(031) Update from the Female Genitopelvic Pain Subcommittee of the International Consultation of Sexual Medicine on a systematic review of the efficacy and safety of treatments for vulvodynia

Abstract

Abstract Introduction Literature on vulvodynia treatment is heterogeneous regarding intervention type and study quality. A recently published systematic review (SR) of treatments focusing on randomized controlled trials (RCTs) and non-RCTs for provoked vestibulodynia (a vulvodynia subtype) concluded that most studies had very low certainty of evidence, which limited the ability to draw conclusions. In addition, the authors noted that their strict eligibility criteria resulted in a restricted number of included studies. It suggests a need for broader, more inclusive SRs to be conducted, which could inform much needed intervention recommendations for vulvodynia. Objective The Female Genitopelvic Pain Subcommittee is conducting a SR of treatments for vulvodynia to assess their effectiveness, safety, and acceptability. The results will provide stakeholders with empirically based treatment recommendations for patients with vulvodynia. Methods Selection criteria: Interventions of interest consist of pharmacological, surgical, psychological, physical therapy, and acupuncture treatments of premenopausal women with clinician-diagnosed vulvodynia (primary, secondary), defined as idiopathic, chronic (≥3 months) vulvar pain. Included studies are RCTs, SRs, and comparative observational studies. Primary outcomes are pain and sexuality, safety, and adverse events, with additional outcomes focusing on mood and quality of life. Selection of studies was done in DistillerSR by two independent reviewers. Conflicts were resolved by discussion or by involving a third reviewer, with excluded studies documented. Full-text screening adheres to the same process. Search methods: A comprehensive search strategy was developed by an information specialist and was peer reviewed. Numerous electronic databases were searched from 1997 to present. No language limit was used. Published filters for controlled trials and other study designs were applied. PubMed/MEDLINE was used to develop the search strategy, which was translated into other databases. A limited grey literature search was also conducted. Data collection and analysis: Data extraction and risk of bias assessment (ROB) will be done in DistillerSR using pre-piloted data extraction forms. Studies will be extracted by one reviewer and independently checked by a second reviewer. Disagreements will be resolved by discussion or by involving a third reviewer. We will extract study characteristics and outcome data. For ROB, we will use the Cochrane Risk of Bias tool and the ROBINS-I tool. We will narratively synthesize the results by comparisons and outcomes. If appropriate, we will conduct a meta-analysis for studies regarded as suitably homogeneous. Last, the certainty of the body of evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Results The search yielded 10,171 references after duplicates were removed for title and abstract screening. Of these, 599 full-text articles were assessed for inclusion. All screening and preliminary data extraction will be completed by October 2022. General characteristics of the included studies, including interventions identified, will be presented. Conclusions We will report on interim progress of the SR. It will be an opportunity to gather initial input from stakeholders on this evidence-based approach. Discussion of possible multi-organization involvement will also help unify intervention recommendations for those with vulvodynia. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Andrew Goldstein – Daré Bioscience (employee), Incyte (consultant), Gynecologic Cancers Research Foundation (Board of Directors, Research Funding).