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Postpartum Pelvic Floor Muscle Training in Women With and Without Injured Pelvic Floor Muscles (PP-PFMT)

This study is currently recruiting participants.
Verified September 2011 by Norwegian School of Sport Sciences
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: September 1, 2011
Last verified: September 2011
History of Changes
  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 (DeLancey & Ashton-Miller 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 Phase
Pelvic Floor
Pelvic Floor Dysfunction
Pelvic Floor Muscle Injury
 Other: Post partum pelvic floor muscle training
 Phase 3

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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Urinary incontinence (ICIQ-UI) Stress incontinence (Leakage index, PAD test) [ Time Frame: 6 weeks post partum (baseline), 6 months post partum (end of intervention), 12 mths post partum (follow up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anal incontinence(ICIQ-Bowel) Pelvic organ prolapse(ICIQ-VS, possition of pelvic organs) PFM strength(vaginal squeeze pressure) Changes in PFM morphology(ultrasound) Resting position of the pelvic organs(ultrasound) Other health related complaints [ Time Frame: 6 weeks post partum (baseline), 6 months post partum (end of intervention), 12 mths post partum (follow up) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2010
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post partum pelvic floor muscle training
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. Adherence is reported in a training diary. Training period is 4 months.
 Other: Post partum pelvic floor muscle training
The participants are given supervised PFMT led by physiotherapists once a week. Three locations for group training within the county of Akershus are available. The aim is to follow general strength training principles and reach 3 sets 8-12 close to maximum PFM contractions (Bø et al 1990b, Haskell 2007). The emphasis will be on progression in force development. In addition, the participants are asked to train at home doing 3 sets of 8-12 contractions every day. The participants are provided with a DVD of the program including abdominal and back training + focus on body posture, ergonomics and relaxation (www.corewellness.co.uk). Adherence is reported in a training diary. Training period is 4 months. At week 4 during the intervention the pelvic floor muscle strength will be assessed for each participant. The protocol follows former successful protocols (Bø et al 1990b, Bø et al 1999, Mørkved and Bø 1997, Mørkved et al 2002, Mørkved et al 2003) in treatment of female SUI.
Other Name: Pelvic floor muscle training
No Intervention: Usual care
The control group receive usual care
 Other: Post partum pelvic floor muscle training
The participants are given supervised PFMT led by physiotherapists once a week. Three locations for group training within the county of Akershus are available. The aim is to follow general strength training principles and reach 3 sets 8-12 close to maximum PFM contractions (Bø et al 1990b, Haskell 2007). The emphasis will be on progression in force development. In addition, the participants are asked to train at home doing 3 sets of 8-12 contractions every day. The participants are provided with a DVD of the program including abdominal and back training + focus on body posture, ergonomics and relaxation (www.corewellness.co.uk). Adherence is reported in a training diary. Training period is 4 months. At week 4 during the intervention the pelvic floor muscle strength will be assessed for each participant. The protocol follows former successful protocols (Bø et al 1990b, Bø et al 1999, Mørkved and Bø 1997, Mørkved et al 2002, Mørkved et al 2003) in treatment of female SUI.
Other Name: Pelvic floor muscle training

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). Prevalens 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 A) (Hay Smith & Dumoulin 2006, Wilson et al 2005, Welsh 2006). The effect of postpartum PFMT in prevention and treatment of urinary incontinence investigated in only four RCTs (Sleep & Grant 1987, Meyer et al 2001, Chiarelli & Cockburn 2001, Ewings et al 2005) and one matched controlled trial (Mørkved & Bø 1997, Mørkved & Bø 2000), shows conflicting results. In the Norwegian matched controlled trial, Mørkved and Bø (1997) showed the far most effective intervention so far with 50% less prevalence of UI in the training group with the same long term effect (Mørkved & Bø 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 et al 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 (Jarvinen et al 2005). Hence, there is a need to conduct a RCT with high methodological and interventional quality (Herbert and Bø 2005) to investigate the effect of PFMT postpartum.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
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)
  • Women who do not speak/ understand Scandinavian language
  • Illnesses that may interfere with the ability to follow-up
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069484

Contacts
Contact: Gunvor Hilde, MSc, PT +47 41366045 gunvor.hilde@gmail.com

Locations
Norway
Akershus University Hospital, Dept of Obstetrics and Gynecology Recruiting
Lørenskog, Akershus, Norway, 1478
Contact: Gunvor Hilde, PT, MSc     +47 41366045     gunvor.hilde@gmail.com    
Principal Investigator: Kari Bø, Prof,PhD,PT,Exercise scientist            
Sub-Investigator: Gunvor Hilde, MSc, PT            
Sponsors and Collaborators
Norwegian School of Sport Sciences
University Hospital, Akershus
The Research Council of Norway
Investigators
Study Director: Kari Bø, Prof,PhD,PT,Exercise scientist Norwegian School of Sport Sciences, Dept of Sports Medicine/Akershus University Hospital, Dept of Obstetrics and Gynecology
  More Information

No publications provided

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
Last Updated: September 1, 2011
Health Authority: Norway: Data Protection Authority

Keywords provided by Norwegian School of Sport Sciences:
Randomized controlled trial
Post partum pelvic floor muscle training
Pelvic floor dysfunction
 Pelvic floor muscle injury
Pelvic floor muscle strength
Pelvic floor muscle morphology

ClinicalTrials.gov processed this record on May 21, 2013