Evidence in practice.

Clinical question: what is the evidence regarding specific methods of pelvic floor exercise for a patient with urinary stress incontinence and mild anterior vaginal wall prolapse?

A 35-year-old woman was referred to my (KF) outpatient clinic by her gynecologist for treatment of urine leakage and symptoms of heaviness in her pelvis. She had a medical diagnosis of anterior vaginal wall prolapse and urinary stress incontinence. The diagnosis of urinary stress incontinence was confirmed by the results of urodynamic testing. Six months earlier she had delivered twin, full-term daughters vaginally. During the latter stages of her pregnancy, she had begun having feelings of heaviness and pressure in her pelvis and urine leakage while lifting and coughing and also during her walking exercise program (3 days a week for 30 minutes). These symptoms progressively worsened over the 6 months following the birth of her daughters. She had no pain or difficulty with urination, elimination, or intercourse. There was no other relevant medical history.

The patient was an elementary school teacher, and she had resumed teaching 3 months before her referral for examination. Her daily fluid intake typically consisted of several cups of coffee and tea and one glass of water. Her schedule permitted her to use the restroom only every 4 to 5 hours. The patient's goals were to reduce the feelings of heaviness and pressure and to eliminate episodes of incontinence because these problems interfered with her ability to teach without interruption and made her less eager to resume walking.

I examined her posture and bony alignment to screen for asymmetry or misalignment, reasoning that these problems could affect the function of the musculoskeletal system relative to the pelvis. With the patient standing as described by Isaacs and Bookhout, (1) I attempted to observe general posture, relative shoulder height, iliac crest height and rotation, posterior superior lilac spine level and rotation, the sacral base, and foot position. I examined the sacroiliac joint by performing the standing forward flexion test, the stork test, and the sitting forward flexion test as described by Isaacs and Bookhout. (1) I noted no asymmetries or abnormal positioning. Although the reliability and validity of measurements obtained using palpation assessments and tests for the sacroiliac joint are questionable, these were the best tools that I had available, and I decided to tentatively rule out misalignment as a cause of any potential pelvic floor dysfunction.

I examined the hip joints using goniometry as described by Norkin and White (2) to measure active range of motion and manual muscle testing as described by Kendall et al. (3) I noted no deficits in hip range of motion or muscle torte. Using a technique described by Lee, (4) I assessed the transversus abdominis and multifidus muscles. Lee proposes that these muscles, along with the pelvic floor muscles, play an important role in lumbopelvic stability. In the hook-lying position, the patient could not maintain a co-contraction of these muscles to maintain her lumbar position while sliding one heel toward the end o[ the examination table, which suggested some weakness in these muscles. (4) Based on the medical diagnosis of urinary stress incontinence and on her symptoms, I suspected that there might be weakness in her pelvic floor muscles. I decided that an internal pelvic floor muscle examination was necessary (1) to determine the patient's ability' to use this muscle group to control urine leakage and (2) to determine whether muscle weakness could be contributing to her symptoms of heaviness and pressure. I explained the role of the pelvic floor muscles in supporting the pelvic viscera and in preventing mine leakage and obtained informed consent from the patient before beginning the examination.

During digital pelvic floor muscle examination, the patient had no muscle tenderness to palpation and had equal sensation on all 4 sides of the vaginal opening. I did not observe any abnormalities in skin integrity, odor, or color other than an episiotomy scar in the perineal body. Using the cues of "holding back gas," "drawing up," and "stopping the flow of urine," I asked the patient to contract her pelvic floor muscles. The patient did not demonstrate a clitoral nod, an anal wink, or a lift of the perineum, all of which would be present during a correct contraction of the pelvic floor muscles. (5,6) I observed the patient bearing down and contracting her gluteal and abdominal muscles, indicating that she was not isolating her pelvic floor muscles correctly. Initially, she was unable to recruit the pelvic floor muscles; however, after 3 trials and verbal and tactile cues, she was able to consistently contract these muscles while maintaining relaxed gluteal and abdominal muscles.

I used the PERFECT method described by Laycock and Jerwood (5) to grade the muscle contraction. I determined that the patient had a 2/5 muscle grade (an increase in tension with no observable or palpable lift of the perineum). (5) She could sustain the contraction at this level for 3 seconds for 3 repetitions. After a 60-second rest period, she could perform 3 quick contractions before I palpated a decrease in the muscle tension. I asked the patient to cough to determine whether she could contract reflexively before an increase in intra-abdominal pressure to prevent urine leakage. The perineum bulged during the cough, indicating that the muscle was not contracting effectively to achieve urethral closure and, therefore, prevent urine leakage. (7) I examined the anterior and posterior vaginal wall by asking the patient to bear down as I looked for a descent, or prolapse, of the vaginal wall. The anterior vaginal wall descended slightly, but not to the level of the hymen.

I determined that my patient had slight anterior vaginal wall prolapse and weakness in her pelvic floor muscles, and she was unable to use these muscles to provide proper organ support and prevent urine leakage during periods of increased intra-abdominal pressure. I classified my patient into Preferred Physical Therapist Practice Pattern[SM] 4C (Impaired Muscle Performance) in the Guide to Physical Therapist Practice. (8) Interventions listed in this practice pattern include strength and endurance training. Many strategies have been promoted to improve muscle force and, therefore, reduce episodes of incontinence--including pelvic floor muscle exercises (Kegel exercises), vaginal cones, electrical stimulation, and biofeedback. The number of visits prescribed and the use of home or office equipment to improve pelvic floor muscle force vary according to clinician. These variations represent a significant difference in treatment cost and in the time required. My patient had a busy schedule with her job, husband, and infant daughters. I wanted to select an evidence based intervention and to develop a plan of care that would both achieve her goals and fit into her busy schedule. I decided to search the literature to find the strongest evidence available to design my plan of care.

