Postpartum Pelvic Floor Muscle Training in Women With and... | NCT01069484

ID	Type	Description	Link
2191411	Other Grant/Funding Number	The Research Council of Norway

Postpartum Pelvic Floor Muscle Training in Women With and... | NCT01069484 | Trialant

Sponsor/Collaborators Module

Name	Class
University Hospital, Akershus	OTHER
The Research Council of Norway	OTHER

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Postpartum pelvic floor muscle training	Experimental	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.	Other: Postpartum pelvic floor muscle training
Control	No Intervention	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Postpartum pelvic floor muscle training	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	6 months postpartum (end of intervention)

Secondary Outcomes

Measure	Description	Time Frame
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.

Contacts/Locations Module

Name	Affiliation	Role
Kari Bø, Prof,PhD,PT	Norwegian School of Sport Sciences, Dept of Sports Medicine/Akershus University Hospital, Dept of Obstetrics and Gynecology	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Akershus University Hospital, Dept of Obstetrics and Gynecology		Lørenskog	Akershus	1478	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20025020	Background	Abrams P, Andersson KE, Birder L, Brubaker L, Cardozo L, Chapple C, Cottenden A, Davila W, de Ridder D, Dmochowski R, Drake M, Dubeau C, Fry C, Hanno P, Smith JH, Herschorn S, Hosker G, Kelleher C, Koelbl H, Khoury S, Madoff R, Milsom I, Moore K, Newman D, Nitti V, Norton C, Nygaard I, Payne C, Smith A, Staskin D, Tekgul S, Thuroff J, Tubaro A, Vodusek D, Wein A, Wyndaele JJ; Members of Committees; Fourth International Consultation on Incontinence. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn. 2010;29(1):213-40. doi: 10.1002/nau.20870. No abstract available.
17416924

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00087 subjects27 in the stratum with major levator ani muscle defects and 60 in the stratum without such defects. FG00188 subjects28 in the stratum with major levator ani muscle defects and 60 in the stratum without such defects.
COMPLETED		FG00075 subjects24 in the stratum with major levator ani muscle defects and 51 in the stratum without such defects. FG00185 subjects27 in the stratum with major levator ani muscle defects and 58 in the stratum without such defects.
NOT COMPLETED		FG00012 subjects FG0013 subjects

Type	Comment	Reasons
Death-in-near-family		FG0001 subjects FG0010 subjects
No specific reason		FG0008 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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.

Posted

Number

participants

6 months postpartum (end of intervention)

ID	Title	Description
OG000	Postpartum Pelvic Floor Muscle Training	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Postpartum Pelvic Floor Muscle Training	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Any serious adverse effect from pelvic floor muscle training	General disorders		Non-systematic Assessment	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.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Gunvor Hilde	Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway	+47 41366045		gunvor.hilde@gmail.com

Condition Browse Module

ID	Term
D014549	Urinary Incontinence

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Sex: Female, Male

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).

Count of Participants

Participants

Title

Denominators