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

February 16, 2010
October 30, 2013
February 2010
December 2012   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01069484 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Postpartum Pelvic Floor Muscle Training in Women With and Without Injured Pelvic Floor Muscles
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Urinary Incontinence
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
  • 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.
    Intervention: Other: Postpartum pelvic floor muscle training
  • No Intervention: Usual care
    The control group receive usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
175
January 2013
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01069484
2799004, 2191411
Yes
Gunvor Hilde, Norwegian School of Sport Sciences
Norwegian School of Sport Sciences
  • University Hospital, Akershus
  • The Research Council of Norway
Study Director: Kari Bø, Prof,PhD,PT Norwegian School of Sport Sciences, Dept of Sports Medicine/Akershus University Hospital, Dept of Obstetrics and Gynecology
Norwegian School of Sport Sciences
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP