Vibrating Vaginal Balls After Childbirth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mitigating Chronic Pelvic Floor Dysfunction Following Childbirth by Pelvic Floor Dynamometry

NCT02391285

Pelvic Floor Dysfunction

COMPLETED NA

Role of Rehabilitation for the Repair of Pelvic Floor Injuries Associated to Vaginal Delivery Identified by 3/4D Transperineal Ultrasound

NCT03592160

Pelvic Floor Disorders Ultrasound Therapy; Complications Physical Disorder +1 more

COMPLETED NA

Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women

NCT07048145

Urinary Dysfunction Vaginal Prolapse Sexual Function Scores +3 more

ACTIVE_NOT_RECRUITING NA

Postpartum pElvic Assisted Recovery With Leva

NCT06609317

Postpartum Pelvic Floor Function and Symptoms

RECRUITING NA

Repair by Rehabilitation of Pelvic Floor Lesions After Vaginal Delivery Identified by Transperineal Ultrasound 3/4 D

NCT03686956

Pelvic Floor Disorders Obstetric Trauma Physical Disorder +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Floor Health After Childbirth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laselle Kegel Exerciser

Group Type EXPERIMENTAL

Laselle Kegel Exerciser

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Pelvic floor muscle exercises

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No