Pelvic Floor Health After Childbirth
Conditions
Brief 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.
Interventions
DEVICELaselle 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.
BEHAVIORALPelvic 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.
Sponsors
Medical University of Vienna
City, University of London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility as measured by budget necessary | Within 4 weeks of ending data collection |
| Feasibility as measured by staff necessary | Within 4 weeks of ending data collection |
| Feasibility as measured by retention rate | Within 4 weeks of ending data collection |
| 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 time necessary | Within 4 weeks of ending data collection |
| Feasibility as measured by post intervention data collection attendance rate | Within 4 weeks of ending data collection |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pelvic floor muscle performance as measured by perineometry | Within 4 days before the intervention | By blinded external assessor |
| Women´s perspectives and experiences as measured by structured interviews | Within 3 weeks before the intervention | 28 of 56 women |
| Women´s perspectives and experiences as measured by structured anonymous questionnaire | Within 3 weeks after the intervention | 28 of 56 women (those not included in the two previous outcome measures) |
| Concordance to interventions as measured by training diary | At time of intervention (12 weeks) | — |
| Type, severity and number of adverse events as measured by active and passive surveillance (interview, self-report) | At time of intervention (12 weeks) | — |
| Type, severity and number of adverse events as measured by active and passive surveillance (interview/questionnaire, self-report) | Up to 1 year after end of intervention | First 28 of 56 women: interview, second 28 of 56 women: questionnaire |
| Participant reported pelvic floor muscle outcomes as measured by structured questionnaire | Within 3 weeks before the intervention | Questionnaire contains self-designed section and also includes the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ UI) |
Countries
Austria
Outcome results
None listed