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

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 30, 2013
Last verified: October 2013
  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 Phase
Urinary Incontinence
Other: Postpartum 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:


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 postpartum (baseline), 6 months postpartum (end of intervention), 12 mths postpartum (follow up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anal incontinence(ICIQ-Bowel) Pelvic organ prolapse(ICIQ-VS, position 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 postpartum (baseline), 6 months postpartum (end of intervention), 12 mths post partum (follow up) ] [ Designated as safety issue: No ]

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
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: Postpartum pelvic floor muscle training
The training participants attend a supervised exercise class once a week led by an experienced physiotherapist and are prescribed daily home training over a period of 4 months. The PFM exercise protocol follows general principles for strength training; 3 sets 8-12 contractions close to maximum (Bø et al 1990, Haskell 2007). The emphasis will be on progression in force development. At week 4 during the intervention, the PFM strength will be assessed for each participant. The participants are provided with a DVD of the program (www.corewellness.co.uk). Adherence is reported in a training diary. The PFMT protocol has shown to be successful in former studies evaluating the effect of PFMT on urinary incontinence (Mørkved & Bø 1997, Bø et al 1990, Bø et al 1999, Mørkved et al 2003).
Other Name: Pelvic floor muscle training
No Intervention: Usual care
The control group receive usual care

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 et al 2010). The effect of postpartum PFMT in prevention and treatment of urinary incontinence is 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). The results are conflicting. The matched controlled trial by Mørkved and Bø (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 & 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 (Järvinen et al 2007). Hence, there is a need to conduct a RCT with high methodological and interventional quality (Herbert and Bø 2005) to investigate the effect of postpartum PFMT.

  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
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:

Additional 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
Last Updated: October 30, 2013
Health Authority: Norway: Data Protection Authority

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
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014