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| ID | Type | Description | Link |
|---|---|---|---|
| 1704/2014 | Other Identifier | Medical University of Vienna |
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| Name | Class |
|---|---|
| Medical University of Vienna | OTHER |
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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laselle Kegel Exerciser | Experimental |
| |
| Pelvic floor muscle exercises | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laselle Kegel Exerciser | Device | 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. |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Participant reported pelvic floor muscle outcomes as measured by structured questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Oblasser, MA, cand.PhD | City, University of London | Principal Investigator |
| Engelbert Hanzal, MD, Prof. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25382375 | Background | 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. | |
| 26428191 | Background | 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. |
| Label | URL |
|---|---|
| Entry at study registry of the Ethics Committee of the Medical University of Vienna | View source |
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| Pelvic floor muscle exercises | Behavioral | 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. |
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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 |
| Pelvic floor muscle performance as measured by perineometry | By blinded external assessor | Within 4 days before the intervention |
| Pelvic floor muscle performance as measured by perineometry | By blinded external assessor | Within 2 weeks after the intervention |
| Women´s perspectives and experiences as measured by structured interviews | 28 of 56 women | Within 3 weeks before the intervention |
| 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 |
| 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 |
| 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) | First 28 of 56 women: interview, second 28 of 56 women: questionnaire | Up to 1 year after end of intervention |
| 26708615 | Background | 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. |