* Database used for search: MEDLINE

As a university alumna, I have access to MEDLINE, an online database, through my alma mater's subscription to Ovid Online * (www.ovid.com). I chose this database because it is comprehensive, and I believed it was the best available to conduct my search. I performed this search on January 20, 2004.

* Initial keyword: pelvic floor muscle

I began my search by typing pelvic floor muscle in the keyword entry box. The box titled Map Term to Subject Heading was checked by default. Because I was only interested in studies concerning humans and because I can only read English, I checked the Limit to: boxes Human and English Language located beneath the keyword box. I clicked on the Perform Search button and a screen listed possible related subject headings that I might want to include in my search. I selected the headings Pelvic Floor; Urinary Incontinence, Stress; Exercise Therapy; and Muscles and selected Pelvic Floor Muscle as a keyword by checking the boxes next to these headings (Fig. 1). I clicked on Continue, and the search revealed 49,560 results. I decided that this search approach and the keywords I used were too broad, so I attempted to narrow it by searching through another keyword.

* Additional keyword: pelvic floor muscle training

I typed the term pelvic floor muscle training in the keyword box, because this term was more specific and it encompassed the possible interventions that I was considering for my patient. I left the Map Term to Subject Heading box checked and again selected the Human and English Language limit boxes before clicking on the Perform Search button. This lime, when the screen displayed several subject headings, I selected only pelvic floor muscle training as the keyword before clicking Continue to limit the search to a manageable number of articles. The search produced 41 citations, a much more manageable number: I clicked on Display to review a list of these citations. As I read the titles, I noticed that many of the citations focused on pharmacologic interventions or fecal incontinence rather than on urinary incontinence, or they did not directly relate to my clinical question. Fifteen of the articles appeared to relate to my clinical question, because they addressed interventions for urinary incontinence, and I clicked on the boxes next to these citations. I clicked on the Main Search Page button to save the list of the citations I selected (Fig. 2).

Figure 2. Citations retrieved by the search of MEDLINE using the
keyword "pelvic floor muscle exercise" and then selected for
relevance to the clinical question.

1. Bo K, Pelvic floor muscle strength and response to
pelvic floor muscle training for stress urinary incontinence.
[Clinical Trial. Journal Article] Neurourology &
Urodynamics. 22(7):654-8, 2003.

2. Aukee P. Immonen P. Penttinen J. Laippala P.
Airaksinen O. Increase in pelvic floor muscle activity after
12 weeks' training: a randomized prospective pilot study.
[Clinical Trial. Journal Article. Randomized Controlled
Trial] Urology. 60(6):1020-3; discussion 1023-4, 2002
Dec.

3. Miller JM. Criteria for therapeutic use of pelvic floor
muscle training in women. [Review] [44 refs] [Journal
Article. Review. Review, Tutorial] Journal of Wound,
Ostomy, & Continence Nursing. 29(6):301-11, 2002 Nov.

4. Morkved S. Bo K. Fjortoft T. Effect of adding
biofeedback to pelvic floor muscle training to treat
urodynamic stress incontinence.[see comment]. [Clinical
Trial. Journal Article. Randomized Controlled Trial]
Obstetrics & Gynecology. 100(4):730-9, 2002 Oct.

5. Jundt K. Peschers UM. Dimpfl T. Long-term efficacy
of pelvic floor re-education with EMG-controlled
biofeedback. [Journal Article] European Journal of
Obstetrics, Gynecology, & Reproductive Biology.
105(2):181-5, 2002 Nov 15.

6. Theofrastaus JP. Wyman JF. Bump RC. McClish DK.
Elser DM. Bland DR. Fantl JA. Effects of pelvic floor
muscle training on strength and predictors of response
in the treatment of urinary incontinence. [Clinical Trial.
Journal Article. Randomized Controlled Trial] Neurourology
& Urodynamics. 21 (5):486-90, 2002.

7. Herbison P. Plevnik S. Mantle J. Weighted vaginal
cones for urinary incontinence.[update of Cochrane
Database Syst Rev. 2000;(2):CD002114; PMID:
10796862]. [Review] [46 refs] [Journal Article. Review.
Review, Academic] Cochrane Database of Systematic
Reviews. (1):CD002114, 2002.

8. Glazener CM. Herbison GP. Wilson PD. MacArthur
C. Lang GD. Gee H. Grant AM. Conservative management
of persistent postnatal urinary and faecal incontinence:
randomised controlled trial. [Clinical Trial
Journal Article. Multicenter Study. Randomized Controlled
Trial] BMJ. 323(73131 :.593-6, 2001 Sep 15.

9. Johnson VY. How the principles of exercise physiology
influence pelvic floor muscle training. [Review] [24 refs]
[Case Reports, Journal Article. Review. Review, Tutorial]
Journal of Wound, Ostomy, & Continence Nursing.
28(3):150-5, 2001 May.

