need to distinguish sample-size planning from observed evidence. Planning assumptions are not a trial’s observed findings and do not establish the precision of a missing outcome. For this study, the primary result is unavailable, so no conclusion about statistical significance, effect size, or achieved precision is possible. The most important statistical message is therefore a limitation of the evidence record: the randomized comparison is documented, but its clinical outcomes are not.
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.
Several trial-specific limitations prevent a detailed assessment. The registry record reports termination but does not state the reason. It gives no participant flow, no account of how many participants completed follow-up, and no explanation of whether the enrolled participants contributed outcome data. The primary endpoint was not collected, leaving no primary result to interpret.
Details of the study population are limited. Although the title refers to lithotripsy and the summary describes cystoscopic/ureteroscopic procedures, detailed eligibility criteria, procedure types, baseline characteristics, and group balance are not reported in the registry record. The record also does not specify how randomization was implemented, whether allocation was concealed, or who was masked. Those details matter when judging risk of bias and the comparability of groups.
Outcome reporting is incomplete. Post-operative pain is listed as a secondary outcome, and the summary identifies bladder spasms, urinary discomfort, oral Ditropan use, and narcotic medication use as objectives, but results for these outcomes are not reported. The primary endpoint has no reported unit, conversion method, summary statistic, or analysis. The record lists 0 analyses and does not report a statistical plan, sample-size justification, analysis populations, multiplicity approach, or missing-data methods.
Safety reporting is limited to group-level counts and does not include event definitions, detailed follow-up, or a comparative analysis. The reason for termination and any connection to the safety findings are not reported. Together, these gaps mean the record documents the intended comparison more fully than its conduct or outcomes, and it does not support conclusions about efficacy or comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms — NCT02865395.
- Registry record last updated 2019-02-20; status last verified 2019-02.
- Results first posted 2019-02-20.
- 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
NCT02865395 is a Phase 4 randomized, single-masked, parallel-group study of belladonna and opium suppository timing for patients undergoing urinary procedures. The groups were pre-operative suppository, post-operative suppository, and rectal examination as a placebo control. Enrollment is recorded as 23; the study status is terminated.
The primary endpoint was post-operative morphine equivalent dose over 24 hours. The registry states that no results were collected for this endpoint because the study terminated prior to results. Post-operative pain is listed as a secondary outcome, but results are not reported. The record lists 0 analyses. It also records 0 serious adverse events, 0 other adverse events, and 0 deaths in each group as listed. The reason for termination, detailed analysis methods, and the trial’s sample-size justification are not reported in the registry record.