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

This study has been completed.
Sponsor:
Collaborators:
University Hospital, Akershus
The Research Council of Norway
Information provided by (Responsible Party):
Gunvor Hilde, Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier:
NCT01069484
First received: February 16, 2010
Last updated: October 7, 2016
Last verified: October 2016
  Purpose

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.


Condition Intervention
Urinary Incontinence
Other: Postpartum pelvic floor muscle training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Postpartum Pelvic Floor Muscle Training in Women With Injured and Non-injured Pelvic Floor Muscles. A Single Blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Norwegian School of Sport Sciences:

Primary Outcome Measures:
  • Urinary Incontinence (Prevalence) [ Time Frame: 6 months postpartum (end of intervention) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Urinary Incontinence (Positive Pad Test) [ Time Frame: 6 months postpartum (end of intervention) ] [ Designated as safety issue: No ]

    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.


Enrollment: 175
Study Start Date: February 2010
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069484

Locations
Norway
Akershus University Hospital, Dept of Obstetrics and Gynecology
Lørenskog, Akershus, Norway, 1478
Sponsors and Collaborators
Norwegian School of Sport Sciences
University Hospital, Akershus
The Research Council of Norway
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
  More Information

Publications:
Bø K, Hagen RH, Kvarstein B, Jørgensen J, Larsen S. Pelvic floor muscle exercise for the treatment of of female stress urinary incontinence. III. Effects of two different degrees of pelvic floor muscleexercises. Neurourol Urodyn 9:489-502,1990.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gunvor Hilde, PT, Msc, Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier: NCT01069484     History of Changes
Other Study ID Numbers: 2799004  2191411 
Study First Received: February 16, 2010
Results First Received: April 27, 2015
Last Updated: October 7, 2016
Health Authority: Norway: Data Protection Authority
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Norwegian School of Sport Sciences:
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

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016