10. Hay-Smith EJ. Bo Berghmans LC. Hendriks HJ.
de Bie PA. van Waalwijk van Doom ES. Pelvic floor
muscle training for urinary incontinence in women.
[Review] [149 refs] [Journal Article. Review. Review,
Academic] Cochrane Database of Systematic Reviews.
(1):CD001407, 2001.

11. Morkved S. Bo K. Effect of postpartum pelvic floor
muscle training in prevention and treatment of urinary
incontinence: a one-year follow up. [Clinical Trial.
Controlled Clinical Trial. Journal Article] B JOG: an
International Journal of Obstetrics & Gynaecology.
107(8): 1022-8, 2000 Aug.

12. Bo K. Talseth T. Vinsnes A. Randomized controlled
trial on the effect of pelvic floor muscle training on
quality of life and sexual problems in genuine stress
incontinent women. [Clinical Trial. Journal Article.
Randomized Controlled Trial] Acta Obstetricia et
Gynecologica Scandinavica. 79(7):598-603, 2000 Jul.

13. Sampselle CM. Wyman JF. Thomas KK. Newman
DK. Gray M. Dougherty M. Burns PA. Continence for
women: a test of AWHONN's evidence-based protocol
in clinical practice. Association of Women's Health
Obstetric and Neonatal Nurses. [Clinical Trial. Journal
Article] JOGNN--Journal of Obstetric, Gynecologic, &
Neonatal Nursing. 29(1):18-26, 2000 Jan-Feb.

14. Elser DM. Wyman JF. McClish DK. Robinson D.
Fantl JA. Bump RC. The effect of bladder training,
pelvic floor muscle training, or combination training
on urodynamic parameters in women with urinary
incontinence. Continence Program for Women
Research Group. [Clinical Trial. Journal Article]
Neurourology & Urodynamics. 18(5):427-36, 1999.

15. Berghmans LC. Frederiks CM. de Bie RA. Weil EH.
Smeets LW. van Waalwijk van Doom ES. Janknegt RA.
Efficacy of biofeedback, when included with pelvic
floor muscle exercise treatment, for genuine stress
incontinence. [Clinical Trial. Journal Article. Randomized
Controlled Trial] Neurourology & Urodynamics.
15(1):37-52, 1996.

* Selection of articles for review: In reading the titles, several of the articles appeared to relate to choosing an intervention arid developing a plan of care for a person with urinary stress incontinence. I decided to prioritize the articles I would read according to the levels of evidence outlined by Sackett. (9) I chose to read the systematic reviews first because rigorous systematic reviews of randomized controlled trials generally have a higher level of evidence and are more likely to reduce bias than a single randomized controlled trial alone. I reviewed the abstracts of the 2 systematic reviews (Fig. 2: citations 10 and 7) first by clicking the Abstract button beneath the citation.

After reading the abstracts, I chose to read the full text of the article by Hay-Smith et al (citation 10) first because it addressed all of the interventions I was considering. I obtained the full text the article by clicking on the OVID full text link beneath the citation.

Hay-Smith EJ. Bo Berghmans LC. Hendriks HJ. de Bie RA. van Waalwijk van Doorn ES. Pelvic floor muscle training for urinary incontinence in women. [Review] [149 refs] Cochrane Database of Systematic Reviews. (1):CD001407, 2001.

BACKGROUND: Pelvic floor muscle training is the most commonly recommended physical therapy treatment for women with stress leakage of urine. It is also used in the treatment of women with mixed incontinence, and less commonly for urge incontinence. Adjuncts, such as biofeedback or electrical stimulation, are also commonly used with pelvic floor muscle training. The content of pelvic floor muscle training programmes is highly variable. OBJECTIVES: To determine the effects of pelvic floor muscle training for women with symptoms or urodynamic diagnoses of stress, urge and mixed incontinence, in comparison to no treatment or other treatment options. SEARCH STRATEGY: Search strategy: We searched the Cochrane Incontinence Group trials register (May 2000), Medline (1980 to 1998), Embase (1980 to 1998), the database of the Dutch National Institute of Allied Health Professions (to 1998), the database of the Cochrane Rehabilitation and Related Therapies Field (to 1998), Physiotherapy Index (to 1998) and the reference lists of relevant articles. We hand-searched the proceedings of the International Continence Society (1980 to 2000). We contacted investigators in the field to locate studies. Date of the most recent searches: May 2000. SELECTION CRITERIA: Randomised trials in women with symptoms or urodynamic diagnoses of stress, urge or mixed incontinence that included pelvic floor muscle training in at least one arm of the trial. DATA COLLECTION AND ANALYSIS: Two reviewers assessed all trials for inclusion/exclusion and methodological quality. Data were extracted by the lead reviewer onto a standard form and cross checked by another. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook. Sensitivity analysis on the basis of diagnosis was planned and undertaken where appropriate. MAIN RESULTS: Forty-three trials met the inclusion criteria. The primary or only reference for 15 of these was a conference abstract. The pelvic floor muscle training programs, and comparison interventions, varied markedly. Outcome measures differed between trials, and methods of data reporting varied, making the data difficult to combine. Many of the trials were small. Allocation concealment was adequate in five trials, and nine trials used assessors masked to group allocation. Thirteen trials reported that there were no losses to follow up, seven trials had dropout rates of less than 10%, but in the remaining trials the proportion of dropouts ranged from 12% to 41%. Pelvic floor muscle training was better than no treatment or placebo treatments for women with stress or mixed incontinence. 'Intensive' appeared to be better than 'standard' pelvic floor muscle training. PPMT may be more effective than some types of electrical stimulation but there were problems in combining the data from these trials. There is insufficient evidence to determine if pelvic floor muscle training is better or worse than other treatments. The effect of adding pelvic floor muscle training to other treatments (e.g. electrical stimulation, behavioural training) is not clear due to the limited amount of evidence available. Evidence of the effect of adding other adjunctive treatments to PFMT (e.g. vaginal cones, intravaginal resistance) is equally limited. The effectiveness of biofeedback assisted PFMT is not clear, but on the basis of the evidence available there did not appear to be any benefit over PFMT alone at post treatment assessment. Long-term outcomes of pelvic floor muscle training are unclear. Side effects of pelvic floor muscle training were uncommon and reversible. A number of the formal comparisons should be viewed with caution due to statistical heterogeneity, lack of statistical independence, and the possibility of spurious confidence intervals in some instances. REVIEWER'S CONCLUSIONS: Pelvic floor muscle training appeared to be an effective treatment for adult women with stress or mixed incontinence. Pelvic floor muscle training was better than no treatment or placebo treatments. The limitations of the evidence available mean that is difficult to judge if pelvic floor muscle training was better or worse than other treatments. Most trials to date have studied the effect of treatment in younger, premenopausal women. The role of pelvic floor muscle training for women with urge incontinence alone remains unclear. Many of the trials were small with poor reporting of allocation concealment and masking of outcome assessors. In addition there was a lack of consistency in the choice and reporting of outcome measures that made data difficult to combine. Methodological problems limit the confidence that can be placed in the findings of the review. Further, large, high quality trials are necessary.

