TPTNS for Treating Patients With Premature Ejaculation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for TPTNS for Treating Patients With Premature Ejaculation (NCT03204890), a na na study. The primary outcome is Clinical Improvement.

2. Clinical Question

3. Trial Design

This completed study is described as a Phase II clinical trial in its title and brief description; the phase classification itself is recorded as NA. It enrolled 26 participants with premature ejaculation and was sponsored by Boston Medical Group. The registry dates the study start as 2017-06-14 and primary completion as 2018-01-15.

The design is recorded as single-group, with no randomized allocation and no masking. Participants were planned to receive transcutaneous posterior tibial nerve stimulation three times per week for 12 weeks. The brief description says that IELT and the PEDT (Premature Ejaculation Diagnostic Tool) scale were to be evaluated at week 6, at the end of treatment, and three months after the protocol was completed.

Because the record describes a single treatment group and no concurrent control, it does not establish a randomized comparison against another treatment or against no treatment. Follow-up measurements could describe changes over time in the participants assessed, but they cannot by themselves separate treatment effects from other explanations for change. The registry record does not report adherence, actual treatment received, the number completing each follow-up, or whether the planned assessment schedule was followed.

The registered primary outcome is a participant count at three months after completion. Secondary outcomes include change in a baseline score, the magnitude of change in the PEDT score, and adverse-event frequency. Detailed methods for measuring or analysing those outcomes are not reported in the registry 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.

Before assignment: Fourteen participants had an IELT value \>1 min during the evaluation with a stopwatch in the 2 weeks prior to the start of therapy and were excluded from the study.

Overall Study

Reasons for not completing this period:

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 Clinical Improvement, measured over Three months after completion..

The primary endpoint is the number of participants with clinical improvement three months after completing treatment. The registry defines improvement as a tripling of the baseline IELT measured without treatment. IELT is the intravaginal ejaculation latency time, so the endpoint translates a change in timing into a threshold-based yes-or-no classification for each participant, then counts those meeting the threshold.

A threshold endpoint can make a result easier to interpret as a count of participants meeting a prespecified definition. However, it discards information about the size of changes that do not cross the threshold, and participants close to the threshold may be classified differently despite similar measurements. General statistical point: continuous measurements such as IELT can preserve more information about the range of observed change, while a binary classification gives a more focused answer to a particular threshold question.

The registry record states the outcome definition and assessment time, but does not report the result, the number assessed, or the underlying IELT values. It also does not report how baseline or follow-up measurements were collected, whether measurement procedures were standardized, or how missing measurements were handled. Therefore, the endpoint’s planned meaning can be described, but its observed frequency and precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a participant count represent?

The primary outcome is a count of participants meeting a defined event criterion: an IELT at least three times baseline, assessed three months after treatment completion. A count is a binary-outcome summary because each participant is classified as meeting or not meeting the criterion. To interpret such a count as a frequency, readers also need the number assessed or included in the analysis. That denominator is not reported in the registry record for the primary endpoint.

General statistical point: counts are easiest to interpret alongside their denominator and an uncertainty interval. A confidence interval describes a range of values compatible with the observed data under the statistical method used; it reflects sampling uncertainty, not certainty that the true value lies within a particular range. No confidence interval or other uncertainty estimate for the primary endpoint is reported in the registry record.

What does the single-group design allow?

The trial is recorded as single-group, with allocation and masking listed as NA and NONE, respectively. There is no registered concurrent control group. This design can describe outcomes observed among participants receiving the intervention, if those outcomes are reported, but it cannot directly compare them with outcomes under a different assigned condition. A baseline measurement can serve as a reference for describing within-participant change, but it is not a randomized control.

General statistical point: random allocation helps make groups comparable, on average, with respect to factors that could affect outcomes. Without it, a difference between measurements over time can reflect treatment as well as other changes. Since the registry record does not report an outcome analysis, there is no posted estimate to evaluate for either within-group change or a treatment contrast.

What can be inferred from the endpoint definition?

The definition specifies a threshold, a baseline reference, a measurement, and a follow-up time. It does not give the actual baseline or follow-up IELT values, the number crossing the threshold, or the number with measurements at both times. Nor does the record report whether an analysis used the threshold exactly as stated or how it handled values that were unavailable or difficult to classify.

