Steve Heymen

Randomized controlled trial shows biofeedback to be superior to pelvic floor exercises for fecal incontinence.

PURPOSE: This study aimed to compare manometric biofeedback with pelvic floor exercises for the treatment of fecal incontinence in a randomized controlled trial controlling for nonspecific treatment effects. METHODS: After excluding patients who were adequately treated with medication, education, and behavioral strategies (21%), 108 patients (83 females; average age, 59.6 years) underwent either pelvic floor exercises alone (n = 63) or manometric biofeedback plus pelvic floor exercises (n = 45). Patients in both groups were taught behavioral strategies to avoid incontinence. RESULTS: At three-month follow-up, biofeedback patients had significantly greater reductions on the Fecal Incontinence Severity Index (P = 0.01) and fewer days with fecal incontinence (P = 0.083). Biofeedback training increased anal canal squeeze pressure more than pelvic floor exercises did (P = 0.014) and with less abdominal tension during squeeze (P = 0.001). Three months after training 76% of patients treated with biofeedback vs. 41% patients treated with pelvic floor exercises (chi-squared = 12.5, P < 0.001) reported adequate relief. Before treatment, the groups did not differ on demographic, physiologic, or psychologic variables, symptom severity, duration of illness, quality-of-life impact, or expectation of benefit. At 12-month follow-up, biofeedback patients continued to show significantly greater reduction in Fecal Incontinence Severity Index scores (F = 4.83, P = 0.03), and more patients continued to report adequate relief (chi-squared = 3.64, P = 0.056). CONCLUSION: This investigation provides definitive support for the efficacy of biofeedback. Biofeedback training resulted in greater reductions in fecal incontinence severity and days with fecal incontinence. Biofeedback was also more effective than pelvic floor exercises alone in producing adequate relief of fecal incontinence symptoms in patients for whom conservative medical management had failed.

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<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<0.001). Similarly, enema use was reported by only three patients, one once weekly and the other two thrice weekly (P<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.

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.

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.

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.

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.

The aim of this study was to compare four methods of biofeedback therapy for patients with faecal incontinence (FI).

Utility of the Balloon-Evacuation Test for Identifying Patients With Dyssynergic Defecation

Background/Aims: Dyssynergic defecation (DD) accounts for 30-40% of patients with chronic constipation and is particularly prevalent in referral practices. Standard treatments (ST) including exercise, avoidance of constipating drugs, and increasing fluid & fiber intake often fail to improve symptoms. Laxatives provide inconsistent relief of constipation related symptoms, particularly in DD patients. Recent studies suggest that biofeedback (BF) therapy provides an effective treatment for DD patients. Aims: To conduct a systematic review and meta-analysis of randomized-controlled trials (RCTs) comparing BF therapy to standard treatments in DD patients. Methods: A search of MEDLINE, EMBASE, Google Scholar, Cochrane Central Register of Controlled Trials, ACP Journal Club, DARE, CMR, HTA, and abstracts from major GI meetings was performed. RCTs comparing the efficacy of BF vs. ST for weekly bowel movement (BM) frequency or global satisfaction in patients with DD were selected. Meta-analysis was performed using metan command in Strata 10.1. A funnel plot was created to assess for publication bias. The heterogeneity of the pooled estimate was tested with the inconsistency index (I2) statistic. Subgroup analyses (type of BF, duration of follow-up, study location, primary & secondary study outcomes, concurrent laxative use) were performed to account for any observed heterogeneity. Results: Systematic review identified >1000 citations. Upon detailed review, 7 treatment trials were identified of which 4 studies which randomized 241 patients with DD fulfilled our inclusion criteria and were included in the meta-analysis. Patients treated with BF reported an increase of 1.30 BM/ week, compared to 0.87 BM/week for patients treated with ST (WMD: 01.11, 95% CI: -0.99-3.20). Significant heterogeneity amongst studies was noted. Three studies reported data on patient satisfaction. The number of patients reporting satisfaction with therapy was higher in the BF group compared to the ST group (75.0% vs. 36.7%, RR: 2.15, 95% CI: 1.64-2.81, I2=81%). No other constipation-related outcomes were consistently reported amongst the included trials. Conclusions: These results suggest that BF therapy offers benefits for global satisfaction in patients with DD. Our analysis identified the need for further large, well designed clinical trials and the development of a common set of outcome measures which can be applied to randomized trials evaluating the efficacy of BF training for DD. Though stool frequency is commonly employed as the primary outcome measure in constipation trials, our results raise questions about whether this endpoint is the most appropriate primary outcome for trials evaluating BF for DD.

