Vibrating Vaginal Balls After Childbirth

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pelvic Floor Health After Childbirth

Intervention / Treatment
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* Device: Laselle Kegel Exerciser
* Behavioral: Pelvic floor muscle exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women from 6 weeks to 6 months after vaginal childbirth (at beginning of intervention) Term birth, i.e. 37+0 or more weeks of gestation 6 weeks postpartum check by obstetrician-gynaecologist performed and woman discharged from postpartum care with diagnostic findings appropriate to this period after childbirth Lochia have ceased Baby alive/not seriously ill Sufficient knowledge of written and spoken German to be able to participate in the study Capacity to consent Exclusion Criteria: Currently enrolled in pelvic floor muscle training with physiotherapist, midwife or fitness trainer Status post perineal tear 3rd or 4th degree at most recent birth Status post continence surgery Current pelvic floor or gynaecological surgery Current infection of genitourinary tract Recurrent (>5 infectious episodes during last 12 months) or chronic (>3 weeks duration of single episode in last 12 months) vaginal infections Neuromuscular conditions influencing pelvic floor muscle function (e.g. multiple sclerosis) Major medical condition influencing infectious risk (diabetes, immune suppressive therapy, HIV infection etc.) Currently on medication that could interfere with treatment or evaluation Currently enrolled in any other research study Pregnancy (also commencing during participation) or pregnancy planned within the study period Retention of ball is impossible Inability to perform the proposed procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laselle Kegel Exerciser<br> | Device: Laselle Kegel Exerciser<br>* 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.<br>|
| Active Comparator: Pelvic floor muscle exercises<br> | Behavioral: Pelvic floor muscle exercises<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by recruitment rate |  | Within 4 weeks of ending recruitment | 
| Feasibility as measured by pre intervention pelvic floor muscle measurement attendance rate |  | Within 4 weeks of ending data collection | 
| Feasibility as measured by start of intervention rate |  | Within 4 weeks of ending data collection | 
| Feasibility as measured by concordance rate |  | Within 4 weeks of ending data collection | 
| Feasibility as measured by retention rate |  | Within 4 weeks of ending data collection | 
| Feasibility as measured by post intervention data collection attendance rate |  | Within 4 weeks of ending data collection | 
| Feasibility as measured by staff necessary |  | Within 4 weeks of ending data collection | 
| Feasibility as measured by time necessary |  | Within 4 weeks of ending data collection | 
| Feasibility as measured by budget necessary |  | Within 4 weeks of ending data collection |