A Pilot Study Investigating the Use of a Therapeutic Wand in Addition to Physiotherapy for Bladder Pain Syndrome: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Pilot Study Investigating the Use of a Therapeutic Wand in Addition to Physiotherapy for Bladder Pain Syndrome (NCT02743962), a randomized na study. The primary outcome is Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score.

2. Clinical Question

The registry describes a pilot study intended to examine whether self-use of a therapeutic wand adds benefit to specialist physiotherapy for bladder pain syndrome. The primary measure is a questionnaire score covering bladder symptoms and how bothersome they are. It is recorded for baseline to 6 weeks and for 6 to 12 weeks. These periods allow the study question to consider change during the treatment period and change across the later follow-up interval, although the record does not report numerical estimates for either comparison.

The clinical question is about the added component: both groups receive specialist physiotherapy, while the wand group is also taught to use a wand at home. It is therefore not a comparison of physiotherapy with no treatment, nor a comparison of wand use alone with physiotherapy. The registry record does not report enough detail to specify all eligibility criteria, the exact content of the wand instructions, or whether participants followed the intended home-use schedule.

3. Trial Design

This was a completed, randomized, parallel-group pilot study with no masking. The registry records an enrollment of 10. The sponsor was the University of Bradford. The study start is recorded as 2016-04 and primary completion as 2016-10. The phase is listed as NA.

The comparison was between usual specialist physiotherapy and the same physiotherapy with a therapeutic wand added. For the usual physiotherapy group, the registry describes dietary advice about fluid and fibre intake, bladder retraining advice, and 15 minutes of manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. The wand group was described as receiving standard specialist physiotherapy for 6 weeks, being provided with an intra-vaginal wand, and being taught how to use it at home twice a week. Further detail on the home-use instructions is not reported in the registry record.

Random allocation can reduce systematic differences between groups at the start of a trial, but a pilot with a small enrollment can still have important baseline imbalances by chance. With no masking, participants and those delivering treatment knew the assigned group. That may matter for outcomes based on participant-reported symptoms, because expectations and awareness of treatment can affect reporting. The registry record does not report the allocation procedure, concealment of assignment, or any steps to limit bias in outcome assessment.

The registry describes the study as completed but does not report a detailed statistical analysis plan or numerical results for the primary endpoint. Completion status alone does not indicate whether the trial answered its clinical question precisely. The study's pilot purpose and the amount of outcome information reported should be considered when interpreting the 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: There was no pre-participation period. Once consented to participate participants began 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 Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score, measured over Baseline to 6 weeks and 6 to 12 weeks.

The primary endpoint is change in the O'Leary-Sant Interstitial Cystitis Symptom Index Score, measured in units on a scale. The registry describes it as a single-page questionnaire with four questions about bladder symptoms and bother. Individual question scores range from 0 to 4 or 5, and the total achievable score ranges from 0 to 19. Higher scores describe greater symptoms of interstitial cystitis. The record states that total scores were collected for analysis.

This type of patient-reported measure is relevant to the stated study question because it captures symptoms and how troublesome they are from the participant's perspective. A score change can summarize whether reported symptom burden shifted over a specified period. However, the meaning of a change depends on its size, precision, and context; the score definition by itself does not establish that a change is important to participants.

The registry specifies baseline to 6 weeks and 6 to 12 weeks as the timeframes. It does not report the numerical group results, the estimated between-group difference, or uncertainty around that estimate. The score range and direction are therefore interpretable, but the record does not support a conclusion about the size or precision of any treatment contrast.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a continuous measure summarized using a mean and standard deviation. Those summaries serve different purposes. The mean describes the average score or change in a group, while the standard deviation describes how spread out individual observations are around that average. A mean alone does not show whether participants had similar experiences or widely varying scores.

What does a between-group estimate represent?

For a randomized comparison, the central quantity is generally the difference in outcome between the assigned groups, defined for a particular time point or change period. An estimate expresses the observed contrast in the outcome's units. Here the score is measured in units on the O'Leary-Sant scale. The registry record does not report a numerical between-group estimate, so its direction and magnitude cannot be described.

A within-group change and a between-group contrast answer different questions. A group can improve or worsen over time for reasons that affect both groups, including time, attention, or other aspects of care. Comparing the groups helps isolate the added treatment component under the randomized design. For this study, both groups were assigned specialist physiotherapy, while the wand group was also assigned home wand use. The registry does not report the numerical changes needed to make that comparison.

How should uncertainty be read?

A confidence interval is a range of values compatible with the observed data and the statistical model used to calculate it. A narrow interval indicates greater precision than a wide interval. It can help distinguish an estimate that is tightly constrained from one that remains compatible with a broad range of effects. A confidence interval is not a guarantee that the true effect lies within its endpoints, and it does not replace judgment about whether a range of effects would matter clinically.