[[c] 2001 Update Software Ltd/Cochrane Collaboration. Abstract reprinted from the Cochrane Library with permission of Update Software Ltd.]

The purpose of this systematic review was to assess the effectiveness of pelvic floor muscle training in treating urinary incontinence. The review also compared pelvic floor muscle exercise with adjunct therapies such as biofeedback, electrical stimulation, and vaginal cones. Of the 43 randomized controlled trials included in the review, 23 included women with the sole diagnosis of genuine stress incontinence (ie, stress incontinence confirmed by urodynamic testing); the remaining 20 studies also included women with urge incontinence or mixed incontinence (ie, both stress and urge incontinence). Thirty-seven of the studies included a home pelvic floor exercise program, with the number of contractions per day varying from 36 to 200. The length of time that the contractions were held varied, ranging from 4 to 30 seconds, and 9 trials included quick contractions in the exercise program. Recommended rest times between contractions ranged from 4 to 10 seconds. Some studies included instruction in a technique called the Knack, a voluntary contraction of the pelvic floor muscles prior to an anticipated increase in intra-abdominal pressure, such as before coughing, laughing, and lifting or during high-impact sporting activities. The length of training programs varied from 1 week to 6 months. Outcome measures varied and included a urinary diary, pad test (in which the amount of uring leakage collected by an absorbent pad is weighed), and patient self-report of improvement. The pad tests varied in the positions tested and in the length of time between measurements. Improvements in muscle force were measured by palpation, perineometry, and electrical activity.

The reviewers concluded that pelvic floor muscle training results in fewer episodes of leakage than no treatment or a placebo treatment. They also concluded that individualized pelvic floor muscle training is superior to group training and increased therapist contact time is helpful in reducing urine leakage. The reviewers hesitantly stated that pelvic floor muscle training is better than electrical stimulation in reducing leakage because of the difficulty in combining the data from different studies and because of the adverse effects associated with electrical stimulation. The reviewers noted, however, that electrical stimulation might be beneficial for women who are unable to voluntarily contract their pelvic floor muscles. The data concerning pelvic floor muscle training with biofeedback versus pelvic floor muscle training alone was difficult to combine because of differences in the study designs, and the reviewers did not find any significant difference between the 2 interventions. The reviewers did not find enough evidence to determine whether pelvic floor muscle training was better than using vaginal cones. The reviewers stated that more clinical trials comparing standardized treatment protocols are needed before strong conclusions could be drawn.

This systematic review provided evidence that pelvic floor muscle training is beneficial, but I still wanted to examine the evidence for other intervention strategies and determine a frequency, intensity, and duration appropriate for my patient. The systematic review by Herbison et al (citation 7) focused on the rise of vaginal cones, and I decided to read the full text of this article next. I access the full text by clicking on the Ovid full-text link.

Herbison P. Plevnik S. Mantle J. Weighted vaginal cones for urinary incontinence.[update of Cochrane Database Syst Rev. 2000;(2):CD002114; PMID: 10796862]. [Review] [46 refs] Cochrane Database of Systematic Reviews. (1):CD002114, 2002.

