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William E Whitehead - One of the best experts on this subject based on the ideXlab platform.
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controlling faecal incontinence in women by performing anal exercises with Biofeedback or loperamide a randomised clinical trial
The Lancet Gastroenterology & Hepatology, 2019Co-Authors: Eric J Jelovsek, Alayne D Markland, William E Whitehead, Matthew D Barber, Diane K Newman, Rebecca G Rogers, Keisha Y DyerAbstract:Summary Background Well designed, large comparative effectiveness trials assessing the efficacy of primary interventions for faecal incontinence are few in number. The objectives of this study were to compare different combinations of anorectal manometry-assisted Biofeedback, loperamide, education, and oral placebo. Methods In this randomised factorial trial, participants were recruited from eight clinical sites in the USA. Women with at least one episode of faecal incontinence per month in the past 3 months were randomly assigned 0·5:1:1:1 to one of four groups: oral placebo plus education only, placebo plus anorectal manometry-assisted Biofeedback, loperamide plus education only, and loperamide plus anorectal manometry-assisted Biofeedback. Participants received 2 mg per day of loperamide or oral placebo with the option of dose escalation or reduction. Women assigned to Biofeedback received six visits, including strength and sensory Biofeedback training. All participants received a standardised faecal incontinence patient education pamphlet and were followed for 24 weeks after starting treatment. The primary endpoint was change in St Mark's (Vaizey) faecal incontinence severity score between baseline and 24 weeks, analysed by intention-to-treat using general linear mixed modelling. Investigators, interviewers, and outcome evaluators were masked to Biofeedback assignment. Participants and all study staff other than the research pharmacist were masked to medication assignment. Randomisation took place within the electronic data capture system, was stratified by site using randomly permuted blocks (block size 7), and the sizes of the blocks and the allocation sequence were known only to the data coordinating centre. This trial is registered with ClinicalTrials.gov, number NCT02008565. Findings Between April 1, 2014, and Sept 30, 2015, 377 women were enrolled, of whom 300 were randomly assigned to placebo plus education (n=42), placebo plus Biofeedback (n=84), loperamide plus education (n=88), and the combined intervention of loperamide plus Biofeedback (n=86). At 24 weeks, there were no differences between loperamide versus placebo (model estimated score change −1·5 points, 95% CI −3·4 to 0·4, p=0·12), Biofeedback versus education (−0·7 points, −2·6 to 1·2, p=0·47), and loperamide and Biofeedback versus placebo and Biofeedback (−1·9 points, −4·1 to 0·3, p=0·092) or versus loperamide plus education (−1·1 points, −3·4 to 1·1, p=0·33). Constipation was the most common grade 3 or higher adverse event and was reported by two (2%) of 86 participants in the loperamide and Biofeedback group and two (2%) of 88 in the loperamide plus education group. The percentage of participants with any serious adverse events did not differ between the treatment groups. Only one serious adverse event was considered related to treatment (small bowel obstruction in the placebo and Biofeedback group). Interpretation In women with normal stool consistency and faecal incontinence bothersome enough to seek treatment, we were unable to find evidence against the null hypotheses that loperamide is equivalent to placebo, that anal exercises with Biofeedback is equivalent to an educational pamphlet, and that loperamide and Biofeedback are equivalent to oral placebo and Biofeedback or loperamide plus an educational pamphlet. Because these are common first-line treatments for faecal incontinence, clinicians could consider combining loperamide, anal manometry-assisted Biofeedback, and a standard educational pamphlet, but this is likely to result in only negligible improvement over individual therapies and patients should be counselled regarding possible constipation. Funding Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health
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anms esnm position paper and consensus guidelines on Biofeedback therapy for anorectal disorders
Neurogastroenterology and Motility, 2015Co-Authors: Satish S.c. Rao, Giuseppe Chiarioni, Marc A Benninga, Adil E Bharucha, C Di Lorenzo, William E WhiteheadAbstract:Anorectal disorders such as dyssynergic defecation, fecal incontinence, levator ani syndrome and solitary rectal ulcer syndrome are common, and affect both the adult and pediatric populations. Although they are treated with several treatment approaches, over the last two decades, Biofeedback therapy using visual and verbal feedback techniques has emerged as an useful option. Because it is safe, it is commonly recommended. However, the clinical efficacy of Biofeedback therapy in adults and children is not clearly known, and there is a lack of critical appraisal of the techniques used and the outcomes of Biofeedback therapy for these disorders. The American Neurogastroenterology and Motility Society and the European Society of Neurogastroenterology and Motility convened a task force to examine the indications, study performance characteristics, methodologies used and the efficacy of Biofeedback therapy, and to provide evidence-based recommendations. Based on the strength of evidence, Biofeedback therapy is recommended for the short term and long term treatment of constipation with dyssynergic defecation (Level I, Grade A), and for the treatment of fecal incontinence (Level II, Grade B). Biofeedback therapy may be useful in the short-term treatment of Levator Ani Syndrome with dyssynergic defecation (Level II, Grade B), and solitary rectal ulcer syndrome with dyssynergic defecation (Level III, Grade C), but the evidence is fair. Evidence does not support the use of Biofeedback for the treatment of childhood constipation (Level 1, Grade D).
