Laser Therapy for Treatment of Urogenital Symptoms in Women: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Laser Therapy for Treatment of Urogenital Symptoms in Women (NCT03681678), a registered phase not stated study. The primary outcome is Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment.

2. Clinical Question

The study also planned to assess changes in several urinary, vaginal, sexual-function, and mental-health measures at six months. Those measures broaden the clinical questions beyond the short-term global impression, but their observed results are not reported in the registry record. Because the study is observational and has no described comparator, it is framed as an assessment of outcomes among treated women, not as a randomized estimate of treatment versus an alternative.

3. Trial Design

This is a prospective observational study of women undergoing vaginal treatment with fractional carbon dioxide laser for various urogenital symptoms. The registry names one group, the fCO2 Laser Therapy Group, and describes its participants as women treated with the laser. It does not describe a control arm or a randomized comparison. Allocation details are not reported in the registry record.

The registry enrollment is 100. The study start date is 2018-10-08, the primary completion date is 2022-12-15, and the status is COMPLETED. Corewell Health East is listed as the sponsor. These record details describe the study’s registration and timing; they do not establish how many participants contributed data to any particular outcome.

The primary outcome is the Patient Global Impression of Improvement score at four weeks after initial treatment. The registry also lists secondary outcomes assessed at six months, including patient-reported improvement, vaginal pH and vaginal health, urinary symptoms, overactive bladder symptom bother, voiding diary counts, sexual function, urinary tract infection occurrences, and mental health status.

The registry lists 31 outcome measures and 0 analyses. It does not report the outcome estimates, the number contributing to each measure, or the statistical methods used to analyze the outcomes. The study’s protocol details, participant flow, treatment schedule, and analysis populations are not reported in the registry record. Consequently, the design can be described as a prospective, treated-group observational study, while details needed to assess the conduct and quantitative findings remain unavailable.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

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.

Population: The overall number enrolled was 100, however over the course of the study the number of participants that completed the study declined. 81 completed the 4 week follow up visit at the primary endpoint. The 6 and 36 month visits had a substantial decline in patient compliance and a high drop out rate. The final number of patients completing all visits was 38. Some visit activities were completed remotely and only questionnaires, diaries, and adverse events were collected.

6. Primary Endpoint

The registry lists the primary outcome as Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment, measured over 4 weeks post-initial treatment.

The primary endpoint is the Patient Global Impression of Improvement score recorded four weeks after initial treatment. The question asks patients to select the response that best describes their urinary and/or vaginal symptoms now compared with before the study. The response scale runs from 1 to 7: 1 is “Very Much Better,” 2 is “Much Better,” 3 is “A Little Bit Better,” 4 is “No Change,” 5 is “A Little Worse,” 6 is “Much Worse,” and 7 is “Very Much Worse.” The registry states that a score from 1 to 3 indicates improvement.

This measure is a patient-reported global assessment: it asks participants to judge their overall change rather than report only one symptom or examination finding. Such a measure can capture a participant’s broad perception of change across symptoms, while remaining dependent on her own comparison with her pre-study state. The registry specifies that the primary outcome is summarized as a mean with a standard deviation. As a general statistical point, a mean gives a measure of the central value and a standard deviation describes spread around that mean; neither shows how responses are distributed across the seven categories.

The primary mean and standard deviation are not reported in the registry record. The registry therefore identifies what was intended to be measured, but the posted record does not provide a numerical primary result or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a continuous summary, reported as a mean with a standard deviation. It does not report an analysis method or an observed primary result. The statistical concepts below are general explanations, not a description of methods confirmed to have been used in this study.

What does a mean describe?

In general, a mean is a measure of the center of a set of numeric observations. For the primary endpoint, the registry describes the Patient Global Impression of Improvement score as being summarized by a mean. The score’s response options are ordered from “Very Much Better” through “Very Much Worse,” and the registry specifies that scores from 1 to 3 indicate improvement. Reporting a mean can give a compact overall summary, but it does not reveal how many responses fell into each category or whether responses clustered near the center or were spread across the scale.

Because these response options are ordered categories, interpretation of a mean should keep the category meanings in view. General statistical practice may present category frequencies alongside a mean when those frequencies are available, since category-level results make it easier to see the pattern of responses. The registry record does not report the primary response distribution.

What does a standard deviation describe?

In general, a standard deviation describes how spread out observations are around their mean. A smaller standard deviation corresponds to observations that are more concentrated around the mean, while a larger one indicates greater dispersion. It is not a measure of the uncertainty in the estimated mean; that is a different concept. The registry names standard deviation as the primary outcome’s dispersion measure, but its value is not reported in the registry record.

