Centre: Western Australian Centre for Evidence Based Nursing and Midwifery
Urinary incontinence is defined as “any uncontrolled leakage of urine, regardless of amount or frequency” (Mason, Glenn, Walton, & Appleton, 1999: 120). The International Continence Society (ICS) (Abrams et al., 2001) definition requires this involuntary loss of urine to be objectively demonstrable with such a degree of severity that it is a social or hygienic problem. Using either the more general or the medical definition, urinary incontinence can and does pose significant problems for a woman, impacting on the quality of her physical, social, emotional and sexual life.
Childbirth is one of the major causes of incontinence in women (Chaliha, Bland, Monga, Stanton, & Sultan, 2000; Groutz et al., 2001; Peyrat et al., 2002; Sampselle, 2000). Studies of incontinence in the post partum period report prevalence between six and 43% (see for example Dimpfl, Hesse, & Schusser, 1992; MacArthur, Lewis, & Bick, 1993; Mason et al., 1999; Morkved & Bo, 1999; Viktrup, Lose, & Rolff, 1992; Wilson, Herbison, & Herbison, 1996).
Pelvic floor muscle exercises (PFME) are aimed at teaching the woman to regain control over the peri-vaginal musculature. These exercises were first described by Kegel in 1948 who found that most women with stress urinary incontinence had pelvic floor muscle insufficiency. Kegel argued that restoring the function of the pelvic floor would in turn increase the urethral closure pressure, thus preventing involuntary loss of urine (de Kruif & van Wegen, 1996).
A number of studies in recent years have sought to measure the effectiveness of PFME. A systematic review by Berghmans et al (Berghmans et al., 1998) of 11 RCT's assessed physical therapies in the treatment and prevention of stress urinary incontinence (SUI) in women and found that there was strong evidence to suggest PFME were effective in reducing the symptoms of SUI. There was limited evidence for the efficacy of high-intensity vs a low intensity regimen of exercising. (Bo, Hagen, Kvarstein, Jorgensen, & Larsen, 1990) The low intensity regimen involved performing a specified number of PFME every day at home. For the high intensity regimen participants performed the same home exercises as well as attending weekly exercise training with an instructor. The systematic review also concluded there was evidence that PFME with biofeedback, for example perineometer measures, were more effective than PFME alone. In prevention of SUI, the efficacy of PFME with or without other adjuncts is uncertain.
A systematic review of 43 studies by the Cochrane Collaboration (Hay-Smith, Berghmans, Hendriks, de Bie, & van Waalwijk van Doorn, 2001) of pelvic floor muscle training for urinary incontinence in women found that this training appeared to be an effective treatment of adult women with stress or mixed incontinence and was better than no treatment or placebo treatments. However, methodological problems limited the confidence that could be placed in the results of the review.
In the reviews discussed above the participants in the studies included adult women of all ages. No existing or ‘in progress’ systematic reviews were identified that focus on pregnant and post natal women.
The methods for conducting the systematic review and for assessing the quality of the evidence are based on the work of the Cochrane Collaboration (Oxman, 1994) and the Centre for Reviews and Dissemination at the University of York (NHS Centre for Reviews and Dissemination, 2001).
The objective of this review is to determine from the available evidence the effectiveness of pelvic floor muscle exercises (PFME) in treating urinary incontinence following childbirth. The specific questions being asked are:
Do antenatal PFME prevent or reduce urinary incontinence following childbirth?
Do PFME following childbirth resolve or reduce subsequent urinary incontinence?
What is the most effective type of instruction of PFME in treating urinary incontinence?
Criteria for considering studies for this review
Types of participants
Women who have delivered at more than 20 weeks gestation and who have experienced a spontaneous onset of labour. The labour may proceed to a caesarean section.
Women who have had an elective caesarean section. Studies have demonstrated that there is a lower prevalence of incontinence in women who have undergone an elective caesarean section as no stress has been placed on the pelvic floor muscles (Dimpfl et al., 1992).
Types of interventions
a) Pelvic floor exercises
b) Type of instruction of PFME e.g. timing, method, content.
Electrical stimulation of pelvic floor muscles or other adjunct therapies. These have been excluded as they are not normally performed by midwives, but rather are part of the physiotherapist's role.
