Relationship between symptoms and quality of life in fecal incontinence.

BACKGROUND: Most measures of fecal incontinence (FI) severity assess the frequency of solid and liquid FI, but may incorporate other features. We compared two scales-the Fecal Incontinence Severity Score (FISS) and Fecal Incontinence Severity Index (FISI)-to determine which questionnaire and which individual questions predict FI Quality of Life (FIQOL). METHODS: A national sample of American adults completed a health questionnaire, and 234 with monthly FI were selected. Participants completed assessments of FI severity, FIQOL, and somatization. Stepwise linear regression models evaluated whether FISS and FISI total scores, or individual items on the FISS and FISI predicted FIQOL after adjusting for gender, age, income, and somatization (Brief Symptom Inventory-18). KEY RESULTS: Reliable responses were provided by 186. Age was 49 years, and 52% were women. The mean FISS score was 8.4 (95% confidence interval [CI] 8.0-8.9, 13 questions) and mean FISI was 29.9 (95% CI 27.4-32.4, 62 questions), indicating moderate FI severity. The mean FIQOL was 2.6 (95% CI 2.4-2.7, 5 questions). Lower income, greater somatization, and total FISS and FISI scores explained 69% of FIQOL; and total FISS and FISI scores were independent predictors. On the FISS, frequency, amount, and urgency to defecate were independently associated with FIQOL. After adding somatization, all but amount remained significant. For the FISI scale, solid and liquid FI and gas were significant predictors, but adjusting for somatization excluded solid FI. CONCLUSIONS AND INFERENCES: Five variables independently explained FIQOL: overall frequency of FI, frequency of liquid and gas leakage, urgency, and somatization.

Patient preferences for endpoints in fecal incontinence treatment studies.

BACKGROUND: Randomized controlled trials of treatments for fecal incontinence (FI) are difficult to compare because case definitions and study endpoints vary. Our aims were to assess patient perspectives on the case definition for FI and how treatment success should be measured. METHODS: In Phase 1, 28 FI patients participated in anonymous on-line focus groups, and in Phase 2, 186 people with FI, stratified by gender, race, and age completed an online survey. KEY RESULTS: Focus group participants described frequency and urgency as the most important characteristics for defining FI. Most (80%) thought staining of underwear constitutes FI, but only 33% thought gas leakage was FI. When asked how the success of treatment should be defined, 77% said by a reduction in frequency or complete cure, but less than half thought a 50% reduction in frequency was enough. When asked how much reduction would be needed, responses averaged 80%. The Phase 2 survey confirmed that frequency, urgency, and intestinal discomfort are the most important characteristics for case definition, and that success should be defined by at least a 75% decrease in frequency. A 50% reduction was an acceptable endpoint for 58% overall but only 26% for those aged ≥65. "Adequate relief" was acceptable to 78%. CONCLUSIONS AND INFERENCES: Inclusion criteria for trials should specify a minimum frequency of FI. Most patients would require a ≥75% reduction in FI frequency to call a treatment successful but young adults and those with more severe FI would accept a ≥50% reduction as meaningful.

Fecal incontinence in irritable bowel syndrome: Prevalence and associated factors in Swedish and American patients.

BACKGROUND: Fecal incontinence (FI) is a prevalent but poorly recognized problem in the general population with profound negative effects on daily life. The prevalence of FI in irritable bowel syndrome (IBS) and its association with clinical, demographic, and pathophysiological factors remain largely unknown. METHODS: One US (n=304) and one Swedish (n=168) patient cohort fulfilling Rome III criteria for IBS completed Rome III diagnostic questions on FI and IBS symptoms, and questionnaires on IBS symptom severity, quality of life, anxiety and depression, and work productivity impairment. The patients also underwent assessments of colorectal sensitivity and motility. KEY RESULTS: Fecal incontinence ≥ one day per month was reported by 19.7% (USA) and 13.7% (Sweden) of IBS patients. These proportions rose to 43.4% and 29.8% if patients with less frequent FI were included. Fecal incontinence prevalence was higher in older age groups, with a clear increase above age 40. Irritable bowel syndrome patients with FI reported greater overall IBS symptom severity, more frequent and loose stools, and greater urgency. Negative effects of FI on quality of life, psychological distress, and work productivity were demonstrated. No associations were found between colorectal physiology and FI. CONCLUSIONS & INFERENCES: Fecal incontinence is common in IBS patients, and similar to previous general population reports, the major risk factors for FI in IBS are older age, rectal urgency, and loose, frequent stools. When IBS patients have comorbid FI, the impact on quality of life, psychological symptoms, and work impairment appears greater.