BACKGROUND: Pelvic floor muscle training has long been the most common form of conservative treatment for stress urinary incontinence. Weighted vaginal cones can be used to help women to 1rain their pelvic floor muscles. Cones are inserted into the vagina and the pelvic floor is contracted to prevent them slipping out. OBJECTIVES: To evaluate the effects of weighted vaginal cones in the treatment of women with urinary incontinence. SEARCH STRATEGY: We searched the Cochrane Incontinence Group specialised register (to February 2001), MEDLINE (January 1966 to August 2001), EMBASE (January 1988 to August 2001) and reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing weighted vaginal cones with alternative treatments or no treatment in women with urinary incontinence. DATA COLLECTION AND ANALYSIS: Three reviewers independently assessed studies for inclusion and trial quality. Data was extracted by one reviewer and cross checked by the others. Study authors were contacted for extra information. MAIN RESULTS: Fifteen studies, involving 1126 women of whom 466 received cones, were included. All of the trials were small and in many the quality was hard to judge. Outcome measures differed between studies, making the results difficult to combine. Some studies reported high drop out rates with both cone and comparison treatments. Four of the studies recruited women with symptoms of stress incontinence without urodynamic confirmation. Six trials were only published as abstracts. Cones were better than no active treatment (RR for failure to cure incontinence 0.74, 95% CI 0.59 to 0.93). There was little evidence of difference between cones and PFMT (RR 1.09, 95% CI 0.86 to 1.38) or electrostimulation (RR 1, 95% CI 0.89 to 1.13), but the confidence intervals were wide. There was not enough evidence to show that that cones plus PFMT was different to either cones alone or PFMT alone. Only two studies used a Quality of Life measure and no study looked at economic outcomes. REVIEWER'S CONCLUSIONS: This review provides some evidence that weighted vaginal cones are better than no active treatment in women with stress urinary incontinence and may be of similar effectiveness to PFMT and electrostimulation. This conclusion must remain tentative until further larger high quality studies are carried out using comparable and relevant outcome measures. Some women treated with cones, pelvic floor muscle training or electrostimulation drop out of treatment early. Therefore, cones should be offered as one option so that if women find them unacceptable they know there are other treatments available.

[[c] 2001 Update Software Ltd/Cochrane Collaboration. Abstract reprinted from the Cochrane Library with permission of Update Software Ltd.]

This systematic review involved 15 randomized and quasi-randomized controlled trials. The same variations in populations, intervention strategies, and outcome measures that were present in the systematic review by Hay-Smith et al were present iii this systematic review, making the data from the small trials difficult to combine. In addition, the dropout rate in the 15 studies was high, ranging from 0% to 63% (average=25%). According to the reviewers, the evidence indicated that the use of vaginal cones was better than no treatment for women with urinary stress incontinence. When the studies were compared, the reviewers found no differences among the use of vaginal cones, pelvic floor muscle training, or electrical stimulation, and they found no evidence that using vaginal cones is either better or worse than other treatment strategies. In view of the high dropout rate in these studies, however, the reviewers noted that it may be beneficial to offer vaginal cones as one of many options to treat urinal, stress incontinence, indicating that having a choice in intervention will improve adherence.

After reading the 2 systematic reviews, I still lacked evidence to determine the best intervention for my patient and the frequency, intensity, and duration of any type of exercise. I decided to review my list of citations and read the abstracts of the randomized trials that related to my question.

After reading the abstract for the study by Morkved et al (Fig 2., citation 4), I decided in read the entire article because it detailed the actual exercise protocol used and it compared 2 of the 4 interventions I was considering. I obtained the article from the university, library.

Morkved, S, Bo K, Fjortoft T. Effect of Adding Biofeedback to Pelvic Floor Muscle Training to Treat Urodynamic Stress Incontinence.[Article] Obstetrics & Gynecology. 100(4):730-739, October 2002.

OBJECTIVE: To compare the effect of individual pelvic floor muscle training with and without biofeedback in women with urodynamic stress incontinence. METHODS: The study was a single, blind, randomized trial. All women completed 6 months of pelvic floor muscle training comprising three sets of ten contractions three times per day, supervised by a physical therapist. One group trained with a biofeedback apparatus at home, the other without biofeedback. The primary outcome measures were pad test with standardized bladder volume and self-report of severity. RESULTS: A total of 103 women were randomized, and data from 94 women were analyzed. Mean age (range) was 46.6 (30-70) years, and mean (range) duration of symptoms was 9.7 (1-25) years. Seventy women had urodynamic stress incontinence alone, and 24 women reported additional urge symptoms. Women training with and without biofeedback showed a statistically significant reduction in leakage on pad test (P < .01) after 6 months of pelvic floor muscle training. Objective cure (2 g or less of leakage) in the total group was 58% in women training with and 46% in women training without biofeedback, and in the subgroup of women with urodynamic stress incontinence alone, 69% in women training with and 50% in women training without biofeedback. There was no statistically significant difference between the groups posttreatment in any outcome measure. CONCLUSION: Cure rate was high, and the reduction in urinary leakage after treatment was statistically significant in both groups. However, there was no statistically significant difference in the effect of individual pelvic floor muscle training with and without biofeedback.

[[c] 2002 The American College of Obstetricians and Gynecologists. Abstract reprinted with permission of Lippincott Williams & Wilkins.]

The purpose of tiffs single-blind, randomized trial was to compare the results of 6 months of pelvic floor muscle training with and without biofeedback in women with genuine stress incontinence. The authors recruited 103 women with genuine stress incontinence and stratified the women into 2 groups based on the results of their pad test with a standardized bladder volume. The subjects from these 2 groups then were randomized into either the pelvic floor muscle exercise group or the biofeedback group. All of the subjects received information about anatomy of their pelvic floor and individualized instruction about how to correctly contract their pelvic floor muscles during a vaginal examination with verbal feedback. Participants in both groups met with the physical therapist once a week for 2 months and then once every, 2 weeks for the following 4 months. The women in both groups performed 3 sets of 10 contractions during each visit with the physical therapist. The subjects attempted to hold each contraction for 6 to 8 seconds and to complete 3 or 4 additional quick contractions at the end of the 6 to 8 seconds. The biofeedback group completed the same regimen with the biofeedback unit. The therapist adjusted the program during each visit. The authors did not describe these program adjustments or the rationale for progression in the article.