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Biofeedback is superior to electrogalvanic stimulation and massage for treatment of levator ani syndrome
Gastroenterology, 2010Co-Authors: Giuseppe Chiarioni, Adriana Nardo, Italo Vantini, Antonella Romito, William E WhiteheadAbstract:Background & Aims Levator ani syndrome (LAS) might be treated using Biofeedback to teach pelvic floor relaxation, electrogalvanic stimulation (EGS), or massage of levator muscles. We performed a prospective, randomized controlled trial to compare the effectiveness of these techniques and assess physiologic mechanisms for treatment. Methods Inclusion criteria were Rome II symptoms plus weekly pain. Patients were categorized as "highly likely" to have LAS if they reported tenderness with traction on the levator muscles or as "possible" LAS if they did not. All 157 patients received 9 sessions including psychologic counseling plus Biofeedback, EGS, or massage. Outcomes were reassessed at 1, 3, 6, and 12 months. Results Among patients with "highly likely" LAS, adequate relief was reported by 87% for Biofeedback, 45% for EGS, and 22% for massage. Pain days per month decreased from 14.7 at baseline to 3.3 after Biofeedback, 8.9 after EGS, and 13.3 after massage. Pain intensity decreased from 6.8 (0–10 scale) at baseline to 1.8 after Biofeedback, 4.7 after EGS, and 6.0 after massage. Improvements were maintained for 12 months. Patients with only a "possible" diagnosis of LAS did not benefit from any treatment. Biofeedback and EGS improved LAS by increasing the ability to relax pelvic floor muscles and evacuate a water-filled balloon and by reducing the urge and pain thresholds. Conclusions Biofeedback is the most effective of these treatments, and EGS is somewhat effective. Only patients with tenderness on rectal examination benefit. The pathophysiology of LAS is similar to that of dyssynergic defecation.
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randomized controlled trial shows Biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia type constipation
Diseases of The Colon & Rectum, 2007Co-Authors: Steve Heymen, Yolanda Scarlett, Kenneth R. Jones, Yehuda Ringel, Douglas A. Drossman, William E WhiteheadAbstract:This study was designed to determine whether Biofeedback is more effective than diazepam or placebo in a randomized, controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented Biofeedback is necessary for successful training. A total of 117 patients participated in a four-week run-in (education and medical management). The 84 who remained constipated were randomized to Biofeedback (n=30), diazepam (n=30), or placebo (n=24). All patients were trained to do pelvic floor muscle exercises to correct pelvic floor dyssynergia during six biweekly one-hour sessions, but only Biofeedback patients received electromyography feedback. All other patients received pills one to two hours before attempting defecation. Diary data on cathartic use, straining, incomplete bowel movements, Bristol stool scores, and compliance with homework were reviewed biweekly. Before treatment, the groups did not differ on demographic (average age, 50 years; 85 percent females), physiologic or psychologic characteristics, severity of constipation, or expectation of benefit. Biofeedback was superior to diazepam by intention-to-treat analysis (70 vs. 23 percent reported adequate relief of constipation 3 months after treatment, chi-squared=13.1, P<0.001), and also superior to placebo (38 percent successful, chi-squared=5.7, P=0.017). Biofeedback patients had significantly more unassisted bowel movements at follow-up compared with placebo (P=0.005), with a trend favoring Biofeedback over diazepam (P=0.067). Biofeedback patients reduced pelvic floor electromyography during straining significantly more than diazepam patients (P<0.001). This investigation provides definitive support for the efficacy of Biofeedback for pelvic floor dyssynergia and shows that instrumented Biofeedback is essential to successful treatment.
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Randomized, Controlled Trial Shows Biofeedback to be Superior to Alternative Treatments for Patients with Pelvic Floor Dyssynergia-Type Constipation
Diseases of the colon and rectum, 2007Co-Authors: Steve Heymen, Yolanda Scarlett, Kenneth R. Jones, Yehuda Ringel, Douglas A. Drossman, William E WhiteheadAbstract:Purpose To determine whether Biofeedback is more effective than diazepam or placebo in a randomized controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented Biofeedback is necessary for successful training.
Steve Heymen - One of the best experts on this subject based on the ideXlab platform.
