Vibrating Vaginal Balls After Childbirth

City, University of London

Status

Completed

Conditions

Pelvic Floor Health After Childbirth

Treatments

Behavioral: Pelvic floor muscle exercises

Device: Laselle Kegel Exerciser

Study type

Interventional

Funder types

Other

Identifiers

NCT02355327

1704/2014 (Other Identifier)

SREC 14-15 02 D 02 12 2014

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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