Comparing patient-reported outcome measures for pain in women with pelvic floor disorders pre- and post-surgical management: A systematic review protocol

Abstract Background: Pelvic floor disorders including stress urinary incontinence and/or pelvic organ prolapse affect more than 50% of Australian women. Pelvic floor disorders cause a wide range of symptoms including painful urination, constipation and lower back pain. Previous surgical treatment may also affect the presence of pelvic symptoms, including pelvic pain, vaginal pain and dyspareunia which can lead to poor health-related quality of life. Patient-reported outcome measures are an important way of examining the health-related quality of life of women with pelvic floor disorders pre- and post-surgery, however, there are very few patient-reported outcome measures measuring this important domain of pelvic or vaginal pain. This paper aims to identify and compare patient-reported outcome measures for pain in women with a pelvic floor disorder in the existing literature, as well as to explore and highlight the gaps regarding the development and validation of a pain instrument. This review also aims to describe the modes and methods for administration of the instruments. Methods: This review will be conducted based on the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols guideline and checklist. Ovid MEDLINE, Ovid Embase, CINAHL Plus and Ovid PsychInfo databases as well as the grey literature will be searched for studies that use, develop or implement patient-reported outcome measures for pain as an HRQoL outcome in adult women with a pelvic floor disorder pre- and post-surgery. Studies reporting on the psychometric properties of patient-reported outcome measures will be included. An independent researcher will screen the title and abstracts of the studies. Two independent researchers will undertake full-text review and any disagreements will be resolved through discussion and consensus. The final selected studies will undergo data extraction, qualitative analysis and synthesis. Discussion: The findings of this review will assist with the development and validation of new pain-specific patient-reported outcome measures for women with pelvic floor disorder in the registry or clinical practice. Trial registration: CRD42022319663