Rationale and design of a multicenter randomized clinical trial of vestibulodynia: understanding pathophysiology and determining appropriate treatments (vestibulodynia: UPDATe).

dc.contributor.author

Carey, Erin T

dc.contributor.author

Geller, Elizabeth J

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Rapkin, Andrea

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Farb, Debbie

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Cutting, Haley

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Akaninwor, Jasmyn

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Stirling, Christopher

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Bortsov, Andrey

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McNulty, Steven

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Merrill, Peter

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Zakroysky, Pearl

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DeLaRosa, Jesse

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Luo, Sheng

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Nackley, Andrea G

dc.date.accessioned

2022-11-01T20:26:41Z

dc.date.available

2022-11-01T20:26:41Z

dc.date.issued

2022-12

dc.date.updated

2022-11-01T20:26:40Z

dc.description.abstract

Background

Limited data are available to establish evidence-based management protocols for vestibulodynia (VBD), a chronic vulvar pain condition that affects approximately 14 million women in the U.S. For the purposes of the study, our group subdivided VBD subtypes that may benefit from different types of treatment: 1) VBD peripheral (VBD-p), characterized by pain localized to the vulvar vestibule and 2) VBD central (VBD-c), characterized by VBD alongside one or more other chronic overlapping pain conditions (e.g. irritable bowel syndrome, temporomandibular disorder, and fibromyalgia syndrome) that affect remote body regions. Here, we describe the rationale and design of an NIH-funded multicenter clinical trial comparing the effectiveness of topical and/or systemic medication for alleviating pain and normalizing pain- relevant biomarkers among women with VBD-p and VBD-c.

Methods

Participants will be randomly assigned to one of four parallel arms: peripheral treatment with 5% lidocaine + 0.5 mg/ml 0.02% oestradiol compound cream + oral placebo pill, 2) central treatment with the tricyclic antidepressant nortriptyline + placebo cream, 3) combined peripheral cream and central pill treatments, or 4) placebo cream and placebo pill. The treatment phase will last 16 weeks, with outcome measures and biomarkers assessed at 4 time points (0, 8, 16, and 24 weeks). First, we will compare the efficacy of treatments in alleviating pain using standardized tampon insertion with a numeric rating scale and self-reported pain on the short form McGill Pain Questionnaire. Next, we will compare the efficacy of treatments in improving perceived physical, mental, and sexual health using standardized questionnaires. Finally, we will measure cytokines and microRNAs in local vaginal and circulating blood samples using multiplex assays and RNA sequencing, and determine the ability of these biomarkers to predict treatment response.

Conclusion

This is the first multicenter randomized controlled trial to evaluate the efficacy of peripherally and centrally acting medications currently used in clinical practice for treating unique VBD subtypes based on distinct clinical and biological signatures.

Administrative information

Vestibulodynia UPDATe is a multi-centre, two-by-two factorial designed randomized, double-blind, placebo-controlled trial registered at clinical trials.gov (NCT03844412). This work is supported by the R01 HD096331 awarded to Drs. Nackley, Rapkin, Geller and Carey by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).Key messagesPeripheral lidocaine and oestradiol and centrally-targeted nortriptyline medications are used for the treatment of pain in women with VBD, but there is a lack of data from well-powered RCTs.This two-by-two factorial RCT will test the efficacy of these medications in VBD subtypes characterized by distinct clinical characteristics and biomarker profiles.We hope that results will provide clinicians with scientific evidence of therapeutic efficacy in distinct VBD subtypes in an effort to direct and optimize treatment approaches.
dc.identifier.issn

0785-3890

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1365-2060

dc.identifier.uri

https://hdl.handle.net/10161/26175

dc.language

eng

dc.publisher

Informa UK Limited

dc.relation.ispartof

Annals of medicine

dc.relation.isversionof

10.1080/07853890.2022.2132531

dc.subject

Humans

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Pain

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Lidocaine

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Nortriptyline

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Estradiol

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MicroRNAs

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Antidepressive Agents, Tricyclic

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Cytokines

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Child

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Female

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Vulvodynia

dc.title

Rationale and design of a multicenter randomized clinical trial of vestibulodynia: understanding pathophysiology and determining appropriate treatments (vestibulodynia: UPDATe).

dc.type

Journal article

duke.contributor.orcid

DeLaRosa, Jesse|0000-0001-7800-2119

duke.contributor.orcid

Luo, Sheng|0000-0003-4214-5809

pubs.begin-page

2885

pubs.end-page

2897

pubs.issue

1

pubs.organisational-group

Duke

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School of Medicine

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Basic Science Departments

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Clinical Science Departments

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Institutes and Centers

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Biostatistics & Bioinformatics

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Pharmacology & Cancer Biology

pubs.organisational-group

Anesthesiology

pubs.organisational-group

Duke Clinical Research Institute

pubs.publication-status

Accepted

pubs.volume

54

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