Biofeedback treatment of fecal incontinence: a critical review.

PURPOSE: The aims of this review are 1) to critically evaluate the literature on the efficacy of biofeedback treatment for fecal incontinence, 2) to compare different types of biofeedback, and 3) to identify patient characteristics which predict a successful outcome. METHODS: The MEDLINE database was searched for articles published between 1973 and 1999 which included the terms "biofeedback" and "fecal incontinence." Pediatric and adult articles in any language were screened. Inclusion for review required that the study be prospective, have five or more subjects, and have a description of the treatment protocol. RESULTS: Thirty-five studies were reviewed. Only six studies used a parallel treatment design and just three of those randomized subjects to treatment groups. A meta-analysis (weighted by subjects) was performed to compare the results of two treatment protocols that dominate the literature. The mean success rate of studies using Coordination training (i.e., coordinating pelvic floor muscle contraction with the sensation of rectal filling) was 67 percent, while the mean success rate for studies using Strength training (i.e., pelvic floor muscle contraction) was 70 percent. Furthermore, the mean success rate for those Strength training studies using electromyographic biofeedback was 74 percent, while the mean success rate for studies using anal canal pressure biofeedback Strength training was 64 percent. However, these conclusions are limited by the absence of clearly identified criteria for determining success. There are also inconsistencies in the literature regarding the patient selection criteria, severity and cause of symptoms, amount of treatment, as well as the type of biofeedback protocols and instrumentation used. Finally, no patient characteristics were identified that would assist in predicting successful outcome. CONCLUSION: Although most studies report positive results using biofeedback to treat fecal incontinence, quality research is lacking. Recommendations are made for future investigations to 1) improve experimental design, 2) include long term follow-up data, and 3) to use an adequate sample size that allows for meaningful analysis.

Prognostic significance of rectocele, intussusception, and abnormal perineal descent in biofeedback treatment for constipated patients with paradoxical puborectalis contraction.

PURPOSE: The findings of paradoxical puborectalis contraction, rectocele, sigmoidocele, intussusception, and abnormal perineal descent often coexist in constipated patients, as noted by defecographic study. Moreover, some of these conditions are often found in asymptomatic patients. Biofeedback is the treatment of choice for constipated patients with paradoxical puborectalis contraction; the main determinant of successful biofeedback is patient compliance. The significance of coexistent and highly prevalent variants, such as rectocele, intussusception, sigmoidocele, or abnormal perineal descent, on the success of biofeedback is unknown. This review was designed to assess whether these coexisting defecographic findings have any prognostic significance for the outcome of biofeedback. METHODS: From July 1988 to December 1996, 209 constipated patients with paradoxical puborectalis contraction underwent biofeedback treatment after defecography. A total of 173 patients (120 females) who had more than one biofeedback session after defecography formed the study group. Defecographic findings included concomitant rectoceles, 40 (23 percent); evidence of circumferential intussusception, 17 (10 percent); sigmoidocele, 13 (8 percent); and abnormal perineal descent, 109 (63 percent). RESULTS: Whereas 65 patients failed to complete the course of biofeedback therapy, 108 (62.4 percent) patients completed the course of biofeedback and were discharged by the therapist. Within the completed group 59 (55 percent) improved, and 49 (45 percent) patients failed biofeedback therapy. In the improved group 14 (23.7 percent) had a rectocele, 5 (8.5 percent) had intussusception, 5 (8.5 percent) had a sigmoidocele, and 37 (62.7 percent) had abnormal perineal descent. In the failure group 9 (18.4 percent) had a rectocele, 5 (10.2 percent) had an intussusception, 2 (4.1 percent) had a sigmoidocele, and 31 (63.3 percent) had abnormal perineal descent (P = not significant). The success of biofeedback was then analyzed relative to the number of coexisting conditions. Specifically, the outcome in patients with paradoxical puborectalis contraction alone and with one, two, and three other defecographic findings were compared. No statistically significant difference was found among these four groups. CONCLUSION: Although other defecographic findings frequently coexist with paradoxical puborectalis contraction, none of the concomitant findings adversely affected the outcome of biofeedback treatment. Therefore, biofeedback can be recommended to patients with coexistent defecographic findings, with expectation of success in over 50 percent of individuals who complete the course of therapy.