Sa1345 Fecal Incontinence Severity Index Helps to Identify Patients Who View Their Symptoms As Severe Enough to Consult a Physician

G A A b st ra ct s for fecal incontinence, and underwent recto-anal manometry. Extraperitoneal rectal tumors staged <T2 N0 and/or with size <4 cm at diagnosis time or after irradiation were submitted to TEM. Ano-rectal manometry was performed using a water-perfused system: pressure at rest and during squeezing, rectal sensitivity and compliance, were evaluated. Mann-Whitney and chi-square tests were used for statistical analysis. Twenty-seven patients (14 F, 72±5 yrs, m±sd) underwent TEM without n-RCT (group A); 10 patients (2 F, 68.8±5 yrs) underwent TEM after n-RCT (group B); 9 M, (67±9 yrs) underwent RT for prostate cancer (group C). In group A mean anal resting pressure decreased from 68±23 to 54±26 mmHg at month 4 (p=0.04) after surgery and returned to normal values 12 months postoperatively (60±30 mmHg). In group B and C, respectively, mean anal resting pressure decreased from 65±23 to 50±18 mmHg and from 94±11 to 72±15 mmHg at month 4, and remained stable 12 month postoperatively (44±11 mmHg, p=0.04 and 72.6±12.4 mmHg, p=0.001 vs preoperative values and ns vs 4 month postoperatively). The anal resting pressure differences between basal and 12 months after irradiation of group B and C was similar and was significantly lower than group A (p=0.001). Gas incontinence, soiling and urgency were reported by 50%, 45% and 25% and by 38%, 12% and 12% of the patient group A, B and C , respectively at 4 and 12 months after treatment. The results of this study indicate that TEM per se does not significantly affect anal function. N-RCT to obtain downstaging and downsizing of distal rectal cancers, in order to perform TEM, affects resting anal pressure but it does not cause major anal incontinence. 1. Loos M, Quentmeier P, Schuster T. Ann Surg Oncol. 2013 Jun;20(6):1816-28.

Temporal Summation in Patients With Irritable Bowel Syndrome (IBS) Compared to Healthy Controls (HC)

INTRODUCTION: A recent study demonstrated a significant correlation between somatic hyperalgesia and increased permeability in patients with irritable bowel syndrome (Pain 2009;146:41-46). In order to determine the importance of this association, we performed quantitative sensory testing in patients with moderately active inflammatory bowel disease (IBD) as a model disease with increased permeability. METHODS: Healthy controls and patients with confirmed Crohns disease or ulcerative colitis were invited. Patients completed the SIBDQ as a validated health status measure for IBD patients. Pain thresholds were determined over the dominant hand and the four abdominal quadrants for pressure and heat application. Threshold and tolerance for ischemic and cold pain were assessed and rated during regular hand exercises with a blood pressure tourniquet inflated to 200 mmHg and during ice water immersion of the dominant hand, respectively. RESULTS: Fifty controls (37±2 years) and 10 IBD patients (36±4 years; SIBD score: 39.9±1.9) were recruited. Pain thresholds for pressure (5.8±0.2 vs. 5.7±0.4 kg/cm2) or heat (44.3±0.4 vs. 43.4±0.4o C; controls vs. IBD) over the dominant did not differ. Pressure thresholds were significantly lower over the abdomen, but did not differ between the groups (figure). In contrast, heat pain thresholds were similar between forearm and abdominal wall and did not differ between the groups. The results for ischemic pain (threshold: 60.0±7.5 vs. 65.2±14.3 s; tolerance: 117.3±8.6 vs. 134.6±14.0 s) or cold pain (threshold: 15.2±4.2 vs. 13.6±4.8 s; tolerance: 51.8±8.3 vs, 68.4±23.3 s) were comparable for both groups. CONCLUSION: We did not find differences in experimental pain in response to several different stimulus modalities between controls and IBD patients, arguing against an importance of increased intestinal permeability in the development of hyperalgesia.