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 Over Active Bladder Patients Having Sling Surgery (NCT00852696), a randomized na study. The primary outcome is To Determine Whether Treatment With Anti-muscarinic Medications Following Sub-urethral Sling Procedures Improves Overall Subjective and Objective Outcomes in Women With Mixed Incontinence With Primary Stress Symptoms..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00852696 |
| Phase | NA |
| Condition | Overactive Bladder |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | Double |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cleveland Clinic Florida |
| Results posted | Yes |
2. Clinical Question
Population
Women with mixed incontinence, primary stress symptoms, and planned sub-urethral sling procedures. The record states that one subject enrolled, but the participant’s assignment is unknown.
Intervention
Solifenacin taken orally once daily for 9 weeks, as described for the Solifenacin Group.
Comparator
Placebo taken orally once daily for 9 weeks, as described for the Placebo Group.
Primary question
Whether perioperative anti-muscarinic medication after sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence and primary stress symptoms.
The clinical question is framed around postoperative overactive bladder symptoms and broader subjective and objective outcomes. It compares a medication strategy with placebo in the context of sling surgery. The registry record describes the intended comparison, but it does not give a specific symptom scale, objective measure, threshold for improvement, or definition of an overall outcome. Those details are not reported in the registry record.
The intended design was randomized and double blind. However, the registry record says that the study was terminated, that only one subject enrolled, that the participant’s assignment is unknown because the study was double blinded, and that data were never collected. Therefore, the registry record cannot answer the clinical question with an estimate of comparative outcomes. The question describes what the study was intended to investigate, not a result supported by recorded outcome data.
3. Trial Design
The registry record describes a randomized, double-blind, placebo-controlled study at Cleveland Clinic Florida. Its official title identifies perioperative solifenacin use in patients with mixed incontinence undergoing suburethral sling procedures. The listed interventions are Solifenacin and Placebo, with each arm description specifying oral dosing once daily for 9 weeks. The stated study purpose is to assess overall subjective and objective outcomes after surgery.
The record lists the study as terminated. It gives a start date of 2008-02 and a primary completion date of 2009-07. Enrollment is listed as 1. The population description adds that the principal investigator left the institution, the subject’s assignment is unknown because the study was double blinded, and data were never collected. The record does not explain further how termination affected the intended study conduct.
There is a classification tension within the record: it identifies randomized allocation and two interventions, while its model classification is single group. The record does not explain this mismatch. With one enrollee and unknown assignment, the intended two-arm comparison did not yield an analyzable comparison in the posted results. The record lists one outcome measure and zero analyses; it also indicates that the primary outcome could not be reduced to a comparison with two arms.
The record does not report the planned recruitment target, sample-size justification, allocation sequence method, concealment procedure, or detailed masking procedures. It also does not report whether any interim analyses were planned. These omissions do not establish what the full protocol contained; they limit what can be described from the registry record. The design details above should be read as the registered intention, not as confirmation that the planned comparison was carried out.
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: 1 subject enrolled, unknown patient assignment because this study was double blinded. To our knowledge, the participant never started this trial and no data was collected as study was terminated.
Overall Study
| Stage | Solifenacin Group | Placebo |
|---|---|---|
| STARTED | 0 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Principal investigator left the institution, no data is available. 1 subject enrolled, unknown patient assignment because this study was double blinded. Data was never collected for this study.
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: 1 patient enrolled, but no analysis completed as study was double blinded, no data is available. Baseline data was not collected.
| Characteristic | Unit | Solifenacin Group |
|---|---|---|
| Participants analysed | 0 | |
| Sex: Female, Male: Female | — | |
| Sex: Female, Male: Male | — |
6. Primary Endpoint
The registry lists the primary outcome as To Determine Whether Treatment With Anti-muscarinic Medications Following Sub-urethral Sling Procedures Improves Overall Subjective and Objective Outcomes in Women With Mixed Incontinence With Primary Stress Symptoms., measured over 9 weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The listed primary objective is to determine whether anti-muscarinic medication after sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence and primary stress symptoms. The stated timeframe is 9 weeks. This describes a broad outcome objective, not a fully specified endpoint with a named instrument or measurement rule.
Subjective outcomes can capture how participants experience symptoms or change, while objective outcomes can record findings measured by a defined procedure. In general, using both kinds of information can address different aspects of a clinical question. For a trial endpoint to support an interpretable comparison, the measures, timing, scoring, and definition of improvement need to be clear. Those operational details are not reported in the registry record.
