Postpartum Pelvic Floor Muscle Training in Women With and Without Injured Pelvic Floor Muscles

NCT01069484 | Completed Results DMC

• 2 other identifiers: 27990042191411
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

Although pregnancy and childbirth are associated with happiness and a positive life change for most women, it can also be considered as risk periods for injuries to the pelvic floor and development of pelvic floor dysfunction. This may leed to devastating loss of function and quality of life (Ashton-Miller \& DeLancey 2007). The aim of this study is to evaluate the effect of postpartum pelvic floor muscle training for primiparous women with and without pelvic floor muscle injury.

Conditions

Urinary Incontinence

Keywords

Randomized controlled trial; Post partum pelvic floor muscle training; Urinary incontinence; Pelvic floor dysfunction; Pelvic floor muscle injury; Pelvic floor muscle strength; Pelvic floor muscle morphology

Outcome Measures

Primary Outcomes (1)

• Urinary Incontinence (Prevalence)

  Urinary incontinence was assessed by The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI Short Form questionnaire, www.iciq.net). Women were considered as incontinent if they reported to leak urine (yes/no) at any frequency.

  6 months postpartum (end of intervention)

Secondary Outcomes (1)

• Urinary Incontinence (Positive Pad Test)

  6 months postpartum (end of intervention)

Study Arms (2)

Postpartum pelvic floor muscle training

EXPERIMENTAL

Beyond a customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the PFM correctly, the participants are given supervised pelvic floor muscle group training led by physiotherapists once a week. In addition, the participants train every day at home, with at least 3 sets of 8-12 contractions. Training period is 4 months.

Other: Postpartum pelvic floor muscle training

Control

NO INTERVENTION

Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the PFM correctly, the control group participants received no further intervention. They were not discouraged from doing PFMT on their own.

Interventions

Postpartum pelvic floor muscle training OTHER

Beyond a customary leaflet and thorough initial instruction on how to contract the PFM correctly, the training participants will attend one weekly supervised exercise class led by an experienced physiotherapist, and perform daily training at home. The intervention starts 6-8 weeks postpartum and last for 4 months. General principles for strength training are followed: 3 sets of 8-12 contractions close to maximum (Bø 1990, Haskell 2007). Emphasis will be on progression in force development. The participants are provided with a DVD of the program (www.corewellness.co.uk). At week 4 during the intervention, the PFM strength will be assessed for each participant. Training adherence at home will be recorded in a training diary, whereas the physical therapist will record group session adherence.

Also known as: Postpartum PFMT

Postpartum pelvic floor muscle training

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primipara women giving birth at Akershus University Hospital, Norway
• Women giving birth to a healthy singleton baby at term
• Women who speak/ understand Scandinavian language

You may not qualify if:

• Multiparity
• C-section
• Premature birth (\< week 32)
• Prior abortion or stillbirth after 16 weeks of gestation
• Perineal tearing graded as 3b, 3c or 4.
• Illnesses that may interfere with the ability to follow-up

Sponsors & Collaborators

• Norwegian School of Sport Sciences: lead
• University Hospital, Akershus: collaborator
• The Research Council of Norway: collaborator

Study Sites (1)

Akershus University Hospital, Dept of Obstetrics and Gynecology

Lørenskog, Akershus, 1478, Norway

Location

Related Publications (27)

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• Hilde G, Staer-Jensen J, Siafarikas F, Gjestland K, Ellstrom Engh M, Bo K. How well can pelvic floor muscles with major defects contract? A cross-sectional comparative study 6 weeks after delivery using transperineal 3D/4D ultrasound and manometer. BJOG. 2013 Oct;120(11):1423-9. doi: 10.1111/1471-0528.12321. Epub 2013 Jul 3.

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• Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.

  PMID: 32378735 DERIVED

• Tennfjord MK, Engh ME, Bo K. The Influence of Early Exercise Postpartum on Pelvic Floor Muscle Function and Prevalence of Pelvic Floor Dysfunction 12 Months Postpartum. Phys Ther. 2020 Aug 31;100(9):1681-1689. doi: 10.1093/ptj/pzaa084.

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• Gluppe SL, Hilde G, Tennfjord MK, Engh ME, Bo K. Effect of a Postpartum Training Program on the Prevalence of Diastasis Recti Abdominis in Postpartum Primiparous Women: A Randomized Controlled Trial. Phys Ther. 2018 Apr 1;98(4):260-268. doi: 10.1093/ptj/pzy008.

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• Kolberg Tennfjord M, Hilde G, Staer-Jensen J, Siafarikas F, Engh ME, Bo K. Effect of postpartum pelvic floor muscle training on vaginal symptoms and sexual dysfunction-secondary analysis of a randomised trial. BJOG. 2016 Mar;123(4):634-42. doi: 10.1111/1471-0528.13823. Epub 2015 Dec 22.

  PMID: 26691895 DERIVED

• Bo K, Hilde G, Staer-Jensen J, Siafarikas F, Tennfjord MK, Engh ME. Postpartum pelvic floor muscle training and pelvic organ prolapse--a randomized trial of primiparous women. Am J Obstet Gynecol. 2015 Jan;212(1):38.e1-7. doi: 10.1016/j.ajog.2014.06.049. Epub 2014 Jun 28.

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• Hilde G, Staer-Jensen J, Siafarikas F, Ellstrom Engh M, Bo K. Postpartum pelvic floor muscle training and urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2013 Dec;122(6):1231-8. doi: 10.1097/AOG.0000000000000012.

  PMID: 24201679 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Gunvor Hilde
• Organization: Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway

gunvor.hilde@gmail.com

+47 41366045

Study Officials

• Kari Bø, Prof,PhD,PT

  Norwegian School of Sport Sciences, Dept of Sports Medicine/Akershus University Hospital, Dept of Obstetrics and Gynecology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, Msc

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: December 1, 2016
• Results First Posted: December 1, 2016

Record last verified: 2016-10

Locations

NO (1)