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

The Effect of Postpartum Pelvic Floor Muscle Training in Women With Injured and Non-injured Pelvic Floor Muscles. A Single Blind Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01069484
Enrollment
175
Registered
2010-02-17
Start date
2010-02-28
Completion date
2013-01-31
Last updated
2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERPostpartum pelvic floor muscle training

Beyond a customary leaflet and thorough initial instruction on how to contract the PFM correctly, the training participants will attend one weekly supervised exercise class led by an experienced physiotherapist, and perform daily training at home. The intervention starts 6-8 weeks postpartum and last for 4 months. General principles for strength training are followed: 3 sets of 8-12 contractions close to maximum (Bø 1990, Haskell 2007). Emphasis will be on progression in force development. The participants are provided with a DVD of the program (www.corewellness.co.uk). At week 4 during the intervention, the PFM strength will be assessed for each participant. Training adherence at home will be recorded in a training diary, whereas the physical therapist will record group session adherence.

Sponsors

University Hospital, Akershus
CollaboratorOTHER
The Research Council of Norway
CollaboratorOTHER
Norwegian School of Sport Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Urinary Incontinence (Prevalence)6 months postpartum (end of intervention)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.

Secondary

MeasureTime frameDescription
Urinary Incontinence (Positive Pad Test)6 months postpartum (end of intervention)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.

Countries

Norway

Participant flow

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).

Participants by arm

ArmCount
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.
87
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.
88
Total175

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath-in-near-family10
Overall StudyIllness mother or child31
Overall StudyNo specific reason82

Baseline characteristics

CharacteristicPostpartum Pelvic Floor Muscle TrainingControlTotal
Age, Continuous29.5 years
STANDARD_DEVIATION 4.3
30.1 years
STANDARD_DEVIATION 4
29.8 years
STANDARD_DEVIATION 4.1
Body mass index (BMI)26.0 kg/m2
STANDARD_DEVIATION 4.1
25.3 kg/m2
STANDARD_DEVIATION 3.9
25.7 kg/m2
STANDARD_DEVIATION 4
Civil status
Married or cohabitant
80 participants86 participants166 participants
Civil status
Single
7 participants2 participants9 participants
Level of education
College or university
64 participants79 participants143 participants
Level of education
Primary school, high school, other
23 participants9 participants32 participants
Major defect of the levator ani muscle
Major defect
27 participants28 participants55 participants
Major defect of the levator ani muscle
No major defect
60 participants60 participants120 participants
Sex: Female, Male
Female
87 Participants88 Participants175 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Urinary incontinence (positive pad test)
Negative pad test
60 participants54 participants114 participants
Urinary incontinence (positive pad test)
Positive pad test
27 participants34 participants61 participants
Urinary Incontinence (Prevalence)
Urinary continent women
53 participants44 participants97 participants
Urinary Incontinence (Prevalence)
Urinary incontinent women
34 participants44 participants78 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 870 / 88
serious
Total, serious adverse events
0 / 870 / 88

Outcome results

Primary

Urinary Incontinence (Prevalence)

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)

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.

ArmMeasureGroupValue (NUMBER)
Postpartum Pelvic Floor Muscle TrainingUrinary Incontinence (Prevalence)Urinary incontinent women30 participants
Postpartum Pelvic Floor Muscle TrainingUrinary Incontinence (Prevalence)Urinary continent women57 participants
ControlUrinary Incontinence (Prevalence)Urinary incontinent women34 participants
ControlUrinary Incontinence (Prevalence)Urinary continent women54 participants
Comparison: Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of last observation carried forward was used.p-value: 0.5795% CI: [0.6, 1.32]Mantel Haenszel
Secondary

Urinary Incontinence (Positive Pad Test)

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)

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.

ArmMeasureGroupValue (NUMBER)
Postpartum Pelvic Floor Muscle TrainingUrinary Incontinence (Positive Pad Test)Positive pad test19 participants
Postpartum Pelvic Floor Muscle TrainingUrinary Incontinence (Positive Pad Test)Negative pad test68 participants
ControlUrinary Incontinence (Positive Pad Test)Positive pad test23 participants
ControlUrinary Incontinence (Positive Pad Test)Negative pad test65 participants
Comparison: Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of last observation carried forward was used.p-value: 0.5195% CI: [0.49, 1.42]Mantel Haenszel

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026