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112 Long-Term Outcomes of Pelvic Floor Exercise and Biofeedback Treatment for Patients With Fecal Incontinence [2003년 8월 DCR] 2011-11-17 3192
 
Chet K. Pager, B.Med.(Hons), Dip.Ed., M.A.,Michael J. Solomon, M.B., B.Ch.(Hons), M.Sc., F.R.A.C.S., Jenny Rex, R.N., S.T.N.,Rachael A. Roberts, B.N.
 
From the Central Sydney Area Departments of Colorectal Surgery at Royal Prince Alfred & Concord
Hospitals, Sydney, Australia, and the Department of Surgery, University of Sydney, Sydney, Australia
 
PURPOSE: The aim of this study was to assess the long-term clinical and quality of life outcomes for patients after referral to a four-month treatment program for fecal incontinence based on pelvic floor exercises and biofeedback. Secondary objectives were to document patients’ subsequent treatment activities and their perception of the biofeedback training; to establish the long-term outcomes and initial predictors for the subset of patients who did not complete the treatment, or who failed to improve during
the program; and to correlate changes in clinical outcome measures and quality of life over time.
METHODS: Patients were contacted by telephone to determine their perception of progress subsequent to the treatment program, any subsequent treatment or activities relating to their fecal incontinence, and which aspect of the treatment program they believed was most helpful. St. Mark’s and Pescatori fecal
incontinence scores were also recorded, along with patients’ self-assessments of their incontinence severity and quality of life.
RESULTS: Eighty-three (69 percent) patients were contacted for interviews at a median of 42 (range,
26–56) months after program completion. At the time of follow-up, patients who completed the program continued to enjoy strongly significant improvements in all outcome measures, with 75 percent perceiving a symptomatic improvement and 83 percent reporting improved quality of life. For many patients, improvement continued subsequent to program completion. Patients whose incontinence
scores became worse during treatment still reported improvement in their quality of life and perceived incontinence severity during the same time period; many experienced some degree of “catch-up” in their continence scores during the follow-up period. Fourteen patients (17 percent) went on to have surgery for fecal incontinence; of these, 6 (7 percent) had a stoma. Twenty (24 percent) regularly took
antidiarrheal medication. Thirty program completers (41 percent) were continuing pelvic floor exercises.
CONCLUSIONS: This study confirms the long-term improvement in fecal incontinence achieved through treatment with biofeedback and pelvic floor exercises. In this study, patients also continued to improve after treatment completion, possibly because of the strong emphasis placed on patients during treatment to continue the pelvic floor exercises on their own. The poor correlation between quality of
life and quantitative scores of fecal incontinence suggests that there are important aspects of continence that are not being appropriately recognized.
 
Fecal incontinence is a debilitating condition affecting up to 7.1 percent of the general population. Fecal incontinence is eight times more frequent in females, and the most common cause is obstetric trauma coupled with age-related degeneration. Programs involving pelvic floor exercises and biofeedback have emerged as the treatment of first choice for patients with mild to moderate symptoms without an underlying correctable abnormality, in part because they are safe, painless, and do not preclude
further treatment should they fail. Numerous studies have reported improvement rates of 50 to 92 percent, although a recent Cochrane review questioned whether firm conclusions can be drawn from these studies because of their methodologic weaknesses. There is even less certainty with the long-term results. Few studies offer follow-up longer than one to two years, with most studies finding that patient continence decreases but remains higher than before treatment. However, although a worsening of continence over time after treatment has been widely reported, the significance of this trend is difficult to interpret because no studies offer longterm comparison with nontreatment controls, and few studies provide results on an intention-to-treat basis accounting for noncompleters. Miner et al. have suggested a “cure rate” over time for all patients regardless of treatment, and Loening-Baucke suggested that improvement may be observed regardless of the intended treatment mechanism as a result of dietary change, antidiarrheal medications, improved toileting habits, and psychological support. In addition,
because most patients seek treatment when their symptoms are at their worst, a certain improvement
through “regression to the mean” would be expected, and in some trials the treatment duration is tailored to the patient, in which case treatment would cease when continence is at its (uncharacteristic) best.
 
Importantly, little is understood about the natural history of fecal incontinence and the further treatments
or activities in which patients engage over time after completing a pelvic floor exercise and biofeedback
treatment program. There is widespread agreement regarding the crucial role of patient motivation
and patient-therapist interaction for successful program outcomes, yet little is known about patient’s
perceptions of their fecal incontinence and the factors influencing improvement.
 