The therapist asked all participants to perform 3 sets of 10 contractions daily at home. The biofeedback group used the biofeedback unit at home, whereas the other group did not. The participants in the biofeedback group used the BF-106 Biofeedback ([dagger]) to measure vaginal squeeze pressure. This unit recorded and measured the contractions and allowed the physical therapist tm modify the subject's home program as necessary. The authors used a pad test with a standardized bladder volume as the primary outcome measure. The authors emptied the bladder using a catheter, refilled it with 300 mL of saline, and fitted each woman with a preweighed pad. The women then performed 20 jumping jacks and coughed 3 times before the pad was reweighed. The authors defined a "cure" as 2 g of leakage or less. The authors also assessed outcomes using a cure rate and the leakage index and social activity index, both of which attempt to measure how women view stress incontinence and how it affects their physical (leakage index) and social (social activity index) activities. The authors also used a 48-hour home pad test to measure leakage, vaginal palpation to measure muscle contraction, and a vaginal balloon catheter to measure muscle force.

Of the 103 women recruited for the study, 9 did not complete the intervention (4 from the biofeedback group and 5 from the exercise group), a dropout rate of 8.7%. Both groups improved significantly after 6 months of training in the amount of leakage on the pad test, 48-hour home pad test, the number of pads used, the leakage index, and a social activity index. Both groups improved significantly in pelvic floor muscle force after 6 months of treatment. There was no difference between the 2 groups for any of the outcome measures. All women in both groups reported being satisfied with their treatment and said that they would recommend it to other women. The authors concluded that adding biofeedback to a pelvic floor training regimen of exercise and personalized instruction does not significantly improve the outcomes. The authors, however, argued that it should be available as a treatment option for women with urinary stress incontinence.

The sample size, randomization, Minding, and good adherence rate in this study provided strong evidence about the benefits of pelvic floor muscle training and the value of biofeedback training as an adjunct treatment. In addition, the participants, like my patient, had urinary stress incontinence confirmed by urodynamic testing, making the results of this study potentially applicable to my patient. However, this study did not have a control group that did not receive any intervention. This limitation weakens the strength of the evidence.

After reading this study, I had some literature describing a specific training protocol for exercise and biofeedback training, but I had not found a study that compared specific exercise protocols of other adjunct interventions. I read the abstracts of the other articles produced in the search, but either they did not directly relate to my clinical question (for example, citation 12 dealt with sexual problems, which did not relate to my patient) or they did not provide an experimental comparison of the interventions. I wanted to find more evidence that specifically described and compared other training protocols for exercise and the other adjunct interventions. I decided to read the randomized controlled trial by Bo et al that Morkved et al frequently referenced, because it specifically compared 3 additional interventions and specifically detailed training protocols for each intervention. This article, however, did not appear in my MEDLINE search. I obtained the full-text article from OVID by typing the name of the first author into the query' box on the main search page and clicking on the link to the full-text article.

Bo, Kari; Talseth, Trygve; Holme, Ingar. Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women.[Article] BMJ. 318(7182):487-493, February 20, 1999.

Objective To compare the effect of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment for genuine stress incontinence. Design Stratified, single blind, randomised controlled trial. Setting Multicentre. Participants 107 women with clinically and urodynamically proved genuine stress incontinence. Mean (range) age was 49.5 (24-70) years, and mean (range) duration of symptoms 10.8 (1-45) years. Interventions Pelvic floor exercise (n = 25) comprised 8-12 contractions 3 times a day and exercise in groups with skilled physical therapists once a week. The electrical stimulation group (n = 25) used vaginal intermittent stimulation with the MS 106 Twin at 50 Hz 30 minutes a day. The vaginal cones group (n = 27) used cones for 20 minutes a day. The untreated control group (n = 30) was offered the use of a continence guard. Muscle strength was measured by vaginal squeeze pressure once a month. Main outcome measures Pad test with standardised bladder volume, and self report of severity. Results Improvement in muscle strength was significantly greater (P = 0.03) after pelvic floor exercises (11.0 cm H2O (95% confidence interval 7.7 to 14.3) before v 19.2 cm H2 O (15.3 to 23.1) after) than either electrical stimulation (14.8 cm H2 O (10.9 to 18.7) v 18.6 cm H2 O (13.3 to 23.9)) or vaginal cones (11.8 cm H20 (8.5 to 15.1) v 15.4 cm H2 O (11.1 to 19.7)). Reduction in leakage on pad test was greater in the exercise group (-30.2 g; -43.3 to 16.9) than in the electrical stimulation group (-7.4 g; -20.9 to 6.1) and the vaginal cones group (-14.7 g; -27.6 to -1.8). On completion of the trial one participant in the control group, 14 in the pelvic floor exercise group, three in the electrical stimulation group, and two in the vaginal cones group no longer considered themselves as having a problem. Conclusion Training of the pelvic floor muscles is superior to electrical stimulation and vaginal cones in the treatment of genuine stress incontinence.

