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Chapter 13 Medical, Behavioural and Minimally Invasive Therapy
Moore KH, O’Sullivan RJ, Simons A, Prashar S,Anderson P, Louey M (2003) Randomised con-
trolled trial of nurse continence advisor therapy compared with standard urogynaecology regimen for conservative incontinence treatment: efficacy, costs and two year follow up.Br J Obstet Gynaecol 110: 649–657
Porru D, Campus G, Caria A, Madeddu G, Cucci A, Rovereto B, Scarpa RM, Pili P, Usai E (2001)
Impact of early pelvic floor rehabilitation after transurethral resection of the prostate.Neu­rourol Urodyn 20 :53–59
Radley SC, Chapple CR,Bryan NP et al (2001) Effect of methoxamine on maximal urethral pres-
sure in women with genuine stress incontinence: a placebo-controlled, double-blind cross­over study. Neurourol Urodyn 20 :43–52
Sander P, Mouritsen L,Andersen JT, Fischer-Rasmussen W (2002) Should measurement of max-
imum urinary flow rate and residual urine volume be a part of a “minimal care” assessment programme in female incontinence? Scand J Urol Nephrol 36: 124–127
Shafik A,Shafik IA (2003) Overactive bladder inhibition in response to pelvic floor muscle exer-
cises.World J Urol 20:374–377
Subak LL,Johnson C,Whitcomb E,Boban D,Saxton J,Brown JS (2002) Does weight loss improve
incontinence in moderately obese women.Int Urogynecol J Pelvic Floor Dysfunct 13 :40–43
Thuroff JW, Bunke B, Ebner A et al (1991) Randomized, double-blind, multicenter trial on treat-
ment of frequency,urgency and incontinence related to detrusor hyperactivity: oxybutynin versus propantheline versus placebo.J Urol 145: 813–816;discussion 816–817
Thüroff JW, Chartier-Kastler E, Corcus J, Humke J,Jonas U, Palmtag H,Tanagho EA (1998) Med-
ical treatment and medical side effects in urinary incontinence in the elderly.World J Urol 16 [Suppl 1]:S48–S61
Truijen G, Wyndaele JJ, Weyler J (2001) Conservative treatment of stress urinary incontinence in
women: who will benefit? Int Urogynecol J Pelvic Floor Dysfunct 12 : 386–390
Van Kampen M, Deweerdt W, van Poppel H,de RidderD,Feys H, Baert L (2000) Effect of pelvic-
floor re-education on duration and degree of incontinence after radical prostatectomy: a ran­domised controlled study. Lancet 355: 98–102
Van Kerrebroeck P, Kreder K, Jonas U,Zinner N, Wein A (2001) Tolterodine once-daily: superior
efficacy and tolerability in the treatment of the overactive bladder. Urology 57: 414–421
Visco AG,Weidner AC, Cundiff GW,Bump RC (1999) Observed patient compliance with a struc-
tured outpatient bladder retraining program.Am J Obstet Gynecol 181: 1392–1394
Wilson PD, Herbison GP (1998) A randomized controlled trial of pelvic floor muscle exercises to
treat postnatal urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 9 : 257–264
197
Chapter 14
Chapter 14 Medical and Behavioral Treatment of Fecal In-
Medical and Behavioral Treatment of Fecal Incontinence
William E.Whitehead
199
14
Contents
14.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . 200
14.2 Education and Medical Management . . . . . . . . . . . . 200
14.2.1 Antidiarrheal Medications . . . . . . . . . . . . . . . . . . 201
14.2.2 Laxatives for Constipation-Related Fecal Incontinence . . 202
14.2.3 Antegrade Colonic Lavage . . . . . . . . . . . . . . . . . . 203
14.3 Biofeedback . . . . . . . . . . . . . . . . . . . . . . . . . . 203
14.3.1 Theory of Biofeedback . . . . . . . . . . . . . . . . . . . . 203
14.3.2 Patient Selection . . . . . . . . . . . . . . . . . . . . . . . 205
14.3.3 Diagnostic Evaluation . . . . . . . . . . . . . . . . . . . . 205
14.3.3 Efficacy of Biofeedback . . . . . . . . . . . . . . . . . . . 205
14.3.4 How Does Biofeedback Work? . . . . . . . . . . . . . . . . 206
14.3.5 Combining Biofeedback with Surgery
or Medical Management . . . . . . . . . . . . . . . . . . . 208
14.4 Summary and Conclusions . . . . . . . . . . . . . . . . . 208
References . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
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William E.Whitehead
14.1 Introduction
The treatment algorithm for fecal incontinence involves a progression from medical management and education to behavioral treatment (pelvic floor exercises and/or bi­ofeedback) to surgical repair of the pelvic floor,and if these steps fail, it may end with the management of incontinence with diapers or other containment devices or with a colostomy. Electrical stimulation of sacral nerves is being investigated as an alterna­tive to surgery (Kenefick et al. 2002; Matzel et al. 2003; Rosen et al. 2001). This algo­rithm is dictated by an effort to try first those treatments that are least costly and have the lowest morbidity. However, there are patient characteristics that help to identify the patients who are most likely to benefit from each type of treatment.These will be discussed in this chapter,along with a description of each treatment and the evidence for its effectiveness.
