Table 1.
Goal 1. | ||
Determine the efficacy of G-ERa for treatment of PVDb compared to placebo | 1a. Pain from tampon insertion will be lower in PVD patients when treated with G-ER compared to when treated with placebo (primary outcome variable. | Diary |
1b. Pain from intercourse will be lower in PVD patients when treated with G-ER compared to when treated with placebo. | Diary | |
1c. 24-hour vulvar pain will be lower in PVD patients when treated with G-ER compared to when treated with placebo. | Diary | |
Goal 2. | ||
Identify psychophysiological measures of treatment response and define mechanistically-based PVD subtypes including central vs. peripheral sensitization, pelvic hypertonicity, tender point tenderness and autonomic dysregulation | 2a. G-ER will reduce mechanical allodynia compared to placebo | Von frey hair, brush, Algesiometer |
2b. G-ER will reduce area and duration of hypersensitivity induced by intradermal capsaicin compared to placebo | Capsaicin skin sensitivity test | |
2c. G-ER will reduce vaginal muscle pain to palpation compared to placebo | Vaginal algometer | |
2d. G-ER will decrease the number and intensity of somatic tender points compared to placebo | Tender point tenderness test | |
2e. G-ER will increase cardiac beat-to-beat variability compared to placebo | Heart rate variability |
G-ER: gabapentin extended release.
PVD: provoked vestibulodynia.