[[c] 1999 British Medical Association. Abstract reprinted with permission of the BMJ Medical Group.]

This single-blind, randomized controlled trial compared the erects of 6 months of pelvic floor exercise, electrical stimulation, use of vaginal cones, and no treatment on the results of a standardized pad test, cure rate, the number of leakage episodes in 3 days, the 24-hour home pad lest, the leakage index, and the social activity index it; women with genuine stress incontinence. The authors recruited 122 women with urodynamically proven stress incontinence and stratified the women into 2 groups based on the results of their pad test, as Morkved et al did in their study. The authors then randomized the women into 4 treatment groups.

As in the study by Morkved et al, all women received instruction about the anatomy of the pelvic floor and the role of their muscles in maintaining continence and learned to correctly contract their pelvic floor muscles. The patients in the 3 treatment groups (exercise, electrical stimulation, and vaginal cones) all met with the physical therapist once a month for assessment and progression of their treatment program. The subjects in the control group did not have any contact with the physical therapist but were given a continence guard device. The therapist instructed the exercise group to complete 8 to 12 maximal contractions, 3 times a day at home, sustaining each contraction for 6 to 8 seconds and adding 3 to 4 quick contractions after each sustained contraction. The therapist provided each participant with an audiotape to use at home for verbal cueing. All participants kept a training diary. The participants also met in a group once a week to exercise with the physical therapist. In the group session, the participants exercised in lying, standing, kneeling, and sitting positions. The therapist instructed the women in strengthening exercises for the abdominal, back, and thigh muscles as well as breathing and relaxation exercises.

The electrical stimulation group used the MS 106 Twin ([dagger]) device for 30 minutes of intermittent vaginal stimulation per day. This protocol was designed according to the recommendations of the manufacturer; The device used a biphasic current at a frequency of 50 Hz, a pulse width of 0.2 milliseconds, and a current intensity between 1 mA and 120 mA. The physical therapist adjusted the duty cycle according to each woman's ability to sustain a contraction and progressed the duty cycle each month as necessary. Patients in the vaginal cones group used the cones 20 minutes per day as recommended by the manufacture. The therapist progressed each individual every month based on improved ability from 20-g weights to 40-g and 70-g weights.

A total of 107 women (88%) completed the study. Adherence to the pelvic floor muscle exercises was significantly greater than adherence to electrical stimulation or use of vaginal cones. The pelvic floor exercise group improved significantly more in muscle force compared with the other 3 groups. The pelvic floor exercise group also showed significantly better improvements in the pad test and the leakage index than the electrical stimulation group. Participants in the pelvic floor exercise group showed significant improvements in the pad test, number of episodes of leakage over 3 days, and the leakage index compared with the vaginal cone group. The exercise group improved significantly in the pad test, the number of episodes of leakage over 3 days, and the social activity and leakage indexes compared with the control group. The exercise group had a significantly higher cure rate than the 3 other groups, and significantly more women in the exercise group reported being continent or almost continent. Significantly fewer women in the exercise group wanted additional treatment. Two women in the electrical stimulation group reported bleeding, tenderness, and discomfort, and 8 in this group had difficulty with the device, to the vaginal cone group, 14 women reported motivational problems with the cones, whereas others reported symptoms of abdominal pain, vaginitis, and bleeding. The exercise group did not report any adverse effects.

The authors concluded that pelvic floor exercise is significantly better than no treatment, use of vaginal cones, or electrical stimulation and that it produces fewer adverse affects. The exercise group also spent less time per day performing their exercises than the other 2 experimental groups. The exercise group did receive additional contact with the physical therapist in the weekly group sessions and used an audiotape to assist them at home. These factors could have influenced motivation and adherence and provided additional feedback and therefore might have affected this group's success. The authors also noted that, although all of the women had urodynamically proven stress incontinence, there are many different causes of stress incontinence. The authors speculated that degree of muscle weakness and the presence of peripheral nerve damage could logically affect the way some of the women responded to the intervention. It is difficult to account for these variables in any type of study design.

* Clinical decision: I decided to proceed with a pelvic floor muscle exercise program for my patient. I based this decision on the evidence supporting the benefit of exercise over no treatment and placebo treatment in the 2 systematic reviews and the 2 randomized controlled trials that I reviewed. I justified my decision to not include adjunct therapies such as biodfeedback, electrical stimulation, or the use of vaginal cones because the evidence did not support their use in addition to exercise and because of the increased cost associated with purchasing the equipment for these therapies. In addition, the use of vaginal cones and electrical stimulation in the study by Bo et al had a higher tale of adverse effects and negatively affected subject motivation. Because the systematic review by Herbison et al reported a high dropout rate from pelvic floor muscle training programs, however, I decided to present all available options to my patient in the event that she was dissatisfied with pelvic floor muscle exercises alone or might prefer additional treatment.

I decided to begin my patient's exercise program with the frequency, intensity, and duration recommended in the Bo et al article of 8 to 12 high-intensity contractions, 3 times a day. Bo et al also recommended that patients should sustain each contraction for 6 seconds and perform 3 to 4 quick contractions at the end of each sustained contraction. In the initial examination, however, my patient demonstrated that she could sustain a contraction only for 3 seconds for 3 repetitions. She was able to perform only 3 quick contractions after a 60-second rest. I needed to modify the exercise program in consideration of her ability. I encouraged her to (1) perform 3 repetitions of 3-second holds and to attempt to add 3 quick contractions at the end of each sustained contraction and (2) perform this series 8 to 12 times pet day to achieve the same number of contractions per day recommended lay Bo et al. I advised her to attempt to sustain each contraction longer and to perform more repetitions as she became able to do so. Even though my patient was weaker than the women in the study by Bo et al, I did not think that the modifications I made to the program would invalidate the evidence found in that study.

