AJOG global reports · 2026
Topical resiniferatoxin for the treatment of vestibulodynia: a prospective observational trial.
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Murina Filippo, Fochesato Cecilia, Mantovani Matteo, Slanzi Matilde, Donini Marianna, Toni Nicla, Savasi Valeria
Аннотация
BACKGROUND: Vestibulodynia is the most common subtype of vulvodynia and is characterized by persitent, contact-evoked pain localized to the vulvar vestibule. Increasing evidence supports a neuropathic pain mechanism in vestibulodynia, including vestibular hyperinnervation, neuroinflammation, and overexpression of the transient receptor potential vanilloid 1 receptor. Despite this, there are no standardized treatment protocols, and available therapies often provide incomplete relief or are limited by systemic side effects. Targeted topical therapies may offer advantages by acting directly on peripheral pain generators. Resiniferatoxin, a highly potent transient receptor potential vanilloid 1 receptor agonist, induces long-lasting desensitization of nociceptive fibers and may represent a novel therapeutic option for vestibulodynia.
OBJECTIVE: To evaluate the clinical efficacy, tolerability, and neurophysiological effects of topical resiniferatoxin cream applied to the vulvar vestibule in women with vestibulodynia.
STUDY DESIGN: This was a prospective, observational pilot study. Premenopausal women aged ≥18 years with a diagnosis of vestibulodynia lasting at least 3 months were enrolled. Participants applied topical resiniferatoxin 10 mcg/mL cream to the vulvar vestibule once daily for 4 weeks using a standardized dosing dispenser. Outcomes included patient-reported pain intensity (visual analog scale for pain and dyspareunia), vestibular cotton swab test scores, levator ani muscle tone, and vestibular current perception thresholds at 2000, 250, and 5 Hz. Baseline and 1-month follow-up values were compared using the Wilcoxon signed-rank test and McNemar test, as appropriate.
RESULTS: Twenty-four women were enrolled (median age 31 years; median vestibulodynia duration 66 months). Most participants reported a transient, tolerable burning sensation after resiniferatoxin application; 5 women (20.8%) discontinued treatment due to local discomfort. Among participants with complete follow-up, significant improvements were observed at 1 month in provoked vulvar pain and dyspareunia, with median Visual Analog Scale reductions of 2.0 (P=.01) and 2.5 (P=.01) points, respectively. Vestibular cotton swab test scores also improved. current perception thresholds values increased significantly at 250 Hz and 5 Hz, indicating reduced sensitivity of Aδ and C fibers, while no significant change was observed at 2000 Hz. A reduction in levator ani hypertonicity was observed but did not reach statistical significance.
CONCLUSION: Topical resiniferatoxin was associated with meaningful reductions in vulvar pain and dyspareunia and with objective improvements in vestibular nerve fiber sensitivity in women with vestibulodynia. These findings support the role of transient receptor potential vanilloid 1 receptor-mediated peripheral mechanisms in vestibulodynia and suggest that resiniferatoxin may be a promising targeted therapy. Larger, placebo-controlled trials with longer follow-up are warranted to confirm these preliminary results.
OBJECTIVE: To evaluate the clinical efficacy, tolerability, and neurophysiological effects of topical resiniferatoxin cream applied to the vulvar vestibule in women with vestibulodynia.
STUDY DESIGN: This was a prospective, observational pilot study. Premenopausal women aged ≥18 years with a diagnosis of vestibulodynia lasting at least 3 months were enrolled. Participants applied topical resiniferatoxin 10 mcg/mL cream to the vulvar vestibule once daily for 4 weeks using a standardized dosing dispenser. Outcomes included patient-reported pain intensity (visual analog scale for pain and dyspareunia), vestibular cotton swab test scores, levator ani muscle tone, and vestibular current perception thresholds at 2000, 250, and 5 Hz. Baseline and 1-month follow-up values were compared using the Wilcoxon signed-rank test and McNemar test, as appropriate.
RESULTS: Twenty-four women were enrolled (median age 31 years; median vestibulodynia duration 66 months). Most participants reported a transient, tolerable burning sensation after resiniferatoxin application; 5 women (20.8%) discontinued treatment due to local discomfort. Among participants with complete follow-up, significant improvements were observed at 1 month in provoked vulvar pain and dyspareunia, with median Visual Analog Scale reductions of 2.0 (P=.01) and 2.5 (P=.01) points, respectively. Vestibular cotton swab test scores also improved. current perception thresholds values increased significantly at 250 Hz and 5 Hz, indicating reduced sensitivity of Aδ and C fibers, while no significant change was observed at 2000 Hz. A reduction in levator ani hypertonicity was observed but did not reach statistical significance.
CONCLUSION: Topical resiniferatoxin was associated with meaningful reductions in vulvar pain and dyspareunia and with objective improvements in vestibular nerve fiber sensitivity in women with vestibulodynia. These findings support the role of transient receptor potential vanilloid 1 receptor-mediated peripheral mechanisms in vestibulodynia and suggest that resiniferatoxin may be a promising targeted therapy. Larger, placebo-controlled trials with longer follow-up are warranted to confirm these preliminary results.