Testing peripheral and central therapies for provoked vestibulodynia: results from the UPDATe trial

Introduction

Vestibulodynia (VBD) is a common chronic pelvic pain condition with heterogeneous clinical presentation, including subtypes distinguished by the presence (VBD-central; VBD-c) or absence (VBD-peripheral; VBD-p) of comorbid pain conditions. Despite frequent prescribing of topical therapies such as lidocaine/estradiol and centrally-acting agents such as tricyclic antidepressants, high-quality evidence for efficacy, alone or in combination, remains limited. This study evaluated effects of peripheral, central, and combined pharmacologic treatments for two VBD subtypes and whether treatment response varied by subtype. Patients and methods: We conducted a multicenter, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial (ClinicalTrials.gov identifier: NCT03844412) at two academic medical centers. Women aged 18-50 with clinician-confirmed VBD were randomized to one of four treatment arms: 1) topical 5% lidocaine + 0.05% estradiol vaginal cream and placebo pill, 2) oral nortriptyline pill and placebo cream, 3) combined active pill and cream, or 4) double placebo for 16 weeks. The primary outcome was provoked vulvovaginal pain by a standardized tampon test (0-10 numeric rating scale).