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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Postpartum pelvic floor muscle training
Sponsored by
Norwegian School of Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Incontinence focused on measuring 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

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Akershus University Hospital, Dept of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Postpartum pelvic floor muscle training

Control

Arm Description

Beyond a customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the PFM correctly, the participants are given supervised pelvic floor muscle group training led by physiotherapists once a week. In addition, the participants train every day at home, with at least 3 sets of 8-12 contractions. Training period is 4 months.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 16, 2010
Last Updated
October 7, 2016
Sponsor
Norwegian School of Sport Sciences
Collaborators
University Hospital, Akershus, The Research Council of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT01069484
Brief Title
Postpartum Pelvic Floor Muscle Training in Women With and Without Injured Pelvic Floor Muscles
Official Title
The Effect of Postpartum Pelvic Floor Muscle Training in Women With Injured and Non-injured Pelvic Floor Muscles. A Single Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian School of Sport Sciences
Collaborators
University Hospital, Akershus, The Research Council of Norway

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postpartum pelvic floor muscle training
Arm Type
Experimental
Arm Description
Beyond a customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the PFM correctly, the participants are given supervised pelvic floor muscle group training led by physiotherapists once a week. In addition, the participants train every day at home, with at least 3 sets of 8-12 contractions. Training period is 4 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Postpartum pelvic floor muscle training
Other Intervention Name(s)
Postpartum PFMT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urinary Incontinence (Prevalence)
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)
Secondary Outcome Measure Information:
Title
Urinary Incontinence (Positive Pad Test)
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kari Bø, Prof,PhD,PT
Organizational Affiliation
Norwegian School of Sport Sciences, Dept of Sports Medicine/Akershus University Hospital, Dept of Obstetrics and Gynecology
Official's Role
Study Director
Facility Information:
Facility Name
Akershus University Hospital, Dept of Obstetrics and Gynecology
City
Lørenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Postpartum Pelvic Floor Muscle Training in Women With and Without Injured Pelvic Floor Muscles

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