Types of outcome measures
Outcomes that are of interest include but are not confined to:
Resolution or reduction in (as appropriate) amount, length, or severity of urinary incontinence up to twelve months following childbirth.
In relation to types of instruction:
effectiveness of pelvic floor contraction period of time PFME continued after initial instruction frequency of PFME undertaken woman's awareness of importance of PFME satisfaction with instruction
Types of studies
The factors identified by research studies that contribute to urinary incontinence have not changed significantly during the last two decades. In addition, pelvic floor muscle exercises have been considered a potentially useful therapy since 1948. The search therefore will seek both published and unpublished studies undertaken between 1981 and 2001. No unpublished studies prior to 1991 will be sought, and only studies published in English and Spanish will be included due to a lack of resources to translate studies published in other languages.
In respect to the intervention of pelvic floor exercises, the review will focus initially on randomised controlled trials. If insufficient RCTs are identified then studies using other methods will be reviewed for possible inclusion in a narrative summary. In relation to types of instruction, all categories of studies will be considered for inclusion, including descriptive studies.
A number of electronic databases will be searched to locate relevant studies in this subject area. Databases to be searched will include:
NHS Centre for Reviews and
Dissemination databases (DARE etc.)
Australian Medical Index
Health and Medical Complete (Proquest 5000)
Expanded Academic Index
The search terms used to locate studies for the review will be drawn from the natural language terms of the topic and the controlled language indexing terms used by different databases, as applicable. Individual search strategies will be developed for each index, adopting the different terminology of index thesauri. In addition, since it has been established that difficulties can arise when using the MeSH terms from MEDLINE to locate clinical trials (Dickersin, Scherer, & Lefebvre, 1994), all databases will also be searched using the keywords of the topic.
Efforts will be made to locate any relevant unpublished materials, such as conference papers, research reports, and dissertations. The sources searched to locate unpublished studies will include:
research and clinical trials registers
WWW sites of relevant associations
direct communication with midwifery organisations, and midwife or physiotherapist researchers
Journals relevant to the topic and accessible in Western Australian libraries or online will be hand-searched to ensure useful studies that have not been listed in the major indexing services are located. For highly relevant journals hand-searches will be conducted for all available issues in the twenty-year period. For journals of lesser relevance to the topic at least the issues for 2001 will be hand-searched. Reference lists of all studies and review papers will be examined to identify additional research studies.
Abstracts (or if not available, titles) of the studies located will be used for the initial assessment against the inclusion and exclusion criteria. Two reviewers will conduct this assessment independently. Where doubt exists, the full article will be retrieved. Full text versions of the studies that meet the inclusion criteria for the review will be located. Bibliographic details of the studies located will be organised using the Endnote software program.
Assessment of methodological quality
Methodological quality of randomised controlled trials (RCT) will be assessed using a checklist (see attached) based on the work of the Cochrane Collaboration (Oxman, 1994) and the Centre for Reviews and Dissemination at the University of York (NHS Centre for Reviews and Dissemination, 2001). A draft of this checklist has been piloted with the reviewers and some wording modifications made to ensure clarity. The discussion arising from the piloting of the checklist contributed to the reviewers’ training. If required, a quality assessment tool will be developed for non-RCT studies.
Two reviewers will independently assess all studies included in the review and disagreements between reviewers will be resolved by discussion with a third reviewer. Assessment of quality will commence with experimental studies (randomised and quasi-randomised controlled trials) and will be extended to include research using other methodologies in the absence of sufficient experimental studies.
Data will be extracted independently by two reviewers using a data extraction tool. A third reviewer will be asked to adjudicate when the initial reviewers disagree. The data extraction tool will be developed and pilot tested before use. This tool will include information such as type of design; details of randomisation (if used), study population, intervention; outcomes as listed above, and quality of study assessment. When necessary, the principal primary researcher of a study will be contacted to obtain missing information.
Heterogeneity between comparable studies will be tested using the standard chi-square test. Where possible, odds ratios and 95% confidence limits will be calculated for each included study. If a sufficient number of studies are identified with appropriate data, results from comparable studies will be pooled in a meta-analysis. Based on this analysis, the effectiveness and relative value of interventions will be estimated. In studies where statistical pooling of results is inappropriate, the findings will be considered for inclusion in the narrative summary.
