An interventional study of Laselle Kegel Exerciser and Pelvic floor muscle exercises in Pelvic Floor Health After Childbirth, sponsored by City, University of London. Completed at 1 site in Austria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-23.
Sponsored by City, University of London · Not applicable and Interventional
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
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.
City, University of London is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Laselle Kegel Exerciser
Behavioral: Pelvic floor muscle exercises
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.
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.
Feasibility as measured by recruitment rate
Time frame: Within 4 weeks of ending recruitment
Feasibility as measured by pre intervention pelvic floor muscle measurement attendance rate
Time frame: Within 4 weeks of ending data collection
Feasibility as measured by start of intervention rate
Time frame: Within 4 weeks of ending data collection
Feasibility as measured by concordance rate
Time frame: Within 4 weeks of ending data collection
Feasibility as measured by retention rate
Time frame: Within 4 weeks of ending data collection
Feasibility as measured by post intervention data collection attendance rate
Time frame: Within 4 weeks of ending data collection
Feasibility as measured by staff necessary
Time frame: Within 4 weeks of ending data collection
Feasibility as measured by time necessary
Time frame: Within 4 weeks of ending data collection
Feasibility as measured by budget necessary
Time frame: Within 4 weeks of ending data collection
Participant reported pelvic floor muscle outcomes as measured by structured questionnaire
Questionnaire contains self-designed section and also includes the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ UI)
Time frame: Within 3 weeks before the intervention
Participant reported pelvic floor muscle outcomes as measured by structured questionnaire
Questionnaire contains self-designed section and also includes the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ UI)
Time frame: Within 2 weeks after the intervention
Pelvic floor muscle performance as measured by perineometry
By blinded external assessor
Time frame: Within 4 days before the intervention
Pelvic floor muscle performance as measured by perineometry
By blinded external assessor
Time frame: Within 2 weeks after the intervention
Women´s perspectives and experiences as measured by structured interviews
28 of 56 women
Time frame: Within 3 weeks before the intervention
Women´s perspectives and experiences as measured by structured interviews
Same 28 of 56 women as for previous outcome measure
Time frame: Within 2 weeks after the intervention
Women´s perspectives and experiences as measured by structured anonymous questionnaire
28 of 56 women (those not included in the two previous outcome measures)
Time frame: Within 3 weeks after the intervention
Concordance to interventions as measured by training diary
Time frame: At time of intervention (12 weeks)
Type, severity and number of adverse events as measured by active and passive surveillance (interview, self-report)
Time frame: At time of intervention (12 weeks)
Type, severity and number of adverse events as measured by active and passive surveillance (interview/questionnaire, self-report)
First 28 of 56 women: interview, second 28 of 56 women: questionnaire
Time frame: Up to 1 year after end of intervention
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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City, University of London