Completed

NCT Number: NCT02355327

Vibrating Vaginal Balls 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.

Completed

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Key information

Conditions

Pelvic Floor Health After Childbirth

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

Feasibility as measured by recruitment rate

Time frame: Within 4 weeks of ending recruitment
Feasibility as measured by pre intervention pelvic floor muscle measurement attendance rate

Time frame: Within 4 weeks of ending data collection
Feasibility as measured by start of intervention rate

Time frame: Within 4 weeks of ending data collection
Feasibility as measured by concordance rate

Time frame: Within 4 weeks of ending data collection
Feasibility as measured by retention rate

Time frame: Within 4 weeks of ending data collection
Feasibility as measured by post intervention data collection attendance rate

Time frame: Within 4 weeks of ending data collection
Feasibility as measured by staff necessary

Time frame: Within 4 weeks of ending data collection
Feasibility as measured by time necessary

Time frame: Within 4 weeks of ending data collection
Feasibility as measured by budget necessary

Time frame: Within 4 weeks of ending data collection

Other outcomes

Participant reported pelvic floor muscle outcomes as measured by structured questionnaire

Time frame: 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)
Participant reported pelvic floor muscle outcomes as measured by structured questionnaire

Time frame: Within 2 weeks after the intervention

Questionnaire contains self-designed section and also includes the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ UI)
Pelvic floor muscle performance as measured by perineometry

Time frame: Within 4 days before the intervention

By blinded external assessor
Pelvic floor muscle performance as measured by perineometry

Time frame: Within 2 weeks after the intervention

By blinded external assessor
Women´s perspectives and experiences as measured by structured interviews

Time frame: Within 3 weeks before the intervention

28 of 56 women
Women´s perspectives and experiences as measured by structured interviews

Time frame: Within 2 weeks after the intervention

Same 28 of 56 women as for previous outcome measure
Women´s perspectives and experiences as measured by structured anonymous questionnaire

Time frame: 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

Time frame: At time of intervention (12 weeks)
Type, severity and number of adverse events as measured by active and passive surveillance (interview, self-report)

Time frame: At time of intervention (12 weeks)
Type, severity and number of adverse events as measured by active and passive surveillance (interview/questionnaire, self-report)

Time frame: Up to 1 year after end of intervention

First 28 of 56 women: interview, second 28 of 56 women: questionnaire

Sponsors and collaborators

Lead sponsor

City, University of London

Other

Collaborators

Medical University of Vienna

Registry information

Official study title

Feasibility Trial on the Effectiveness of Vibrating Vaginal Balls to Improve Pelvic Floor Muscle Performance in Women After Childbirth

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Feb 4, 2015
Registry last updated: Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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Transperineal Ultrasound as a Biofeedback Tool for Pelvic Floor Muscle Therapy in Postpartum Patients

NCT07065708

Biofeedback Therapy, Female Urogenital Diseases

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View Trial Details

Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

Medical University of Vienna

About this study

Who can participate

Treatment and study plan

Laselle Kegel Exerciser

Pelvic floor muscle exercises

Primary outcomes

Feasibility as measured by recruitment rate

Feasibility as measured by pre intervention pelvic floor muscle measurement attendance rate

Feasibility as measured by start of intervention rate

Feasibility as measured by concordance rate

Feasibility as measured by retention rate

Feasibility as measured by post intervention data collection attendance rate

Feasibility as measured by staff necessary

Feasibility as measured by time necessary

Feasibility as measured by budget necessary

Other outcomes

Participant reported pelvic floor muscle outcomes as measured by structured questionnaire

Participant reported pelvic floor muscle outcomes as measured by structured questionnaire

Pelvic floor muscle performance as measured by perineometry

Pelvic floor muscle performance as measured by perineometry

Women´s perspectives and experiences as measured by structured interviews

Women´s perspectives and experiences as measured by structured interviews

Women´s perspectives and experiences as measured by structured anonymous questionnaire

Concordance to interventions as measured by training diary

Type, severity and number of adverse events as measured by active and passive surveillance (interview, self-report)

Type, severity and number of adverse events as measured by active and passive surveillance (interview/questionnaire, self-report)