Although the Bo et al article included a group exercise session, I chose not to do so for my patient because of her busy schedule and because there was not an available group in which to include her. I encouraged my patient to begin performing the exercises while lying down, because she does not yet have antigravity strength in her pelvic floor muscles. As her ability to recruit her pelvic floor muscle improves and the muscle begins to strengthen, I will encourage her to perform these exercises in the other "functional" positions (sitting, kneeling, and standing) recommended in the Be et al article. This is important, because she will need to use her pelvic floor muscles functionally in these everyday, antigravity positions. Eventually, I plan to incorporate these exercises as a part of her daily routine. The Hay-Smith et al article described the technique called the Knack, in which a woman contracts the pelvic floor prior to an anticipated increase in intra-abdominal pressure. Because my patient reported leakage during lifting and coughing, I would encourage her to contract her pelvic floor muscles prior to these activities.

I decided to see my patient again in one week to assess her exercise performance and reevaluate her muscle force. If she had difficulty with the exercises and requested an adjunct treatment to help perform her exercises, I would assist her in incorporating biofeedback, electrical stimulation, or the use of vaginal cones into her daily exercises. If she did well, I would progress her exercise program as her available muscle force allowed and increase the time until her next visit. Conclusions from the systematic review by Hay-Smith et al suggested that increased physical therapist contact is beneficial for adherence. However, my patient's busy schedule prevented her from coming in more than once per week, and she was eager to be independent from therapy.

My original search produced a large number of articles, and I decided to limit my keyword search based on the period of time I had to make my clinical decision. I realize that in doing so I may not have found all of the relevant literature. I will need to continue searching the literature to evaluate the many other studies available on pelvic floor muscle training for women with urinary stress incontinence because of the amount of research available to help guide future clinical decisions. Initially, I decided to begin reading the articles that were at a higher level of evidence. (9) The systematic reviews, although a higher level of evidence, were less useful in making my clinical decision. Because the data in the studies included in those reviews were difficult to combine, the reviewers were not able to draw meaningful conclusions about the recommended frequency, intensity, and duration of treatment.

I anticipate that my patient will improve her pelvic floor muscle force and experience a decrease in the amount and frequency of urine leakage. However, because my patient is weaker and cannot begin exercising at the same intensity as the subjects in the Bo et al study, I anticipate that her improvement may be slower than that reported for these subjects. The articles I read did not evaluate change in "heaviness" and pressure in the pelvis. Based on the theory that inadequate muscular support for the pelvic floor musculature is the cause of these symptoms, however, I anticipate that my patient's symptoms will decrease as her muscle force improves.

I justified my clinical decision to create an exercise program based on both the evidence I reviewed and the unique needs of my patient. I believe that blending these 2 principles will result in the best possible outcomes for my patient.

References

(1) Isaacs ER, Bookhout MR. Examination: general considerations. In: Isaacs ER, Bookhout MR. Bourdillion's Spinal Manipulation. 6th ed. Boston, Mass: Butterworth-Heineman Inc; 2002:35-60.

(2) Norkin CC, White DJ. Measurement of Joint Motion: A Guide to Goniometry. 2nd ed. Philadelphia, Pa: FA Davis Co; 1995.

(3) Kendall FP, McCreary EK, Provance PG. Muscles: Testing and Function, With Posture and Pain. 4th ed. Baltimore, Md: Williams & Wilkins; 1993.

(4) Lee D. The Pelvic Girdle. 2nd ed. Edinburgh, UK: Churchill Livingstone Inc; 1999.

(5) Laycock J, Jerwood D. Pelvic floor muscle assessment: the PERFECT scheme. Physiotherapy. 2001;87:631-642.

(6) Dougherty M. Current status of research on pelvic muscle strengthening techniques. J Wound Ostomy Continence Nurs. 1998;25:75-83.

(7) Miller JM. Criteria for therapeutic use of pelvic floor muscle training in women. J Wound Ostomy Continence Nurs. 2002;29:301-311.

(8) Guide to Physical Therapist Practice. 2nd ed. Alexandria, Va: American Physical Therapy Association; 2001.

(9) Sackett DL. Levels of evidence and clinical decision making. In: Basmajian JV, Banerjee SN, eds. Clinical Decision Making in Rehabilitation: Efficacy and Outcomes. New York, NY: Churchill Livingstone Inc; 1996.

* Ovid Technologies, 333 Seventh Ave, 4ch Fl, New York, NY 10001.

([dagger]) Vitacon, Vegamot 8, N-7048 Trondheim, Norway.

Kimberly Fisher, PT, MPT, is a physical therapist at OU Physicians Women's Pelvic and Bladder Clinic, Oklahoma City, Okla.

Lisa Riolo, PT, PhD, NCS, is Associate Professor, Department of Rehabilitation Science and Geriatric Medicine and Jill Pittman Jones Professor of Physical Therapy at University of Oklahoma Health Sciences Center.

The authors acknowledge Debra Clark, PT, OCS, for reviewing a previous draft of the patient description section.