14.2 Education and Medical Management
A recently published controlled clinical trial (Norton et al. 2003) shows that education about the causes of incontinence and advice about diet can improve bowel control even in patients who have been referred to a tertiary referral center. Norton and col­leagues showed that education by a nurse was as effective as biofeedback training and that approximately 80% of patients were improved. The effectiveness of education combined with medical management was confirmed by our laboratory (Heymen et al. 2001a): we found that 35% of patients referred by gastroenterologists for behavioral treatment obtained adequate relief of their fecal incontinence after 4 weeks of medical management.
14
The educational component of medical management should include
A description of the anatomy of the pelvic floor and the mechanisms for main-
taining continence. If the patient has undergone a diagnostic evaluation, this description can be individualized to include a description specific to the pa­tient, i.e., whether the incontinence is the result of impaired sensation, weak muscles, anatomical defect, etc.
Education should also include taking a history or having the patient keep a
symptom diary to identify precipitants of incontinence that may be unique to the patient and then providing suggestions for how to avoid or minimize the impact of these factors. For example,a patient whose incontinence is precipitat­ed by coughing or lifting may be taught to contract pelvic floor muscles before these events,while a patient with incontinence precipitated by diarrhea may be offered an antidiarrheal medication.
The educational component should also include dietary advice to improve
stool consistency.
For patients with constipation as a contributing cause of incontinence, educa-
tion should include habit training,i.e., encouragement to take advantage of the gastrocolic reflex by scheduling bowel movements after the same meal each day (Shepherd et al. 1989; Lowery et al. 1985; Tariy et al. 2003).
Chapter 14 Medical and Behavioral Treatment of Fecal Incontinence
Diarrhea (Leigh and Turnberg 1982; Nelson et al.1998) and constipation (Nelson et al. 1998; Chassagne et al. 1999) are both recognized risk factors for fecal incontinence.Di­arrhea increases the risk of incontinence because liquid stools are more difficult to control,especially in the presence of an anatomical defect in the sphincter,and also be­cause forceful peristaltic contraction may overwhelm the sphincter.Constipation con­tributes to incontinence when a large fecal impaction develops in the rectum and caus­es reflex dilation of the internal anal sphincter, allowing liquid stool to leak out. Diar­rhea or constipation is often not the sole cause of fecal incontinence but interacts with injuries to the pelvic floor or its innervation. In these cases drugs directed at normal­izing stool consistency may be combined with behavioral or surgical treatment.
14.2.1 Antidiarrheal Medications
The most common antidiarrheal medications are listed in Table 14.1, together with rec­ommended doses and precautions.These medications include loperamide,which is an opioid analog that does not cross the blood–brain barrier; and diphenoxylate,an opi­oid analog that acts peripherally to control diarrhea but does cross the blood–brain barrier and cause CNS side effects. Figure 14.1 shows a comparison of loperamide to codeine and diphenoxylate in a randomized cross-over study (Palmer et al. 1980) of patients with diarrhea and fecal incontinence. Loperamide is the preferred drug both because it has fewer side effects and because it is more effective than diphenoxylate. The major precaution with loperamide is that patients may tend to exceed the recom­mended dose and to develop constipation. Loperamide is sold as a 2-mg tablet, which may not allow titration to the appropriate level because this drug is very potent, but a liquid formulation of loperamide is sold for this purpose.
The tricyclic antidepressant, amitriptyline, has also been found to be an effective antidiarrheal agent that improves fecal incontinence (Santoro et al. 2000). However, amitriptyline has potent CNS effects and should probably be reserved for patients with fecal incontinence associated with irritable bowel syndrome, where its antinoci­ceptive properties are also desirable (Jackson et al. 2000).
Other antidiarrheal agents such as bulking agents and bismuth compounds may also be helpful for milder diarrhea. Fiber supplements have specifically been shown to reduce fecal incontinence in the elderly (Bliss et al. 2001).
