VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

FSFI is considered the gold standard for the measurement of sexual function in women. It's a 19-item questionnaire that uses a 5 point Likert scale ranging from 1-5, with higher scores indicating greater levels of sexual functioning on the respective item. To score the measure, the sum of each domain score is multipled by a domain factor ratio (0.6 for desire, 0.3 for arousal, 0.3 for lubrication, 0.4 for orgasm, 0.4 for satisfaction, and 0.4 for pain) in order to place all domain tools on a comparable scale. The subsequent scores are summed to derive a total FSFI score. The possible range of scores is 2-36. A score less than or equal to 26.55 reflects clinically relevant sexual dysfunction.

The Female Sexual Distress Scale - Distress/Arousal/Orgasm (FSDS-DAO) Questionnaire is a validated patient-reported outcome measure designed to assess sexually related distress in women, with a particular focus on distress associated with arousal and orgasmic difficulties. The FSDS-DAO consists of 15 items that assess three key domains: sexually related distress, arousal difficulties, and orgasmic dysfunction. Each item is rated on a five-point Likert scale, ranging from 0 (Never) to 4 (Always), with higher total scores indicating greater distress and dysfunction.

This is a seven item questionnaire in which each question queries whether the subject has in the last four weeks attempted intercourse, insertion of one or two fingers (by self or by partner), insertion of other objects (by self or by partner). There are four responses to choose from for each question: not attempted, attempted but not successful, attempted and sometimes successful, attempted and always successful.

Patient Global Impression of Severity (PGI-S) is a single item questionnaire to assess a person's impression of disease severity. For purposes of this trial, it will ask participants to "Check the one number that best describes how your urinary tract condition is now" on a 4-point Likert scale ranging from (1) "normal" to (4) "severe". The PASS threshold PGI-S score is < 3.

The Patient Global Impression of Improvement (PGI-I) is a single item questionnaire to assess an individual's impression of change in urinary symptoms. For purposes of this trial the PGI-S has been adapted by removing "taking medication" and it will ask participants to "Check the one number that best describes how your urinary tract condition is now, compared with how it was before you began this study" on a 7-point Likert scale ranging from (1) "very much better" to (7) "very much worse". The PASS threshold PGI-I score is < 3.

The Self Stimulation/Penetration Interference and Q7 (Vulvar Pain Assessment Questionnaire- Screening Form) asks the subject "How often do the following situations/activities cause vulvar pain?" The following situations/activities are queried: using tampons, solitary masturbation, masturbation while partner is present, solitary self penetration with fingers, solitary self penetration with sex toy.