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

October 7, 2016 updated by: Gunvor Hilde, Norwegian School of Sport Sciences

The Effect of Postpartum Pelvic Floor Muscle Training in Women With Injured and Non-injured Pelvic Floor Muscles. A Single Blind Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Injuries to the pelvic floor muscles (PFM) and fascias may lead to urinary incontinence (UI), fecal incontinence, pelvic organ prolapse (POP), sensory and emptying abnormalities of the lower urinary tract, defecatory dysfunction, sexual dysfunction and chronic pain syndromes (Bump & Norton 1998, MacLennan et al 2009, Turner et al 2000). Prevalence rates of the most common pelvic floor disorders are generally high in the fertile female population

To date many randomized controlled trials (RCT) have demonstrated significant effect of pelvic floor muscle training (PFMT) in treatment of stress and mixed urinary incontinence, and it is recommended as first line treatment for stress and mixed UI in women (Level I, Grade A) (Abrams 2010). The effect of postpartum PFMT in prevention and treatment of urinary incontinence is investigated in only four RCTs (Sleep 1987, Meyer 2001, Chiarelli 2001, Ewings 2005) and one matched controlled trial (Mørkved 1997). The results are conflicting. The matched controlled trial by Mørkved (1997) shows the far most effective intervention so far, with 50% less prevalence of UI in the training group. Similar results were found for the same long term effect with 50% less prevalence of UI in the training group with the same long term effect (Mørkved 2000). The high effect size may be explained by the close follow-up and relative high training dosage. However, as this was not a RCT, the effect may be overestimated and the trial is often not included in systematic reviews (Hay-Smith 2008).

Only few research groups have measured PFM function and strength, and there are no studies evaluating possible effects of PFMT on PFM injuries and morphology following pregnancy and childbirth. DeLancey (1996) have suggested that the effect of PFMT would be much higher if we knew the causes of incontinence and were able to include only those with intact pelvic floor muscles. This may be true, but the statement also reflects a belief that muscle injury of the PFM cannot be treated with exercise. However, this is in contrast to common practice in treatment of other skeletal muscles e.g. after sport injuries, where all injuries are treated and it is believed that early mobilization and training is important in speeding up tissue healing (Järvinen 2007). Hence, there is a need to conduct a RCT with high methodological and interventional quality (Herbert 2005) to investigate the effect of postpartum PFMT.

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Lørenskog, Akershus, Norway, 1478
        • Akershus University Hospital, Dept of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Postpartum pelvic floor muscle training
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
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.
Other Names:
  • Postpartum PFMT
NO_INTERVENTION: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Incontinence (Prevalence)
Time Frame: 6 months postpartum (end of intervention)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Incontinence (Positive Pad Test)
Time Frame: 6 months postpartum (end of intervention)

Urinary incontinence assessed by pad test, as described by Mørkved and Bø (1997). The cutoff value for a positive test was 2 gram.

After voiding, the women drank one litre of water. Thirty minutes later they wore a pre-weighted pad and performed a stress test as follows:

  • Jumping up and down with maximal intensity for 30 seconds.
  • Jumping with the legs in alternate abduction and adduction (Jumping Jacks) with maximal intensity for another 30 seconds.
  • Coughing as hard as possible three times. As in the study by Mørkved and Bø (1997), a positive pad-test was set to a cut-off of 2 gram of leakage.
6 months postpartum (end of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian School of Sport Sciences

Collaborators

The Research Council of Norway
University Hospital, Akershus

Investigators

  • Study Director: Kari Bø, Prof,PhD,PT, Norwegian School of Sport Sciences, Dept of Sports Medicine/Akershus University Hospital, Dept of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (ESTIMATE)

February 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 1, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2799004
  • 2191411 (OTHER_GRANT: The Research Council of Norway)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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