201
Table 14.1. Drugs for diarrhea-related fecal incontinence
Drug Dose Comments
Loperamide 2–4 mg average (titrate) No CNS action; may cause consti-
Diphenoxylate ± atropine 2 × 2.5-mg tablets Less effective than loperamide,
Amitriptyline 20 mg Decreases urgency and frequency
Psyllium and gum agar Milder cases, elderly
pation
more side effects than lopera­mide
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William E.Whitehead
Fig. 14.1. Cross-over study comparing loperamide,codeine, and diphenoxylate.*Loperamide sig­nificantly better than diphenoxylate.From Palmer et al.(1980)
14.2.2 Laxatives for Constipation-Related Fecal Incontinence
14
Constipation is known to be the cause of incontinence in more than 90% of fecally in­continent children (Shepherd et al. 1989;Levine 1975), and it is also associated with fe­cal incontinence in many elderly people (Chassagne et al. 1999).This type of inconti­nence is often referred to as overflow incontinence.Its treatment consists of removing the fecal impaction, which is the cause of internal anal sphincter inhibition, and pre­venting the recurrence of fecal impaction through (a) teaching the patient to attempt defecation at a regular time each day (following a meal) and (b) starting the patient on a daily or frequent laxative regimen (Lowery et al. 1985; Tariy et al. 2003).
Early attempts to treat overflow incontinence in children used enemas; patients were instructed to take an enema if they had no bowel movement for 2 days (Lowery et al. 1985). However, there are two practical problems with enemas: (a) They are poor­ly tolerated by patients, especially children,and (b) if given daily,they cause tolerance and become less effective. In recent studies, investigators have shown that oral laxa­tives are as effective as enemas (van der Plas et al.1996; van Ginkel et al.2003).
As shown in Table 14.2, there are several classes of laxatives that can be used to treat constipation.The stimulant laxatives based on bisacodyl, cascara,or senna are the best known laxatives, and they are effective if used intermittently, i.e., no more often than three times per week. However, if used daily, patients rapidly become tolerant and re­quire increasing doses.
Osmotic laxatives are those that act primarily by causing secretion of water into the small intestine. The most popular is polyethylene glycol, now marketed as Mirilax. This compound is more effective than placebo at a dose of 8–16 oz daily (Cleveland et al. 2001). Two different formulations of magnesium solutions are also used: magne­sium citrate and milk of magnesia. Milk of magnesia is relatively cheap and is effec­tive; it is the most common laxative used in nursing homes in the United States and is also effective when used in children. Sorbitol and lactulose are also used as osmotic
Chapter 14 Medical and Behavioral Treatment of Fecal Incontinence
Table 14.2. Drugs for constipation-related fecal incontinence
Drug type Examples Comments
203
Stimulant laxatives Bisacodyl, senna,cascara Use no more than every other day to
Osmotic laxatives PEG, Mg solutions, Good for daily dosing. Some cause
lactulose, sorbitol electrolyte imbalance
Stool softeners Docusate sodium Mild. Require daily dosing
Enemas Phosphosoda Alternate day dosing to avoid toler-
avoid tolerance
ance. Less effective than other types
laxatives but are poorly tolerated by adults because they produce excessive gas and bloating. The chief advantage of the osmotic laxatives is that they do not result in tol­erance, so they can be used daily without losing effectiveness.The only caution is that some of these compounds may cause electrolyte imbalance through absorption of salts or loss of potassium through high-volume secretion.
The overall effectiveness of laxatives for constipation-related fecal incontinence in children is 60%–80% (Lowery et al. 1985; Brazzelli and Griffiths 2001). There are no good studies to estimate effectiveness in adults.
14.2.3 Antegrade Colonic Lavage
Patients with spina bifida frequently have a combination of a denervated sphincter (no voluntary contraction) and constipation (Whitehead et al. 1986). Malone et al. (1990) pioneered a technique for treating this twin deficit by creating an appendicostomy or an artificial conduit to the cecum or proximal colon and having the patient irrigate their colon each morning with large volumes of tap water or a saline enema while sit­ting on the toilet.Although time consuming, this usually eliminates fecal incontinence for at least a day. In published series, the use of this technique was associated with achieving continence in 77% (Yerkes et al. 2003).Although the Malone procedure has been used mostly in children with spina bifida, it may also be effective in adults with overflow incontinence or in adults with constipation without incontinence (Marshall et al. 2001). Modification of the Malone antegrade colonic enema procedure includes irrigating the descending and sigmoid colon by introducing a tube per rectum, ad­vancing it approximately 25 cm,and pumping water or saline enema solution in by this route. This technique is also reported to substantially reduce constipation and may eliminate constipation-related fecal incontinence (Christensen et al.2000).
