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Abstract

Background
Vibrating vaginal balls are available in Austria and other countries to enhance women’s pelvic floor muscles following childbirth. There is currently little research evidence to assess their relative effectiveness in comparison to current standard care, which involves pelvic floor muscle exercises.

Aim
To assess practical issues and feasibility for optimal design of a future randomised controlled trial (RCT) which shall determine the efficacy of vibrating vaginal balls to improve pelvic floor muscle performance in postpartum women; to monitor potential harms of the experimental intervention and explore women’s perspectives on and experiences with the interventions and the trial.

Design
Single (assessor) blind, randomised controlled feasibility RCT with two parallel groups.

Methods
Women after vaginal birth in Vienna were randomised into one of two intervention groups to use either a vibrating vaginal ball or the comparator pelvic floor muscle exercises for 12 weeks. Primary outcomes were feasibility criteria and necessary resources, secondary outcomes preliminary effect/harm and women’s views and experiences. Data were analysed by statistics and content analysis, for effect by modified intention-to-treat and per protocol with Welch’s t-test, for harms descriptively per protocol.

Results
134 women were screened, 56 randomised (35/18 into experimental/comparison group), 134 and 53-56 respectively analysed for feasibility objectives. The recruitment rate was 48.3%, 95% CI [39.2, 57.4], the adherence rate at best 62.9%, 95% CI [46.9, 78.9]. Change score difference for participant reported pelvic floor muscle strength was -5.1%, 95% CI [-18.0, 7.8], for maximum perineometric squeeze strength pressure 4.6 cm H2O, 95% CI [-0.3, 9.4]. For vaginal balls, the risk for potential harm in the form of vulvovaginal symptoms was 13.5%, 95% CI [4.5, 28.8], for local discomfort 33.3%, 95% CI [17.9, 48.7]. Participants’ opinion on the trial was encouraging.

Conclusion
A full RCT seems feasible with modifications. Public and patient involvement needs to clarify women’s opinion on such a trial in the light of the feasibility findings.

Keywords
feasibility studies, randomised controlled trial, pelvic floor, vaginal balls/cones, resistance training, pelvic floor muscle performance, urinary incontinence, postnatal care, postpartum period

Publication Type:	Thesis (Doctoral)
Subjects:	Q Science > QM Human anatomy
Departments:	Doctoral Theses School of Health & Psychological Sciences > School of Health & Psychological Sciences Doctoral Theses School of Health & Psychological Sciences > Healthcare Services Research & Management

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