Running head: MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN

In women, is there a difference in the use of weighted vaginal cones and pelvic floor muscle training in improving symptoms of stress incontinence? Christian Yoder, Hannah Krzeminski, Caroline Adams, Kelsey Rape Auburn University April 1, 2013

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN PICO Question and Significance Approximately 29.5 million Americans are affected by urinary incontinence every day, and an estimated 26.4 billion dollars are spent each year in attempts to control symptoms (Castro, Arruda,. Zanetti, Santos, Sartori, Giro , 2008). Stress urinary incontinence is the most common type, mainly affecting women in everyday social, domestic, physical, occupational and leisure activities (Herbison GP, Dean N, 2009). When progressing throughout the day, women struggling with stress incontinence experience an involuntary loss of urine during physical

activities such as coughing, laughing, or exercising. Stress incontinence is caused by a change in position of the bladder and urethra, reducing the function of the pelvic floor muscles (Herbison GP, Dean N, 2009). Numerous women admittedly struggle with this disorder, but research shows that there is room for a decrease in incidents by using external interventions (Castro et al., 2008). Because there is no official cure for stress incontinence, this additional effort must be used to manage symptoms. Weighted vaginal cones and pelvic floor muscle training programs are two applications targeted at improving this widespread health problem. Vaginal cones (I) and muscle training programs (C) both equally improve the outcome (O) of women struggling with stress incontinence (P). Evidence based practice helps determine the best possible outcome by presenting material through an essential question, also referred to as a PICO question. The PICO question will help formulate an answer that aids in proving the most appropriate effort to decrease the problems that result from stress incontinence. Because stress incontinence affects an increasing amount of women, the population (P) is focused primarily on this group to provide a direct correlation to interventions that will verify positive results. Two interventions that have shown improvement in strengthening the pelvic floor muscles are vaginal cones (I) and muscle training

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN programs (C). A comparison between the two in contrast to no intervention is necessary to determine the efficiency of decreasing the involuntary loss of urine. Because both improve symptoms of this condition, it is important to teach women that the outcome (O) of these interventions will both equally improve their quality of life. This particular PICO question is significant because it highlights two important interventions while seeking to find the best method available for struggling women. Because

women already have a gender predisposition towards stress urinary incontinence, they fall victim to this disorder. Not only do these women battle with the physical conflicts related to their involuntary urination patterns, but they also struggle with emotional embarrassment. However, with the help of weighted vaginal cones and muscles training programs, women can optimize their chances of a normal lifestyle. These changes are significant in impacting womens health by minimizing serious social and psychological problems (Castro et al., 2008). There has proven to be a significant change in womens lifestyles by simply raising awareness and teaching patients the importance of these interventions. Muscle training programs and vaginal cones yield positive results for the treatment of urinary leakage, pelvic floor muscle pressure, and quality of life for women (Pereira, De Melo, Correia, Driusso, 2008). Reviewing the Evidence To obtain our evidence, we used the Auburn University L ibrarys website t o search for research regarding the effectiveness of therapies for stress urinary incontinence. We searched the following databases: CINAHL, MEDLINE, and PubMed. To gather the best evidence possible, we browsed specifically for experimental design articles and systematic reviews. Because the articles needed to be up-to-date with current practice, we searched the databases for articles that fell with a parameter of 10 years and were published after the year 2003. Using the phrases and

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN words, stress incontinence, behavioral therapy, pelvic floor, exercise, and vaginal

cone, we were able to find research that fit the 1st and 2nd level of evidence criteria, including a systematic review from Cochrane. In addition, we set a parameter that all results would have full-text links to aid in gathering proper evidence. We found our recommendation for best practice using the AHRQ website.

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN Evidence Analysis Grid Article Citation
Pereira VS, De Melo MV, Correia GN, Driusso P. (2012). Vaginal cone for postmenopausal women with stress urinary incontinence: randomized, controlled trial. Climacteric: the journal of the International Menopause Society, 15, 4551. LOE: 2

Purpose of Study
The purpose of this study is to investigate the short-term effect of vaginal cones and pelvis floor muscle training in postmenopausal women with SUI.

