Pelvic Floor Health After Childbirth Clinical Trial
Official title:
Feasibility Trial on the Effectiveness of Vibrating Vaginal Balls to Improve Pelvic Floor Muscle Performance in Women After Childbirth
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.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | May 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| City University, London | Medical University of Vienna |
Austria,
Oblasser C, Christie J, McCourt C. Vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women post partum: A quantitative systematic review. Midwifery. 2015 Nov;31(11):1017-25. doi: 10.1016/j.midw.2015.08.011. Epub 2015 Sep 9. Review. — View Citation
Oblasser C, Christie J, McCourt C. Vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women postpartum: a quantitative systematic review and meta-analysis protocol. J Adv Nurs. 2015 Apr;71(4):933-41. doi: 10.1111/jan.12566. Epub 2014 Nov 10. Review. — View Citation
Oblasser C, McCourt C, Hanzal E, Christie J. Vibrating vaginal balls to improve pelvic floor muscle performance in women after childbirth: a protocol for a randomised controlled feasibility trial. J Adv Nurs. 2016 Apr;72(4):900-14. doi: 10.1111/jan.12868. Epub 2015 Dec 28. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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) | Within 3 weeks before the intervention | No |
| Other | 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) | Within 2 weeks after the intervention | No |
| Other | Pelvic floor muscle performance as measured by perineometry | By blinded external assessor | Within 4 days before the intervention | No |
| Other | Pelvic floor muscle performance as measured by perineometry | By blinded external assessor | Within 2 weeks after the intervention | No |
| Other | Women´s perspectives and experiences as measured by structured interviews | 28 of 56 women | Within 3 weeks before the intervention | No |
| Other | Women´s perspectives and experiences as measured by structured interviews | Same 28 of 56 women as for previous outcome measure | Within 2 weeks after the intervention | No |
| Other | Women´s perspectives and experiences as measured by structured anonymous questionnaire | 28 of 56 women (those not included in the two previous outcome measures) | Within 3 weeks after the intervention | No |
| Other | Concordance to interventions as measured by training diary | At time of intervention (12 weeks) | No | |
| Other | Type, severity and number of adverse events as measured by active and passive surveillance (interview, self-report) | At time of intervention (12 weeks) | Yes | |
| Other | 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 | Up to 1 year after end of intervention | Yes |
| Primary | Feasibility as measured by recruitment rate | Within 4 weeks of ending recruitment | No | |
| Primary | Feasibility as measured by pre intervention pelvic floor muscle measurement attendance rate | Within 4 weeks of ending data collection | No | |
| Primary | Feasibility as measured by start of intervention rate | Within 4 weeks of ending data collection | No | |
| Primary | Feasibility as measured by concordance rate | Within 4 weeks of ending data collection | No | |
| Primary | Feasibility as measured by retention rate | Within 4 weeks of ending data collection | No | |
| Primary | Feasibility as measured by post intervention data collection attendance rate | Within 4 weeks of ending data collection | No | |
| Primary | Feasibility as measured by staff necessary | Within 4 weeks of ending data collection | No | |
| Primary | Feasibility as measured by time necessary | Within 4 weeks of ending data collection | No | |
| Primary | Feasibility as measured by budget necessary | Within 4 weeks of ending data collection | No |