How is precision different from the observed result?

In general, a confidence interval expresses uncertainty around an estimate, subject to the model and assumptions used to construct it. Its interpretation depends on the method and the data that went into the calculation. The registry record does not provide a confidence interval for the primary outcome, nor does it report a statistical analysis for that outcome. It is therefore not possible to judge the precision of the primary estimate from the posted record. Enrollment alone cannot substitute for an outcome estimate or its uncertainty.

Why does the observational design matter?

In general, a comparison group can help distinguish changes associated with an intervention from changes that might occur over time or for other reasons. A randomized comparison can, under appropriate conduct and analysis, support a different kind of causal interpretation from an observational description. This record describes a prospective observational study and lists only the fCO2 Laser Therapy Group. It does not describe a control group, and allocation details are not reported in the registry record. The record therefore supports no randomized contrast between treatment options.

Even within a treated group, a before-and-after change is not automatically attributable to treatment. General considerations include natural change over time, other care, expectations, and differences in who contributes follow-up information. Whether these considerations were measured or addressed in this study is not reported in the registry record.

What can be learned from the posted analysis information?

The registry lists 31 outcome measures and 0 analyses. It names the primary endpoint and lists secondary endpoints, but it does not provide their numerical estimates or a statistical plan. The planned or actual handling of repeated measurements, baseline values, covariates, and any departures from assumptions is not reported in the registry record. It is also not reported whether analyses were adjusted or unadjusted, or how uncertainty was calculated.

As a general concept, statistical methods need to match the form of the outcome and the study design. For a continuous summary, an analysis might estimate an average and its uncertainty. For ordered categorical responses, an analysis might instead preserve category information or use a model suited to ordered outcomes. For counts or event outcomes, distributional assumptions may differ. These are general options only; the registry does not identify which, if any, were used for this study.

The record’s outcome descriptions include measures with different constructs and time points, from the four-week global impression to six-month assessments of symptoms and health status. In general, results from different instruments or follow-up times answer different questions and should not be collapsed into one conclusion. Since observed estimates and analysis details are absent, no independent recalculation is possible from the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("fCO2 Laser Therapy Group")
n   <- c(81)
m   <- c(2.675)
sp  <- c(0.88)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  fCO2 Laser Therapy Group  81  2.675  0.880  2.480  2.870

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 31 outcome measures, with a Patient Global Impression of Improvement score at four weeks as the primary outcome and a range of secondary measures at six months. The listed secondary outcomes address vaginal health, urinary symptoms, voiding, sexual function, urinary tract infection occurrences, and mental health. The registry also lists 0 analyses, and outcome estimates are not reported in the registry record.

When a study evaluates multiple outcomes, the chance of at least one apparently unusual result can increase if each is tested separately without accounting for the multiplicity. General approaches include designating a primary outcome in advance, adjusting for multiple testing, or treating secondary analyses as exploratory. The statistical plan for multiplicity, including whether any adjustment was intended or performed, is not reported in the registry record. With no posted outcome results or analyses, it is not possible to assess the impact of multiplicity on the findings.

Information about missing data is also not reported in the registry record. The record does not say how many participants provided each follow-up measure, why data may have been unavailable, or how missing observations were handled. These details matter because the set of participants contributing to an outcome may differ from the enrollment count. No assumptions about missingness or imputation can be attributed to this study.

Analysis populations are not described. The registry does not report whether outcomes were analyzed for everyone enrolled, only those completing treatment, or another defined group. It also does not provide participant flow or outcome-specific denominators, apart from the safety figures. Thus, the posted record does not allow readers to determine how complete the outcome data were or which participants were included in each analysis.

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

For the fCO2 Laser Therapy Group, the registry lists 0 serious adverse events among 81 at risk, 64 affected by other adverse events among 81 at risk, and 0 deaths. These are the safety figures recorded in the registry for the group.

The serious-event and other-event entries are distinct registry categories. The record does not provide the specific events included in the other-adverse-event category, their severity, their timing, or whether they were considered related to treatment. It also does not list serious adverse event terms. The meaning of a category count should therefore remain limited to what the registry records; it should not be taken as a detailed description of the events or their causes.

As a general statistical point, adverse-event counts describe events recorded under the study’s collection and reporting procedures. Interpretation also depends on the definitions used, the observation period, and completeness of reporting. Those details are not reported in the registry record. The safety entries do not provide the primary symptom score or its precision, and they are not a comparison with an untreated or alternative-treatment group.

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

The registry record is useful for identifying the study’s intended question, design, outcome measures, and recorded safety categories. It states that the study was prospective and observational, involved women treated with the fCO2 laser, and designated the four-week Patient Global Impression of Improvement score as the primary outcome. The response scale and the interpretation of scores from 1 to 3 as improvement are described.