Design Type and Methods

Design: RCT Population: Postmenopausal women who complained of stress urinary incontinence Sampling method: Randomized, controlled study, with parallel randomization (1: 1: 1) Sample size: 45 postmenopausal women with stress urinary incontinence Methods/Interventions: The women were divided into three groups: 15 were given therapy with vaginal cones, 15 were receiving therapy with PFTM, and 15 served as the control group. Subjects in the intervention group carried out the pelvic floor muscle strengthening with vaginal cones. The control group did not receive any treatment during the corresponding time. They were evaluated before, at the end of the treatment, and 6 weeks after treatment completion for primary and secondary outcomes Outcomes measured: Primary outcomes included 1-h pad test for urinary loss and pelvic floor muscle pressure and secondary outcomes included Quality of Life Kings Health Questionnaire, satisfaction with treatment, and continuity of training.

Major Findings
-There was a significant decrease in urinary leakage in the VC group when comparing value at the end and 6 weeks after treatment with values at baseline. -In the analysis of pelvic floor muscle pressure, a significant increase in pelvic floor muscle pressure was shown in the VC group and in the PMFT group when comparing value at the end and 6 weeks after treatment with values at baseline. -In the control group, no differences were observed between the evaluations for any variable. -14 of 15 of the VC subjects and 12 of 13 of the PFMT subjects showed that they were satisfied with treatment. -There were no complaints of adverse effects due to the treatment from either group.

Critique of Validity and Significance

-The sample size of 45 was rather small, so a larger number of participants would be needed for more valid research. -The therapist that carried out the evaluation and treatment was not blinded and this could have influence the results, consciously or not. -Future studies should also perform follow-up for periods exceeding 1 year to verify the maintenance of long-term gains. Significance: This study still proved to verify similar positive results for treatment with vaginal cones and pelvic floor muscle training for urinary leakage, pelvic floor muscle pressure, and quality of life for postmenopausal women with SUI.

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN

Herbison GP, Dean N. (2009).Weighte d vaginal cones for urinary incontinence. Cochrane Database of Systematic Reviews 2002, Issue 1. Art. No.: CD002114. DOI: 10.1002/146518 58.CD002114. LOE: 1 The objective of this review is to determine the effectiveness of vaginal cones in the management of female urinary stress incontinence (SUI). Design: RCT, systemic review Population: Women whose predominant complaint is stress urinary incontinence (SUI), diagnosed either by symptom classification or urodynamic. Sampling method: Review of 17 studies from both randomized and quasi randomized trials. Sample size: 1484 women Methods/ Interventions: The women were divided into various groups such as groups treated with PFMT and groups treated with WVC and groups that were used as the control received no formal treatment. Outcomes measured- The efficacy of WVC were compared to no active treatment, and compared to PFMT. -Treatments with cones were better than control treatments in the subjective reporting of cure or improvement (relative risk of failure. to cure or improve -In addition to the prespecified outcomes, a study reported that cones were better than control for the leakage index. -Eight trials compared cones with PFMT. There was limited overlap with the outcome measures, and all the regimens of PFMT were different. -There were no statistically significant differences in subjective improvement or cure, subjective cure, no improvement in pad test or pelvic floor muscle strength, but PFMT was better than cones for leakage episodes per day (reported in three trials).

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-Because participants knew what the physical therapies were, such as cones, it is not possible to blind the participants to the treatment they are receiving. -Many of the assessments were done with questionnaires by the participants, so they were aware they were being studied. -The trials were small, and only two trials were randomized. More than 60 women were given treatment with cone, but the remaining studies had between 10 and 60 women participating. Significance: This series of studies holds significance because of the amount of trials that were performed that basically led to the same outcome among efficacy of treatment.

