The UNC Center for Functional GI & Motility Disorders www.med.unc.edu/ibs Biofeedback for Pelvic Floor Disorders and Incontinence Olafur S. Palsson, Psy.D. Associate Professor of Medicine UNC Center for GI Functional & Motility Disorders University of North Carolina at Chapel Hill Pelvic Floor Disorders Include: Constipation Fecal Incontinence Urinary Incontinence Pelvic and rectal pain Rectal and/or Vaginal Prolapse Dyspareunia Pelvic Floor Disorders Include: Constipation Fecal Incontinence Urinary Incontinence Pelvic and rectal pain Rectal and/or Vaginal Prolapse Dyspareunia Percent 8 Self-Reported Constipation: Gender & Age Harari, et al. Arch Intern Med 99;5:35-3 < -9 5-59 -9 7-79 8+ Age Decade Females Males n=,375 35 Percent 3 5 5 5 Laxative Use in Last Month: Gender and Age Harari, et al. Arch Intern Med 99;5:35-3 < -9 5-59 -9 7-79 8+ Age Decade Females Males n=,375 Epidemiology of Constipation Overall U.S. Prevalence About 3% Constipation increases with age Women outnumber men -3 times Risk factors include: Poverty Low fiber diet Sedentary life-style Race: African Americans > Caucasians
Current Diagnostic Criteria for Constipation (Rome II) Adults: Two or more of the following for at least weeks (not necessarily consecutive) in the previous months: Straining in 5% of bowel movements Lumpy or hard stools in 5% of bowel movements Sensation of incomplete evacuation in 5% of bowel movements Sensation of anorectal obstruction or blockage in 5% of bowel movements Manual maneuvers to facilitate 5% of bowel movements Fewer than three bowel movements (defecations) a week Loose stools not present, and insufficient criteria for irritable bowel syndrome Children: Pebble-like, hard stools for most bowel movements for weeks Firm stools less than two times a week for weeks No evidence of structural, endocrine, or metabolic disease Subtypes of Constipation Subtype Physiology Symptoms Slow transit Pelvic floor dyssynergia IBSconstipation Decreased peristaltic contractions Infrequent, hard stools External sphincter Straining, contracts when straining incomplete BM to defecate Increased segmental (non-peristaltic) contractions Pain relieved by BM, straining, incomplete BM Pelvic Floor Dyssynergia A type of chronic constipation where patients fail to relax, or paradoxically contract, the pelvic floor muscles, and thereby inhibit defecation. Diagnosis requires physiological evidence (manometry, EMG or X-ray) of inappropriate muscle use during defecation attempts Other causes of constipation, like slow transit, must also be excluded Accounts for 5-5% of adult constipation and 5% of childhood constipation (Lestar, Penninck & Kerremans, 989; Wald et al., 99) Responds poorly to standard medical treatment with laxatives and dietary fiber, leaving most patients with unresolved symptoms Standard Treatments for Constipation Healthy diet with plenty of fiber-rich foods or fiber supplements Plenty of daily fluids Regular exercise Laxatives (ineffective for PFD) Functional Fecal Incontinence (Rome II definition) Prevalence of FI by Age Group Recurrent uncontrolled passage of fecal material in an individual with a developmental age of at least years, that is associated with fecal impaction, diarrhea, or nonstructural anal dysfunction (Whitehead et al., ) % 9% 8% 7% % 5% % 3% % % % Soiling (.9%) Gross FI (.7%) 8-9 3-3 35-39 - 5-5 5-59 & over Age (Years) Survey of 5,38 U.S. Households. Drossman et al. Dig Dis Sci 993;38:59-8.
Causes of Gross Fecal Incontinence Childbirth (pudendal nerve and sphincter damage) - forceps delivery, prolonged labor, large baby (>9 lbs), multiple vaginal births Diarrhea-predominant IBS Constipation with overflow Immobility Cognitive impairment Physical injury or illness causing sphincter, nerve or sensory damage Fecal Incontinence is greatly underestimated problem because patients rarely discuss it with others Only a third of adult patients discuss FI problem with their physician (Johanson & Lafferty, 99) Impact of Fecal Incontinence: - Social isolation - Poor self-esteem - Impairment of intimate relationships - Impact on mobility and ability to travel freely - Confinement to nursing home (second leading cause): 5-7% in U.S. nursing home residents vs. 3% of the community-dwelling elderly (Dey, 998; Nelson, Furner & Jesudason, 998). Psychological Symptoms in Patients with Fecal Incontinence Scale Score..8... Fecal Incontinence Patients Som Obs- Com Int Sen Other clinical GI Patients Dep Anx Hostil Phob Anx SCL-9-R Scale Pts with FI > control GI patients on all scales, p<.5 N=9 Scale Score Psychological Symptoms in Patients with Chronic Constipation..8... Constipation Patients Som Obs- Com Int Sen Other clinical GI Patients Dep Anx Hostil Phob Anx SCL-9-R Scale Pts with Constipation > control GI patients on all scales, p<.5 N=9 Standard Treatments for Fecal Incontinence Biofeedback is commonly The first treatment recommended if medical management fails. It is appealing because it is simple, cheap, and without adverse physical effects Madoff et al., Lancet l3; -3. 3
