Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity (NCT01837654), a randomized na study. The primary outcome is Mean Peak Detrusor Pressures.

2. Clinical Question

The clinical question concerns whether the timing of continuous plantarflexion during filling cystometry is associated with changes in urinary urgency and detrusor contraction pressure among patients with detrusor overactivity. The registry describes plantarflexion as pushing the tiptoes against the floor. One group began the maneuver at the beginning of the second wave, while the other began it at the beginning of the third wave. The record does not define the waves further.

This distinction matters for interpretation: the comparison concerns when plantarflexion was initiated within the test, rather than whether it was used at all. The record does not report a group without plantarflexion, so it cannot directly establish how either timing compares with no plantarflexion. The urgency measure provides a separate patient-reported outcome alongside the pressure measure; the record does not describe further details of how urgency was elicited or scored during testing.

3. Trial Design

The registry describes a randomized, parallel-group trial with no masking. It lists the status as completed, enrollment as 22, and the phase as not applicable. The sponsor is Assaf-Harofeh Medical Center. The recorded start was 2012-06, and primary completion was 2012-08. These registry fields describe the study record; they do not by themselves establish how randomization was implemented or whether the actual conduct matched every planned procedure.

The two groups differed in the wave at which participants were asked to begin continuous plantarflexion during cystometry. In the second-wave group, participants were asked to push their tiptoes against the floor at the beginning of the second wave. In the third-wave group, they were asked to do so at the beginning of the third wave. The registry does not describe what the waves represent, the precise interval between them, or whether participants continued the maneuver for a specified duration beyond the word “continuous.”

The primary outcome was mean peak detrusor pressure for each contraction, reported in cm H2O. The timeframe is through test completion, described as an average of 10 minutes. The secondary outcome was urgency severity on a 0–10 visual analogue scale over the same stated timeframe. The posted results give 11 participants in each group for both outcomes. The registry record does not report the allocation sequence, concealment procedures, participant or assessor blinding, detailed eligibility criteria, baseline characteristics, or the original statistical analysis plan.

Randomization can support a causal comparison when allocation and follow-up are implemented appropriately, but the registry fields alone do not document those details. With no masking listed, participants and study personnel were not reported as masked; whether outcome assessors were masked is not reported in the registry record. The record reports group summaries and a primary comparison, but does not describe analysis-population rules or the handling of missing observations.

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: Twenty seven patients were diagnosed with DO. Twenty two patients were included in the study and comprised the study cohort. Five patients were excluded due to physical disability.

Overall 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.

6. Primary Endpoint

The registry lists the primary outcome as Mean Peak Detrusor Pressures, measured over through test completion, an average of 10 minutes.

The primary endpoint is the mean peak detrusor pressure of contractions during filling cystometry, expressed in cm H2O. Detrusor pressure describes pressure generated by the bladder’s detrusor muscle; the peak value captures the highest reported pressure for each contraction. The registry summarizes these contraction-level peaks as a group mean over the stated testing timeframe, through test completion, an average of 10 minutes.

Pressure is a continuous physiological measure. Reporting a mean gives a group-level summary of the observed values, while the standard deviation describes how much participant-level values vary around that mean. These answer different questions: the mean describes the average level, and the standard deviation describes dispersion among observations. The posted summaries report a mean and standard deviation for each group, but do not explain exactly how multiple contractions within a participant were combined or whether the analysis accounted for repeated measurements.

This endpoint is relevant to the stated study question because the registry asks whether plantarflexion timing relates to the amplitude of detrusor contraction. It is not interchangeable with urgency: pressure is a physiological measurement, whereas urgency severity is reported on a visual analogue scale. Neither endpoint alone provides a complete description of the testing experience or of outcomes beyond the stated cystometry timeframe. Further details about measurement procedures, device calibration, and the analysis unit are not reported in the registry record.

7. Results Posted in the Registry

• Plantarflexion - 3rd Wave: mean 31.00 versus 58.00 on control; difference -27.00 (95% CI -40.95 to -13.05), standardized effect d = -1.62; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS).

