Vibrating vaginal balls to improve pelvic floor muscle performance in women after childbirth: Preliminary results (recruitment and survey) of a randomised controlled feasibility trial

Abstract

Background: Vibrating vaginal pelvic floor training balls are available in Austria and Germany to enhance women’s pelvic floor muscles and thus prevent urinary incontinence and other pelvic floor problems following childbirth. Nonetheless, there is currently little empirical knowledge to substantiate their use or assess their relative effectiveness in comparison to current standard care, which involves pelvic floor muscle exercises [1]. Aims/research question: This feasibility trial aims at assessing practical issues and feasibility of a future randomised controlled trial (RCT) to determine the effectiveness of vibrating vaginal pelvic floor training balls for postpartum pelvic floor muscle rehabilitation, at monitoring harms of the experimental intervention, and at exploring women´s perspectives on and experiences with the interventions and the trial [2]. Methods: Design: Single blind, randomised controlled feasibility trial with two parallel groups. 56 women from six weeks until six months postpartum are recruited in Vienna and randomised into one of two intervention groups to use either vibrating vaginal balls or a comparator pelvic floor muscle exercises for 12 weeks. As this is a feasibility study, study design features (recruitment, selection, randomisation, intervention and concordance, retention, data collection methods/tools, sample size calculation for full trial) are assessed, and participants’ views and experiences are surveyed. Tested outcome measure, collected before and after the intervention, is pelvic floor muscle performance as reported by participants and measured by perineometry by a blinded assessor. Descriptive and inferential statistics and content analysis serve the preparation of the future trial. Results: The results of this feasibility trial will inform the design and conduct of a full randomised controlled trial and provide insight into the experiences of women regarding the interventions and study participation. At the conference, preliminary results concerning recruitment and participants´ opinion and experiences will be presented. Relevance: Knowledge about pelvic floor muscle rehabilitation after childbirth enables midwives to promote women´s pelvic floor health. Recommendations/conclusions: Recommendations/conclusions of this ongoing study will be available at the conference and focus on the feasibility of the planned RCT and on midwifery practice. Ethical considerations: Approved by the ethics committees of the Medical University of Vienna and City University London. Trial registration: NCT02355327. Financing: This is a PhD project, funded by a City University London Scholarship