Vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women postpartum: a quantitative systematic review and meta-analysis protocol.

AIM To identify, critically appraise and synthesize the best current evidence on the use of vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women post partum. BACKGROUND The vaginal use of cones or balls is a pelvic floor muscle training method that aims to enhance muscle performance and thereby prevent or treat urinary incontinence. Nonetheless to date, no systematic review has focused on the effectiveness of these devices specifically during the postpartum period. DESIGN Quantitative systematic review with potential meta-analysis. METHODS The review will be undertaken by searching 14 scientific databases (including PubMed and CINAHL, without date restriction) and the world-wide web; experts will also be contacted for published and unpublished data. Included studies must be randomized or quasi-randomized trials and have female participants until 1 year after childbirth. The intervention will be compared with no treatment, placebo, sham treatment or active controls. Outcome measures will relate to pelvic floor muscle performance or urinary incontinence. Studies will be selected, 'risk of bias' assessed and data extracted by two reviewers independently. Following inter-reviewer agreement of included studies, data will be checked after entry into systematic review processing software. If appropriate, data will be synthesized by meta-analysis; if this is not possible, a narrative review only will be undertaken. DISCUSSION The information gained from this systematic review will help midwives, nurses, other health professionals and women after childbirth decide how to promote female pelvic floor health and in defining further areas of study.