To Örebro University

BACKGROUND: Treatment recommendations for provoked vulvodynia (PVD) are based on clinical experiences and there is a need for systematically summarizing the controlled trials in this field.

AIM: To provide an overview of randomized controlled trials and non-randomized studies of intervention for PVD, and to assess the certainty of the scientific evidence, in order to advance treatment guidelines.

DATA SOURCES: The search was conducted in CINAHL (EBSCO), Cochrane Library, Embase (Embase.com), Ovid MEDLINE, PsycINFO (EBSCO) and Scopus. Databases were searched from January 1, 1990 to January 29, 2021.

STUDY ELIGIBILITY CRITERIA: Population: Premenopausal women with PVD.

INTERVENTIONS: Pharmacological, surgical, psychosocial and physiotherapy, either alone or as combined/team-based interventions.

CONTROL: No treatment, waiting-list, placebo or other defined treatment.

OUTCOMES: Pain during intercourse, pain upon pressure or touch of the vaginal opening, sexual function/satisfaction, quality of life, psychological distress, adverse events and complications.

STUDY DESIGN: Randomized controlled trials and non-randomized studies of interventions with a control group.

STUDY APPRAISAL AND SYNTHESIS METHODS: 2 reviewers independently screened citations for eligibility and assessed relevant studies for risk of bias using established tools. The results from each intervention were summarized. Studies were synthesized using a narrative approach, as meta-analyses were not considered appropriate. For each outcome, we assessed the certainty of evidence using grading of recommendations assessment, development, and evaluation (GRADE).

RESULTS: Most results of the evaluated studies in this systematic review were found to have very low certainty of evidence, which means that we are unable to draw any conclusions about effects of the interventions. Multimodal physiotherapy compared with lidocaine treatment was the only intervention with some evidential support (low certainty of evidence for significant treatment effects favoring physiotherapy). It was not possible to perform meta-analyses due to a heterogeneity in interventions and comparisons. In addition, there was a heterogeneity in outcome measures, which underlines the need to establish joint core outcome sets.

CLINICAL IMPLICATIONS: Our result underscores the need of stringent trials and defined core outcome sets for PVD.

STRENGTH AND LIMITATIONS: Standard procedures for systematic reviews and the Population Intervention Comparison Outcome model for clinical questions were used. The strict eligibility criteria resulted in limited number of studies which might have resulted in a loss of important information.

CONCLUSION: This systematic review underlines the need for more methodologically stringent trials on interventions for PVD, particularly for multimodal treatments approaches. For future research, there is a demand for joint core outcome sets.

Bohm-Starke N, Ramsay KW, Lytsy P, et al. Treatment of Provoked Vulvodynia: A Systematic Review. J Sex Med 2021;XX:XXX-XXX.