The registry record lists one outcome measure, but the posted information does not supply an outcome value, summary statistic, or analysis. It states that the single enrolled subject’s assignment is unknown and that data were never collected. Consequently, there is no endpoint result in the record to interpret, and no estimate of the difference between solifenacin and placebo. The registered objective explains what investigators intended to assess; it does not establish what happened to symptoms or other outcomes.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted record describes an intended randomized comparison, but it does not contain comparative outcome results. Enrollment is listed as 1, the participant’s assignment is unknown, and the record explicitly says that data were never collected. It also lists zero analyses. These registry entries mean there is no treatment-effect estimate, confidence interval, or outcome-based test in the registry record to interpret.
This distinction is important: an absent result is not evidence that the groups had the same outcomes, and it is not evidence that one intervention was better. The record cannot establish the direction or size of any effect. It also cannot show whether subjective and objective outcomes agreed, whether any apparent changes were clinically meaningful, or how uncertain an estimate would have been. There is no outcome estimate from which to judge precision.
The stated objective focuses on overall subjective and objective outcomes over 9 weeks. Yet the record does not name the measures or explain how an overall result would be formed. Without a recorded outcome and a defined comparison, there is no basis for interpreting a p-value, confidence interval, or clinical importance. The tables and plots on the page should therefore be read in light of the record’s lack of collected outcome data; they cannot supply evidence that the registry record itself does not contain.
The sample-size material is described as a planning illustration based on an observed effect, with assumptions of a two-sided significance level of 0.05, equal allocation, and a normal approximation. The trial record, however, states that no data were collected and lists no analyses. Any planning illustration is not an observed treatment effect and must not be read as observed power. The assumptions do not repair the absence of outcome information, nor do they show what the study’s own design justification was. That justification is not reported in the registry record.
The record also lists serious and other adverse-event counts, but those counts need cautious interpretation because the participant’s assignment is unknown and the study population description says no data were collected. A registry count should not be mistaken for a complete safety assessment or evidence about the comparative safety of the two intended interventions.
Overall, the record documents a registered research question and limited enrollment, but it does not answer that question. It supports conclusions about the availability and limitations of the posted record, not about the effects of solifenacin or placebo.
9. Statistical Methods Explained
The methods information is limited. The record identifies randomized allocation, double masking, a placebo comparator, a 9-week dosing description, and an intended primary objective. It does not report an analysis plan, outcome values, or any completed analyses. The explanations below distinguish those record details from general statistical concepts; they should not be read as claims that a particular method was used in this study.
What randomization is intended to do
In general, randomization assigns participants to study groups using a chance-based process. When carried out as planned, it can reduce systematic differences between groups at the start of a study. It does not guarantee that groups are identical, especially in a small study, and it cannot create a valid comparison when usable outcomes are absent. Here, although the record labels allocation as randomized, it reports only one enrollee and an unknown assignment. It does not report the sequence-generation or allocation-concealment methods. The registry record therefore does not permit evaluation of how randomization was implemented.
What masking can and cannot address
In general, masking means that specified people involved in a trial do not know which intervention a participant received. This can reduce the risk that expectations influence care, reporting, or outcome assessment. The record labels the study double blind and says the participant’s assignment is unknown because the study was double blinded. It does not specify which people were masked or how masking was maintained. Masking is not a substitute for outcome collection: without recorded outcomes, it cannot support an estimate of treatment effect.
Why a comparison needs outcome information
In general, an effect estimate summarizes the difference or contrast between intervention groups for a defined outcome. Its interpretation depends on a clear outcome definition, an analysis population, and an analysis method. The posted record has no outcome data and lists zero analyses. It also indicates that the primary outcome could not be reduced to a comparison involving two arms. As a result, there is no reported estimate to assess, regardless of the intended randomized design.
A confidence interval, in general, describes the range of values compatible with the data and the method used, under its assumptions. A narrower interval generally indicates greater precision, while a wider interval indicates greater uncertainty. No confidence interval is reported for this study. It would be inappropriate to infer precision from enrollment alone or to treat a planning illustration as a confidence interval. The absence of an interval is consistent with the absence of an outcome analysis.