A prospective randomized trial comparing four biofeedback techniques for patients with faecal incontinence.

OBJECTIVE: The aim of this study was to compare four methods of biofeedback therapy for patients with faecal incontinence (FI). PATIENTS AND METHODS: All patients with FI who were ineligible for surgical management were prospectively randomized using a computer generated randomization method into one of four protocols: 1, out-patient intra-anal electromyographic biofeedback training (EMG); 2, EMG plus intrarectal balloon training (BT); 3, EMG plus a home trainer (HT); and 4, EMG, BT and HT. All patients received weekly, 1 h, out-patient biofeedback training. Success for patients with FI was measured by a reduction in incontinent episodes (days/week). In all instances, patients maintained a daily log in which documentation was recorded regarding each bowel evacuation. RESULTS: Forty patients were randomized into one of the four groups. Six patients withdrew after one session and were not included in the analysis. Therefore, 34 patients (23 female and 11 male) with a mean incontinence score of 12 (range 7-14) were randomized to one of the four groups (n=8, 8, 8, and 10, respectively). There was a statistically significant reduction in incontinent episodes for all groups. However, there were no significant differences in treatment outcome found in comparisons among the four groups. CONCLUSION: Biofeedback therapy significantly improves FI. Moreover, EMG training was as effective alone as was the addition of HT, BT or both for the treatment of FI.

Prospective, randomized trial comparing four biofeedback techniques for patients with constipation.

PURPOSE: The aim of this study was to compare four methods of biofeedback for patients with constipation. METHODS: Thirty-six patients were prospectively, randomly assigned to one of four protocols: 1) outpatient intra-anal electromyographic biofeedback training; 2) electromyographic biofeedback training plus intrarectal balloon training; 3) electromyographic biofeedback training plus home training; or 4) electromyographic biofeedback training, balloon training, and home training. All 36 patients received weekly one-hour outpatient biofeedback training. Success was measured by increased unassisted bowel movements and reduction in cathartic use. In all instances patients maintained a daily log in which documentation was maintained regarding each bowel evacuation and the need for any cathartics. RESULTS; There was a statistically significant increase in unassisted bowel movements for Groups 1, 2, and 4 (P < 0.05) and a reduction in the use of cathartics in Groups 1, 2, and 3 (P < 0.05). CONCLUSION: There was a significant improvement in outcome after all four treatment protocols for constipation; however, no significant difference was found among the treatments. Therefore, electromyographic biofeedback training alone is as effective as with the addition of balloon training, home training, or both.

Outcome and predictors of success of biofeedback for constipation.

BACKGROUND: A study was undertaken to determine outcome and to identify predictors of success for biofeedback for constipation. METHODS: Patients who had at least one biofeedback session were evaluated whether or not they completed a treatment course. Parameters assessed included use of cathartics, number of spontaneous bowel movements per week, presence of rectal pain, number of biofeedback sessions and results of anorectal physiology. RESULTS: A total of 194 patients (59 male, 135 female) of median age 71 (range 11-96) years, including 30 with concomitant rectal pain, were treated. The median number of spontaneous bowel movements per week before treatment was 0. Some 35 per cent of patients had complete success (three or more spontaneous bowel movements per week with discontinuation of cathartics), 13 per cent had partial success (fewer than three spontaneous bowel movements per week with continued use of cathartics) and 51 per cent had no improvement. Neither patient age, sex nor duration of symptoms significantly affected outcome. Only 18 per cent of patients who had between two and four sessions had complete success, compared with 44 per cent of those who had five or more (P < 0.001). A total of 63 per cent of patients who completed the treatment protocol experienced complete success, compared with 25 per cent of those who self-discharged (P < 0.0001). CONCLUSIONS: This large study indicates that the success rate of biofeedback for patients with constipation is less than previously reported. However, the success rate improves significantly after five or more sessions and is significantly related to the patient's willingness to complete treatment.

