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

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ClinicalTrials.gov Identifier: NCT01069484
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : December 1, 2016
Last Update Posted : December 1, 2016
Sponsor:
Collaborators:
University Hospital, Akershus
The Research Council of Norway
Information provided by (Responsible Party):
Gunvor Hilde, Norwegian School of Sport Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Urinary Incontinence
Intervention Other: Postpartum pelvic floor muscle training
Enrollment 175
Recruitment Details 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  
Arm/Group Title Postpartum Pelvic Floor Muscle Training Control
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 87 [1] 88 [2]
Completed 75 [3] 85 [4]
Not Completed 12 3
Reason Not Completed
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.
Arm/Group Title Postpartum Pelvic Floor Muscle Training Control Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 87 88 175
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 88 participants 175 participants
29.5  (4.3) 30.1  (4.0) 29.8  (4.1)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
Female
87
 100.0%
88
 100.0%
175
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: 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)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 87 participants 88 participants 175 participants
26.0  (4.1) 25.3  (3.9) 25.7  (4.0)
Level of education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
College or university 64 79 143
Primary school, high school, other 23 9 32
Civil status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
Married or cohabitant 80 86 166
Single 7 2 9
Major defect of the levator ani muscle  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
Major defect 27 28 55
No major defect 60 60 120
Urinary Incontinence (Prevalence)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
Urinary incontinent women 34 44 78
Urinary continent women 53 44 97
Urinary incontinence (positive pad test)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
Positive pad test 27 34 61
Negative pad test 60 54 114
1.Primary Outcome
Title Urinary Incontinence (Prevalence)
Hide Description Urinary incontinence was assessed by The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI Short Form questionnaire, www.iciq.net). Women were considered as incontinent if they reported to leak urine (yes/no) at any frequency.
Time Frame 6 months postpartum (end of intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
Primiparous women who delivered a singleton baby vaginally after more than 32 weeks of gestation. They had to have Scandinavian language skills, no severe perineal tearing, no prior abortion or stillbirth after 16 weeks of gestation, and no illnesses interfering with the ability to follow-up.
Arm/Group Title Postpartum Pelvic Floor Muscle Training Control
Hide Arm/Group Description:

Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).

Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence.

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
Overall Number of Participants Analyzed 87 88
Measure Type: Number
Unit of Measure: participants
Urinary incontinent women 30 34
Urinary continent women 57 54
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postpartum Pelvic Floor Muscle Training, Control
Comments Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of “last observation carried forward” was used.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power calculation was based on the study by Mørkved and Bø (1997), showing 67% prevalence reduction of UI in the PFMT group and 34% reduction in the control group. Assuming a similar effect, two-sided significance of <0.05, and a power of 0.90, required a total of 62 women. Stratified analysis on major levator ani (LA) muscle defects was planned, but the effect of PFMT in women with such defects was unknown. The statistical advice was to aim for 80 women with- and 80 women without such defects.
Statistical Test of Hypothesis P-Value 0.57
Comments P-values < 0.05 were considered significant.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.60 to 1.32
Estimation Comments "Pelvic floor muscle training arm" represents the numerator for relative risk and "usual care arm" represents the denominator for relative risk
2.Secondary Outcome
Title Urinary Incontinence (Positive Pad Test)
Hide Description

Urinary incontinence assessed by pad test, as described by Mørkved and Bø (1997). The cutoff value for a positive test was 2 gram.

After voiding, the women drank one litre of water. Thirty minutes later they wore a pre-weighted pad and performed a stress test as follows:

  • Jumping up and down with maximal intensity for 30 seconds.
  • Jumping with the legs in alternate abduction and adduction (Jumping Jacks) with maximal intensity for another 30 seconds.
  • Coughing as hard as possible three times. As in the study by Mørkved and Bø (1997), a positive pad-test was set to a cut-off of 2 gram of leakage.
Time Frame 6 months postpartum (end of intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
Primiparous women who delivered a singleton baby vaginally after more than 32 weeks of gestation. They had to have Scandinavian language skills, no severe perineal tearing, no prior abortion or stillbirth after 16 weeks of gestation, and no illnesses interfering with the ability to follow-up.
Arm/Group Title Postpartum Pelvic Floor Muscle Training Control
Hide Arm/Group Description:

Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).

Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence.

Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the control group received no further intervention..
Overall Number of Participants Analyzed 87 88
Measure Type: Number
Unit of Measure: participants
Positive pad test 19 23
Negative pad test 68 65
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postpartum Pelvic Floor Muscle Training, Control
Comments Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of “last observation carried forward” was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments P-values < 0.05 were considered significant.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.49 to 1.42
Estimation Comments "Pelvic floor muscle training arm" represents the numerator for relative risk and "usual care arm" represents the denominator for relative risk
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Postpartum Pelvic Floor Muscle Training Control
Hide Arm/Group Description

Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).

Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence.

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
All-Cause Mortality
Postpartum Pelvic Floor Muscle Training Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Postpartum Pelvic Floor Muscle Training Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)   0/88 (0.00%) 
General disorders     
Any serious adverse effect from pelvic floor muscle training * [1]  0/87 (0.00%)  0/88 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
The participants were asked to inform the physiotherapist delivering the intervention if they experienced any serious adverse effect from pelvic floor muscle training. Muscle soreness was not considered as a side effect.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Postpartum Pelvic Floor Muscle Training Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)   0/88 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Gunvor Hilde
Organization: Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway
Phone: +47 41366045
EMail: 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.
Layout table for additonal information
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 )
First Submitted: February 16, 2010
First Posted: February 17, 2010
Results First Submitted: April 27, 2015
Results First Posted: December 1, 2016
Last Update Posted: December 1, 2016