A p-value, in general, measures how unusual data at least as incompatible with a specified null hypothesis would be, assuming that hypothesis and the analysis assumptions. It does not measure the probability that a treatment works, and it does not convey the size or clinical importance of an effect. No p-value or completed test is reported. The registered significance-level assumption of 0.05 appears in the description of a planning illustration; it is not a trial result and does not establish that a hypothesis test was conducted.
How to read the planning assumptions
The sample-size description characterizes its figures as a planning illustration based on an observed effect. It states a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. These are assumptions for an illustration, not evidence that the enrolled study achieved a particular power. Sample-size calculations depend on design choices and assumed effects; changing those assumptions can change the resulting planning requirement. The registry record does not report the study’s own sample-size justification.
In general, power is a design-stage probability of detecting an effect of a specified size under stated assumptions if that effect is real and the planned analysis is carried out. It is not a measure of whether a completed study has produced a reliable result. A post hoc calculation based on an observed effect should not be called observed power. In this case, there are no collected outcome data in the registry record from which to interpret an observed effect. Any displayed sample-size figures should therefore be understood only as planning illustrations and not as a summary of trial performance.
Why over-dispersion can matter in general
For outcomes such as counts, some statistical models assume a particular relationship between the average outcome and its variability. Over-dispersion means the observed variability is greater than the model allows. If it is ignored, standard errors can be too small and confidence intervals or tests can appear more certain than warranted. This is a general consideration for count-data analyses, not a method reported for this study. The registry record does not identify the primary outcome’s data type or report a model, so there is no basis to say that over-dispersion was present or that a particular remedy was used.
Likewise, general choices such as covariate adjustment, handling repeated measurements, and defining an analysis population can affect estimates and their uncertainty. The registry record does not report these methods. They cannot be reconstructed from the randomized and double-blind labels, the intervention descriptions, or the intended timeframe. The methods that can be described are therefore the registered design labels and the planning assumptions; the analysis methods and empirical findings are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one outcome measure and one primary objective, but it does not report a detailed statistical analysis plan. It gives no named endpoint instrument, scoring rule, hierarchy of outcomes, or procedure for controlling the chance of false-positive findings when multiple outcomes or analyses are considered. A specific multiplicity strategy is not reported in the registry record. The number of measures listed does not establish how many outcomes or analyses were planned in the full protocol.
In general, multiplicity arises when investigators make multiple statistical comparisons or examine multiple outcomes. If each is assessed separately without a suitable plan, the chance of at least one apparently noteworthy result can increase. Methods to address multiplicity depend on the scientific question and analysis plan. There are no completed analyses here, so the record does not permit assessment of whether multiplicity affected any reported finding.
Missing-data methods are also not reported in the registry record. The study description says data were never collected, rather than describing a set of collected outcomes with some values missing. The record does not explain whether any baseline information was recorded, how the planned analysis would have treated incomplete observations, or what sensitivity analyses were intended. Those details should not be inferred.
The analysis population is not reported in the registry record. In general, trial analyses may define populations according to randomization, intervention received, or other criteria; the choice affects the interpretation of an estimate. Here, with one enrollee, an unknown assignment, no collected data, and zero listed analyses, there is no analysis population or outcome comparison to evaluate. The record’s omissions limit statistical interpretation, but do not establish which methods investigators might have intended to use.
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 |
|---|---|---|---|
| Solifenacin Group | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Solifenacin Group | 0 of 1 |
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 |
|---|---|
| Solifenacin Group | 0 of 1 |
The registry record lists the Solifenacin Group with 1 participant at risk, 0 participants affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. These are the posted counts for that listed group. They should not be read as a comparative safety result: the registry record does not provide corresponding usable information for a two-arm analysis, and it says the single participant’s assignment is unknown.
The population description also states that data were never collected. In that context, the listed counts do not establish that the participant received solifenacin, that safety events were systematically assessed, or that no events occurred in the intended study population. They are registry entries, not evidence of a complete safety assessment. No serious adverse-event terms are listed.
In general, adverse-event counts require context about who was monitored, the observation period, event definitions, and completeness of reporting. Those details are not reported in the registry record. The posted zero counts therefore cannot demonstrate absence of risk or support a comparison between solifenacin and placebo. They describe only what the registry record lists, alongside substantial uncertainty about assignment and data collection.