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Plantarflexion - 3rd Wave: mean 4.70 versus 4.70 on control; difference 0.00 (95% CI -4.85 to 4.85), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Plantarflexion - 3rd Wave and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcome is urgency severity on a 0–10 visual analogue scale. The posted group means are both 4.7, with a mean difference of 0.0 and an interval from -4.853 to 4.853. The unadjusted p-value is 1.0. Across the posted outcomes, the pressure comparison shows separation in the group means, whereas the urgency comparison does not show a difference in the reported means. These endpoints capture different dimensions and should not be expected to move together as a matter of statistical necessity.

Pressure is a physiological measurement, while urgency is a rating. A difference in pressure without a difference in the average urgency score does not establish that one endpoint validates or contradicts the other. The registry does not report a participant-level association between pressure and urgency, nor an analysis of whether changes in one measure track changes in the other. The group summaries alone cannot answer that question.

The urgency interval is broad and includes values on both sides of zero. As a result, the same group means do not demonstrate equivalence or rule out potentially meaningful differences. The scale’s interpretation, an equivalence margin, and a minimally important difference are not reported in the registry record. Without those details, the estimate should be described as uncertain rather than as proof of no effect.

Secondary findings generally carry less weight than a prespecified primary analysis because multiple outcomes or analyses create more opportunities for chance findings. The urgency p-value is unadjusted, and no multiplicity procedure is reported. The record lists no reported secondary analyses. It is not possible to determine from the registry whether urgency was prespecified as a secondary endpoint in a full analysis plan, whether other outcomes were considered, or whether all analyses are posted. The secondary result is therefore useful as a descriptive companion to the primary outcome, but should not be treated as an independent confirmation of the pressure result.

The urgency scale is labeled as a mean with standard error in the record. That differs from the primary outcome’s standard deviation summaries. This distinction matters when interpreting spread and precision: the posted urgency dispersion figures describe standard errors, not variation among individual participant ratings. The record does not provide additional distributional summaries or analysis details that would allow a fuller assessment of the secondary outcome.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS).

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous, so its group summaries are reported as means with standard deviations. A mean gives the arithmetic average of the measured peak pressures, while a standard deviation describes the spread of observations around that average. A standard deviation is not the uncertainty of the mean. The registry reports group standard deviations of 14.0 cm H2O and 19.0 cm H2O, alongside the respective group means.

What does the mean difference represent?

The posted contrast is the third-wave group mean minus the second-wave group mean. Its estimate is -27.0 cm H2O. The negative direction means that the third-wave group’s reported mean is lower under this subtraction order. The direction depends on which group is subtracted from which, so a negative sign is not inherently evidence of benefit or harm. The comparison is specifically between the two recorded plantarflexion timings.

A mean difference preserves the original measurement units, making it directly interpretable on the pressure scale. The reported interval, from -40.95 to -13.05 cm H2O, expresses uncertainty around the estimated difference under the method used to produce it. The registry record does not identify the confidence level or give a detailed model specification, so those details should not be inferred. An interval describes a range of estimates compatible with the analysis; it is not a range containing a known proportion of individual participant outcomes.

How should the p-value be read?

The posted unadjusted p-value for the primary comparison is <0.001. In general, a p-value describes how unusual a test statistic at least as extreme as the observed one would be under a specified null hypothesis and the assumptions of the test. It is not the probability that the null hypothesis is true, and it is not the probability that the result occurred by chance. Because the registry labels the value unadjusted, it should not be treated as corrected for the consideration of multiple outcomes or analyses.

The secondary urgency comparison has a reported mean difference of 0.0 units, an interval from -4.853 to 4.853, and an unadjusted p-value of 1.0. A p-value of 1.0 does not establish equality. In general, a non-significant result can reflect a small estimated difference, imprecision, or both. The width of the interval is important when judging which differences remain compatible with the observed summary results.

Why does variability matter?

Variation among observations affects the precision of estimates. The primary group standard deviations are 14.0 and 19.0 cm H2O. The reported pooled standard deviation is 16.69, and the standardized effect estimate is -1.618. A standardized effect expresses a difference relative to a measure of variability, rather than in the original pressure units. It can assist comparisons across scales, but it does not replace the unit-based mean difference, and its interpretation depends on the quality and relevance of the variability estimate.

