Vibrating Vaginal Balls After Childbirth

June 22, 2016 updated by: City, University of London

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laselle Kegel Exerciser
Device: Laselle 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.
Active Comparator: Pelvic floor muscle exercises
Behavioral: Pelvic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility as measured by recruitment rate
Time Frame: Within 4 weeks of ending recruitment
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
Within 4 weeks of ending data collection
Feasibility as measured by start of intervention rate
Time Frame: Within 4 weeks of ending data collection
Within 4 weeks of ending data collection
Feasibility as measured by concordance rate
Time Frame: Within 4 weeks of ending data collection
Within 4 weeks of ending data collection
Feasibility as measured by retention rate
Time Frame: Within 4 weeks of ending data collection
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
Within 4 weeks of ending data collection
Feasibility as measured by staff necessary
Time Frame: Within 4 weeks of ending data collection
Within 4 weeks of ending data collection
Feasibility as measured by time necessary
Time Frame: Within 4 weeks of ending data collection
Within 4 weeks of ending data collection
Feasibility as measured by budget necessary
Time Frame: Within 4 weeks of ending data collection
Within 4 weeks of ending data collection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Within 3 weeks before the intervention
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)
Within 2 weeks after the intervention
Pelvic floor muscle performance as measured by perineometry
Time Frame: Within 4 days before the intervention
By blinded external assessor
Within 4 days before the intervention
Pelvic floor muscle performance as measured by perineometry
Time Frame: Within 2 weeks after the intervention
By blinded external assessor
Within 2 weeks after the intervention
Women´s perspectives and experiences as measured by structured interviews
Time Frame: Within 3 weeks before the intervention
28 of 56 women
Within 3 weeks before the intervention
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
Within 2 weeks after the intervention
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)
Within 3 weeks after the intervention
Concordance to interventions as measured by training diary
Time Frame: At time of intervention (12 weeks)
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)
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
Up to 1 year after end of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City, University of London

Collaborators

Medical University of Vienna

Investigators

  • Principal Investigator: Claudia Oblasser, MA, cand.PhD, City, University of London
  • Principal Investigator: Engelbert Hanzal, MD, Prof., Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimate)

February 4, 2015

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

June 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • SREC 14-15 02 D 02 12 2014
  • 1704/2014 (Other Identifier: Medical University of Vienna)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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