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randomized controlled trial shows Biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia type constipation
Diseases of The Colon & Rectum, 2007Co-Authors: Steve Heymen, Yolanda Scarlett, Kenneth R. Jones, Yehuda Ringel, Douglas A. Drossman, William E WhiteheadAbstract:This study was designed to determine whether Biofeedback is more effective than diazepam or placebo in a randomized, controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented Biofeedback is necessary for successful training. A total of 117 patients participated in a four-week run-in (education and medical management). The 84 who remained constipated were randomized to Biofeedback (n=30), diazepam (n=30), or placebo (n=24). All patients were trained to do pelvic floor muscle exercises to correct pelvic floor dyssynergia during six biweekly one-hour sessions, but only Biofeedback patients received electromyography feedback. All other patients received pills one to two hours before attempting defecation. Diary data on cathartic use, straining, incomplete bowel movements, Bristol stool scores, and compliance with homework were reviewed biweekly. Before treatment, the groups did not differ on demographic (average age, 50 years; 85 percent females), physiologic or psychologic characteristics, severity of constipation, or expectation of benefit. Biofeedback was superior to diazepam by intention-to-treat analysis (70 vs. 23 percent reported adequate relief of constipation 3 months after treatment, chi-squared=13.1, P<0.001), and also superior to placebo (38 percent successful, chi-squared=5.7, P=0.017). Biofeedback patients had significantly more unassisted bowel movements at follow-up compared with placebo (P=0.005), with a trend favoring Biofeedback over diazepam (P=0.067). Biofeedback patients reduced pelvic floor electromyography during straining significantly more than diazepam patients (P<0.001). This investigation provides definitive support for the efficacy of Biofeedback for pelvic floor dyssynergia and shows that instrumented Biofeedback is essential to successful treatment.
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Randomized, Controlled Trial Shows Biofeedback to be Superior to Alternative Treatments for Patients with Pelvic Floor Dyssynergia-Type Constipation
Diseases of the colon and rectum, 2007Co-Authors: Steve Heymen, Yolanda Scarlett, Kenneth R. Jones, Yehuda Ringel, Douglas A. Drossman, William E WhiteheadAbstract:Purpose To determine whether Biofeedback is more effective than diazepam or placebo in a randomized controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented Biofeedback is necessary for successful training.
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prognostic significance of rectocele intussusception and abnormal perineal descent in Biofeedback treatment for constipated patients with paradoxical puborectalis contraction
Diseases of The Colon & Rectum, 2000Co-Authors: Steve Heymen, Augustine J N Iroatulam, Omer Alabaz, Steven D. WexnerAbstract: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.
Douglas A. Drossman - One of the best experts on this subject based on the ideXlab platform.
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randomized controlled trial shows Biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia type constipation
Diseases of The Colon & Rectum, 2007Co-Authors: Steve Heymen, Yolanda Scarlett, Kenneth R. Jones, Yehuda Ringel, Douglas A. Drossman, William E WhiteheadAbstract:This study was designed to determine whether Biofeedback is more effective than diazepam or placebo in a randomized, controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented Biofeedback is necessary for successful training. A total of 117 patients participated in a four-week run-in (education and medical management). The 84 who remained constipated were randomized to Biofeedback (n=30), diazepam (n=30), or placebo (n=24). All patients were trained to do pelvic floor muscle exercises to correct pelvic floor dyssynergia during six biweekly one-hour sessions, but only Biofeedback patients received electromyography feedback. All other patients received pills one to two hours before attempting defecation. Diary data on cathartic use, straining, incomplete bowel movements, Bristol stool scores, and compliance with homework were reviewed biweekly. Before treatment, the groups did not differ on demographic (average age, 50 years; 85 percent females), physiologic or psychologic characteristics, severity of constipation, or expectation of benefit. Biofeedback was superior to diazepam by intention-to-treat analysis (70 vs. 23 percent reported adequate relief of constipation 3 months after treatment, chi-squared=13.1, P<0.001), and also superior to placebo (38 percent successful, chi-squared=5.7, P=0.017). Biofeedback patients had significantly more unassisted bowel movements at follow-up compared with placebo (P=0.005), with a trend favoring Biofeedback over diazepam (P=0.067). Biofeedback patients reduced pelvic floor electromyography during straining significantly more than diazepam patients (P<0.001). This investigation provides definitive support for the efficacy of Biofeedback for pelvic floor dyssynergia and shows that instrumented Biofeedback is essential to successful treatment.
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Randomized, Controlled Trial Shows Biofeedback to be Superior to Alternative Treatments for Patients with Pelvic Floor Dyssynergia-Type Constipation
Diseases of the colon and rectum, 2007Co-Authors: Steve Heymen, Yolanda Scarlett, Kenneth R. Jones, Yehuda Ringel, Douglas A. Drossman, William E WhiteheadAbstract:Purpose To determine whether Biofeedback is more effective than diazepam or placebo in a randomized controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented Biofeedback is necessary for successful training.