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN

Castro RA, Arruda RM, Zanetti MRD, Santos PD, Sartori MGF, Giro MJBC. (2008). Singleblind, randomized, controlled trial of pelvic floor muscle training, electrical stimulation, vaginal cones, and no active treatment in the management of stress urinary incontinence. Clinics, 63, 465-472. doi: 10.1590/S18075932200800040 0009 LOE: 2 The purpose of this study is to compare the effectiveness of pelvic floor exercises, electrical stimulation, vaginal cones, and no active treatment in women with urodynamic stress urinary incontinence. Design: RCT Population: Women with SUI Sampling method: Single-blinded, controlled, randomized trial of women with proven urodynamic urinary stress incontinence at the Urogynecology and Reconstructive Pelvic Surgery, a division of the Gynecology Department at the Federal University of So Paulo. Sample size: 118 women Methods/Interventions: Clients were divided into groups: PFMT, WVC, electrical stimulation, and control groups. Each group received a different treatment and at the end of the trial, their progress was measured. Outcomes measured: The efficacy of WVC therapy when compared to PFMT therapy in women with SUI. -At the end of the trial, 26 women did pelvic floor muscle training, 24 used vaginal cones, and 24 women were untreated (control). 12 (46%) of the subjects in the PFMT group had a negative pad test, while 11 (46%) of the subjects in the vaginal cones group had a negative pad test as well. Only 2 (8%) of the women had a negative pad test in the untreated group. -.The results of the quality of life questionnaire showed an increase of 28.4% in the PFMT group and 30.3% in the WVC group, proving that both treatments contribute to an increased quality of life.

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-The researchers state that the various treatments (PFMT and WVC) present conflicting results, which proves that more evidence is needed. -They have determined that there is still a need for larger clinical trials with more concise methods (because of the differences in incontinence type, training methods, and outcome measures). Significance: This study is significant to our final conclusion that PFMT and WVC produce similar outcomes because the trial concludes that women in both treatment groups expressed an increase in quality of life and a negative pad test.

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN

Ferreira, M., Santos, P., Duarte, J., & Rodrigues, R. (2012). Exercise programmes for women with stress urinary incontinence. Primary Health Care, 22(3), 2427. LOE: 2 The purpose of this study was to compare the efficacy of two different programs where both groups of women with mild-to-moderate SUI had a six month learning period to help them identify and understand correct contraction of PFMs. Design: RCT Population: Women with mild-tomoderate stress urinary incontinence Sampling Method: Women being treated at the center hospitals in Guimerals, Portugal were recruited on on a waitlist for pelvic floor muscle re-education with a clinical and urodynamic diagnosis of SUI Sampling size: 76 women made inclusion criteria; however, 38 women were chosen to participate in the end (The 76 were then called on the phone to confirm symptoms of urine loss at least once a month and to assess desire to participate. 56 were left and came to a meeting to clarify objectives and procedures. Five women were excluded because they had severe SUI. This left a remaining 38) Methods/Interventions: The thirty eight women were randomly distributed between two groups. Both groups attended a 60 minute education session. Exercises were either home based or supervised in a physicians office. The exercises included 10 second contractions, quickly followed by 4 quick contractions of 10 sets. Participants also had several positions to do the exercises in. Outcomes measured: Included vaginal pressure during maximum voluntary contraction of PFM by a perineometer, the 1 hour pad test, perception of improvement, and a voiding diary, which recorded all episodes of urinary leakage over 7 days. -Finding in this study supported the treatment of pelvic floor muscle exercises in the treatment of SUI. -After a continuation of exercises over several months, pelvic muscle stress was still adequate and had increased from the initial study. -The education and exercises improved quality of life, decreased urine loss, and increased muscle strength in women suffering from SUI.