14.3 Biofeedback
14.3.1 Theory of Biofeedback
Biofeedback is a form of motor skills learning in which the individual tries to perform a task and learns from successes and failures how to refine their performance. This is the way we learn to kick a soccer ball. In the case of weak muscles such as a partially
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William E.Whitehead
denervated sphincter, however,the intrinsic feedback to know how well we have con­tracted the muscle may be too weak to support learning. To compensate for this lack of intrinsic sensory feedback, in biofeedback training we measure the sphincter contrac­tion sensitively, amplify it electronically,and feed it back to the patient as a visual dis­play (Whitehead and Thompson 1993).
In clinical biofeedback training, a nurse or other therapist works with the patient and provides verbal instructions on how to contract the sphincter as well as encour­agement and praise for successive approximations to the desired response,which may include stronger contractions or responses to weaker distensions of the rectum. The therapist also helps the patient to recognize when (if) they are inappropriately con­tracting the rectus abdominis muscles when they attempt to contract the sphincter and teaches them to keep these muscles relaxed while practicing sphincter contrac­tions.
Biofeedback for fecal incontinence is usually done with a balloon-tipped catheter, which is used to simulate the sensation of rectal filling, and a pressure sensor in the anal canal which is used to measure voluntary sphincter contraction. The patient is in­structed to contract whenever they detect the distention of the balloon.An alternative technique is to use the averaged electromyographic (EMG) activity from the external anal sphincter as the feedback signal. This EMG can be recorded with an acrylic anal plug that has metal plates on its surface to detect the EMG activity. The electrical po­tentials recorded by these sensors are amplified, filtered to eliminate smooth muscle EMG, averaged, and displayed to the patient.In an intact sphincter muscle, this aver­aged EMG activity is proportional to the squeeze pressure in the sphincter. However, if there is a significant anatomical defect (sphincter muscle separation), EMG activity may be normal despite ineffective squeeze pressures.
There are no direct comparisons between pressure biofeedback training and EMG to indicate which is more effective. Potential advantages of pressure feedback over EMG include (a) avoiding the confounding effect of anatomical defects in the sphinc­ter on the feedback display and (b) the greater ease of combining sensory training (learning to detect and respond to weaker rectal distensions) with training to improve sphincter strength. However, in a meta-analysis of the literature on biofeedback train­ing, Heymen and colleagues (2001b) found that clinical outcomes reported in studies that used EMG feedback were significantly better than those reported in studies using pressure feedback.Direct comparisons are needed to confirm this.
Biofeedback training requires a median of four training sessions (range,1–12) car­ried out at weekly or biweekly intervals. Each session lasts 40–60 min. Training ses­sions in the clinic are normally combined with daily pelvic floor exercises carried out by the patient at home, and the biofeedback sessions with the therapist are used to teach the patient how to contract appropriately and how to recognize weak sensations of rectal distention.Weekly or less frequent biofeedback sessions with the therapist are preferable to daily sessions because the patient needs time to practice and to benefit from daily pelvic floor exercises.
Biofeedback training is normally carried out by a nurse,physiotherapist, or a psy­chologist rather than a physician because physician time is more expensive. The cost of biofeedback training varies by provider and setting, and there is no standard cost. In the author’s medical center,biofeedback training is provided by a nurse under phy­sician supervision and costs $194 per visit (CPT code 90911).
Chapter 14 Medical and Behavioral Treatment of Fecal Incontinence
14.3.2 Patient Selection
The data on which patients respond best to biofeedback training is limited, but the fol­lowing are general guidelines. Since biofeedback requires a motivated and cooperative patient, it is less likely to succeed in children younger than 7 years old and in adults with dementia, anxiety, or depression (Whitehead et al.1985, 1986; Heyman et al. 2001). It is also unlikely to benefit patients with a completely denervated sphincter such as those with a spinal cord transaction (Whitehead et al. 1986),and it is less likely to ben­efit those with substantial impairment in the ability to appreciate rectal distention (Chiarioni et al. 2002). However,patients with partial loss of sensation or with sphinc­ter weakness that is due to partial nerve injury may be the best candidates for biofeed­back. On logical grounds, one would expect patients with anatomical defects in the pelvic floor resulting from trauma to be poor candidates for biofeedback training, but studies have so far not confirmed that sphincter morphology predicts the outcome of biofeedback training (Norton et al.2003).
