Postpartum Pelvic Floor Muscle Training in Women With and Without Injured Pelvic Floor Muscles (PP-PFMT)
| Tracking Information | |||||
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| First Received Date ICMJE | February 16, 2010 | ||||
| Last Updated Date | September 1, 2011 | ||||
| Start Date ICMJE | February 2010 | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01069484 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Postpartum Pelvic Floor Muscle Training in Women With and Without Injured Pelvic Floor Muscles | ||||
| Official Title ICMJE | The Effect of Postpartum Pelvic Floor Muscle Training in Women With Injured and Non-injured Pelvic Floor Muscles. A Single Blind Randomized Controlled Trial | ||||
| 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 (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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
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| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01069484 | ||||
| Other Study ID Numbers ICMJE | 2799004, 2191411 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Gunvor Hilde, Norwegian School of Sport Sciences | ||||
| Study Sponsor ICMJE | Norwegian School of Sport Sciences | ||||
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| Information Provided By | Norwegian School of Sport Sciences | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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