Pelvic Floor Health After Childbirth Clinical Trial
Official title:
Feasibility Trial on the Effectiveness of Vibrating Vaginal Balls to Improve Pelvic Floor Muscle Performance in Women After Childbirth
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.
Background: Pelvic floor muscle training after childbirth is recommended to prevent or treat
urinary incontinence and other pelvic floor problems. A device that is sometimes recommended
to women in Austria to enhance their pelvic floor muscles are vibrating vaginal pelvic floor
training balls. To date, only a small study on vibrating balls exists, and it researched
women with urinary incontinence and not women after childbirth. Therefore, research is
needed to scientifically objectify the popular claim of these balls´ effectiveness in the
postpartum period and further evidence based practice.
Method: The tested study features comprise
- recruitment strategies,
- inclusion and exclusion criteria,
- the necessary number of participants,
- the randomisation procedure,
- the interventions themselves,
- concordance and retention measures,
- data collection,
- effectiveness outcomes,
- a survey of women's views of and experiences,
- statistics and content analysis.
Results: The results of this trial will inform the features and feasibility of a future full
RCT. It will be concluded that a full RCT to determine the effectiveness of vibrating
vaginal pelvic floor training balls post partum is feasible as planned, feasible with
modifications or not feasible. If considered feasible, the results will enable the full
study to be planned correctly.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)