title: Vibrating vaginal balls to improve pelvic floor muscle performance in women after childbirth: a protocol for a randomised controlled feasibility trial.
abstract: OBJECTIVE
  This paper presents a feasibility trial protocol the purpose of which is to prepare for a future randomised controlled trial to determine the effectiveness of vibrating vaginal pelvic floor training balls for postpartum pelvic floor muscle rehabilitation.
  
  
  BACKGROUND
  Vibrating vaginal pelvic floor training balls are available in Austria to enhance women's pelvic floor muscles and thus prevent or treat 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.
  
  
  METHODS
  Single blind, randomised controlled feasibility trial with two parallel groups.
  
  
  METHODS
  It is planned to recruit 56 postpartum women in Vienna, who will be 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 concordance, data collection methods and tools) will be assessed and participants' views and experiences will be surveyed. Tested outcome measures, collected before and after the intervention, will be pelvic floor muscle performance as reported by participants and measured by perineometry. Descriptive and inferential statistics and content analysis will serve the preparation of the future trial.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Midwifery and Radiography, Centre for Maternal and Child Health Research, School of Health Sciences, City University London, UK.
authors.forename: Claudia
authors.identifier: http://orcid.org/0000-0001-9534-3249
authors.initials: C
authors.lastname: Oblasser
authors.affiliation: Division of Midwifery and Radiography, Centre for Maternal and Child Health Research, School of Health Sciences, City University London, UK.
authors.forename: Christine
authors.identifier: http://orcid.org/0000-0003-4765-5795
authors.initials: C
authors.lastname: McCourt
authors.affiliation: Division of General Gynaecology and Gynaecologic Oncology, Department of Obstetrics and Gynaecology, Medical University of Vienna, Austria.
authors.forename: Engelbert
authors.initials: E
authors.lastname: Hanzal
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, UK.
authors.forename: Janice
authors.initials: J
authors.lastname: Christie
mesh_terms: D005081:Exercise Therapy / Q000295:instrumentation* / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D017773:Pelvic Floor / Q000502:physiology; D059952:Pelvic Floor Disorders / Q000503:physiopathology / Q000534:rehabilitation*; D011644:Puerperal Disorders / Q000503:physiopathology / Q000534:rehabilitation*; D016037:Single-Blind Method; D014732:Vibration
keywords: RCT; feasibility studies; midwifery; pelvic floor; perineal care; postnatal care; postpartum period; resistance training; urinary incontinence; vaginal balls/cones