MMPI assessment of patients with functional bowel disorders.

This prospective study was undertaken to assess personality differences among patients with chronic pelvic floor disorders. Sixty patients (43 females and 17 males) of a mean age of 58 (range, 33-87) years with fecal incontinence (n = 19), constipation (n = 30), or levator spasm (n = 11) had a mean duration of symptoms of 35 (range, 2-50) years. The Minnesota Multiphasic Personality Inventory (MMPI) was utilized for psychologic assessment for all patients prior to treatment. Mean scores for scales 1 (hypochondriasis), 2 (depression), and 3 (hysteria) were significantly elevated for the levator spasm group (71, 75, and 73, respectively). A similar pattern was seen for the constipation group, where the mean scores for scales 1 and 2 were significantly elevated (70 and 74, respectively) with a moderate elevation on scale 3 (68). The hypochondriasis (1), depression (2), and hysteria (3) scales are referred to as the "neurotic triad," and profile patterns such as these indicate that these subjects may manifest their psychologic distress as physical symptoms. By contrast, the fecal incontinence patients were within the normal range on all scales. The information from these MMPI profiles can be used to understand the personality and emotional composition of these patients to assist in their evaluation and treatment.

Evaluation and treatment of chronic intractable rectal pain--a frustrating endeavor.

A study was undertaken to assess the evaluation and treatment of chronic intractable rectal pain. Sixty consecutive patients, 23 males and 37 females with a mean age of 69 (range, 29-87) years and a mean length of symptoms of 4.5 years, were evaluated by questionnaire, office examination, anal manometry, electromyography, cinedefecography, and pudendal nerve study. In all cases, organic abdominopelvic and anorectal etiologies for the pain were excluded by extensive radiologic and endoscopic evaluation. All patients had failed conservative and medical therapy. Ninety-five percent of patients had one or more associated factors: constipation or dyschezia (57 percent), prior pelvic surgery (43 percent), prior anal surgery (32 percent), prior spinal surgery (8 percent), irritable bowel syndrome (10 percent), or psychiatric disorders (depression or anxiety; 25 percent). Possible etiologies for the pain included levator spasm or anismus in 62 percent, coccygodynia in 8 percent, and pudendal neuropathy in 24 percent of patients. Therapy for pain control included electrogalvanic stimulation (EGS) in 29, biofeedback (BF) in 14, and steroid caudal block (SCB) in 11 patients. Pain control was assessed by an independent observer at a mean of 15 (range, 2-36) months after completion of therapy. Continued successful pain relief was classified by patients as good or excellent after EGS in 38 percent, after BF in 43 percent, and after SCB in 18 percent; overall success was reported by 47 percent of patients. The presence of levator spasm, coccygodynia, or pudendal neuropathy did not influence outcome. The routine use of physiologic investigation of rectal pain may not be justifiable. Moreover, more than half of the patients were refractory to all three therapeutic options used in this study.

Prospective assessment of biofeedback for the treatment of paradoxical puborectalis contraction.

Eighteen patients with chronic constipation were diagnosed as having paradoxical puborectalis contraction (PPC) as the cause for their constipation. The diagnosis of PPC was made after office evaluation, colonic transit study, manometry, cinedefecography, and electromyography (EMG). These 18 patients had a mean duration of symptoms of 26.9 years; none of these patients had unassisted bowel movements. Fourteen patients had a mean of 4.6 laxative-induced bowel evacuations per week, and 11 patients had a mean of 4.4 enema-induced bowel evacuations per week. Patients underwent a mean of 8.9 one-hour EMG-based biofeedback sessions. At a mean follow-up of 9.1 (range, 0.5-12) months, these 18 patients had a mean of 7.3 unassisted bowel actions per week (P less than 0.0001). In addition, persistent laxative use was reported by only two patients, and, in both cases, this was once a week or less (P less than 0.001). Similarly, enema use was reported by only three patients, one once weekly and the other two thrice weekly (P less than 0.002). No biofeedback-related complications were identified. EMG-based biofeedback is a valuable technique associated with an 89 percent success rate in the treatment of PPC.