Finally, although rarely reported as an outcome measure, quality of life is a crucial factor, in that episodes of fecal incontinence could be rare, yet uncertainty of when they might occur would severely
restrict work and social and sexual activity. Although many studies have noted the perplexing lack of relationship between clinical outcomes and physiologic measures, no studies have investigated their
relationship with quality of life over time.
 
The present study involved interviewing 83 patients at a median of 42.5 months after treatment completion with five objectives: 1) to report long-term clinical and quality of life outcomes for patients after completion of a biofeedback and pelvic floor exercise training program; 2) to document patients’ subsequent treatment activities; 3) to document patients’ perception of the biofeedback training; 4) to establish the long-term outcomes and initial predictors for the subset of patients who did not complete the treatment, or who failed to improve during the program; and 5) to correlate changes in clinical outcome measures and quality of life over time.
 
DISCUSSION
The first and foremost finding of this study is that completion of a biofeedback and pelvic floor exercise
program affords patients significant long-term improvement in fecal incontinence, a finding reinforced
by the few studies that have reported follow-up beyond two years. However, this study differs from most in that patients did not only maintain improvement compared with their pretreatment status, but they continued to improve subsequent to program completion, albeit to a more modest degree. A possible explanation for why patients in this study did not experience the expected worsening with time is the strong emphasis placed on continuing exercises. Patients were urged to complete 10 sets of 10 fivesecond sphincter contractions (100 contractions) twice each day between their monthly treatment sessions, and the average self-reported compliance with these exercises was 83 percent. Indeed, 41 percent of respondents were continuing to do these pelvic floor exercises several times each week, and many described how the exercises had become such a habit they did so without even thinking about it, before going to bed or when driving in their car. It is possible that many of the patients who reported doing exercises once per week or less were in fact unintentionally completing exercises more frequently, or that even infrequent exercises were sufficient to maintain and extend posttreatment improvement. Although some studies have suggested instituting reinforcement programs to maintain posttreatment improvement, it may be that the same benefits could be more economically achieved by simply encouraging patients to continue conducting pelvic floor exercises at home.
 
It is interesting that patients who continued to exercise reported somewhat worse incontinence scores
than those not regularly exercising. However, both exercising and nonexercising patients frequently volunteered that they recommenced the exercises during periods when they believed they needed them.
 
All groups studied did experience a gradual improvement over time. It seemed that more treatment was better, in that patients who continued monthly sessions after the completion of the four-month program
reported better results on all outcome measures. Patients who did not complete the program did improve
between initial assessment and follow-up, but at a “baseline rate” similar to completing patients’
postprogram improvement, and less than the improvement completing patients experienced over time-slices including the treatment period itself. However, it must be acknowledged that patients continuing
treatment or exercises were a self-selected population, and the correlation between further treatment
and improvement does not establish causality. In our study, a common cause of noncompletion was moving on to surgery—a failure of treatment—and younger, male, and less severe patients were also
more likely to abandon treatment.
 
As with other studies, it has been difficult to meaningfully predict, based on initial factors, which
patients will not complete or fail treatment. Unlike one previous report, treatment failures in our study
displayed a significant postprogram catch-up improvement. It may be that the sphincter exercises—
also continued by this group—are for some patients less effective under certain conditions or that a longer duration of treatment is required, beyond the fivemonths afforded by the treatment program. However, what was far more remarkable about the treatment failures is that—despite worsening fecal incontinence— their self-assessment of incontinence severity and quality of life at the time of program completion was no different from patients whose symptom scores improved. Likewise, patients whose symptom scores worsened after program completion still reported an increase in quality of life during this time period.
 
Because patients’ self-assessment of severity correlated with quality of life whereas incontinence scores did not, there are clearly other factors involved in the patient’s self-assessment beyond those addressed by the St. Mark’s and Pescatori quantitative scales, which in part explains the 18 percent of respondents who believed that neither the exercises nor the biofeedback were the most helpful component of the program, but rather “talking about things.” Many patients explained their subjective improvement in terms of “I’ve gotten used to it” or “I’ve learned to cope with it.” Although we should not abandon our fecally incontinent patients to their own devices or to the healing forces of time, further research into what factors underpin clinical and quality of life improvements, and their relationship, is important. Although quality of life is the crucial issue for many patients suffering with fecal incontinence, it is little researched and seldom reported in conjunction with treatment programs. Although improving greatly with treatment, it correlates poorly with scores of fecal incontinence, suggesting that there are important aspects of treatment programs independent of the primary intervention that are not being appropriately recognized.