Clinical trial NCT02355327: Vibrating Vaginal Balls After Childbirth
Official title: Feasibility Trial on the Effectiveness of Vibrating Vaginal Balls to Improve Pelvic Floor Muscle Performance in Women After Childbirth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Health After Childbirth
Lead sponsor: City, University of London
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
First posted: 2015-02-04
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as measured by recruitment rate
timeFrame: Within 4 weeks of ending recruitment
measure: Feasibility as measured by pre intervention pelvic floor muscle measurement attendance rate
timeFrame: Within 4 weeks of ending data collection
measure: Feasibility as measured by start of intervention rate
timeFrame: Within 4 weeks of ending data collection
measure: Feasibility as measured by concordance rate
timeFrame: Within 4 weeks of ending data collection
measure: Feasibility as measured by retention rate
timeFrame: Within 4 weeks of ending data collection
measure: Feasibility as measured by post intervention data collection attendance rate
timeFrame: Within 4 weeks of ending data collection
measure: Feasibility as measured by staff necessary
timeFrame: Within 4 weeks of ending data collection
measure: Feasibility as measured by time necessary
timeFrame: Within 4 weeks of ending data collection
measure: Feasibility as measured by budget necessary
timeFrame: Within 4 weeks of ending data collection
Secondary outcomes:
Other outcomes:
measure: Participant reported pelvic floor muscle outcomes as measured by structured questionnaire
timeFrame: Within 3 weeks before the intervention
measure: Participant reported pelvic floor muscle outcomes as measured by structured questionnaire
timeFrame: Within 2 weeks after the intervention
measure: Pelvic floor muscle performance as measured by perineometry
timeFrame: Within 4 days before the intervention
measure: Pelvic floor muscle performance as measured by perineometry
timeFrame: Within 2 weeks after the intervention
measure: Women´s perspectives and experiences as measured by structured interviews
timeFrame: Within 3 weeks before the intervention
measure: Women´s perspectives and experiences as measured by structured interviews
timeFrame: Within 2 weeks after the intervention
measure: Women´s perspectives and experiences as measured by structured anonymous questionnaire
timeFrame: Within 3 weeks after the intervention
measure: Concordance to interventions as measured by training diary
timeFrame: At time of intervention (12 weeks)
measure: Type, severity and number of adverse events as measured by active and passive surveillance (interview, self-report)
timeFrame: At time of intervention (12 weeks)
measure: Type, severity and number of adverse events as measured by active and passive surveillance (interview/questionnaire, self-report)
timeFrame: Up to 1 year after end of intervention
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: City, University of London
name: Claudia Oblasser, MA, cand.PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Engelbert Hanzal, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.