General statistical point: converting a continuous measurement into a binary outcome can make the target easier to communicate, but it loses distinctions among participants who fall on the same side of the threshold. The threshold-based count therefore does not describe the full distribution of IELT changes. The separate planned PEDT outcomes may capture another dimension, but their results and analysis details are not reported in the registry record.

What information is absent about analysis?

The registry record reports zero analyses and does not describe an inferential statistical plan, the model used, any adjustment for baseline values, or a method for calculating uncertainty. It also does not report a sample-size justification for this single-group study. A planned schedule of measurements is not a statistical analysis plan; details such as which measurement time was primary in the analysis, how repeated measurements were handled, and what analysis population was intended are not reported in the registry record.

The sample-size planning assumptions described for planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. Those assumptions are planning conventions, not observed trial outcomes, and they do not establish the trial’s own design justification. They also describe a two-arm planning framework, whereas this registry record identifies a single-group trial. Any such illustration should not be read as observed power or as evidence that the trial had a particular probability of detecting an effect.

Why does over-dispersion matter in general?

General statistical point: over-dispersion means that observed variation is greater than a model expects. If a model assumes less variability than is present, standard errors may be too small and uncertainty may be understated. The registered primary outcome is a participant count, but the registry record does not identify a count model or report data that would allow over-dispersion to be assessed. It would therefore be inappropriate to claim that over-dispersion occurred or that a particular adjustment was used.

Overall, the registry record supports a description of the intended endpoint and study structure, but not a reconstruction of the statistical analysis. Without outcome counts, denominators, and analysis details, effect size and precision cannot be evaluated.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("TPTNS")
n      <- c(11)
events <- c(8)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  TPTNS  11  8  72.7  39.0  94.0  43.4  90.3  42.8  90.1

11. Multiplicity, Missing Data and Analysis Populations

The record lists the primary clinical-improvement outcome and secondary outcomes concerning baseline score change, magnitude of PEDT score change, and adverse-event frequency. It reports four outcome measures and zero analyses. It does not describe an adjustment for multiple comparisons, a hierarchy among secondary outcomes, or a plan for interpreting several outcome tests together. These procedures are not reported in the registry record.

General statistical point: when multiple outcomes or repeated tests are considered, the chance of at least one apparently notable result can increase if each is judged separately without a prespecified strategy. An adjustment or hierarchy can help control how such evidence is interpreted. The registry record does not establish whether any such approach was planned or used, and no outcome-analysis results are posted to evaluate.

Missing-data handling is also not described. The record does not report how many participants posted IELT or PEDT measurements at each planned time, whether participants discontinued treatment or follow-up, or how missing observations were treated. It does not identify an analysis population, such as all enrolled participants or those with complete measurements. These details matter because an endpoint count can depend on who was assessed and how unavailable outcomes were classified.

The enrollment total of 26 does not resolve these questions. The safety record uses 11 participants at risk, but the relationship between that safety denominator and enrollment is not reported. The primary-outcome denominator is also not reported. Readers therefore cannot assume that all enrolled participants contributed to each outcome or that missing data had no effect on the findings.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The safety record lists the TPTNS group with 11 participants at risk. It reports zero serious adverse events and two other adverse events among those 11 at risk. No serious adverse-event terms are listed. The record does not describe the two other events, their severity, timing, relatedness to treatment, or whether they occurred in the same or different participants.

These figures should be read with their stated denominator, rather than as counts among all 26 enrolled participants. The registry record does not explain why 11 participants are listed as at risk or how that group relates to enrollment and follow-up. The counts also do not establish whether safety events were collected consistently over the same observation period for every participant.

General statistical point: a zero count in a limited group does not prove that an event cannot occur. Its interpretation depends on the number observed, the observation period, and how events were monitored and defined. The record’s serious-event count is therefore a descriptive safety result for the listed risk group, not a complete characterization of all possible harms. No broader safety conclusion can be drawn from these counts alone.

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

The registry record defines a clinically interpretable target: the number of participants whose IELT reached at least three times baseline three months after treatment ended. It also documents a planned course of TPTNS and planned follow-up assessments. Those details clarify what the study intended to evaluate, but the record does not report the primary outcome count or denominator. The central efficacy result therefore cannot be estimated from the posted registry results.