Biofeedback training methods Anorectal manometric tracings of a normal subject and a patient with pelvic floor dyssynergia during straining at defecation (arrows). The normal subject relaxes the anal sphincter, whereas the patient displays a paradoxical contraction of the sphincter + Electromyography (EMG) and/or intracanal pressure sensors Auditory or visual moment-to-moment physiological feedback Bassotti et al, BMJ ;38:393-39 Biofeedback Training Protocols For PFD constipation: Teach patients to relax their pelvic floor muscles while simultaneously applying a downward intra-abdominal pressure to generate propulsive force. For Fecal Incontinence: A) Coordination training: coordinates muscle contractions in response to intra-rectal balloon distension using pressure feedback from pelvic floor muscle contractions (the most common type of training) B) Strength training: strengthens the external anal sphincter without employing rectal distension C) Sensory training: improves ability to sense diminishing rectal distentions without muscle training, by using controlled amounts of intra-rectal pressure applied via a computer-inflated balloon Advantages of Biofeedback for Constipation and FI Inexpensive (3- sessions with a nurse or technician) No significant adverse side effects Improvement often lasts for years Complements standard medical care and substantially enhances clinical outcomes Sometimes makes surgery (an intervention causing permanent anatomical change with substantial risk of negative side effects) unnecessary Can help individuals who have been unresponsive to standard medical treatment to achieve normal quality of life and (for FI) maintain independence Comprehensive Efficacy Review Palsson, Heymen & Whitehead Appl Psychophysiol Biofeedback. Sep;9(3):53-7 Reviewed all adult and pediatric articles published in Medline and PsychInfo 975-3 in all languages. 33 trials on fecal incontinence (FI), 38 on pelvic floor dyssynergia (PFD) or functional constipation Only % of studies were controlled outcome trials. Treatment protocols, etiological subgroups studied and outcome measures varied greatly. The overall average success rate 7. % for functional FI and.% for constipation. Per subject success rate was significantly higher for biofeedback treatment than for standard medical care for both constipation and FI (p<. for both). Comparison of Clinical Outcomes for Biofeedback vs. Standard Medical Care Constipation Fecal Incontinence (3 patients) (57 patients) 9 p <.* p <.* 8 7.% 7.% 5 5.% 35.9% 3 Biofeedback Standard care Biofeedback Standard care + Standard care alone + Standard care alone Palsson, Heymen & Whitehead Appl Psychophysiol Biofeedback. Sep;9(3):53-7
Biofeedback For Fecal Incontinence (FI) Norton et al. Gastroenterology 3;5(5):3-9 Biofeedback vs. Standard Care Only for Pediatric Constipation (PFD) with Encopresis Loening-Baucke. Journal of Pediatrics 99;():-. 9 8 7 5 3 55% 5% % 5% 7 months months Symptom Resolution 77% 3% Normalization Of Defecation Dynamics Biofeedback + Standard Care Standard Care only N=7 Ages: 5- UNC Chapel Hill Randomized Controlled Trial of Biofeedback vs. Diazepam vs. Placebo Several high-quality controlled trials in this domain are about to be published N= 38 patients Run-in Conservative Management 3 days Run-In Responders x Biofeedback Follow-Up Evaluation Diazepam 5mg Placebo Pills EOT 3mo mo mo 8% 7% % 5% % 3% % % % Proportion Reporting Adequate Relief 3 months following end of treatment ** p<. ** ** ** Education Diazepam Placebo Biofdbk Unassisted Bowel Movements per Week 3 months following end of treatment 5 3 * ** Diazepam Placebo Biofeedback * p<.5 ** p<. 5
Maintenance: % of Responders at 3 mo who are still responders at and mo FU % 8% % % % % mo FU mo FU Education Pills Biofeedback Bowel Movements/Week Bowel movements per week.5 N=5; treatment= 5 biofeedback sessions ** ** ** ** 3.5 3.5.5.5 Baseline -mo FU -mo FU -mo FU -mo FU Slow Transit Slow Transit + PFD Chiarioni et al. Gastroenterology ;(): A9. Laxatives per week.5.5.5 Laxatives per week N=5; treatment= 5 biofeedback sessions ** ** ** Baseline -mo FU -mo FU -mo FU mo FU Slow Transit Slow Transit + PFD Chiarioni et al. Gastroenterology ;(): A9. Gut Transit: Number of Sitzmarks on Day 5 # of Sitzmarks 8 8 Baseline -mo FU -mo FU -mo FU -mo FU Slow Transit N=5; treatment= 5 biofeedback sessions ** ** ** ** Slow Transit + PFD Chiarioni et al. Gastroenterology ;(): A9. Overall Conclusions Biofeedback is the treatment of choice for PFD constipation More effective than an active placebo (diazepam) and ordinary placebo (inert pill) More effective than laxatives More effective than education and good clinical management Biofeedback is ineffective for slow transit constipation or constipation-type IBS if PFD is not co-present Biofeedback is the treatment of choice for fecal incontinence that does not respond to initial standard management, if the incontinence is not due to serious nerve damage or serious anatomical defect Biofeedback has significantly higher success rates than standard medical treatment for PFD and FI Biofeedback is inexpensive, without significant negative side effects, and leads to long-term improvement