No confidence interval for the primary outcome is reported in the registry record. Nor are the group means and standard deviations available for evaluating the outcome's distribution or the precision of a contrast. The lack of these quantities means that a reader cannot determine whether an apparent difference, if any, would be estimated precisely.

What role does the pilot design play?

A pilot study can assess whether a research approach is workable and can generate preliminary information for future research. It is not automatically designed or powered to give a definitive estimate of treatment effect. The record does not report the protocol's aims in enough detail to establish whether feasibility was the primary purpose, nor does it report a sample-size justification. No assumption about the original design rationale should be made from the pilot label alone.

The record includes sample-size planning assumptions based on the observed effect: a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Such calculations are planning illustrations, not observed power and not evidence that the study was designed to detect a particular effect. The record does not include numerical planning outputs in the information, so no required sample size can be interpreted. Planning values based on an observed effect also depend on the estimate used; preliminary effects from a small pilot can be uncertain.

Why can extra variation matter?

Standard deviation describes the spread of individual scores. When outcomes vary substantially between participants, the group average is less informative about any one participant, and a treatment contrast can be estimated less precisely. In count outcomes, over-dispersion means that variation exceeds what a simple model assumes; accounting for it can be important to avoid overstated precision. The primary endpoint in this trial is continuous, and the registry does not report evidence about over-dispersion or describe a model that would require such an adjustment. This is a general statistical point, not a claim about the trial's data.

The record names two analyses, but it does not provide their methods or results. It does not state whether the primary analysis adjusted for baseline score, how repeated time periods were handled, or which observations were included. Those details matter because different analysis choices can lead to estimates with different interpretations. The registry record does not report enough information to reconstruct or evaluate those choices.

What can be concluded from missing estimates?

Statistical interpretation requires more than knowing the outcome scale and trial assignment. A reader needs the observed estimates, their uncertainty, and a clear description of the comparison. Because the registry record does not report those results for the primary endpoint, no effect size or precision claim can be made. General descriptions of means, standard deviations, confidence intervals, and planning calculations explain how such evidence is usually read; they do not substitute for the trial's missing numerical results.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is recorded for baseline to 6 weeks and 6 to 12 weeks, rather than as one reported comparison. Considering multiple periods or outcomes creates a multiplicity issue: the more contrasts examined, the greater the opportunity for an apparently notable result to arise by chance if each is treated as an independent confirmatory test. This general concern does not establish that any particular result is false. The registry record does not report a hierarchy of outcomes, a prespecified primary time point, or a method for adjusting for multiple comparisons.

The registry records 8 outcome measures. Named secondary outcomes include change in the Genitourinary Pain Index, a pelvic pain and urinary urgency/frequency symptom scale, perceived urinary urgency, perceived overall pain, and perceived ease of wand use. The record does not report numerical results for these measures or explain how they relate to the primary outcome in the analysis plan. It also records 2 analyses without describing their statistical methods or identifying the contrasts tested.

Missing-data procedures are not reported in the registry record. The number assigned to a group need not be the same as the number with complete outcome data, and the record does not state how missing questionnaires, withdrawals, or incomplete follow-up were handled. The analysis population is also not reported: it is unclear from this record whether results were intended to include everyone randomized, only those who received treatment, or another defined set of participants.

These omissions limit assessment of selective outcome reporting, the treatment of repeated measurements, and the possible effects of missing observations. They do not establish that data were missing or that analyses were inappropriate; the relevant details are simply not reported in the registry record.

11. Safety Results

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

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 lists no serious adverse events among the participants recorded as at risk in either group: the usual physiotherapy group lists 4 at risk and 0 affected, and the therapeutic wand group lists 5 at risk and 0 affected. Other adverse events are also listed as 0 affected in both groups, with the same at-risk counts. These figures describe the entries in the registry record and should not be read as a guarantee that no harms occurred.

The registry lists deaths as not reported, rather than as a numerical zero. It gives no serious adverse-event terms and does not describe event definitions, collection procedures, observation completeness, or follow-up beyond the figures shown. The at-risk counts are the denominators attached to the adverse-event entries; the record does not explain why they differ from the enrollment figure.

Zero recorded events in a small pilot is limited evidence about uncommon harms. It cannot establish that a treatment is free of risk, and it does not tell readers how well adverse events were sought or documented. Conversely, the registry entries do not show an adverse-event signal in the groups as recorded. Safety interpretation should remain bounded by the small counts and the reporting detail available in the registry record.