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-This research was based on a pervious study and was a continuation of assessing the effects of pelvic floor muscle exercises of women with SUI. -The sample size of 38 was rather small, so a larger number of participants would be needed for more valid research. -The measurements and procedures used were explained thoroughly and no farther equipment was used since the exercises are physical work. This follow up study was a positive way of assessing and validating the previous research of the positive effects of pelvic floor muscle exercises on women with SUI. Significance: This study expanded on the typical therapy of PFME and reevaluated its significance after 6 months, farther establishing the benefit of PFME by alleviating symptom of SUI.

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN

Borello-France, D. F., Zyncynski, H. M., Downey, P. A., Rause, C. R., & Wister, J. A. (2006). Effect of Pelvic-Floor Muscle Exercise Position on Continence and Quality-of-Life Outcomes in Women With Stress Urinary Incontinence. Physical Therapy, 86, 974-986. LOE: 2 The aim of the current investigation was to compare the efficacy of a PFM exercise progression that included practice in upright positions (supine, sitting, and standing) with the efficacy of one that included practice in the supine position only in reducing female SUI. Design: RCT Sampling Method: Purposive sample of women with stress urinary incontinence between the ages of 38-70. Sample size: 44 women; 22 randomly assigned to each exercise position group. Methods/Interventions: Therapy and education once a week throughout a 9-12 week period about how to perform pelvic floor muscles exercises in different positions; patients were assigned an exercise program, which increased each week based on their progress Outcomes measured: Baseline to post-intervention changes in bladder diary, pad test, quality of life, and PFM strength. -Prevalence of SUI decreased from 59% to 41% of participants. -Almost 41% of women experienced 100% resolution of SUI symptoms, and 20.5% of the women experienced 75% reduction of symptoms. -Overall, the women in the study experienced a 67.9% reduction in frequency of incontinence episodes. Exercise position did not affect outcomes. -Other variables may be more critical than position in enhancing urinary continence outcomes. -The larger number of PFM contractions may have contributed to the higher cure rate.

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-Threat of therapist bias was greatest for PFM strength outcomes, as it required the physical therapist to evaluate examination findings when assigning Brink score. -Statistical power to detect a difference in the reduction of urine leaks per week between women who exercised in the supine position only and women who exercised in the combined supine-upright positions was low (18%) -It is possible that women did not adhere to their assigned exercise position, diluting group outcome differences. They did not formally track participants adherence to the assigned exercise position. Strengths: 1) The use of randomization to assign groups. -They were specific, and the only type of urinary incontinence patients eligible was Stress Urinary Incontinence. The specificity ensured results were not clouded. -This also supports the benefits of PFM therapy. Significance: While this study found that the exercise position was not significant, it did add the evidence that PFM training helps to decrease Stress Urinary Incontinence.

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN

Borello-France, H. M., Downey, D. F., Zyncynski, P. A., & Rause, C. R. (2008). Continence and Quality-of-Life Outcomes 6 Months Following an Intensive Pelvic-Floor Muscle Exercise Program for Female Stress Urinary Incontinence: A Randomized Trial Comparing Low-and-HighFrequency Maintenance Exercise. Physical Therapy, 88, 1545-1553. LOE: 2 This study evaluated continence and quality-of-life outcomes of women 6 months following formalized therapy and determined whether low- and high-frequency maintenance exercise programs were equivalent in sustaining outcomes. Design: RCT Population: Women with Stress Urinary Incontinence between the ages of 38-70 Sampling method: Random sample of women with stress urinary incontinence who completed an intensive PFM exercise intervention Sample size: 36 women Methods/Interventions: This study was a follow-up to another study that implemented therapy and education once a week throughout a 9-12 week period about how to perform pelvic floor muscles exercises in different positions; patients were assigned an exercise program, which increased each week based on their progress. During this study, women were assigned either a low-frequency (once a week) or high frequency (four times a week) exercise program to maintain for six months. Outcomes measured: Number of urine leakage episode recorded in a bladder diary, evidence of urine leakage during urodynamic testing, volume of urine loss during a pad test, Quality of Life, and PFM strength. -Stress incontinence decreased from 60.7% to 42.8% after PFM treatment and after 6 months, this decreased to 35%. -Further research is needed to establish whether continued PFM exercise at a reduced exercise frequency is needed to sustain outcomes beyond a period of 6 months following an exercise program. -Future investigations need to weigh the benefits of including a control group to determine if continued exercise is necessary. -Effectiveness of PFM strengthening in the management of SUI is established.