14.3.3 Diagnostic Evaluation
Because biofeedback is relatively inexpensive compared to surgery and because it in­volves no morbidity, some advocate trying biofeedback in all patients who have not benefited from medical management rather than performing an expensive diagnostic evaluation to identify the mechanism of incontinence. However, a diagnostic evalua­tion by anorectal manometry and anal canal ultrasound will influence my expectation of success and direct how the biofeedback training is done, i.e.,whether to emphasize strength training or sensory training. For this reason, the author recommends a diag­nostic evaluation prior to initiating biofeedback training. Anorectal manometry is used to assess resting and squeeze pressures in the anal canal, thresholds for the per­ception of rectal distention and urge to defecate,and compliance of the rectum; it is di­rected towards assessing the innervation of the pelvic floor and rectum. Endoanal ultrasound, on the other hand, tells us nothing about the innervation of the rectum but is the gold standard for assessment of morphological defects. Pudendal nerve motor latencies, which were once advocated to evaluate the innervation of the pelvic floor, has insufficient specificity to be recommended (Diamant et al.1999).
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14.3.3 Efficacy of Biofeedback
Our laboratory conducted a systematic review and meta-analysis of the literature on biofeedback treatment for fecal incontinence up to 2001 (Heymen et al. 2001b),which indicates that the median proportion of patients reporting a significant improvement is 74%. Studies varied in how they defined improvement. The proportion of patients who met a criterion of continence was approximately 50%.Follow-up has been report­ed for periods up to 1 year and suggests that the benefits of training are well sustained for at least this length of time.We were unable to find adequately controlled studies of biofeedback prior to 2002.
Since publication of this review, a randomized controlled trial was reported form St. Mark’s Hospital (Norton et al.2003),which compared four treatments of increasing complexity and cost: one-fourth of patients were provided education by a nurse with
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William E.Whitehead
education about incontinence, a second group received education plus pelvic floor ex­ercises, a third group received biofeedback in addition to education and pelvic floor exercises, and the last group received all these components plus a portable biofeed­back device to practice with at home.A total of 171 patients were randomized to these groups (159 were women). The overall results were excellent: 80% of patients de­scribed themselves as improved,and there were significant increases in sphincter rest­ing and squeeze pressures,decreases in the frequency of incontinence, improvements in quality of life, and decreases in anxiety and depression. However, there were no dif­ferences between the groups on any of these outcome measures: the education-only group achieved improvements comparable to the biofeedback and home practice groups.
The results of the Norton trial (Norton et al. 2003) suggest that biofeedback pro­vides no specific benefit and that the cost associated with it may be unjustified. How­ever, this study contrasts with a large literature suggesting that biofeedback is effective (Heymen et al. 2001b).Additional studies are needed to evaluate the specific benefit of biofeedback after controlling for standard medical management,and such studies are underway.
14.3.4 How Does Biofeedback Work?
There is controversy as to whether biofeedback works primarily by improving the strength of pelvic floor muscles (reflected in increased anal canal squeeze pressures) or whether it works primarily by improving the patient’s ability to detect rectal disten­sions. The earliest publications on biofeedback emphasized the acquisition of muscle strength and paid relatively little attention to sensation (Whitehead et al. 1985; Engel et al. 1974; Cerulli et al. 1979). However, studies by Latimer et al. (1984) and Miner et al. (1990) suggested that sensory discrimination training (i.e., improving the patient’s ability to recognize weaker rectal distensions and to respond to them more quickly may be the most important ingredients of successful training.A recent study by Chi­arioni and colleagues (2002) provides the most compelling data to date supporting the view that sensory training is the key ingredient of biofeedback training.
Chiarioni and colleagues (2002) recruited 24 patients with severe fecal inconti­nence (loss of solid stool at least once a week) from a consecutive series of patients and provided biofeedback training to all of them. The biofeedback consisted of coordina­tion training in which they were asked to respond to the sensation of rectal distention by contracting the pelvic floor muscles. Emphasis was placed both on increasing squeeze pressures and on learning to recognize and respond to weaker sensations. At the end of 3 months of biofeedback training, 17 patients were judged to be responders because they showed at least a 75% reduction in the frequency of fecal incontinence, and this group included 12 patients who were completely continent following biofeed­back training. The remaining seven patients were labeled non-responders.The inves­tigators then contrasted the responders to the non-responders with respect to both squeeze pressures and sensory thresholds before and after biofeedback training. As shown in Fig. 14.2,all responders had sensory thresholds (threshold for first sensation) of 20 ml or less following training, whereas all but one of the non-responders had sen­sory thresholds of 50 ml or greater. Moreover, pretreatment sensory thresholds were predictive of which patients would respond to biofeedback training: all responders had baseline sensory thresholds of 50 ml or less, whereas the majority of non-respond­ers had sensory thresholds higher than this range prior to training. Figure 14.3 shows