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Vibrating Vaginal Balls After Childbirth

NCT02355327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2016-06-23

No results posted yet for this study

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.

Conditions

  • Pelvic Floor Health After Childbirth

Interventions

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.

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.

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • City, University of London

    lead OTHER

Principal Investigators

  • Claudia Oblasser, MA, cand.PhD · City, University of London

  • Engelbert Hanzal, MD, Prof. · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02355327 on ClinicalTrials.gov