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Postpartum Pelvic Floor Muscle Training in Women With and Without Injured Pelvic Floor Muscles

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 7, 2016
Last verified: October 2016
Results First Received: April 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Urinary Incontinence
Intervention: Other: Postpartum pelvic floor muscle training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participant were recruited from a cohort study at Akershus University Hospital (Hilde 2012), or from the hospital's maternity ward or from community health care clinics after giving birth (Hilde 2013).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Postpartum Pelvic Floor Muscle Training Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the pelvic floor muscle (PFM) correctly, the training participants attended a supervised exercise class once a week led by an experienced physiotherapist and were prescribed daily home training over a period of 4 months. The PFM exercise protocol followed general principles for strength training; 3 sets 8-12 contractions close to maximum (Bø et al 1990, Haskell 2007). The participants are provided with a DVD of the program (www.corewellness.co.uk). Training adherence at home was recorded in a training diary whereas the physical therapist recorded group session adherence. Training participants were continuously motivated by the physical therapist to keep up their adherence to training classes and home training, and high performance during training was strongly emphasised.
Control Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the PFM correctly, the control group participants received no further intervention. They were not discouraged from doing PFMT on their own.

Participant Flow:   Overall Study
    Postpartum Pelvic Floor Muscle Training   Control
STARTED   87 [1]   88 [2] 
COMPLETED   75 [3]   85 [4] 
NOT COMPLETED   12   3 
Death-in-near-family                1                0 
No specific reason                8                2 
Illness mother or child                3                1 
[1] 27 in the stratum with major levator ani muscle defects and 60 in the stratum without such defects.
[2] 28 in the stratum with major levator ani muscle defects and 60 in the stratum without such defects.
[3] 24 in the stratum with major levator ani muscle defects and 51 in the stratum without such defects.
[4] 27 in the stratum with major levator ani muscle defects and 58 in the stratum without such defects.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Assuming a similar difference among comparison groups as found by Mørkved and Bø (1997), a two-sided significance of < 0.05 and a power of 0.90 requiered a total of 62 women. For applying stratified analysis on major levator ani (LA) muscle defects, the statistical advice was to aim for 80 women with- and 80 women without major LA muscle defects.

Reporting Groups
  Description
Postpartum Pelvic Floor Muscle Training Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the training participants attended a supervised exercise class once a week led by an experienced physiotherapist and were prescribed daily home training over a period of 4 months.
Control Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention.
Total Total of all reporting groups

Baseline Measures
   Postpartum Pelvic Floor Muscle Training   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 87   88   175 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.5  (4.3)   30.1  (4.0)   29.8  (4.1) 
Gender [1] 
[Units: Participants]
     
Female   87   88   175 
Male   0   0   0 
[1] Only primiparous women who delivered a singleton baby vaginally were included. They were included 6 weeks after delivery (mean: 6.1 week, standard deviation: 0.9).
Body mass index (BMI) 
[Units: Kg/m2]
Mean (Standard Deviation)
 26.0  (4.1)   25.3  (3.9)   25.7  (4.0) 
Level of education 
[Units: Participants]
     
College or university   64   79   143 
Primary school, high school, other   23   9   32 
Civil status 
[Units: Participants]
     
Married or cohabitant   80   86   166 
Single   7   2   9 
Major defect of the levator ani muscle 
[Units: Participants]
     
Major defect   27   28   55 
No major defect   60   60   120 
Urinary Incontinence (Prevalence) 
[Units: Participants]
     
Urinary incontinent women   34   44   78 
Urinary continent women   53   44   97 
Urinary incontinence (positive pad test) 
[Units: Participants]
     
Positive pad test   27   34   61 
Negative pad test   60   54   114 


  Outcome Measures
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1.  Primary:   Urinary Incontinence (Prevalence)   [ Time Frame: 6 months postpartum (end of intervention) ]

2.  Secondary:   Urinary Incontinence (Positive Pad Test)   [ Time Frame: 6 months postpartum (end of intervention) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Gunvor Hilde
Organization: Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway
phone: +47 41366045
e-mail: gunvor.hilde@gmail.com


Publications:
Bø K, Hagen RH, Kvarstein B, Jørgensen J, Larsen S. Pelvic floor muscle exercise for the treatment of of female stress urinary incontinence. III. Effects of two different degrees of pelvic floor muscleexercises. Neurourol Urodyn 9:489-502,1990.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gunvor Hilde, Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier: NCT01069484     History of Changes
Other Study ID Numbers: 2799004
2191411 ( Other Grant/Funding Number: The Research Council of Norway )
Study First Received: February 16, 2010
Results First Received: April 27, 2015
Last Updated: October 7, 2016
Health Authority: Norway: Data Protection Authority