Vibrating Vaginal Balls After Childbirth

Not Applicable

Completed

• Conditions: Pelvic Floor Health After Childbirth
• Interventions: Device: Laselle Kegel Exerciser; Behavioral: Pelvic floor muscle exercises

• Registration Number: NCT02355327
• Lead Sponsor: City, University of London

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.

Study Timeline

• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-30
• Study Start: 2015-02
• Study First Posted: 2015-02-04
• Status Verified: 2016-01
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-06-22
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laselle Kegel Exerciser	Laselle Kegel Exerciser	-
Pelvic floor muscle exercises	Pelvic floor muscle exercises	-

Primary Outcome Measures

Name	Time	Method
Feasibility as measured by staff necessary	Within 4 weeks of ending data collection
Feasibility as measured by recruitment rate	Within 4 weeks of ending recruitment
Feasibility as measured by time necessary	Within 4 weeks of ending data collection
Feasibility as measured by pre intervention pelvic floor muscle measurement attendance 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 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 budget necessary	Within 4 weeks of ending data collection

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria