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Pelvic Floor Muscle Training to Manage Overactive Bladder and Urinary Incontinence
A Second Look
Title BYLINE
Pelvic Floor Muscle Training to Manage Overactive Bladder and Urinary Incontinence
U Photo © Mikolette / iStockphoto.com
Urinary incontinence (UI) is defined by the International Continence Society as any involuntary leakage of urine (Haylen et al., 2010). UI is a chronic debilitating condition for both men and women, but it is more common in women, with more than half of American women reporting UI (Markland, Richter, Fwu, Eggers, & Kusek, 2011). UI is characterized as stress, urge, or mixed incontinence. Stress incontinence occurs
KIMBERLY ANGELINI
when the muscles that control the urethra, mainly the detrusor muscle, are not able to hold urine in times of increased stress on the bladder (e.g., coughing, sneezing, laughing, jumping; Rogers, 2008). Urge UI, also known as overactive bladder, is a sudden need to urinate in which leakage occurs before making it to the bathroom (Abrams, Artibani, Cardozo, Dmochowshi, &
Abstract Overactive bladder (OAB) and urinary incontinence (UI) are common chronic conditions that can negatively affect women’s quality of life. Pelvic floor muscle training is the first-line treatment. Two recent Cochrane Reviews examining pelvic floor muscle training for the treatment of UI and OAB are summarized here to provide women’s health nurses with current recommendations for UI and OAB management. This column also identifies practice improvement education in the area of pelvic floor muscle training and treatment for OAB and UI. http://dx.doi.org/10.1016/j.nwh.2016.12.004 Keywords Kegel | overactive bladder | pelvic floor muscle training | urinary incontinence
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van Kerrebroeck, 2009). Mixed incontinence is a combination of stress and urge UI. Overactive bladder (OAB) is currently defined as urinary urgency, frequency, and nocturia, with or without UI (Abrams et al., 2009, 2003; Haylen et al., 2010). OAB is characterized by urgency and frequency of urination with
The muscles of the pelvic floor support the urethra, vagina, and rectum and play a role in sexual function
nocturia and can be with incontinence episodes (wet OAB) or without incontinence (dry OAB). Wet OAB, or urge UI, is particularly problematic to treat because not only is the detrusor muscle involved, as in stress UI, but there is also an altered state of neural regulation of the bladder (Banakhar, Al-Shaiji, & Hassouna, 2012). The National Association for Continence (2015) reports that more than 17% of women over the age of 18 years report signs of OAB, making the prevalence of both UI and OAB higher than other chronic conditions, including diabetes at 9.3% (Centers
for Disease Control and Prevention, 2014b) and asthma at 7.7% (Centers for Disease Control and Prevention, 2014a). Prevalence of OAB and UI is thought to be dramatically underreported because of embarrassment and the false belief that symptoms are a normal part of aging (Irwin et al., 2006; Milsom et al., 2001; Wallner et al., 2009). The first-line treatment recommended by the American Urological Association and the International Continence Society is behavior modification, which includes a toileting schedule, avoiding bladder irritants, and pelvic floor muscle training (PFMT; Duomulin & HaySmith, 2010; Gormley et al., 2014). Arnold Kegel made PFMT a popular treatment for stress UI in 1948 (Kegel, 1948). The muscles of the pelvic floor support the urethra, vagina, and rectum and play a role in sexual function. This column takes a second look at two recent Cochrane Reviews that examine PFMT in the treatment of UI. Both reviews summarized here are classified as Level I evidence (see Box 1).
The First Review The purpose of the systematic review by Dumoulin et al. (2014) was to assess the use of
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Photo © Visual Art by GAJIC / iStockphoto.com
Kimberly Angelini, WHNP, is a women’s health nurse practitioner at Dowd Medical Gynecology in Reading, MA, and a doctoral student at Boston College in Chestnut Hill, MA. The author reports no conflicts of interest or relevant financial relationships. Address correspondence to: pomerlek@ bc.edu.
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PFMT for women with UI versus no treatment, placebo, or inactive controls.
Design, Sample, and Data Analysis The authors conducted a systematic review of the Cochrane Central Register of Control Trials, MEDLINE, and hand-searched journals from reference lists and conference proceedings. Only randomized or quasi-experimental trials were included. The inclusion criteria for the trials were that they (a) were a randomized or quasi-randomized control trial; (b) studied women with stress, urge, or mixed UI; and (c) compared outcomes of receiving PFMT versus no treatment control, placebo, or inactive controls. Two reviewers assessed the identified articles for eligibility and cross-checked data. Articles were divided and subgrouped by type of UI being assessed (Dumoulin et al., 2014).
Findings After inclusion criteria were met, 21 trials remained for review, of which four were considered to be at high risk for biased results because of lack of true randomization, lack of baseline comparability, lack of blinding, and high rates of unaccounted attrition. Trials had small to medium sample sizes and were predominantly moderate in quality, except for one trial, which was rated as high quality (Dumoulin et al., 2014). The type of PFMT intervention and study populations varied considerably across the trials. The specific exercise program in the clinic-based and home-based PFMT programs was incompletely reported, making comparison across studies difficult (Dumoulin et al., 2014). Most studies were on the effect of PFMT on women with stress UI or UI in general. Other categories of mixed UI and urge UI were not investigated alone. Many secondary outcomes were missing or rarely reported across studies, including longterm effects and treatment adherence
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Box 1.
Levels of Evidence The quality of evidence for a study is based on a grading system that evaluates the scientific rigor of a design, as developed by the U.S. Preventive Services Task Force. The levels are as follows:
I: Evidence obtained from at least one properly randomized controlled trial.
II-1: Evidence obtained from well-designed controlled trials without randomization. II-2: Evidence obtained from well-designed cohort or case–control analytic studies, preferably from more than one center or research group.
II-3: Evidence obtained from multiple time series with or without intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.
III: Opinions of respected authorities, based on clinical experience: descriptive studies and case reports or reports of expert committees. Source: U.S. Preventive Services Task Force (1996).
(Dumoulin et al., 2014). Across the studies, there was a lack of reporting on inclusion criteria and participant selection as well as a lack of clear PFMT program description (Dumoulin et al., 2014). Pelvic muscle function was evaluated based on reported measures in 11 studies, ultrasonography in one study, vaginal squeeze pressure in five studies, digital assessment in eight studies, and electromyography in three studies (Dumoulin et al., 2014). There was no consistent measurement of function across studies. The primary outcome measure was symptom cure or improvement. All trials reported that women who received PFMT were statistically significantly more likely to report symptom improvement or cure. Women who received PFMT reported symptom cure (56.1%) and improvement (55%) significantly more than control subjects (6% and 3.2%, respectively; Dumoulin et al., 2014). Similar results were found in women with urge and mixed incontinence. Women receiving PFMT
reported greater satisfaction with the treatment plan than women in the control groups. Secondary outcome measures included long-term cure/improvement after stopping treatment. There were limited data from two small/moderate studies that suggested that the benefits of PFMT persist for up to a year after PFMT; however, the confidence intervals were wide, and more data are needed to further support long-term effects (Dumoulin et al., 2014). Another secondary measure looked at satisfaction with treatment. Only three trials measured satisfaction and found that women who received PFMT were five times more likely to report satisfaction with treatment than the control subjects. Numbers of leakage episodes within a 24-hour period were compared across studies. Women with PFMT were found to report one fewer episode of incontinence in a 24-hour period compared with control subjects (Dumoulin et al., 2014). In two trials that reported
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data on urinary frequency, women in the PFMT group reported 2.5 fewer voids per day than control subjects (Dumoulin et al., 2014). Women in the PFMT group lost significantly less urine on a 1-hour pad test than women in the control group; however, these findings were not significant in studies using a 24-hour pad test (Dumoulin et al., 2014).
Conclusion Results of this review support use of PFMT compared with no treatment, placebo, or inactive control treatments for women with stress UI and unspecified UI. No specific information was provided on the effect of PFMT on UI episodes in women with urge and mixed UI.
All trials reported that women who received PFMT were statistically significantly more likely to report symptom improvement or cure Women in the PFMT group were more likely to report improvement or cure and increased quality of life and to have fewer leakage episodes per day. Findings support recommendations of national organizations that PFMT be included in first-line treatment for UI. Long-term effects of treatment and cost efficacy remain uncertain. Most of the data in this review came from small- to moderate-sized trials with moderate quality of evidence. Future research should include larger sample size, specific primary urinary symptom and quality of life outcomes, reporting of PFMT program, reporting of adherence, reporting on secondary outcomes including sexual function, and longterm follow-up.
The Second Review The purpose of the systematic review by Ayeleke et al. (2015) was to compare the effect of PFMT in combination with another active treatment for UI versus the active treatment alone. Other active treatments included physical therapies for muscle contraction (vaginal cones and balls), behavioral therapy (diet modification and bladder training), electrical stimulation, mechanical devices (pessaries), pharmacologic management (anticholinergics and duloxetine), and surgical
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treatments (sling procedures and colposuspension; Ayeleke et al., 2015).
Design, Sample, and Data Analysis The authors conducted a systematic review of CENTRAL, MEDLINE, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform, and hand-searched journals from reference lists and conference proceedings (Ayeleke et al., 2015). Only randomized or quasi-experimental trials were included of women with stress, urge, or mixed UI. One arm of the study received PFMT in addition to another active treatment, and one arm received the active treatment alone. Two reviewers assessed the identified articles for eligibility and cross-checked data. Any disagreements or questions in grading were resolved in consultation with a third party. Articles were divided and subgrouped by type of active treatment (Ayeleke et al., 2015).
Findings The review contained 13 randomized controlled trials targeting women with stress, urge, and mixed incontinence comparing the addition of PFMT to an active treatment versus the active treatment alone on urinary symptoms (Ayeleke et al., 2015). Primary outcome measures included symptom improvement/cure and quality of life. Most studies reviewed did not report on any of the primary outcomes, and when they did, measurements of outcomes varied across studies, making comparison difficult. The effect sizes were indeterminate for the primary outcomes, and the authors rated the studies as predominantly having low or very low quality (Ayeleke et al., 2015), with the exception of one study that found a significant improvement of symptom cure when adding PFMT to a heat and steam sheet therapy (51%) compared with the therapy alone (22%) in women with stress, urge, and mixed UI (Ayeleke et al., 2015). In two trials on electrical stimulation, more women in the PFMT plus active treatment group reported improvement/cure of symptoms (35%) than the electrical stimulation alone group (17%); however, these results were not statistically significant (Ayeleke et al., 2015). Similarly, more women reported symptom improvement/cure with PFMT in addition to vaginal cone use (97%) than with vaginal cone use alone (75%), but this was also not statistically
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significant. All of the evidence quality for outcome measures was low to very low. There was moderate quality of evidence reported for one study, which reported an improved cure of symptoms with PFMT added to heat and steam therapy (51%) than with heat and steam therapy alone (22%; Ayeleke et al., 2015). There was no statistically significant benefit on quality of life in women with PFMT added to bladder training, pessary, or duloxetine than women receiving bladder training, pessary, or duloxetine alone (Ayeleke et al., 2015). Across all of these studies, quality of evidence was moderate to very low, and effect sizes were small.
Conclusion The authors found insufficient evidence to support any additional benefit of adding PFMT to other active therapies for women with stress, urge, or mixed UI (Ayeleke et al., 2015). None of the trials in this study were large enough to provide reliable quality evidence (Ayeleke et al., 2015). Results of the review should be interpreted with caution regarding the safety and efficacy of adding PFMT to another active treatment.
evidence to support the addition of PFMT to other active treatments for UI. The limitations of their study included small, single-arm studies, low quality of evidence, different outcome measures, and inconsistent forms of evaluating outcome measures across the studies (Ayeleke et al., 2015). There were also insufficient data to evaluate any adverse effects of adding PFMT to active therapy (Ayeleke et al., 2015). It is clear that additional research is needed to fully explore the use of PFMT in management of UI in women. Because PFMT is recommended as a first-line treatment by many national organizations (Duomulin & Hay-Smith, 2010; Gormley et al., 2014), future research is needed to determine additional benefits of adding PFMT to another treatment method and any potential adverse effects of using PFMT.
Implications for Nursing Practice UI is a common issue for women and includes a wide range of urinary symptoms, which often worsen with age and can significantly affect women’s quality of life. Many of the pharmacologic, surgical, and device treatments carry a high financial burden (Hu et al., 2004). Using PFMT as a first-line treatment for UI either alone (Dumoulin et al., 2014) or in conjunction with another active therapy (Ayeleke et al., 2015) can decrease cost of treatment and increase symptom relief. Nurses play a key role in helping women manage UI symptoms and in promoting first-line treatment therapies. The results of these two reviews support the national recommendations to use PFMT in first-line therapy for women with stress, urge, and mixed
When recommending PFMT to women, it is essential for nurses and other clinicians to ensure that women understand the proper method of performing and conducting the exercise regimen
Photo © People Images / iStockphoto.com
Discussion of These Two Reviews These two systematic reviews provide critical insight into the state of the science on PFMT for UI and supply recommendations for practice. Both studies efficiently extracted and graded trials using the Cochrane Handbook for Systematic Reviews of Interventions (Higgins & Green, 2008). Dumoulin et al. (2014) were able to find evidence to support the recommendation for PFMT in the treatment of UI. Although the trials reviewed by Dumoulin et al. (2014) were single studies and ranged from low to moderate evidence, the existing evidence supports a benefit in symptom improvement and cure. The following year, Ayeleke et al. (2015) were not able to find substantial
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UI (Abrams et al., 2010; Gormley et al., 2014). PFMT is an excellent recommendation for women with poor pelvic floor muscle tone. In some cases, UI is caused by a hypertonic pelvic floor, and PFMT causes only further contraction of the muscles and inability to respond dynamically to increases in intra-abdominal pressure. In these cases, women should be referred to physical therapy for appropriate therapy and muscle relaxation techniques. As highlighted in these reviews, the research and evidence on PFMT use in UI therapy and in addition to other active treatments are limited and of low quality (Ayeleke et al., 2015; Dumoulin et al., 2014). Future research is needed to have a more robust understanding of this treatment modality. Although Dumoulin et al. (2014) were able to find conclusive evidence to support the use of PFMT for women with stress, urge, and mixed incontinence, there is also evidence that many women are not efficiently performing PFMT. One study reported that of the 15.1% of women who reported receiving training about Kegel exercises during pregnancy and postpartum, 59.4% of them were performing the exercises incorrectly (Riyazi, Bashirian, & Ghelich, 2007). When recommending PFMT to women, it is essential for nurses and other clinicians to ensure that women understand the proper method of performing and conducting the exercise regimen. Nurses working with women across the life span, and particularly with childbearing women, for whom increased intra-abdominal pressure and vaginal birth can cause weakening of pelvic floor muscles, need to be aware of and educate women on the appropriate way to isolate the pelvic floor and perform PFMT (sources of additional information on PFMT are listed in Box 2). Women’s health physical therapists are experts in this field, and if women are reporting symptoms and are not noticing relief with basic education, referral for individualized care is important. For nurses caring for women prenatally and postpartum, educating them on pelvic floor health and appropriate PFMT is important as first-line prevention. Discussing urinary symptoms and when to report symptoms to a provider is also important during this period. For example, a woman in the postpartum
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Box 2.
Selected Sources of Information on Pelvic Floor Muscle Training http://www.pelvicfloorfirst.org.au/pages/ working-your-pelvic-floor.html https://medlineplus.gov/ency/article/003975.htm http://www.continence.org.au/pages/ pelvic-floor-muscle-exercises.html http://www.mayoclinic.org/healthylifestyle/womens-health/in-depth/ kegel-exercises/art-20045283
period can be educated to isolate and contract her pelvic floor muscles before picking up her 2-year-old son, known as the “Knack technique,” to decrease urinary leakage. Despite the lack of evidence to support the addition of PFMT to other active treatment therapies (Ayeleke et al., 2015), findings from Dumoulin et al. (2014) should be taken into consideration when prescribing therapy. In cases in which other therapies are not managing symptoms, adding PFMT might be considered. Future research is needed to determine the adverse effects and potential benefit of PFMT addition in other therapy. Further, assessing how a woman is actually performing PFMT is important in managing her care.
Conclusion This column described the results of the two recent Cochrane Reviews on PFMT in the treatment of women with stress, urge, and mixed incontinence. It is evident that there is limited research in this area. Future research is needed to continue to explore outcome measures of PFMT alone and in addition to other active treatments for women with UI. Nurses are positioned to be front-line leaders in screening and educating women on UI as well as reviewing therapies, including PFMT, to reduce or prevent symptoms of UI. NWH
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Abrams, P., Andersson, K. E., Birder, L., Brubaker, L., Cardozo, L., Chapple, C., . . . Drake, M. (2010). Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourology and Urodynamics, 29(1), 213–240. doi:10.1002/ nau.20870 Abrams, P., Artibani, W., Cardozo, L., Dmochowshi, R., & van Kerrebroeck, P. (2009). Reviewing the ICS 2002 terminology report: The ongoing debate. Neurological Urology, 28(4), 287. doi:10.1002/nau.20737 Abrams, P., Cardozo, L., Fall, M., Griffiths, D., Rosier, P., Ulmsten, U., . . . Wein, A. (2003). The standardization of terminology in lower urinary tract function: Report from the standardization sub-committee of the International Continence Society. Urology 61(1), 37–49. Ayeleke, R. O., Hay-Smith, E. J. C., & Omar, M. I. (2015). Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women. Cochrane Database of Systematic Reviews, 2015(11), CD010551. doi:10.1002/14651858.CD010551.pub3 Banakhar, M. A., Al-Shaiji, T. F., & Hassouna, M. M. (2012). Pathophysiology of overactive bladder. International Urogynecology Journal, 23(8), 975–982. doi:10.1007/s00192-012-1682-6 Centers for Disease Control and Prevention. (2014a). National current asthma prevalence (2014). Retrieved from http://www.cdc.gov/ asthma/most_recent_data.htm Centers for Disease Control and Prevention. (2014b). National diabetes statistics report: Estimates of diabetes and its burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services. Dumoulin, C., Hay-Smith, E. J. C., & Mac Habée-Séguin, G. (2014). Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database of Systematic Reviews, 2014(5), CD005654. doi:10.1002/14651858. CD005654.pub3 Gormley, E. A., Lightner, J., Burgio, K. L., Chai, T. C., Clemens, J. Q., Culkin, D. J., . . . Vasavada, S. P. (2014). Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. Linthicum, MD: American Urological Association Education and Research, Inc. Haylen, B. T., de Ridder, D., Freeman, R. M., Swift, S. E., Berghmans, B., Lee, J., . . . Schaer, G.N. (2010). An International Urogynecological Association (IUGA)/International Continence
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Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourology and Urodynamics, 29(1), 4–20. doi:10.1007/ s00192-009-0976-9 Higgins, J. P., & Green, S. (Eds.). (2008). Cochrane handbook for systematic reviews of interventions (Vol. 5). Chichester, UK: Wiley-Blackwell. Hu, T. W., Wagner, T. H., Bentkover, J. D., Leblanc, K., Zhou, S. Z., & Hunt, T. (2004). Costs of urinary incontinence and overactive bladder in the U.S.: A comparative study. Urology, 63(3), 461–465. doi:10.1016/j.urology.2003.10.037 Irwin, D. E., Milsom, I., Hunskaar, S., Reilly, K., Kopp, Z., Herschorn, S., . . . Abrams, P. (2006). Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: Results of the EPIC study. European Urology, 50(6), 1306–1314. doi:10.1016/j.eururo.2006.09.019
A Second Look
References
Kegel, A. H. (1948). Progressive resistance exercise in the functional restoration of the perineal muscles. American Journal of Obstetrics and Gynecology, 56(2), 238–248. doi:10.1016/0002-9378(48)90266-X Markland, A. D., Richter H. E., Fwu, C. W., Eggers, P., & Kusek, J. W. (2011). Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. Journal of Urology, 186, 589–593. doi:10.1016/j.juro.2011.03.114 Milsom, I., Abrams, P., Cardazo, L., Roberts, R. G., Thuroff, J., & Wein, A. J. (2001). How widespread are symptoms of overactive bladder and how are they managed? British Journal of Urology, 88(7), 760–766. doi:10.1046/j.1464-410x.2001.02228.x National Association for Continence. (2015). Overactive bladder. Retrieved from http://www .nafc.org/overactive-bladder Riyazi, H., Bashirian, S., Ghelich, K. S. (2007). Kegel exercise application during pregnancy and postpartum in women visited at Hamadan health care centers. Iranian Journal of Obstetrics, Gynecology and Infertility, 10(1), 47–54. Rogers, R. G. (2008). Urinary stress incontinence in women. New England Journal of Medicine, 358(10), 1029–1036. doi:10.1056/ NEJMcp0707023 U.S. Preventive Services Task Force. (1996). Guide to clinical preventive services: Report of the US Preventive Services Task Force. Washington, DC: Office of Disease Prevention and Health Promotion, U.S. Government Printing Office. Wallner, L. P., Porten, S., Meenan, R. T., Rosetti, M. C. K., Calhoun, E. A., Sarma, A. V., & Clemens, J. Q. (2009). Prevalence and severity of undiagnosed urinary incontinence in women. The American Journal of Medicine, 122(11), 1037–1042. doi:10.1016/j.amjmed.2009.05.016
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Title BYLINE
Pelvic Floor Muscle Training to Manage Overactive Bladder and Urinary Incontinence
U Photo © Mikolette / iStockphoto.com
Urinary incontinence (UI) is defined by the International Continence Society as any involuntary leakage of urine (Haylen et al., 2010). UI is a chronic debilitating condition for both men and women, but it is more common in women, with more than half of American women reporting UI (Markland, Richter, Fwu, Eggers, & Kusek, 2011). UI is characterized as stress, urge, or mixed incontinence. Stress incontinence occurs
KIMBERLY ANGELINI
when the muscles that control the urethra, mainly the detrusor muscle, are not able to hold urine in times of increased stress on the bladder (e.g., coughing, sneezing, laughing, jumping; Rogers, 2008). Urge UI, also known as overactive bladder, is a sudden need to urinate in which leakage occurs before making it to the bathroom (Abrams, Artibani, Cardozo, Dmochowshi, &
Abstract Overactive bladder (OAB) and urinary incontinence (UI) are common chronic conditions that can negatively affect women’s quality of life. Pelvic floor muscle training is the first-line treatment. Two recent Cochrane Reviews examining pelvic floor muscle training for the treatment of UI and OAB are summarized here to provide women’s health nurses with current recommendations for UI and OAB management. This column also identifies practice improvement education in the area of pelvic floor muscle training and treatment for OAB and UI. http://dx.doi.org/10.1016/j.nwh.2016.12.004 Keywords Kegel | overactive bladder | pelvic floor muscle training | urinary incontinence
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van Kerrebroeck, 2009). Mixed incontinence is a combination of stress and urge UI. Overactive bladder (OAB) is currently defined as urinary urgency, frequency, and nocturia, with or without UI (Abrams et al., 2009, 2003; Haylen et al., 2010). OAB is characterized by urgency and frequency of urination with
The muscles of the pelvic floor support the urethra, vagina, and rectum and play a role in sexual function
nocturia and can be with incontinence episodes (wet OAB) or without incontinence (dry OAB). Wet OAB, or urge UI, is particularly problematic to treat because not only is the detrusor muscle involved, as in stress UI, but there is also an altered state of neural regulation of the bladder (Banakhar, Al-Shaiji, & Hassouna, 2012). The National Association for Continence (2015) reports that more than 17% of women over the age of 18 years report signs of OAB, making the prevalence of both UI and OAB higher than other chronic conditions, including diabetes at 9.3% (Centers
for Disease Control and Prevention, 2014b) and asthma at 7.7% (Centers for Disease Control and Prevention, 2014a). Prevalence of OAB and UI is thought to be dramatically underreported because of embarrassment and the false belief that symptoms are a normal part of aging (Irwin et al., 2006; Milsom et al., 2001; Wallner et al., 2009). The first-line treatment recommended by the American Urological Association and the International Continence Society is behavior modification, which includes a toileting schedule, avoiding bladder irritants, and pelvic floor muscle training (PFMT; Duomulin & HaySmith, 2010; Gormley et al., 2014). Arnold Kegel made PFMT a popular treatment for stress UI in 1948 (Kegel, 1948). The muscles of the pelvic floor support the urethra, vagina, and rectum and play a role in sexual function. This column takes a second look at two recent Cochrane Reviews that examine PFMT in the treatment of UI. Both reviews summarized here are classified as Level I evidence (see Box 1).
The First Review The purpose of the systematic review by Dumoulin et al. (2014) was to assess the use of
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Photo © Visual Art by GAJIC / iStockphoto.com
Kimberly Angelini, WHNP, is a women’s health nurse practitioner at Dowd Medical Gynecology in Reading, MA, and a doctoral student at Boston College in Chestnut Hill, MA. The author reports no conflicts of interest or relevant financial relationships. Address correspondence to: pomerlek@ bc.edu.
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PFMT for women with UI versus no treatment, placebo, or inactive controls.
Design, Sample, and Data Analysis The authors conducted a systematic review of the Cochrane Central Register of Control Trials, MEDLINE, and hand-searched journals from reference lists and conference proceedings. Only randomized or quasi-experimental trials were included. The inclusion criteria for the trials were that they (a) were a randomized or quasi-randomized control trial; (b) studied women with stress, urge, or mixed UI; and (c) compared outcomes of receiving PFMT versus no treatment control, placebo, or inactive controls. Two reviewers assessed the identified articles for eligibility and cross-checked data. Articles were divided and subgrouped by type of UI being assessed (Dumoulin et al., 2014).
Findings After inclusion criteria were met, 21 trials remained for review, of which four were considered to be at high risk for biased results because of lack of true randomization, lack of baseline comparability, lack of blinding, and high rates of unaccounted attrition. Trials had small to medium sample sizes and were predominantly moderate in quality, except for one trial, which was rated as high quality (Dumoulin et al., 2014). The type of PFMT intervention and study populations varied considerably across the trials. The specific exercise program in the clinic-based and home-based PFMT programs was incompletely reported, making comparison across studies difficult (Dumoulin et al., 2014). Most studies were on the effect of PFMT on women with stress UI or UI in general. Other categories of mixed UI and urge UI were not investigated alone. Many secondary outcomes were missing or rarely reported across studies, including longterm effects and treatment adherence
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Box 1.
Levels of Evidence The quality of evidence for a study is based on a grading system that evaluates the scientific rigor of a design, as developed by the U.S. Preventive Services Task Force. The levels are as follows:
I: Evidence obtained from at least one properly randomized controlled trial.
II-1: Evidence obtained from well-designed controlled trials without randomization. II-2: Evidence obtained from well-designed cohort or case–control analytic studies, preferably from more than one center or research group.
II-3: Evidence obtained from multiple time series with or without intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.
III: Opinions of respected authorities, based on clinical experience: descriptive studies and case reports or reports of expert committees. Source: U.S. Preventive Services Task Force (1996).
(Dumoulin et al., 2014). Across the studies, there was a lack of reporting on inclusion criteria and participant selection as well as a lack of clear PFMT program description (Dumoulin et al., 2014). Pelvic muscle function was evaluated based on reported measures in 11 studies, ultrasonography in one study, vaginal squeeze pressure in five studies, digital assessment in eight studies, and electromyography in three studies (Dumoulin et al., 2014). There was no consistent measurement of function across studies. The primary outcome measure was symptom cure or improvement. All trials reported that women who received PFMT were statistically significantly more likely to report symptom improvement or cure. Women who received PFMT reported symptom cure (56.1%) and improvement (55%) significantly more than control subjects (6% and 3.2%, respectively; Dumoulin et al., 2014). Similar results were found in women with urge and mixed incontinence. Women receiving PFMT
reported greater satisfaction with the treatment plan than women in the control groups. Secondary outcome measures included long-term cure/improvement after stopping treatment. There were limited data from two small/moderate studies that suggested that the benefits of PFMT persist for up to a year after PFMT; however, the confidence intervals were wide, and more data are needed to further support long-term effects (Dumoulin et al., 2014). Another secondary measure looked at satisfaction with treatment. Only three trials measured satisfaction and found that women who received PFMT were five times more likely to report satisfaction with treatment than the control subjects. Numbers of leakage episodes within a 24-hour period were compared across studies. Women with PFMT were found to report one fewer episode of incontinence in a 24-hour period compared with control subjects (Dumoulin et al., 2014). In two trials that reported
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data on urinary frequency, women in the PFMT group reported 2.5 fewer voids per day than control subjects (Dumoulin et al., 2014). Women in the PFMT group lost significantly less urine on a 1-hour pad test than women in the control group; however, these findings were not significant in studies using a 24-hour pad test (Dumoulin et al., 2014).
Conclusion Results of this review support use of PFMT compared with no treatment, placebo, or inactive control treatments for women with stress UI and unspecified UI. No specific information was provided on the effect of PFMT on UI episodes in women with urge and mixed UI.
All trials reported that women who received PFMT were statistically significantly more likely to report symptom improvement or cure Women in the PFMT group were more likely to report improvement or cure and increased quality of life and to have fewer leakage episodes per day. Findings support recommendations of national organizations that PFMT be included in first-line treatment for UI. Long-term effects of treatment and cost efficacy remain uncertain. Most of the data in this review came from small- to moderate-sized trials with moderate quality of evidence. Future research should include larger sample size, specific primary urinary symptom and quality of life outcomes, reporting of PFMT program, reporting of adherence, reporting on secondary outcomes including sexual function, and longterm follow-up.
The Second Review The purpose of the systematic review by Ayeleke et al. (2015) was to compare the effect of PFMT in combination with another active treatment for UI versus the active treatment alone. Other active treatments included physical therapies for muscle contraction (vaginal cones and balls), behavioral therapy (diet modification and bladder training), electrical stimulation, mechanical devices (pessaries), pharmacologic management (anticholinergics and duloxetine), and surgical
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treatments (sling procedures and colposuspension; Ayeleke et al., 2015).
Design, Sample, and Data Analysis The authors conducted a systematic review of CENTRAL, MEDLINE, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform, and hand-searched journals from reference lists and conference proceedings (Ayeleke et al., 2015). Only randomized or quasi-experimental trials were included of women with stress, urge, or mixed UI. One arm of the study received PFMT in addition to another active treatment, and one arm received the active treatment alone. Two reviewers assessed the identified articles for eligibility and cross-checked data. Any disagreements or questions in grading were resolved in consultation with a third party. Articles were divided and subgrouped by type of active treatment (Ayeleke et al., 2015).
Findings The review contained 13 randomized controlled trials targeting women with stress, urge, and mixed incontinence comparing the addition of PFMT to an active treatment versus the active treatment alone on urinary symptoms (Ayeleke et al., 2015). Primary outcome measures included symptom improvement/cure and quality of life. Most studies reviewed did not report on any of the primary outcomes, and when they did, measurements of outcomes varied across studies, making comparison difficult. The effect sizes were indeterminate for the primary outcomes, and the authors rated the studies as predominantly having low or very low quality (Ayeleke et al., 2015), with the exception of one study that found a significant improvement of symptom cure when adding PFMT to a heat and steam sheet therapy (51%) compared with the therapy alone (22%) in women with stress, urge, and mixed UI (Ayeleke et al., 2015). In two trials on electrical stimulation, more women in the PFMT plus active treatment group reported improvement/cure of symptoms (35%) than the electrical stimulation alone group (17%); however, these results were not statistically significant (Ayeleke et al., 2015). Similarly, more women reported symptom improvement/cure with PFMT in addition to vaginal cone use (97%) than with vaginal cone use alone (75%), but this was also not statistically
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significant. All of the evidence quality for outcome measures was low to very low. There was moderate quality of evidence reported for one study, which reported an improved cure of symptoms with PFMT added to heat and steam therapy (51%) than with heat and steam therapy alone (22%; Ayeleke et al., 2015). There was no statistically significant benefit on quality of life in women with PFMT added to bladder training, pessary, or duloxetine than women receiving bladder training, pessary, or duloxetine alone (Ayeleke et al., 2015). Across all of these studies, quality of evidence was moderate to very low, and effect sizes were small.