Yehuda Ringel - One of the best experts on this subject based on the ideXlab platform.
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randomized controlled trial shows Biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia type constipation
Diseases of The Colon & Rectum, 2007Co-Authors: Steve Heymen, Yolanda Scarlett, Kenneth R. Jones, Yehuda Ringel, Douglas A. Drossman, William E WhiteheadAbstract:This study was designed to determine whether Biofeedback is more effective than diazepam or placebo in a randomized, controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented Biofeedback is necessary for successful training. A total of 117 patients participated in a four-week run-in (education and medical management). The 84 who remained constipated were randomized to Biofeedback (n=30), diazepam (n=30), or placebo (n=24). All patients were trained to do pelvic floor muscle exercises to correct pelvic floor dyssynergia during six biweekly one-hour sessions, but only Biofeedback patients received electromyography feedback. All other patients received pills one to two hours before attempting defecation. Diary data on cathartic use, straining, incomplete bowel movements, Bristol stool scores, and compliance with homework were reviewed biweekly. Before treatment, the groups did not differ on demographic (average age, 50 years; 85 percent females), physiologic or psychologic characteristics, severity of constipation, or expectation of benefit. Biofeedback was superior to diazepam by intention-to-treat analysis (70 vs. 23 percent reported adequate relief of constipation 3 months after treatment, chi-squared=13.1, P<0.001), and also superior to placebo (38 percent successful, chi-squared=5.7, P=0.017). Biofeedback patients had significantly more unassisted bowel movements at follow-up compared with placebo (P=0.005), with a trend favoring Biofeedback over diazepam (P=0.067). Biofeedback patients reduced pelvic floor electromyography during straining significantly more than diazepam patients (P<0.001). This investigation provides definitive support for the efficacy of Biofeedback for pelvic floor dyssynergia and shows that instrumented Biofeedback is essential to successful treatment.
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Randomized, Controlled Trial Shows Biofeedback to be Superior to Alternative Treatments for Patients with Pelvic Floor Dyssynergia-Type Constipation
Diseases of the colon and rectum, 2007Co-Authors: Steve Heymen, Yolanda Scarlett, Kenneth R. Jones, Yehuda Ringel, Douglas A. Drossman, William E WhiteheadAbstract:Purpose To determine whether Biofeedback is more effective than diazepam or placebo in a randomized controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented Biofeedback is necessary for successful training.
Kenneth R. Jones - One of the best experts on this subject based on the ideXlab platform.
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randomized controlled trial shows Biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia type constipation
Diseases of The Colon & Rectum, 2007Co-Authors: Steve Heymen, Yolanda Scarlett, Kenneth R. Jones, Yehuda Ringel, Douglas A. Drossman, William E WhiteheadAbstract:This study was designed to determine whether Biofeedback is more effective than diazepam or placebo in a randomized, controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented Biofeedback is necessary for successful training. A total of 117 patients participated in a four-week run-in (education and medical management). The 84 who remained constipated were randomized to Biofeedback (n=30), diazepam (n=30), or placebo (n=24). All patients were trained to do pelvic floor muscle exercises to correct pelvic floor dyssynergia during six biweekly one-hour sessions, but only Biofeedback patients received electromyography feedback. All other patients received pills one to two hours before attempting defecation. Diary data on cathartic use, straining, incomplete bowel movements, Bristol stool scores, and compliance with homework were reviewed biweekly. Before treatment, the groups did not differ on demographic (average age, 50 years; 85 percent females), physiologic or psychologic characteristics, severity of constipation, or expectation of benefit. Biofeedback was superior to diazepam by intention-to-treat analysis (70 vs. 23 percent reported adequate relief of constipation 3 months after treatment, chi-squared=13.1, P<0.001), and also superior to placebo (38 percent successful, chi-squared=5.7, P=0.017). Biofeedback patients had significantly more unassisted bowel movements at follow-up compared with placebo (P=0.005), with a trend favoring Biofeedback over diazepam (P=0.067). Biofeedback patients reduced pelvic floor electromyography during straining significantly more than diazepam patients (P<0.001). This investigation provides definitive support for the efficacy of Biofeedback for pelvic floor dyssynergia and shows that instrumented Biofeedback is essential to successful treatment.
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Randomized, Controlled Trial Shows Biofeedback to be Superior to Alternative Treatments for Patients with Pelvic Floor Dyssynergia-Type Constipation
Diseases of the colon and rectum, 2007Co-Authors: Steve Heymen, Yolanda Scarlett, Kenneth R. Jones, Yehuda Ringel, Douglas A. Drossman, William E WhiteheadAbstract:Purpose To determine whether Biofeedback is more effective than diazepam or placebo in a randomized controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented Biofeedback is necessary for successful training.