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-There was a lack of full adherence to exercise programs: 15/28 kept a full diary, and only 4 of these 15 maintained 100% adherence -Information was obtained from a self-report diary -There was no control group -Difficult to apply to a larger population because it did not include women with severe or mixed incontinence, prior treatment failures, or unsatisfactory outcomes from PFM interventions -However, There was randomization of group assignments where the groups showed no statistically significant differences in the groups. -The long-term follow up further validated their previous study. Significance: This study further established the effectiveness of PFM strengthening exercises in decreasing SUI.

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN Synthesis of Evidence

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Stress Incontinence, the most common type of urinary incontinence, has become one of the most serious public health problems in the world, particularly in developing countries because of the high cost of treatment and prevalence (Castro et al., 2008). In efforts to decrease incontinence among women, researchers have studied and compared the use of two of the major treatment options: weighted vaginal cones (WVCs) and pelvic floor muscle (PFM) training. To begin weighted vaginal cone (WVC) treatment, women are told to insert the heaviest cone they can maintain while standing, moving around, and coughing while in the upright position. At each point when they progress, they are to increase the weight of the cones. This will help to strengthen the function of the urethral sphincter. The general recommendation states that women carry the cone for about fifteen minutes twice per day for a few months (Castro et al., 2008). There are several perceived advantages of using the weighted cone therapy. One perceived advantage is that the therapy is individualized for each woman. When the woman has achieved a certain weight, she is able to advance to another weight and increase strength of the pelvic floor muscles. In addition to that, the advancement of weights instills a sense of accomplishment within the woman which serves as a motivator (Herbison GP, Dean N, 2009). Three trials have compared the outcomes of weighted vaginal cones with no specific treatment, which was deemed the control group. In each of the three control groups, they were given different instructions. In one, the women were offered the use of a vaginal device called the Continence Guard in which half of the women used. The second instructed them to carry on with their normal pelvi c floor muscle training regimen. In the last group, they were given a handout explaining the pelvic floor muscle exercises and were instructed to see a nurse every

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two weeks. Although each of the women had slight differences in their SUI, treatments with the weighted vaginal cones were better than the control groups treatment in terms of subjectively improving with symptoms of SUI (Herbison GP, Dean N, 2009). Because pelvic floor muscles are the major structures in the body that help to control incontinence, this is typically the first line of treatment for patients with stress urinary incontinence (Ferreira, Santos, Duarte, Rodrigues, 2012). The levator ani muscles give support to organs of the pelvis and increase closure of the urethra (Borello-France et al., 2006). These muscles work to contract fibers during an increase in pressure, which is exactly what happens during stress incontinence (Ferreira et al., 2012). By strengthening pelvic floor muscles, they also help to reduce frequency as well as urine loss (Ferreira et al., 2012). Not only do the patients rely on the strength of their muscles, but they must also be trained how to anticipate an event that could lead to stress incontinence, such as coughing, sneezing, or anything else that may apply pressure to the abdomen (Borello-France et al., 2006). Borello-France and colleagues conducted a 9-12 week study to test the effects of performing pelvic floor muscle therapy in different positions, such as sitting, standing, or lying in the supine position. Before the study began, the therapists determined the strength of the participants pelvic floor muscles by performing the digital Brink Scale. The Brink Scale measures muscle contraction duration, squeeze pressure, and vertical displacement of exa miners fingers as the muscles contract. Bladder diaries were given to the participants to fill out each week to help the physical therapist guide exercise treatment and educate the participant on how to control future SUI episodes. In order to measure the amount of leakage before and after the treatment, the therapists used 1-hour pads after urodynamic testing and instructed the participants to cough, bounce, or perform an activity that could result in stress incontinence. Throughout the

