Evidence map›Paper›PMID 42857927›Full record

Trial reportAnnals of medicine2026

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

Chloe Shudt, Erin T Carey, Elizabeth J Geller, Andrea Rapkin, Debbie Farb, Haley Cutting, Jasmyn Akaninwor, Jesse DeLaRosa, Christopher Stirling, Andrey Bortsov and 4 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03844412 (Vestibulodynia), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03844412 phase2completednot on this map

Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments

TypeinterventionalSponsorDuke UniversityRan2019 to 2024Enrolled209ConditionsVestibulodynia, Temporomandibular Disorder, Fibromyalgia Syndrome, Irritable Bowel SyndromeArms5% lidocaine/5 mg/ml 0.02% estradiol compound cream, Nortriptyline, Placebo cream, Placebo pill
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Chloe ShudtCenter for Translational Pain Medicine, Department of Anesthesiology, Duke University School of Medicine, Durham, NC, USA.
Erin T CareyDepartment of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Elizabeth J GellerDepartment of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Andrea RapkinDepartment of Obstetrics and Gynecology, University of California at Los Angeles, Los Angeles, CA, USA.
Debbie FarbDepartment of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Haley CuttingDepartment of Obstetrics and Gynecology, University of California at Los Angeles, Los Angeles, CA, USA.
Jasmyn AkaninworDepartment of Obstetrics and Gynecology, University of California at Los Angeles, Los Angeles, CA, USA.
Jesse DeLaRosaDuke Clinical Research Institute, Duke University, Durham, NC, USA.
Christopher StirlingCenter for Translational Pain Medicine, Department of Anesthesiology, Duke University School of Medicine, Durham, NC, USA.
Andrey BortsovCenter for Translational Pain Medicine, Department of Anesthesiology, Duke University School of Medicine, Durham, NC, USA.
Pearl RoweDuke Clinical Research Institute, Duke University, Durham, NC, USA.
Sheng LuoDuke Clinical Research Institute, Duke University, Durham, NC, USA.
Marguerita E KleinCenter for Translational Pain Medicine, Department of Anesthesiology, Duke University School of Medicine, Durham, NC, USA.
Andrea G NackleyCenter for Translational Pain Medicine, Department of Anesthesiology, Duke University School of Medicine, Durham, NC, USA.

Funding

UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (Vestibulodynia: UPDATe)R01HD096331 · NICHD · DUKE UNIVERSITY · PI NACKLEY, ANDREA G · 2018 to 2024
$4.1M
NCATS NIH HHS UL1 TR001881NICHD NIH HHS R01 HD096331
6 · The paper itself

Abstract

introductionVestibulodynia (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

methodsWe 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).

resultsOf 209 participants, 69 had VBD-p and 140 had VBD-c. Tampon test pain decreased modestly across all arms, with the greatest proportion of decrease in the combined nortriptyline plus lidocaine/estradiol group, but there was no difference between subtypes. In the primary model, baseline pain strongly predicted Week 16 pain (β = 0.68,

conclusionsIn this trial, neither peripheral nor centrally targeted pharmacotherapies demonstrated superiority over placebo in reducing provoked vulvovaginal pain at 16 weeks.

Indexed as

EstradiolLidocaineNortriptylineVulvodyniaAdolescentAdultAnesthetics, LocalAntidepressive Agents, TricyclicDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMiddle AgedPain MeasurementTreatment OutcomeVaginal Creams, Foams, and JelliesAnesthetics, LocalAntidepressive Agents, TricyclicEstradiolLidocaineNortriptylineVaginal Creams, Foams, and JelliesChronic primary painestradiollidocainenociplastic painnortriptylinepelvic pain

Identifiers

PMID42857927
PMCPMC13656646

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.