Biofeedback for fecal incontinence: short-term outcomes of 513 consecutive patients and predictors of successful treatment.

PURPOSE: Biofeedback is well established as a treatment for fecal incontinence but little is known about factors that may be associated with its effectiveness. This study assessed short-term outcomes, predictors of patients who completed treatment, and predictors of treatment success. METHODS: This study was a retrospective review of consecutive patients treated with biofeedback at a tertiary referral colorectal clinic during ten years. Clinical, physiologic, and quality of life measures were collected prospectively at the time of treatment. Regression analysis was performed. RESULTS: Of 513 patients, 385 (75 percent) completed the treatment program. Each outcome was improved for more than 70 percent of patients. Incontinence scores decreased by 32 percent (from 7.5 to 5.2 of 13), patient assessment of continence increased by 40 percent (from 5.3 to 3.2 of 10), quality of life improved by 89 percent (from 0.34 to 0.67 of 1.0), and maximum anal sphincter pressure increased by a mean 12 mmHg (14 percent; from 90 to 102 mmHg). Patients who did not complete treatment were younger, were more likely to be male, and had less severe incontinence. Treatment success was predicted by completion of all treatment sessions (odds ratio, 10.34; 95 percent confidence interval, 4.46-24.19), female gender (odds ratio, 4.11; 95 percent confidence interval, 1.04-7.5), older age (odds ratio, 1.02 per year; 95 percent confidence interval, 1-1.04), and more severe incontinence before treatment (odds ratio, 1.19 per unit increase in St. Mark's score; 95 percent confidence interval, 1.05-1.34). CONCLUSIONS: More than 70 percent of patients in this large series demonstrated improved short-term outcomes. Treatment success was more likely in those who completed six training sessions, were female, older, or had more severe incontinence. Patients were less likely to complete treatment if they were male, younger, or had milder incontinence.

Telephone vs. face-to-face biofeedback for fecal incontinence: comparison of two techniques in 239 patients.

PURPOSE: Biofeedback is an effective treatment for patients with fecal incontinence, yet little is known about how it works or the minimum regime necessary to provide clinical benefit. This study compares the effectiveness of a novel protocol of telephone-assisted biofeedback treatment for patients living in rural and remote areas with the standard face-to-face protocol for patients with fecal incontinence. METHODS: A new treatment program comprising an initial face-to-face assessment and treatment with transanal manometry and ultrasound biofeedback, followed by three treatments conducted via telephone and a final face-to-face assessment, was developed. Standard treatment involved five face-to-face treatment sessions with manometry and ultrasound. Patients from rural areas were offered the telephone-assisted treatment protocol. Data gathered prospectively included incontinence scores, a quality of life index, anal manometry, and external sphincter isometric and isotonic fatigue times. RESULTS: A total of 239 consecutive patients treated between July 2001 and July 2004 were enrolled. There were no significant differences in demographic details, past history, or pretreatment measures of the two groups. Forty-six of 55 patients (84 percent) treated with the telephone protocol and 129 of 184 (70 percent) treated by the standard technique completed treatment. There were substantial, significant improvements after treatment, including 54 percent mean improvement in patient's own rating of their incontinence in both groups; a mean decrease of 3.1 and 3.2 on the St. Mark's incontinence score (from 7.9 to 4.7 and 7.4 to 4.2 of 13) and relative improvements of 128 and 130 percent in the quality of life index (from 0.29 to 0.65 and 0.3 to 0.69 of 1) for the telephone-assisted and standard groups respectively. Importantly, there were no significant differences between the telephone-assisted or standard groups in any outcome. Of patients who completed treatment, 78 percent were better or much better. CONCLUSIONS: A less intensive regime of biofeedback seems to be equally effective as the standard intensive protocol. This finding adds weight to the evolving concept that the physical aspects of biofeedback treatment, such as manometry or ultrasound, may not be necessary in the treatment of most patients with fecal incontinence. This needs to be further tested in a randomized, controlled trial.