12. What the Result Does, and Does Not, Mean
This record means that a randomized, double-blind study was registered to examine perioperative solifenacin versus placebo for women undergoing sub-urethral sling procedures. It also means that the registry record reports termination, enrollment of 1, an unknown participant assignment, no collected data, and zero analyses. These registry entries are relevant to understanding why the clinical question remains unanswered in the posted results.
It does not mean that solifenacin improved postoperative symptoms, that it failed to improve them, or that it had the same effect as placebo. There is no outcome estimate in the record, so neither direction nor magnitude can be established. The record also cannot show how precise an estimate would be, whether an apparent difference would be clinically important, or whether subjective and objective outcomes would point in the same direction.
The record does not establish how the study would have analyzed the primary objective, how outcomes were to be measured, or how missing information would have been handled. Those details are not reported in the registry record. The planning assumptions described elsewhere are not outcome results, and sample-size illustrations are not observed power.
Similarly, the listed adverse-event counts do not establish comparative safety. Assignment is unknown, the record says data were never collected, and there is no completed two-arm safety analysis. The most defensible interpretation is limited: the registered question and intervention descriptions are documented, but the posted record contains no evidence with which to estimate the effects or harms of either intervention.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the difference between a well-defined research question and an answer supported by data. The record describes randomization, masking, a medication, a placebo, and an intended postoperative outcome question. Yet those design labels cannot substitute for recorded outcomes. With one enrollee, an unknown assignment, no collected data, and zero analyses, no comparison can be estimated from the posted record.
It also shows why the structure of a registry entry should be interpreted carefully. The record lists two interventions but classifies the model as single group, and it describes a broad primary objective without naming the measurement tools or rules. A reader should distinguish those registered descriptions from details of implementation or analysis that are not reported. The record does not resolve the classification mismatch.
The study also highlights the limits of statistical planning illustrations. A significance level and other assumptions can frame a sample-size calculation, but such planning does not demonstrate that the trial enrolled enough participants, produced an outcome, or had any particular power. An illustration based on an assumed or observed effect is separate from a treatment-effect estimate and cannot compensate for missing trial results.
Finally, a zero adverse-event count is not self-interpreting. Assignment, monitoring, and data completeness matter to the meaning of safety counts. Here, the registry’s own description of unknown assignment and absent data makes the listed counts especially limited. The central statistical lesson is not about the direction of treatment effect; it is about the boundary between a planned comparison and evidence from an analyzed 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 most consequential limitation is that the registry record says no data were collected. Enrollment is listed as 1, the participant’s assignment is unknown, and the study is marked terminated. Consequently, there are no posted outcome results and no completed analysis from which to estimate an effect.
The primary objective is broad, referring to overall subjective and objective outcomes, but the record does not identify instruments, definitions, scoring, or criteria for improvement. Although one outcome measure is listed, its operational details are not reported in the registry record. The stated 9-week timeframe does not by itself specify how an endpoint would be measured or summarized.
There is also a classification inconsistency: the record describes randomized allocation and Solifenacin and Placebo interventions, while its model classification is single group. It does not explain this mismatch. The primary outcome is also indicated as not reducible to a comparison with two arms, consistent with the absence of a usable comparison, but the record gives no additional explanation.
Important design and analysis details are not reported in the registry record, including the planned recruitment target, sample-size justification, randomization procedures, analysis population, missing-data approach, multiplicity plan, and any interim analyses. The listed safety counts have limited interpretability because assignment is unknown and the record says no data were collected. These limitations are specific to the record’s sparse and incomplete account; they do not establish what may have appeared in other documents.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Over Active Bladder Patients Having Sling Surgery — NCT00852696.
- Registry record last updated 2022-07-01; status last verified 2022-06.
- Results first posted 2022-07-01.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a randomized, double-blind, placebo-controlled study of perioperative solifenacin in women with mixed incontinence and primary stress symptoms undergoing sub-urethral sling procedures. The intervention descriptions specify oral solifenacin or placebo once daily for 9 weeks. Cleveland Clinic Florida is listed as the sponsor. The study is marked terminated, with a start date of 2008-02 and a primary completion date of 2009-07.
Enrollment is listed as 1. The record states that the principal investigator left the institution, the participant’s assignment is unknown, and data were never collected. One primary outcome measure is listed, but the record gives no outcome result and lists zero analyses. It therefore contains no comparative estimate of benefit or harm. The listed adverse-event counts should be interpreted cautiously because of the unknown assignment and absent data. The record documents the intended research question, but it does not provide an empirical answer.