Vibrating Vaginal Balls After Childbirth

NCT02355327 | Completed

• 2 other identifiers: SREC 14-15 02 D 02 12 20141704/2014
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Health After Childbirth

Outcome Measures

Primary Outcomes (9)

• Feasibility as measured by recruitment rate

  Within 4 weeks of ending recruitment

• Feasibility as measured by pre intervention pelvic floor muscle measurement 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 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 staff necessary

  Within 4 weeks of ending data collection

• Feasibility as measured by time necessary

  Within 4 weeks of ending data collection

• Feasibility as measured by budget necessary

  Within 4 weeks of ending data collection

Other Outcomes (10)

• Participant reported pelvic floor muscle outcomes as measured by structured questionnaire

  Within 3 weeks before the intervention

• Participant reported pelvic floor muscle outcomes as measured by structured questionnaire

  Within 2 weeks after the intervention

• Pelvic floor muscle performance as measured by perineometry

  Within 4 days before the intervention

Study Arms (2)

Laselle Kegel Exerciser

EXPERIMENTAL

Device: Laselle Kegel Exerciser

Pelvic floor muscle exercises

ACTIVE COMPARATOR

Behavioral: Pelvic floor muscle exercises

Interventions

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.

Laselle Kegel Exerciser

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.

Pelvic floor muscle exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City, University of London: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (3)

• Oblasser C, Christie J, McCourt C. Vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women postpartum: a quantitative systematic review and meta-analysis protocol. J Adv Nurs. 2015 Apr;71(4):933-41. doi: 10.1111/jan.12566. Epub 2014 Nov 10.

  PMID: 25382375 BACKGROUND

• Oblasser C, Christie J, McCourt C. Vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women post partum: A quantitative systematic review. Midwifery. 2015 Nov;31(11):1017-25. doi: 10.1016/j.midw.2015.08.011. Epub 2015 Sep 9.

  PMID: 26428191 BACKGROUND

• Oblasser C, McCourt C, Hanzal E, Christie J. Vibrating vaginal balls to improve pelvic floor muscle performance in women after childbirth: a protocol for a randomised controlled feasibility trial. J Adv Nurs. 2016 Apr;72(4):900-14. doi: 10.1111/jan.12868. Epub 2015 Dec 28.

  PMID: 26708615 BACKGROUND

Related Links

• Entry at study registry of the Ethics Committee of the Medical University of Vienna

Study Officials

• Claudia Oblasser, MA, cand.PhD

  City, University of London

  PRINCIPAL INVESTIGATOR

• Engelbert Hanzal, MD, Prof.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: February 4, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 23, 2016

Record last verified: 2016-01

Locations

AU (1)