Randomized, controlled trial of biofeedback with anal manometry, transanal ultrasound, or pelvic floor retraining with digital guidance alone in the treatment of mild to moderate fecal incontinence.

BACKGROUND: A prospective, three-armed, randomized, controlled trial was performed to assess whether pelvic floor exercises with biofeedback using anal manometry or transanal ultrasound are superior to pelvic floor exercises with feedback from digital examination alone in terms of continence, quality of life, physiologic sphincter strength, and compliance. Its secondary objectives were to assess whether there are any differences in these outcomes between biofeedback with transanal ultrasound vs. anal manometry and to correlate the physiologic measures with clinical outcome. METHODS: One hundred twenty patients with mild to moderate fecal incontinence were randomized into one of three treatment groups: biofeedback with anal manometry, biofeedback with transanal ultrasound, or pelvic floor exercises with feedback from digital examination alone. Commencing one week after an initial 45-minute assessment session, patients attended monthly treatments for a total of five sessions. Each session lasted 30 minutes and involved sphincter exercises with biofeedback that involved instrumentation or digital examination alone, and patients were encouraged to perform identical exercises twice per day between outpatient visits. RESULTS: One hundred two patients (85 percent) completed the four-month treatment program. Across all treatment allocations, patients experienced modest but highly significant improvements in all nine outcome measures during treatment, with 70 percent of all patients perceiving improvement in symptom severity and 69 percent of patients reporting improved quality of life. With the possible exception of isotonic fatigue time, there were no significant differences between the three treatment groups in compliance, physiologic sphincter strength, and clinical or quality-of-life measures. Correlations between physiologic measures and clinical outcomes were much stronger with ultrasound-based measures than with manometry. CONCLUSIONS: Although patients in this study who completed pelvic floor exercises with feedback from digital examination achieved no additional benefit from biofeedback and measurement with transanal ultrasound or manometry, it may be that the guidance received through digital examination alone offered patients in the pelvic floor exercise group an effective biofeedback mechanism. Contrary to our hypothesis, the use of transanal ultrasound offered no benefit over manometry, but the use of ultrasound for isotonic fatigue time and isometric fatigue contractions provided potentially important physiologic measures that require further study. This study has confirmed, through a large sample of patients, that pelvic floor retraining programs are an effective treatment for improving physiologic, clinical, and quality-of-life parameters in the short term.

Assessment of quality of life in the treatment of patients with neuropathic fecal incontinence.

INTRODUCTION: Development of quality-of-life measures has been the focus of research in colorectal disorders in recent years. The assessment of quality of life for fecal incontinence should be more important than quantitative measurement of soiling. PURPOSE: This study assesses specific patient quality-of-life objectives, categorizes objectives, and correlates these objectives with continence scores. METHODS: One hundred eighteen patients entered into a randomized, controlled trial of biofeedback were assessed using the Direct Questioning of Objectives quality-of-life measure. All objectives were documented, categorized, and correlated with continence scores and analog scales. RESULTS: In patients with neuropathic fecal incontinence, the most frequent quality-of-life group concerned the ability to get out of home, to socialize outside of home, to go shopping, and not to have to worry about the location of the nearest toilet while out of home (34 percent; 123/364). At least one of these four objectives was stated by 72 percent of patients (85/118). Only 31 percent of patients (37/118) nominated an objective related to the physical act of soiling. The ability to travel (29 percent), exercise including walking (25 percent), perform home duties (19 percent), family and relationships (22 percent), and job (13 percent) were less frequently cited by patients. CONCLUSION: Continence scores focus heavily on the physical aspects of incontinence such as soiling and hygiene, aspects which seem to be less important to the patients themselves. It is important, therefore, that assessments of fecal incontinence should include reference to quality of life, and in particular to its impact on activities relating to "getting out of the house."

Long-term outcomes of pelvic floor exercise and biofeedback treatment for patients with fecal incontinence.

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.