The registry also reports standard errors for the two primary group means, 4.221 and 5.729. A standard error estimates the variability of a statistic across repeated samples under a statistical model; it is not the spread of individual participant values. For urgency, the posted group spread is identified as standard error, with values of 1.8 and 1.7. These are not interchangeable with standard deviations, so the urgency spread should be understood according to the registry’s stated label rather than treated as participant-level dispersion.

What can randomization and masking tell us?

Random allocation is intended to make groups comparable on average, including for factors that were not measured, but the registry’s “randomized” designation does not explain how sequence generation or allocation concealment were performed. The trial is listed as unmasked. Lack of masking can matter particularly for subjective outcomes such as urgency ratings, as expectations or awareness of assignment may influence reporting or assessment. The record does not say whether outcome assessors were masked. These are considerations for interpreting the results, not proof that bias occurred.

The parallel model indicates that the record presents separate groups assigned to different timings. The registry gives no detail about any within-participant repeated measurements or the exact analytical unit for contractions. If multiple contractions contributed to an individual’s mean, their dependence would be relevant to statistical analysis; whether and how this was handled is not reported in the registry record. A general statistical concern is that treating correlated measurements as independent can understate uncertainty. That concern cannot be resolved from the posted description.

What does the analysis record include?

The primary summaries and comparison are posted, while the registry lists no reported analyses for the secondary outcome. The record does not report a full statistical analysis plan, covariate adjustments, an intention-to-treat rule, missing-data methods, or prespecified subgroup analyses. The reported unadjusted comparisons therefore should be read as the available summaries, not as evidence that these additional analytical choices were made or that all planned analyses are represented.

11. Confidence Intervals and Precision

The primary mean difference is -27.0 cm H2O, with a reported interval from -40.95 to -13.05. The interval is entirely below zero, consistent with a lower observed mean in the third-wave group under the stated subtraction order. It also spans a range of possible magnitudes, so the estimate is not exact. The posted interval does not communicate the distribution of individual pressure values; the group standard deviations describe that variation separately.

Confidence intervals are generally used to convey the uncertainty of an estimate under a statistical model. They are not guarantees that the true value lies inside a particular interval, and they do not account for sources of bias or uncertainties omitted from the model. The registry record does not report the interval’s confidence level or enough detail to independently assess its construction. The interval should therefore be interpreted as the uncertainty range attached to the posted comparison, rather than assigned an unstated confidence level.

For urgency, the estimated mean difference is 0.0, while the reported interval runs from -4.853 to 4.853. This wide range includes zero and differences in either direction. It leaves substantial uncertainty about the between-group contrast on the stated scale; the identical rounded group means do not by themselves establish equivalence.

Precision is affected by sample size, variability, study conduct, and the analysis method. The posted groups each include 11 participants, and the primary outcome has substantial reported spread relative to its standard error. These summaries help describe the precision of the estimates, but do not reveal whether all randomized participants contributed usable outcomes or whether observations were missing. Missing-data details are not reported in the registry record.

The primary p-value is small, but the interval is more informative about the range of estimated differences than the p-value alone. Neither measure resolves uncertainty about generalizability, outcome measurement, or analysis decisions absent from the record. Statistical precision and the broader credibility of an estimate are related but distinct considerations.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total events. They are illustrations based on the observed primary effect and are not the trial’s original design calculation. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set as a stated fraction of the observed effect. The registry record does not report the trial’s own original sample-size assumptions or justification.

The 80% power column gives the illustrative number of participants per arm for a design intended to have an 80% chance of detecting the specified effect under the stated assumptions, if that effect and the model assumptions were correct. The 90% power column uses a higher target probability of detection, and therefore generally calls for more participants per arm under the same planning framework. These are planning targets, not guarantees of a result.

The rows describe planning for 100%, 75%, and 50% of the observed effect. The corresponding participants-per-arm figures are 6 and 9 for 100% of the observed effect; 11 and 15 for 75%; and 24 and 33 for 50%, with the first figure in each pair for 80% power and the second for 90% power. The pattern illustrates a general planning principle: smaller effects are harder to distinguish from random variation, so detecting them requires more participants under otherwise unchanged assumptions.