The completed status and enrollment of 26 describe the study’s administrative and recruitment record; they do not establish how many participants completed treatment or posted the measurements needed for analysis. Nor do they indicate whether the endpoint threshold was reached by any particular number of participants. No conclusion about effectiveness follows from the intervention description or the endpoint definition alone.

The design also limits causal interpretation. With a single group and no randomized comparator, reported change over time, if available, would not isolate the effect of TPTNS from other influences. General statistical point: controlled comparisons help distinguish an intervention-related difference from changes that could occur over time or through measurement variability. The registry record does not report such a comparison.

The safety figures provide limited descriptive information: zero serious adverse events and two other adverse events among 11 at risk. The event details and relation of this denominator to enrollment are not reported. These counts should not be treated as a complete safety assessment.

In short, the posted record establishes the study question, design features, planned measurements, and a small amount of safety information. It does not provide the primary efficacy result, its precision, missing-data information, or a detailed analysis plan. The evidence available in the registry record is therefore insufficient to judge the magnitude or reliability of any clinical-improvement result.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of why a clearly defined endpoint and a reported result are both needed. The registry specifies a threshold-based outcome tied to IELT and a follow-up time three months after treatment completion. That gives the planned endpoint a concrete interpretation: a count of participants meeting the improvement criterion. Yet without the count and its denominator, neither the frequency nor its uncertainty can be assessed.

The single-group structure also makes the distinction between description and comparison especially important. A study may collect repeated measurements, but change from baseline is not equivalent to a randomized treatment contrast. General statistical point: causal interpretation depends not only on the outcome measure but also on the design and the assumptions connecting observed results to the comparison of interest.

The record highlights the value of reporting analysis populations, follow-up completeness, and missing-data methods. Such details let readers judge whether the participants contributing to an outcome represent the enrolled group and whether the endpoint calculation is transparent. They are not reported for the primary endpoint in this record.

Finally, the safety denominator differs from the enrollment total, and the registry does not explain that relationship. Clear reporting of who was observed for each outcome is essential for interpreting both efficacy and safety counts. The study’s record illustrates that design details and outcome definitions are useful, but cannot substitute for posted outcome estimates and their precision.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary limitation for interpretation is that the registry record does not report the number of participants meeting the clinical-improvement definition. It also does not report the corresponding denominator, IELT values, or an uncertainty estimate. The main outcome therefore cannot be quantified from the posted results.

The single-group, unmasked design provides no concurrent randomized control. Even if within-participant changes had been reported, the design would not establish that those changes were caused by TPTNS. The record does not report actual adherence, treatment completion, follow-up completion, or whether the planned assessments at week 6, treatment end, and three months afterward were conducted as intended.

Participant characteristics beyond the diagnosis and clinic setting are not reported in the registry record. Eligibility criteria and details of outcome collection are also not reported. These omissions limit assessment of how broadly any result might apply and how consistently IELT and PEDT were measured.

For the primary endpoint, the record does not describe missing-data handling, analysis-population definitions, statistical methods, or multiplicity procedures. It does not report a sample-size justification for the single-group design. The safety record lists 11 at risk, while enrollment is 26; the relationship between these numbers is not reported. The two other adverse events are not described. Together, these gaps prevent a full assessment of efficacy, precision, completeness, and safety from the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: TPTNS for Treating Patients With Premature Ejaculation — NCT03204890.
• Registry record last updated 2024-04-15; status last verified 2023-10.
• Results first posted 2024-04-15.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT03204890 is a completed, single-group study of transcutaneous posterior tibial nerve stimulation for patients with premature ejaculation. The registry reports enrollment of 26 and describes a planned schedule of three therapies per week for 12 weeks. It specifies IELT and PEDT assessments at week 6, treatment completion, and three months after the protocol.

The primary outcome is the count of participants with an IELT at least three times baseline three months after treatment completion. The registry record does not report that outcome count, its denominator, or an estimate of precision. It also does not report the statistical analysis plan, missing-data methods, or analysis population. Safety information lists zero serious adverse events and two other adverse events among 11 at risk, without event descriptions or an explanation of the denominator. The posted record therefore describes the intended study and limited safety counts, but does not provide the primary result needed to evaluate clinical improvement.