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entirety of this study, 44 women participated and 22 were randomly assigned to the two different exercise groups: supine only or supine-upright. Over the next weeks, the participants went through a series of exercise trainings; and, upon visiting with the therapist, the amount of exercise increased. The results of this study showed that there was no significance in the difference in position, but they did show the benefits of pelvic muscle floor training: 41% of the women experienced 100% resolution of the incontinence, 20.5% of the women had 75% reduction of symptoms, and based on the total number of women, 67.9% experienced a reduction of incontinence episodes (Borello-France et al., 2006). In a randomized controlled trial examining the efficacy of various SUI treatments, researchers aimed to determine whether weighted vaginal cones or pelvic floor muscle training proved to be more helpful in improving symptoms of SUI. Subjects were required to have urodynamic stress incontinence and not simply urinary over activity. Subjects were required to have a positive cough stress test, and > 3g leakage measured by a pad test with a standardized bladder volume (200ml). All subjects included in the study had symptoms of SUI with an average of at least 3 stress incontinence episodes a week. In order to measure a successful outcome related to a specific treatment, the objective cure of stress incontinence was based on a negative pad test with a standardized bladder volume (<2g in weight). In addition, outcome measures included changes in the validated quality of life questionnaire, and the number of leakages in the voiding diary. Subjectively, patients were asked about their feelings related to their SUI after the treatment, given the option of describing it as satisfied or unsatisfied (Castro et al 2008). In each of the three groups (women treated with PFMT, WVC, electrical stimulation) qualified instructors educated the women on the specifics of the pelvic floor muscles, and how to

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN correctly contract them. They were also told that each of the three treatments was thought to equally improve SUI symptoms. The control group did not have specified treatment but did receive a motivational phone call once per month. Each groups exercises were done at the

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urogynecology unit under supervision three times per week during the six month trial period. For the sake of our PICO question, we will only discuss the outcomes of the PFMT and WVC groups, while also referring to the control group. At the end of the trial, 26 women did pelvic floor muscle training, 24 used vaginal cones, and 24 women were untreated (control). 12 (46%) of the subjects in the PFMT group had a negative pad test, while 11 (46%) of the subjects in the vaginal cones group had a negative pad test as well. Only 2 (8%) of the women had a negative pad test in the untreated group. The results of the quality of life questionnaire showed an increase of 28.4% in the PFMT group and 30.3% in the WVC group, proving that both treatments contribute to an increased quality of life. There was no change in the control group. In terms of muscle strength, those in the control group had no improvement, and while both of the active groups showed significant improvement, the PFMT group showed the most improvement (Castro et al, 2008). Out of the seventeen studies that are presented in the Cochrane review, eight studies compared the use of weighted vaginal cones to the use of pelvic floor muscle training in women with SUI. Data reveals that there were no statistically significant differences in subjective improvement or cure (reported in five trials), subjective cure (reported in four trials), no improvement in pad test (reported in six trials) or pelvic floor muscle strength (reported in three trials, but PFMT was better than cones for leakag e episodes per day (reported in three trials) (Herbison GP, Dean N, 2009). One trial included in the Cochrane review compared active versus passive use of cones. For passive use the cones were simply held in the vagina, but for