This is not observed power. It is a prospective planning illustration calculated from an effect estimated in the trial, and the observed effect may be uncertain or overstated. The registry record does not report whether the original study used these assumptions or these planning figures when it was designed. The illustration should not be read as a retrospective measure of how likely the completed study was to find a result.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -27.000; pooled standard deviation σ = 16.688.
2. n = 2 × (1.96 + 0.842)² × 16.688² / -27.000² = 6.0, rounded up to 6 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -27                      # observed difference in means
sigma <- 16.6883192682786                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1837654)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 6 (80% power), 9 (90% power)
 75% of observed effect: n per arm = 11 (80% power), 15 (90% power)
 50% of observed effect: n per arm = 24 (80% power), 33 (90% power)
power.t.test: 7.1 
Simulated power at n = 6 per arm: 0.714 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several outcomes, comparisons, time points, or analytical choices are considered. If each is tested separately, the chance of at least one apparently strong result can rise across the set. The primary comparison is reported with an unadjusted p-value, and the urgency comparison is also unadjusted. The registry record does not report a multiplicity adjustment, a hierarchy among outcomes, or a prespecified strategy for controlling error across analyses.

The registry lists the pressure measure as primary and urgency severity as secondary. That distinction helps identify the outcome emphasized in the record, but does not show whether other outcomes or time points were considered in the full study. The record lists two outcome measures and no reported secondary analyses. It does not report a complete statistical analysis plan, the timing of analysis decisions, or whether the outcome hierarchy was established before data were examined. As a result, the extent of multiplicity cannot be fully assessed from the posted information.

Missing-data handling is also not reported in the registry record. The posted results give 11 participants per group for the primary and secondary outcomes, but do not state whether those values reflect everyone randomized, everyone who completed the test, or only participants with usable measurements. There is no reported account of withdrawals, incomplete cystometry, missing urgency ratings, exclusions after randomization, or methods used to handle missing values.

The analysis population is not specified. The registry does not report whether participants were analyzed according to randomized assignment, according to the maneuver actually performed, or under another rule. It also does not report adjustments for baseline characteristics, treatment adherence, or repeated contractions. These absences do not demonstrate that particular methods were omitted from the study; they mean that the registry record does not document them.

For interpretation, the posted comparisons should be considered unadjusted and incomplete with respect to these methodological details. Multiplicity and missingness can affect uncertainty and the credibility of estimates, but their impact cannot be quantified from the available record. No assumption about the intended analysis, planned interim analyses, or handling of incomplete data is justified by the posted fields.

15. 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 0% reporting threshold.

The adverse-event record reports zero serious adverse events and zero deaths in each group. It also reports zero other adverse events in each group. The at-risk count is 11 for serious adverse events and 11 for other adverse events in each group. These figures describe the events recorded during the period covered by the registry entry.

Zero recorded events does not establish that the maneuver has no risks. Event counts in a small study can provide limited information about uncommon events, and the registry record does not specify the safety observation period or provide detailed event definitions, severity grading, or collection procedures. It also does not report whether all participants completed safety follow-up.

The absence of recorded events should therefore be read as a report of what appears in the registry, not as proof of safety or a guarantee that no event occurred outside the recorded reporting process. The posted counts are descriptive and do not establish a comparative safety difference between the two timings.

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

The posted results describe a randomized comparison of two timings of continuous plantarflexion during filling cystometry. The mean peak detrusor pressure was 58.0 cm H2O in the second-wave group and 31.0 cm H2O in the third-wave group. The reported mean difference was -27.0 cm H2O for third wave minus second wave, with an interval from -40.95 to -13.05 and an unadjusted p-value of <0.001. In this trial record, the group assigned to begin at the third wave had the lower reported pressure mean.

This result does not compare plantarflexion with no plantarflexion. Both groups were asked to perform the maneuver; timing was the contrast. The registry does not give a control group without plantarflexion, so the observed contrast cannot establish the effect of plantarflexion itself relative to no maneuver. It also does not establish the effect of changing timing in other clinical settings or populations.

The urgency means were both 4.7, with a reported difference of 0.0 and a broad interval from -4.853 to 4.853. This does not prove that urgency scores are equivalent between groups. Pressure and urgency are distinct outcomes, and the registry does not report whether participant-level changes in pressure corresponded to changes in urgency.

The posted statistical evidence should be understood alongside the limited study size and the missing methodological details. The record does not report a clinically important difference threshold for pressure, an equivalence margin for urgency, the handling of missing data, or the detailed analysis plan. Thus, statistical separation in the pressure summaries is not by itself evidence of clinical importance, and the urgency result cannot be interpreted as proof that no difference exists.

