Introduction
As a common denominator of all the clinical aspects treated in this book, there is the awareness of poten- tial benefits derived from rational management of fecal incontinence (FI) and the need for further efforts to improve the effectiveness of traditional and new treatments. Indeed, although progress made in this field during the last few decades has been signif- icant, the lack of detailed knowledge in the physiolo- gy of fecal continence far too frequently makes the application of therapeutic procedures empiric and pragmatic. Moreover, there are discrepancies between countries and regions in referring patients to centers dedicated to FI management. This causes different attitudes in performing a homogeneous diagnostic workup, in application of similar strict selection criteria to the variety of available treat- ments, and in reporting results of the applied thera- pies. Worldwide, national institutes for health inade- quately support medical research on FI treatment, even though the social, economic, and clinical importance of FI to society has been very well recog- nized. On the other hand, research into FI is all too frequently sponsored only by companies with a com- mercial interest in the subject.
Nevertheless, a number of priorities have been identified. In 2002, the Consensus Conference
“Advancing the Treatment of Fecal and Urinary Incontinence Through Research: Trial Design, Out- come Measures, and Research Priorities” [1], empha- sized the fields of primary interest (Table 1) to im- prove knowledge and treatment of FI by further plan- ning research programs. Representatives of all spe- cialties involved in FI management contributed to this conference. Even if the goal of the conference to produce significant results in 5–10 years is very ambitious, the relevance of the priorities identified remains actual. Following the same schema of this book, the conference emphasized: (1) pathophysio- logical and behavioral aspects, (2) diagnostic prob- lems, (3) treatment-related issues, and (4) aspects related to specific clinical conditions.
Pathophysiological and Behavioral Aspects
Further studies investigating pathophysiological mechanisms of FI is of crucial importance because progress will have an impact on both diagnostic and therapeutic strategies. Due to the possible multifac- torial origin of FI and the existence of different clini- cal presentations, basic research into the influence played by each of the numerous factors involved in continence control can be of help [2]. Future studies must consider that the traditional assumption that women younger than 65 years of age are at maximum risk of FI because of obstetric trauma to anal sphinc- ters or pudendal neuropathy is not true [3]. Preva- lence of FI in men has been certainly underestimated.
Also, other causative factors, different than those secondary to childbirth, have to be of primary inter- est, these being neuropathies (diabetes, multiple scle- rosis, Parkinson’s disease, spinal cord injury, sys- temic sclerosis, myotonic dystrophy, amyloidosis) and conditions related to idiopathic FI. Moreover, conditions affecting general health or ability to per- form daily activities (stroke, immobility) are signifi- cantly related to FI. These features could explain why nursing home residence is the most prominent factor associated with FI in patients affected by the above- mentioned diseases.
The real role of sphincter tears, recent or previous, in the development of FI is being rethought, not only in relation to the pathophysiological aspect but also to treatment strategy. Primary conditions and associ- ated factors need to be elucidated in regard to whether a limited or extended (how long? how large?) lesion involving either or both internal and external anal sphincters has caused FI [4–6]. Relationships between sphincter integrity and anorectal sensorial perception should be deeply studied, because they probably are the interpretation key of positive effects recently observed using sacral nerve stimulation (SNS) in patients with iatrogenic FI. On the other hand, nontraumatic FI is worthy of special attention because of the complexity of patterns possibly involved. Studies with electrophysiological tech-
Future Perspectives in Management and Research of Fecal Incontinence
Carlo Ratto, Angelo Parello, Lorenza Donisi, Francesco Litta, Giovanni B. Doglietto
37
niques, magnetic resonance imaging (MRI), and positron emission tomography (PET) could explain aspects of the correlation between the central nerv- ous system (CNS) and targeted pelvic organs involved in fecal and urinary continence. This will contribute to a more rational application of SNS using adequate criteria for patient selection [7].
Behavior in relation to FI is of unique impact on a patient’s lifestyle and quality of life (QoL). Coping mechanisms should be analyzed in different sub- groups of patients according to their specific clinical conditions [8–10]. For this purpose, adequate meth- ods to measure coping mechanisms and behavior
related to FI severity should be found and used [11].
Unfortunately, each of the scales most often used to measure QoL [12–18] has its strengths and weak- nesses. Efforts should be directed to validate these scales in translated versions in order to use compara- ble forms in different countries [19].