Based on the findings of this systematic review a ‘Best Practice Guideline’, in the format designed by the Joanna Briggs Institute for Evidence Based Nursing and Midwifery, will be developed.
Abrams, P., Cardozo, L., Fall, M., Griffiths, D., Rosier, P., Ulmsten, U., van Kerrebroeck, P., Victor, A., & Wein, A. (2001). The Standardisation of Terminology in Lower Urinary Tract Function
: Report from the Standardisation Sub-committee of the International Continence Society.
Berghmans, L. C., Hendriks, H. J., Bo, K., Hay-Smith, E. J., de Bie, R. A., & van Waalwijk van Doorn, E. S. (1998). Conservative treatment of stress urinary incontinence in women: a systematic review of randomized clinical trials. Br J Urol, 82
Bo, K., Hagen, R. H., Kvarstein, B., Jorgensen, J., & Larsen, S. (1990). Pelvic floor muscle exercise for the treatment of female stress urinary incontinence: III. Effects of two different degrees of pelvic floor muscle exercises. Neurourology and Urodynamics, 9
Chaliha, C., Bland, J. M., Monga, A., Stanton, S. L., & Sultan, A. H. (2000). Pregnancy and delivery: a urodynamic viewpoint. British Journal of Obstetrics & Gynaecology, 107
de Kruif, Y., & van Wegen, P. (1996). Pelvic Floor Muscle Exercise Therapy with Myofeedback for Women with Stress Urinary Incontinence: A Meta-analysis
(122687): NHS Centre for Reviews and Dissemination.
Dickersin, K., Scherer, R., & Lefebvre, C. (1994). Identifying relevant studies for systematic reviews. BMJ, 309
Dimpfl, T. H., Hesse, U., & Schusser, B. (1992). Incidence and cause of postpartum urinary stress incontinence. European Journal of Obstetrics and Gynaecology, 43
Groutz, A., Gordon, D., Wolman, I., Jaffa, A., Kupferminc, M. J., & Lessing, J. B. (2001). Persistent postpartum urinary retention in contemporary obstetric practice: definition, prevalence and clinical implications. Journal of Reproductive Medicine, 46
Hay-Smith, E., Berghmans, L., Hendriks, H., de Bie, R., & van Waalwijk van Doorn, E. (2001). Pelvic Floor Muscle Training for Urinary Incontinence in Women
(142392): NHS Centre for Reviews and Dissemination.
MacArthur, C., Lewis, M., & Bick, D. (1993). Stress incontinence after childbirth. British Journal of Midwifery, 1
Mason, L., Glenn, S., Walton, I., & Appleton, C. (1999). The prevalence of stress incontinence during pregnancy and following delivery. Midwifery, 15
Morkved, S., & Bo, K. (1999). Prevalence of urinary incontinence during pregnancy and postpartum. International Urogynecology Journal and Pelvic Floor Dysfunction, 10
NHS Centre for Reviews and Dissemination. (2001). Undertaking Systematic Reviews of Research on Effectiveness
(CRD Report Number 4 (2nd Edition)). York: NHS Centre for Reviews and Dissemination, University of York.
Oxman, A. (1994). The Cochrane Collaboration Handbook
. Oxford: The Cochrane Collaboration.
Peyrat, L., Haillot, O., Bruyere, F., Boutin, J. M., Bertrand, P., & Lanson, Y. (2002). Prevalence and risk factors of urinary incontinence in young and middle-aged women. BJU International, 89
Sampselle, C. M. (2000). Behavioral intervention for urinary incontinence in women: evidence for practice. Journal of Midwifery and Women's Health, 45
Viktrup, L., Lose, M. D., & Rolff, M. (1992). The symptoms of stress incontinence caused by pregnancy or delivery in primiparas. Obstetrics and Gynecology, 79
Wilson, P. D., Herbison, R. M., & Herbison, G. P. (1996). Obstetric practice and the prevalence of urinary incontinence three months after delivery. British Journal of Obstetrics & Gynaecology, 103