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

The registry record establishes that a completed randomized pilot compared standard specialist physiotherapy with the same care plus home therapeutic wand use. It also defines a primary questionnaire outcome that assesses bladder symptoms and bother, including its score range, direction, and follow-up periods. These details make the clinical question and measurement approach understandable.

The record does not provide the numerical primary outcome results needed to assess what the comparison showed. It reports no group changes, between-group estimate, or measure of uncertainty for baseline to 6 weeks or 6 to 12 weeks. Consequently, it is not possible from the registry record to describe the direction or size of an effect, or how precisely it was estimated. The absence of those numerical findings is not evidence that the groups had identical outcomes.

The study's pilot designation and enrollment of 10 also put its role in context. A pilot can contribute preliminary information, but the registry does not state its sample-size rationale or report whether the study was designed to estimate efficacy, assess feasibility, or serve both purposes. No definitive conclusion about treatment benefit should be inferred from the study label, the completed status, or the safety counts alone.

Likewise, the listed adverse-event entries show zero affected for the categories recorded among the participants listed at risk, but they do not establish that uncommon harms cannot occur. The registry does not report enough detail about event monitoring or deaths to extend the interpretation beyond those entries.

In short, the record conveys a randomized pilot design and a relevant symptom measure, but not the primary numerical results. It therefore supports description of what was compared and what was measured, rather than a conclusion about whether adding the wand changed symptoms.

13. Why This Trial Matters Statistically

This trial raises a useful statistical question about an added component of care. Because both groups were assigned specialist physiotherapy, the comparison is focused on whether home wand use contributes information beyond the shared treatment. That design makes the contrast clinically interpretable in principle, provided the outcome estimates and their uncertainty are reported.

The primary measure is based on participant reports of symptoms and bother, which directly reflects the experience the study set out to examine. At the same time, the unmasked design makes clear reporting of the analysis and potential sources of bias especially important. The registry identifies the measurement periods but does not provide a single numerical comparison or explain how the multiple periods were addressed.

The pilot context also illustrates why estimates and precision matter together. A treatment contrast without its uncertainty can be difficult to interpret, particularly when enrollment is small. A planning illustration based on an observed effect cannot resolve that uncertainty or substitute for a well-described primary analysis. Readers need the actual estimates, the number analyzed, and the methods used to judge what the trial contributes.

The registry record documents a completed randomized study and describes its intervention and outcome framework. Its incomplete numerical reporting also demonstrates the difference between a trial being completed and its findings being interpretable. Clear outcome estimates, missing-data information, and a prespecified analysis description would allow the clinical and statistical question to be evaluated more fully.

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 important limitation for interpretation is that numerical results for the primary endpoint are not reported in the registry record. Without group-level changes and an uncertainty estimate, the size and precision of the treatment contrast cannot be evaluated. The record also identifies multiple follow-up periods without reporting a single comparison, making it unclear which contrast should be treated as the main one.

The enrollment of 10 limits the amount of information available from this pilot, although the precision cannot be quantified without the outcome variability and analysis counts. The adverse-event denominators are 4 for the usual physiotherapy group and 5 for the therapeutic wand group; these entries do not account for every aspect of safety follow-up, and the registry does not explain the denominators' relationship to enrollment.

The trial was unmasked and relied on a participant-reported primary measure. Participants knew whether they received the wand, so expectations could influence responses. The registry record does not describe safeguards against this possibility. It also does not report baseline group summaries, allocation concealment, missing-data methods, or the analysis population.

Some intervention details are incomplete. The usual physiotherapy description includes advice and manual treatment, while the wand description states that participants were taught home use twice a week but does not give the full instructions in the registry record. Adherence to wand use is not reported. The record also does not give a sample-size justification or explain the two recorded analyses. These limits constrain interpretation but do not establish that the trial was conducted improperly.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Pilot Study Investigating the Use of a Therapeutic Wand in Addition to Physiotherapy for Bladder Pain Syndrome — NCT02743962.
• Registry record last updated 2018-05-03; status last verified 2018-05.
• Results first posted 2018-05-03.
• 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.

18. Record Summary

NCT02743962 is a completed, randomized, unmasked, parallel-group pilot study sponsored by the University of Bradford. The registry records enrollment of 10, with a start date of 2016-04 and primary completion in 2016-10. It compares usual specialist physiotherapy with physiotherapy plus a therapeutic wand for home use.

The primary outcome is change in the O'Leary-Sant Interstitial Cystitis Symptom Index Score, assessed from baseline to 6 weeks and from 6 to 12 weeks. Higher scores indicate greater symptoms. The registry record does not report numerical primary outcome results, a single primary comparison, or the analysis population. Adverse-event entries list 0 serious events and 0 other events affected in each group, with deaths not reported.