The adverse-event figures report no recorded serious or other adverse events and no deaths in either group. They are descriptive counts and do not demonstrate absence of risk. Overall, the registry supports a careful description of the observed outcomes under the study conditions, but not a broad claim about treatment effectiveness, clinical benefit, or safety.

17. Why This Trial Matters Statistically

This trial is statistically instructive because its main contrast changes the timing of a maneuver rather than comparing the maneuver with no maneuver. The distinction determines what the estimated mean difference can answer. An estimate between the second-wave and third-wave groups addresses those recorded strategies only; it cannot isolate the effect of plantarflexion compared with usual testing or no plantarflexion.

The pressure endpoint and urgency endpoint also show why different outcome types should be interpreted separately. A physiological pressure measure and a subjective rating can yield different patterns without one invalidating the other. The reported pressure contrast is distinct from the urgency comparison, and the registry does not provide participant-level evidence linking the two. Keeping endpoints conceptually separate helps prevent an overstatement that one result confirms or explains the other.

The example also highlights the difference between statistical evidence and precision. The pressure result has an unadjusted p-value of <0.001 and an interval that does not cross zero, while its interval still covers a range of possible effect magnitudes. The urgency interval is broad despite identical reported means. Neither a p-value nor a rounded mean alone captures the full uncertainty of an estimate.

Finally, a registry record can give useful outcome summaries while leaving important analytic details undocumented. The allocation procedure, handling of missing observations, analysis population, multiplicity strategy, and original sample-size justification are not reported in the registry record. Recognizing these gaps is part of statistical interpretation: it distinguishes what the reported estimates show from what would require additional study documentation.

18. 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 record describes a small randomized comparison, with 11 participants reported in each group. The estimates may therefore be sensitive to the outcomes of individual participants, and the posted pressure interval remains broad enough to represent a range of possible differences. The planning illustrations are based on the observed effect; they do not provide evidence that the study was originally designed around those assumptions.

The comparison has no group without plantarflexion. Since both groups were instructed to perform the maneuver, the result is limited to the relative timing contrast. The record does not describe the waves in detail, the interval between them, or the duration and adherence to the maneuver. This limits how specifically the intervention can be reproduced or the timing contrast interpreted.

The registry does not report detailed participant characteristics, eligibility criteria, baseline outcome values, or the methods used to generate and conceal random allocation. Masking is listed as none, and masking of outcome assessors is not reported in the registry record. These gaps are relevant to judging group comparability and the susceptibility of a subjective urgency rating to measurement or expectation effects.

The outcomes are described as summaries through test completion, an average of 10 minutes. The registry does not explain how repeated contractions were combined for analysis, whether outcomes were missing, or how missing values were handled. It also does not report a full analysis plan, adjustment for multiple outcomes, or clinically meaningful thresholds. These omissions make it difficult to assess the completeness and prespecification of the posted comparisons.

Finally, the adverse-event record reports no events, but the safety observation period and collection procedures are not reported. The result should be interpreted as a limited record of events rather than a comprehensive assessment of safety. The stated limitations reflect absent documentation and study scope; they do not establish that a particular bias or problem occurred.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity — NCT01837654.
• Registry record last updated 2019-03-11; status last verified 2018-11.
• Results first posted 2019-03-11.
• 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.

22. Record Summary

The registry record describes NCT01837654, titled “Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity.” It is listed as randomized, parallel, unmasked, and completed, with enrollment of 22. The sponsor is Assaf-Harofeh Medical Center; the recorded start was 2012-06 and primary completion was 2012-08.

The primary outcome was mean peak detrusor pressure during filling cystometry. The posted group means were 58.0 cm H2O for plantarflexion beginning at the second wave and 31.0 cm H2O for beginning at the third wave. The reported mean difference was -27.0 cm H2O, with an interval from -40.95 to -13.05 and an unadjusted p-value of <0.001. The secondary urgency means were both 4.7, with a reported mean difference of 0.0.

The registry reports no serious or other adverse events and no deaths in either group. Details of the original sample-size rationale, analysis population, missing-data handling, multiplicity strategy, and full statistical plan are not reported in the registry record.