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active use the women were instructed to carry out a specific series of activities while maintaining the cone in place. There were no statistically significant benefits when the women carried out the set activities while holding the cone, but it was reported that 70% (21/30) of women with the active treatment reported no leakage after coughing compared with the 58% (18/31) of participants in the passive group who reported no leakage (Herbison GP, Dean N, 2009). In conclusion, Castro et al 2008 states that Despite the fact that all active groups were equally effective, pelvic floor muscle training must still be the first-line of conservative management programs for women with SUI. Electrical stimulation and vaginal cones should be offered to patients who cannot contract their pelvic floor muscle. Therefore, although evidence discussed in this paper has provided sufficient evidence proving both WVC and PFMT to be effective treatments, researchers still recommend the use of the first line treatment of PMFT. Consistency of Evidence A. There are numerous studies designed around stress urinary incontinence. The majority of articles found represented either level I or level II evidence. The sources used included one meta-analysis and five Randomized Controlled Trials. The one meta-analysis reviewed RCTs, which ordains it as level I evidence. The five RCTs used an experimental design based on randomization and manipulation, establishing them as level II evidence. The interventions used in the studies, along with the educational sources and tools used are described in detail. Several studies had large sample sizes, while the others had shockingly few participants. The populations in each article were generalized based on the target population, composed of women with stress urinary incontinence, through an assorted mixture of participants. B. While each of the studies portrayed differing qualities, they all yielded consistent results. Each study began by dividing up clinical groups including, pelvic floor muscle exercises and

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weighted vaginal cones, comparing these to other treatments, or each other. The studies started by doing a pre-examination to assess the baseline level of incontinence. After establishing an appropriate baseline for each participant, individuals were taught how to perform pelvic muscle exercises or how to insert and vaginal cones correctly. Each study then provided participants with exercise intensity and specific instructions regarding number of contractions and duration of contractions expected, but each research group varied. Exercises were also either supervised or completed in the home. Throughout all of the studies measurements including quality of life, urinary leakage, and pelvic muscle strength. Muscle strength was assessed using the Perinastem, Brink Scale, or Oxford grading system. Urinary leakage was tested using the one hour pad test. Quality of life was measured by the KHQ, IIQ, or the I-QoL questionnaire. The studies resulted in differing rates of effectiveness, depending on exercise regimen. Although results differed in their comparative approach as well as the exercise intensity applied, all of the studies demonstrated pelvic floor muscle exercises or weighted vaginal cones and measured similar outcomes. Differing degrees of results were found, but all concluded that the use of weighted vaginal cones and pelvic floor muscle exercises reduced urinary leakage, increased pelvic muscle strength, and increased quality of life among individuals with stress urinary incontinence. C. The findings supporting recommendations among systematic reviews, EBP guidelines, and individual studies are consistent. Since there is no official cure for stress urinary incontinence, studies must cover numerous treatments in order to help optimize patient care. All data suggests that both pelvic floor muscle exercises and weighted vaginal cones reduce effects of stress urinary incontinence. Among findings, there was no significant difference between therapies, concluding that there is no superior treatment for the relief of stress urinary

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incontinence. Even though studies varied slightly in exercise intensity, all resulted in a decrease of symptoms. D. The strength of pelvic muscles is the most important evidence based practice recommendation identified. Individuals suffering from SUI need education on the anatomy of the urinary system, in order to understand the effects of their assigned exercises. Without adequate pelvic muscle strength, an individual may be prone to episodes of incontinence. Unless proper and thorough education is provided, the focused population will be unable to execute particular therapies properly. All of the subjects involved in the considered studies participated in some type of education. Based on results, individuals participating in the varying treatments benefited with decreased symptoms and an advanced education on the disorder. E. Cost studies were not mentioned in the reflected studies. Pelvic floor muscle exercises would seem to be cost efficient though, seeing as no additional tools are needed. For weighted vaginal cone therapy, a set of cones of all different weights would need to be purchased. Although the cost of these tow treatments was not directly addressed in the compiled articles, the nationwide cost of urinary incontinence was. According to one of the RCTs, urinary incontinence costs an estimated 26.4 billion dollars annually in the United States (Castro et al., 2008). Recommendations A moderate level of evidence indicated no difference in outcomes for UI treated with PFMT compared to vaginal cones o Grade: A o Herbison GP, Dean N. (2009).Weighted vaginal cones for urinary incontinence.

