Clinical trial NCT01069484: Postpartum Pelvic Floor Muscle Training in Women With and Without Injured Pelvic Floor Muscles
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: 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
Lead sponsor: Norwegian School of Sport Sciences
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
name: The Research Council of Norway
First posted: 2010-02-17
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Urinary Incontinence (Prevalence)
timeFrame: 6 months postpartum (end of intervention)
Secondary outcomes:
measure: Urinary Incontinence (Positive Pad Test)
timeFrame: 6 months postpartum (end of intervention)
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital, Dept of Obstetrics and Gynecology
state: Akershus
Study officials:
affiliation: Norwegian School of Sport Sciences, Dept of Sports Medicine/Akershus University Hospital, Dept of Obstetrics and Gynecology
name: Kari Bø, Prof,PhD,PT
role: STUDY_DIRECTOR
References:
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