Vibrating Vaginal Balls After Childbirth

City, University of London56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Pelvic Floor Health After Childbirth

Interventions

Laselle Kegel ExerciserDEVICE

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.

Pelvic floor muscle exercisesBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna

Vienna, Austria

Outcomes