NCT02355327

Vibrating Vaginal Balls After Childbirth

Feasibility Trial on the Effectiveness of Vibrating Vaginal Balls to Improve Pelvic Floor Muscle Performance in Women After Childbirth

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: City, University of London · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pelvic Floor Health After Childbirth

Interventions

Type	Name	Description
DEVICE	Laselle Kegel Exerciser	Participants use a vibrating pelvic floor muscle training ball for 12 weeks. The ball is inserted into the vagina and left for 15 minutes daily in the first week, and if well tolerated 30 minutes daily from the second week onwards. To achieve the vibrating effect, the balls are worn while moving - performing everyday tasks or going for a walk.
BEHAVIORAL	Pelvic floor muscle exercises	Participants get standard care after childbirth, which is the routine recommendation of pelvic floor muscle exercises. Participants will be asked to continue/start the pelvic floor muscle exercises they routinely were recommended by customary written instructions from their health professionals after birth. Intervention duration for this study is 12 weeks.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-02-04
• Last updated: 2016-06-23

Locations

1 site across 1 country: Austria