What the posted record does not establish is the numerical primary result. The mean and standard deviation are not reported in the registry record, and the record lists 0 analyses. As a result, it is not possible to say what average score was observed, how widely scores varied, or how precisely any estimated effect was measured. The registry’s enrollment figure does not supply those missing outcome data.

The record also does not establish a causal treatment effect. It describes an observational treated group and no comparator. Without a comparison group, changes or reports among treated participants cannot be separated from other explanations by a randomized contrast. This remains true even if participants reported improvement: a treated-group report alone would not show what their outcomes would have been without treatment.

The secondary outcomes cover additional areas, including urinary and vaginal symptoms, sexual function, and mental health, but their observed results are not reported in the registry record. Their presence indicates the range of questions the study intended to assess, not evidence of a particular change in any outcome.

The safety record reports no serious adverse events and no deaths in the listed group, along with 64 affected by other adverse events among 81 at risk. The registry does not supply event-level detail or a comparison that would establish relative safety. Taken together, the record documents study intent and limited safety counts, but it does not provide enough statistical results to quantify clinical outcomes or support a comparative conclusion.

14. Why This Trial Matters Statistically

This study illustrates an important distinction between a registered outcome and a reported result. The registry defines a patient-reported primary endpoint, specifies when it was measured, and explains what the response categories mean. Yet the mean and standard deviation are not reported in the registry record, and the listed count of analyses is 0. A clearly named endpoint is not, by itself, evidence about the observed outcome.

It also shows why design labels matter in clinical interpretation. A prospective observational study can describe outcomes among treated participants, but without a comparator it does not provide a randomized estimate of what treatment changed relative to another course. Readers should distinguish a planned assessment of change from a causal comparison.

The study includes a broad range of secondary outcomes and different follow-up times. Statistically, that breadth raises questions about how outcomes were prioritized, how multiple analyses were handled, and how missing observations were addressed. Those details are not reported in the registry record. Their absence limits assessment of how the planned outcome set relates to any results.

Finally, the record demonstrates that safety counts and clinical outcome estimates answer different questions. The registry reports safety categories, but those figures do not replace the missing primary score, and their interpretation is limited by the lack of event details. A careful statistical reading therefore separates what the record documents from what it does not quantify or compare.

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 most direct limitation for interpreting outcomes is that the registry record does not report the primary endpoint’s mean or standard deviation. It lists 0 analyses, so no primary or secondary outcome estimate can be evaluated from the posted results. The registry identifies 31 outcome measures, but it does not state which secondary outcomes have results available in other records or provide their values.

The observational design and absence of a described comparator limit causal interpretation. Allocation details are not reported in the registry record, and no randomized comparison is described. The record also does not provide eligibility criteria beyond the broad description of women undergoing treatment for various urogenital symptoms, nor does it report baseline participant characteristics. This makes it difficult to understand which patients the study findings would represent, even if outcome estimates were available.

Further limitations include missing information on treatment delivery, outcome-specific numbers analyzed, participant flow, missing-data handling, analysis populations, and the statistical plan. The registry record does not report whether repeated observations or baseline measures were incorporated into analyses. It also does not describe how multiplicity across the listed outcomes was addressed.

For safety, the record provides group counts but not detailed event terms, timing, severity, attribution, or collection procedures. The listed figures therefore offer only a limited account of reported safety outcomes. These limitations are specific to the information available in the registry record and do not establish what may have been documented elsewhere.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Laser Therapy for Treatment of Urogenital Symptoms in Women — NCT03681678.
• Registry record last updated 2026-08-17; status last verified 2026-06.
• Results first posted 2024-10-16.
• 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

NCT03681678, titled “Laser Therapy for Treatment of Urogenital Symptoms in Women,” is a completed prospective observational study sponsored by Corewell Health East. The official title describes fractional carbon dioxide laser therapy of the vagina for treatment of urogenital symptoms in women. The registry enrollment is 100; the study start date is 2018-10-08 and the primary completion date is 2022-12-15.

The record describes one group of women treated with fCO2 laser therapy. Its primary outcome is the Patient Global Impression of Improvement score at four weeks after initial treatment. Secondary outcomes address several symptom, examination, and health-status measures at six months. The registry lists 31 outcome measures and 0 analyses, and the primary outcome estimate is not reported in the registry record.

For safety, the registry lists 0 serious adverse events among 81 at risk, 64 affected by other adverse events among 81 at risk, and 0 deaths. No comparator is described, and further statistical methods, outcome results, and event details are not reported in the registry record.