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

Urinary Incontinence Clinical Trial

— PP-PFMT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069484
• Other study ID #: 2799004
• Secondary ID: 2191411
• Status: Completed
• Phase: Phase 3
• First received: February 16, 2010
• Last updated: October 30, 2013
• Start date: February 2010
• Est. completion date: January 2013

Study information

• Verified date: October 2013
• Source: Norwegian School of Sport Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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 et al 2010). The effect of postpartum PFMT in prevention and treatment of urinary incontinence is investigated in only four RCTs (Sleep & Grant 1987, Meyer et al 2001, Chiarelli & Cockburn 2001, Ewings et al 2005) and one matched controlled trial (Mørkved & Bø 1997). The results are conflicting. The matched controlled trial by Mørkved and Bø (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 & Bø 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 et al 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 et al 2007). Hence, there is a need to conduct a RCT with high methodological and interventional quality (Herbert and Bø 2005) to investigate the effect of postpartum PFMT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

• Women who do not speak/ understand Scandinavian language

• Illnesses that may interfere with the ability to follow-up

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Other:
• Postpartum pelvic floor muscle training
The training participants attend a supervised exercise class once a week led by an experienced physiotherapist and are prescribed daily home training over a period of 4 months. The PFM exercise protocol follows general principles for strength training; 3 sets 8-12 contractions close to maximum (Bø et al 1990, Haskell 2007). The emphasis will be on progression in force development. At week 4 during the intervention, the PFM strength will be assessed for each participant. The participants are provided with a DVD of the program (www.corewellness.co.uk). Adherence is reported in a training diary. The PFMT protocol has shown to be successful in former studies evaluating the effect of PFMT on urinary incontinence (Mørkved & Bø 1997, Bø et al 1990, Bø et al 1999, Mørkved et al 2003).

Locations

Country	Name	City	State
Norway	Akershus University Hospital, Dept of Obstetrics and Gynecology	Lørenskog	Akershus

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian School of Sport Sciences	The Research Council of Norway, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

References & Publications (19)

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. Review. — View Citation

Ashton-Miller JA, DeLancey JO. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci. 2007 Apr;1101:266-96. Epub 2007 Apr 7. Review. — View Citation

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.

Bø K, Talseth T, Holme I. Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ. 1999 Feb 20;318(7182):487-93. — View Citation

Bump RC, Norton PA. Epidemiology and natural history of pelvic floor dysfunction. Obstet Gynecol Clin North Am. 1998 Dec;25(4):723-46. Review. — View Citation

Chiarelli P, Cockburn J. Promoting urinary continence in women after delivery: randomised controlled trial. BMJ. 2002 May 25;324(7348):1241. — View Citation

DeLancey JO. Stress urinary incontinence: where are we now, where should we go? Am J Obstet Gynecol. 1996 Aug;175(2):311-9. Review. — View Citation

Ewings P, Spencer S, Marsh H, O'Sullivan M. Obstetric risk factors for urinary incontinence and preventative pelvic floor exercises: cohort study and nested randomized controlled trial. J Obstet Gynaecol. 2005 Aug;25(6):558-64. Erratum in: J Obstet Gynaecol. 2005 Nov;25(8):834-5. — View Citation

Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. — View Citation

Hay-Smith J, Mørkved S, Fairbrother KA, Herbison GP. Pelvic floor muscle training for prevention and treatment of urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD007471. doi: 10.1002/14651858.CD007471. Review. Update in: Cochrane Database Syst Rev. 2012;10:CD007471. — View Citation

Herbert RD, Bø K. Analysis of quality of interventions in systematic reviews. BMJ. 2005 Sep 3;331(7515):507-9. Review. — View Citation

Järvinen TA, Järvinen TL, Kääriäinen M, Aärimaa V, Vaittinen S, Kalimo H, Järvinen M. Muscle injuries: optimising recovery. Best Pract Res Clin Rheumatol. 2007 Apr;21(2):317-31. Review. — View Citation

MacLennan AH, Taylor AW, Wilson DH, Wilson D. The prevalence of pelvic floor disorders and their relationship to gender, age, parity and mode of delivery. BJOG. 2000 Dec;107(12):1460-70. — View Citation

Meyer S, Hohlfeld P, Achtari C, De Grandi P. Pelvic floor education after vaginal delivery. Obstet Gynecol. 2001 May;97(5 Pt 1):673-7. — View Citation

Mørkved S, Bø K, Schei B, Salvesen KA. Pelvic floor muscle training during pregnancy to prevent urinary incontinence: a single-blind randomized controlled trial. Obstet Gynecol. 2003 Feb;101(2):313-9. — View Citation

Mørkved S, Bø K. Effect of postpartum pelvic floor muscle training in prevention and treatment of urinary incontinence: a one-year follow up. BJOG. 2000 Aug;107(8):1022-8. — View Citation

Mørkved S, Bø K. The effect of postpartum pelvic floor muscle exercise in the prevention and treatment of urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1997;8(4):217-22. — View Citation

Sleep J, Grant A. Pelvic floor exercises in postnatal care. Midwifery. 1987 Dec;3(4):158-64. — View Citation

Turner CE, Young JM, Solomon MJ, Ludlow J, Benness C. Incidence and etiology of pelvic floor dysfunction and mode of delivery: an overview. Dis Colon Rectum. 2009 Jun;52(6):1186-95. doi: 10.1007/DCR.0b013e31819f283f. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary incontinence (ICIQ-UI) Stress incontinence (Leakage index, PAD test)		6 weeks postpartum (baseline), 6 months postpartum (end of intervention), 12 mths postpartum (follow up)	No
Secondary	Anal incontinence(ICIQ-Bowel) Pelvic organ prolapse(ICIQ-VS, position of pelvic organs) PFM strength(vaginal squeeze pressure) Changes in PFM morphology(ultrasound) Resting position of the pelvic organs(ultrasound) Other health related complaints		6 weeks postpartum (baseline), 6 months postpartum (end of intervention), 12 mths post partum (follow up)	No