Qualisex shows a stable two-factor structure in lichen sclerosus sexual health assessment
In lichen sclerosus, sexual symptoms can dominate the patient experience long after the skin findings are recognized. Pain, reduced arousal, impaired satisfaction, and relationship strain often sit outside the narrow frame of routine dermatologic follow-up, even though they are central to disease burden. This preprint tackles that blind spot by validating the Italian version of the Qualisex questionnaire in patients with confirmed lichen sclerosus and testing whether the instrument performs similarly in women and men.
The study enrolled 211 patients, including 167 women and 44 men, with a mean age of 52.9 years. Participants completed the Italian Qualisex alongside the Skindex-29, DASS-21, and sex-specific reference scales: the Female Sexual Function Index for women and the International Index of Erectile Function for men. The design was cross-sectional, which makes the work a measurement study rather than an outcomes trial, but the psychometric question is a clinically important one. A questionnaire that can separate disease-driven sexual impairment from general distress and age-related decline can change how clinicians ask about intimate symptoms and how research captures them.
One item did not survive the validation process. Item 2 was removed because of low communality, measured at 0.167, leaving a 9-item instrument for analysis. In practical terms, that is the sort of refinement that strengthens a scale rather than weakens it. A poorly performing item can blur the signal in a questionnaire that is supposed to detect disease-specific distress, especially in a condition where embarrassment and relational concerns can suppress candid reporting.
Internal consistency stayed high after item removal
The remaining 9 items formed a clear two-factor structure in principal component analysis, accounting for 72.5% of total variance. Component 1, labeled “Sexual Functioning and Satisfaction,” carried 59.89% of the variance; Component 2, “Partner Devaluation,” accounted for 12.66%. This pattern is clinically intuitive. Sexual dysfunction in lichen sclerosus is not only about mechanics, lubrication, erection, or pain. It also affects self-image, intimacy, and the patient’s perception of how a partner sees them, which means the psychosocial dimension is not a side effect of the symptom burden but part of the symptom burden itself.
Reliability was strong across the cohort. Cronbach’s alpha reached 0.911 overall, 0.841 in women, and 0.899 in men. Those values indicate that the questionnaire items moved together in a coherent way without becoming redundant. For a patient-reported outcome measure, that balance matters. A scale that is too fragmented loses precision; a scale that is too repetitive becomes fatiguing and less informative.
Disease-specific distress separated from general psychological burden
The strongest external validity signals came from the expected domains. Qualisex correlated strongly with the Skindex-29 Social Functioning subscale, with r = 0.582, and with the Emotions subscale, with r = 0.531. It also correlated with the sex-specific reference measures, including the FSFI in women at r = −0.391 and the IIEF in men at ρ = −0.566. Those associations fit the biology and the bedside reality of lichen sclerosus. Chronic vulvar or penile inflammation, scarring, fissuring, and dyspareunia or sexual avoidance can degrade both function and satisfaction, while the social and emotional consequences deepen the injury.
At the same time, Qualisex remained only weakly to moderately associated with the DASS-21 domains, with correlations below 0.38. That pattern supports discriminant validity. The questionnaire appears to measure sexual-health impairment that is not reducible to anxiety, depression, or stress alone. For clinicians, the distinction is useful because a high distress score does not automatically explain away the sexual symptoms, and a low mood score does not exclude substantial disease-related sexual burden.
The age results were equally important. FSFI and IIEF both showed significant negative correlations with age, with p = 0.002, which is consistent with the known influence of aging on sexual function. Qualisex did not behave the same way. Scores remained age-independent across sexes, with p values above 0.05. In a disorder that affects adults across a broad age range, that is a meaningful property. It suggests the instrument is picking up the disease signal rather than simply tracking the passage of time or the expected physiologic changes of aging.
A sex-symmetrical instrument may improve both care and research
Sex symmetry is one of the most useful features of this validation. Many available sexual-health instruments are built around one sex or one anatomical model of dysfunction, which leaves clinicians with tools that are difficult to compare across patients. Lichen sclerosus does not respect those measurement boundaries. Women and men can experience different anatomic injuries, but the disease still converges on sexual pain, reduced satisfaction, and interpersonal strain. A questionnaire that can be interpreted across sexes offers a more practical framework for routine care and comparative studies.
The findings support the 9-item Italian Qualisex as a reliable, sex-symmetrical, age-independent measure for sexual health impairment in lichen sclerosus. The questionnaire appears to isolate disease-specific distress from general emotional symptoms and from physiologic aging, which is exactly the kind of separation needed in chronic dermatologic disease where symptom burden and quality of life often diverge from visible exam findings.
The study remains a preprint and has not undergone peer review, so the psychometric results should be treated as provisional until independent evaluation confirms them. The cohort also came from a specialized setting in Rome, which may limit how broadly the findings generalize to less selected populations. Even so, the measurement message is straightforward: sexual health in lichen sclerosus can be assessed with greater precision than many clinics currently manage, and this instrument may help bring that domain into routine conversation rather than leaving it buried beneath the skin findings.