Conclusion The authors found insufficient evidence to support any additional benefit of adding PFMT to other active therapies for women with stress, urge, or mixed UI (Ayeleke et al., 2015). None of the trials in this study were large enough to provide reliable quality evidence (Ayeleke et al., 2015). Results of the review should be interpreted with caution regarding the safety and efficacy of adding PFMT to another active treatment.
evidence to support the addition of PFMT to other active treatments for UI. The limitations of their study included small, single-arm studies, low quality of evidence, different outcome measures, and inconsistent forms of evaluating outcome measures across the studies (Ayeleke et al., 2015). There were also insufficient data to evaluate any adverse effects of adding PFMT to active therapy (Ayeleke et al., 2015). It is clear that additional research is needed to fully explore the use of PFMT in management of UI in women. Because PFMT is recommended as a first-line treatment by many national organizations (Duomulin & Hay-Smith, 2010; Gormley et al., 2014), future research is needed to determine additional benefits of adding PFMT to another treatment method and any potential adverse effects of using PFMT.
Implications for Nursing Practice UI is a common issue for women and includes a wide range of urinary symptoms, which often worsen with age and can significantly affect women’s quality of life. Many of the pharmacologic, surgical, and device treatments carry a high financial burden (Hu et al., 2004). Using PFMT as a first-line treatment for UI either alone (Dumoulin et al., 2014) or in conjunction with another active therapy (Ayeleke et al., 2015) can decrease cost of treatment and increase symptom relief. Nurses play a key role in helping women manage UI symptoms and in promoting first-line treatment therapies. The results of these two reviews support the national recommendations to use PFMT in first-line therapy for women with stress, urge, and mixed
When recommending PFMT to women, it is essential for nurses and other clinicians to ensure that women understand the proper method of performing and conducting the exercise regimen
Photo © People Images / iStockphoto.com
Discussion of These Two Reviews These two systematic reviews provide critical insight into the state of the science on PFMT for UI and supply recommendations for practice. Both studies efficiently extracted and graded trials using the Cochrane Handbook for Systematic Reviews of Interventions (Higgins & Green, 2008). Dumoulin et al. (2014) were able to find evidence to support the recommendation for PFMT in the treatment of UI. Although the trials reviewed by Dumoulin et al. (2014) were single studies and ranged from low to moderate evidence, the existing evidence supports a benefit in symptom improvement and cure. The following year, Ayeleke et al. (2015) were not able to find substantial
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UI (Abrams et al., 2010; Gormley et al., 2014). PFMT is an excellent recommendation for women with poor pelvic floor muscle tone. In some cases, UI is caused by a hypertonic pelvic floor, and PFMT causes only further contraction of the muscles and inability to respond dynamically to increases in intra-abdominal pressure. In these cases, women should be referred to physical therapy for appropriate therapy and muscle relaxation techniques. As highlighted in these reviews, the research and evidence on PFMT use in UI therapy and in addition to other active treatments are limited and of low quality (Ayeleke et al., 2015; Dumoulin et al., 2014). Future research is needed to have a more robust understanding of this treatment modality. Although Dumoulin et al. (2014) were able to find conclusive evidence to support the use of PFMT for women with stress, urge, and mixed incontinence, there is also evidence that many women are not efficiently performing PFMT. One study reported that of the 15.1% of women who reported receiving training about Kegel exercises during pregnancy and postpartum, 59.4% of them were performing the exercises incorrectly (Riyazi, Bashirian, & Ghelich, 2007). When recommending PFMT to women, it is essential for nurses and other clinicians to ensure that women understand the proper method of performing and conducting the exercise regimen. Nurses working with women across the life span, and particularly with childbearing women, for whom increased intra-abdominal pressure and vaginal birth can cause weakening of pelvic floor muscles, need to be aware of and educate women on the appropriate way to isolate the pelvic floor and perform PFMT (sources of additional information on PFMT are listed in Box 2). Women’s health physical therapists are experts in this field, and if women are reporting symptoms and are not noticing relief with basic education, referral for individualized care is important. For nurses caring for women prenatally and postpartum, educating them on pelvic floor health and appropriate PFMT is important as first-line prevention. Discussing urinary symptoms and when to report symptoms to a provider is also important during this period. For example, a woman in the postpartum
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Box 2.
Selected Sources of Information on Pelvic Floor Muscle Training http://www.pelvicfloorfirst.org.au/pages/ working-your-pelvic-floor.html https://medlineplus.gov/ency/article/003975.htm http://www.continence.org.au/pages/ pelvic-floor-muscle-exercises.html http://www.mayoclinic.org/healthylifestyle/womens-health/in-depth/ kegel-exercises/art-20045283
period can be educated to isolate and contract her pelvic floor muscles before picking up her 2-year-old son, known as the “Knack technique,” to decrease urinary leakage. Despite the lack of evidence to support the addition of PFMT to other active treatment therapies (Ayeleke et al., 2015), findings from Dumoulin et al. (2014) should be taken into consideration when prescribing therapy. In cases in which other therapies are not managing symptoms, adding PFMT might be considered. Future research is needed to determine the adverse effects and potential benefit of PFMT addition in other therapy. Further, assessing how a woman is actually performing PFMT is important in managing her care.