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN Cochrane Database of Systematic Reviews 2002, Issue 1. Art. No.: CD002114. DOI: 10.1002/14651858.CD002114 o Grade: B o Castro RA, Arruda RM, Zanetti MRD, Santos PD, Sartori MGF, Giro MJBC. (2008). Single-blind, randomized, controlled trial of pelvic floor muscle training, electrical stimulation, vaginal cones, and no active treatment in the management of stress urinary incontinence. Clinics, 63, 465-472. doi: 10.1590/S1807-59322008000400009

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o Borello-France, D. F., Zyczynski, H. M., Downey, P. A., Rause, C. R., & Wister, J. A. (2006). Effect of Pelvic-Floor Muscle Exercise Position on Continence and Quality-of-Life Outcomes in Women With Stress Urinary Incontinence. Physical Therapy, 86(7), 974-986 o Pereira VS, De Melo MV, Correia GN, Driusso P. (2012). Vaginal cone for postmenopausal women with stress urinary incontinence: randomized, controlled trial. Climacteric: the journal of the International Menopause Society, 15, 45-51. o Borello-France, D., Downey, P., Zyczynski, H., & Rause, C. (2008). Continence and quality-of-life outcomes 6 months following an intensive pelvic-floor muscle exercise program for female stress urinary incontinence: a randomized trial comparing low- and high-frequency maintenance exercise. Physical Therapy, 88(12), 1545-1553. doi:http://dx.doi.org/10.2522/ptj.20070257 o Ferreira, M., Santos, P., Duarte, J., & Rodrigues, R. (2012). Exercise programmes for women with stress urinary incontinence. Primary Health Care, 22(3), 24-27.

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN References

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Borello-France, D. F., Zyncynski, H. M., Downey, P. A., Rause, C. R., & Wister, J. A. (2006). Effect of Pelvic-Floor Muscle Exercise Position on Continence and Quality-of-Life Outcomes in Women With Stress Urinary Incontinence. Physical Therapy, 86, 974-986. Borello-France, H. M., Downey, D. F., Zyncynski, P. A., & Rause, C. R. (2008). Continence and Quality-of-Life Outcomes 6 Months Following an Intensive Pelvic-Floor Muscle Exercise Program for Female Stress Urinary Incontinence: A Randomized Trial Comparing Low-andHigh-Frequency Maintenance Exercise. Physical Therapy, 88, 1545-1553. Castro RA, Arruda RM, Zanetti MRD, Santos PD, Sartori MGF, Giro MJBC. (2008). Single-blind, randomized, controlled trial of pelvic floor muscle training, electrical stimulation, vaginal cones, and no active treatment in the management of stress urinary incontinence. Clinics, 63, 465-472. doi: 10.1590/S1807-59322008000400009 Ferreira, M., Santos, P., Duarte, J., & Rodrigues, R. (2012). Exercise programmes for women with stress urinary incontinence. Primary Health Care, 22 (3), 24-27. Herbison GP, Dean N. (2009).Weighted vaginal cones for urinary incontinence. Cochrane Database of Systematic Reviews 2002, Issue 1. Art. No.: CD002114. doi: 10.1002/14651858.CD002114 Pereira VS, De Melo MV, Correia GN, Driusso P. (2012). Vaginal cone for postmenopausal women with stress urinary incontinence: randomized, controlled trial. Climacteric: the journal of the International Menopause Society, 15, 45-51. Shamliyan T, Wyman J, Kane RL. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness. Comparative Effectiveness Review No. 36. (Prepared by the University of Minnesota Evidence-based Practice Center under Contract No. HHSA 2902007-10064-I.) AHRQ Publication No. 11(12)-EHC074- EF. Rockville, MD. Agency for

MANAGING SYMPTOMS OF STRESS INCONTINENCE IN WOMEN

Healthcare Research and Quality. April 2012. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm.

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