Trial Outcomes & Findings for Postpartum Pelvic Floor Muscle Training in Women With and Without Injured Pelvic Floor Muscles (NCT NCT01069484)
NCT ID: NCT01069484
Last Updated: 2016-12-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
6 months postpartum (end of intervention)
Results posted on
2016-12-01
Participant Flow
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).
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
88
|
|
Overall Study
COMPLETED
|
75
|
85
|
|
Overall Study
NOT COMPLETED
|
12
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death-in-near-family
|
1
|
0
|
|
Overall Study
No specific reason
|
8
|
2
|
|
Overall Study
Illness mother or child
|
3
|
1
|
Baseline Characteristics
Postpartum Pelvic Floor Muscle Training in Women With and Without Injured Pelvic Floor Muscles
Baseline characteristics by cohort
| Measure |
Postpartum Pelvic Floor Muscle Training
n=87 Participants
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
n=88 Participants
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
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
30.1 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
29.8 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body mass index (BMI)
|
26.0 kg/m2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
25.3 kg/m2
STANDARD_DEVIATION 3.9 • n=7 Participants
|
25.7 kg/m2
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Level of education
College or university
|
64 participants
n=5 Participants
|
79 participants
n=7 Participants
|
143 participants
n=5 Participants
|
|
Level of education
Primary school, high school, other
|
23 participants
n=5 Participants
|
9 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Civil status
Married or cohabitant
|
80 participants
n=5 Participants
|
86 participants
n=7 Participants
|
166 participants
n=5 Participants
|
|
Civil status
Single
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Major defect of the levator ani muscle
Major defect
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Major defect of the levator ani muscle
No major defect
|
60 participants
n=5 Participants
|
60 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Urinary Incontinence (Prevalence)
Urinary incontinent women
|
34 participants
n=5 Participants
|
44 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Urinary Incontinence (Prevalence)
Urinary continent women
|
53 participants
n=5 Participants
|
44 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Urinary incontinence (positive pad test)
Positive pad test
|
27 participants
n=5 Participants
|
34 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Urinary incontinence (positive pad test)
Negative pad test
|
60 participants
n=5 Participants
|
54 participants
n=7 Participants
|
114 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months postpartum (end of intervention)Population: 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.
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.
Outcome measures
| Measure |
Postpartum Pelvic Floor Muscle Training
n=87 Participants
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.
|
Control
n=88 Participants
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
|
|---|---|---|
|
Urinary Incontinence (Prevalence)
Urinary incontinent women
|
30 participants
|
34 participants
|
|
Urinary Incontinence (Prevalence)
Urinary continent women
|
57 participants
|
54 participants
|
SECONDARY outcome
Timeframe: 6 months postpartum (end of intervention)Population: 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.
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.
Outcome measures
| Measure |
Postpartum Pelvic Floor Muscle Training
n=87 Participants
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.
|
Control
n=88 Participants
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
|
|---|---|---|
|
Urinary Incontinence (Positive Pad Test)
Negative pad test
|
68 participants
|
65 participants
|
|
Urinary Incontinence (Positive Pad Test)
Positive pad test
|
19 participants
|
23 participants
|
Adverse Events
Postpartum Pelvic Floor Muscle Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Postpartum Pelvic Floor Muscle Training
n=87 participants at risk
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.
|
Control
n=88 participants at risk
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
|
|---|---|---|
|
General disorders
Any serious adverse effect from pelvic floor muscle training
|
0.00%
0/87
|
0.00%
0/88
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gunvor Hilde
Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway
Phone: +47 41366045
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place