Conclusion This column described the results of the two recent Cochrane Reviews on PFMT in the treatment of women with stress, urge, and mixed incontinence. It is evident that there is limited research in this area. Future research is needed to continue to explore outcome measures of PFMT alone and in addition to other active treatments for women with UI. Nurses are positioned to be front-line leaders in screening and educating women on UI as well as reviewing therapies, including PFMT, to reduce or prevent symptoms of UI. NWH
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Abrams, P., Andersson, K. E., Birder, L., Brubaker, L., Cardozo, L., Chapple, C., . . . Drake, M. (2010). Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourology and Urodynamics, 29(1), 213–240. doi:10.1002/ nau.20870 Abrams, P., Artibani, W., Cardozo, L., Dmochowshi, R., & van Kerrebroeck, P. (2009). Reviewing the ICS 2002 terminology report: The ongoing debate. Neurological Urology, 28(4), 287. doi:10.1002/nau.20737 Abrams, P., Cardozo, L., Fall, M., Griffiths, D., Rosier, P., Ulmsten, U., . . . Wein, A. (2003). The standardization of terminology in lower urinary tract function: Report from the standardization sub-committee of the International Continence Society. Urology 61(1), 37–49. Ayeleke, R. O., Hay-Smith, E. J. C., & Omar, M. I. (2015). Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women. Cochrane Database of Systematic Reviews, 2015(11), CD010551. doi:10.1002/14651858.CD010551.pub3 Banakhar, M. A., Al-Shaiji, T. F., & Hassouna, M. M. (2012). Pathophysiology of overactive bladder. International Urogynecology Journal, 23(8), 975–982. doi:10.1007/s00192-012-1682-6 Centers for Disease Control and Prevention. (2014a). National current asthma prevalence (2014). Retrieved from http://www.cdc.gov/ asthma/most_recent_data.htm Centers for Disease Control and Prevention. (2014b). National diabetes statistics report: Estimates of diabetes and its burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services. Dumoulin, C., Hay-Smith, E. J. C., & Mac Habée-Séguin, G. (2014). Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database of Systematic Reviews, 2014(5), CD005654. doi:10.1002/14651858. CD005654.pub3 Gormley, E. A., Lightner, J., Burgio, K. L., Chai, T. C., Clemens, J. Q., Culkin, D. J., . . . Vasavada, S. P. (2014). Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. Linthicum, MD: American Urological Association Education and Research, Inc. Haylen, B. T., de Ridder, D., Freeman, R. M., Swift, S. E., Berghmans, B., Lee, J., . . . Schaer, G.N. (2010). An International Urogynecological Association (IUGA)/International Continence
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Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourology and Urodynamics, 29(1), 4–20. doi:10.1007/ s00192-009-0976-9 Higgins, J. P., & Green, S. (Eds.). (2008). Cochrane handbook for systematic reviews of interventions (Vol. 5). Chichester, UK: Wiley-Blackwell. Hu, T. W., Wagner, T. H., Bentkover, J. D., Leblanc, K., Zhou, S. Z., & Hunt, T. (2004). Costs of urinary incontinence and overactive bladder in the U.S.: A comparative study. Urology, 63(3), 461–465. doi:10.1016/j.urology.2003.10.037 Irwin, D. E., Milsom, I., Hunskaar, S., Reilly, K., Kopp, Z., Herschorn, S., . . . Abrams, P. (2006). Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: Results of the EPIC study. European Urology, 50(6), 1306–1314. doi:10.1016/j.eururo.2006.09.019
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References
Kegel, A. H. (1948). Progressive resistance exercise in the functional restoration of the perineal muscles. American Journal of Obstetrics and Gynecology, 56(2), 238–248. doi:10.1016/0002-9378(48)90266-X Markland, A. D., Richter H. E., Fwu, C. W., Eggers, P., & Kusek, J. W. (2011). Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. Journal of Urology, 186, 589–593. doi:10.1016/j.juro.2011.03.114 Milsom, I., Abrams, P., Cardazo, L., Roberts, R. G., Thuroff, J., & Wein, A. J. (2001). How widespread are symptoms of overactive bladder and how are they managed? British Journal of Urology, 88(7), 760–766. doi:10.1046/j.1464-410x.2001.02228.x National Association for Continence. (2015). Overactive bladder. Retrieved from http://www .nafc.org/overactive-bladder Riyazi, H., Bashirian, S., Ghelich, K. S. (2007). Kegel exercise application during pregnancy and postpartum in women visited at Hamadan health care centers. Iranian Journal of Obstetrics, Gynecology and Infertility, 10(1), 47–54. Rogers, R. G. (2008). Urinary stress incontinence in women. New England Journal of Medicine, 358(10), 1029–1036. doi:10.1056/ NEJMcp0707023 U.S. Preventive Services Task Force. (1996). Guide to clinical preventive services: Report of the US Preventive Services Task Force. Washington, DC: Office of Disease Prevention and Health Promotion, U.S. Government Printing Office. Wallner, L. P., Porten, S., Meenan, R. T., Rosetti, M. C. K., Calhoun, E. A., Sarma, A. V., & Clemens, J. Q. (2009). Prevalence and severity of undiagnosed urinary incontinence in women. The American Journal of Medicine, 122(11), 1037–1042. doi:10.1016/j.amjmed.2009.05.016
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