Also, social stigma associated with FI must be acknowledged and then addressed. Due to their reluc- tance to confess to this disabling disorder, patients often renounce or refuse any diagnosis and treatment.
Moreover, depression and anxiety affecting a very large percentage of FI patients (larger than in urinary incon- tinent patients) increase alienation from family and Table 1.Priorities for treatment-related research on fecal incontinence (modified from [1])
Research priorities
Randomized controlled trials
Biofeedback vs. education and medical management Biofeedback strength training vs. sensory training Combined biofeedback plus surgery vs. each alone Combined biofeedback plus drugs vs. each alone Sacral nerve stimulation vs. biofeedback or surgery Development of novel treatments
Develop and test new drugs
Identify the most effective surgery for obstetric tears Optimize existing therapies
Improve adherence and maintenance Evaluate long-term outcomes of surgery
Identify psychological symptoms that predict who consults Geriatric population
Practical treatments for frail/demented elderly Evaluate assisted toileting in nursing homes Diagnostic tests
Develop normative values for diagnostic tests
Compare history and physical examination with diagnostic tests in predicting pathophysiology and response to biofeedback
Evaluate electromyogram of external anal sphincter and puborectalis muscle for diagnosis of neurogenic fecal incontinence
Evaluate relationship of quality of life to fecal incontinence severity Standardize evaluation of severity and quality of life
Further studies of pathophysiological mechanisms Prevention
Determine which diagnostic tests predict obstetric injury
Longitudinal studies of relationship of fecal incontinence to functional gastrointestinal disorders Prevent anatomic defects leading to surgery by modifying behaviors (e.g., straining or hard stools) Patient concerns
Counter social stigma associated with fecal incontinence Provide better patient education regarding risk factors Pediatric gastroenterology
Randomized controlled trial of laxative regimens in pediatric fecal incontinence Compare enemas with oral laxatives in pediatric fecal incontinence
Compare enemas with toilet training in functional nonretentive fecal soiling
Randomized controlled trial comparing appendicostomy, colostomy, sphincter reconstruction, and artificial bowel sphincter in spinal cord injury and anorectal malformations
friends and create social isolation, with a significant impact on the social costs attributable to the disease. All these factors should be detailed and evaluated. There- after, informative campaigns should be promoted and psychological measures standardized to support these patients. In particular, risk factors of FI must be illus- trated to subjects who are potentially incontinent in order to motivate them to investigate their condition.
Diagnostic Problems
Related to prevention of FI, of primary importance is the identification of diagnostic tests predicting sphincter lesions, not only obstetric [20] but second- ary to other surgical procedures. Moreover, the rela- tionship of FI to other functional gastrointestinal dis- orders should be better investigated in order to delimitate this subgroup of patients and address spe- cific treatments [2].
The lack of homogeneity in the diagnostic workup for FI should be solved. One measure could be the identification of reference centers in which all the basic diagnostic tools are available and procedures performed according to largely shared standards [21]. Efforts must be made to improve diagnostic accuracy of anorectal tests, and normative values for each diagnostic test should be provided according to patients’ age and gender [22]. The actual difficulty of finding measurable physiological parameters predict- ing FI severity, as well as treatment outcome, should be overcome by specifically designed trials using standard procedures for anorectal manometry (ARM) plus rectal sensory assessment, endoanal ultrasound (EAUS), and anorectal electrophysiology (AREP) in order to definitely establish the diagnostic value of each diagnostic tool alone and together in a multimodal diagnosis [23]. A specific set of parame- ters should be identified for each condition as a min- imum required standard [24–26]. Moreover, other procedures (MRI, contrast defecography, and MRI defecography) could be selectively used in specific clinical conditions. Due to the large – and often con- trasting – amount of data available in the literature concerning the diagnostic and prognostic value of physiological parameters [27–29], an accurate revi- sion is desirable with the aim of achieving consensus.
It would be beneficial to relate diagnostic and prog- nostic parameters to specific treatment options in order to elucidate the therapeutic potentials of each.
Treatment-Related Issues
Randomized controlled trials (RCTs) demonstrating not only effectiveness but also therapeutic validation
are needed concerning almost all of the available treatments (biofeedback, sphincteroplasty, medica- tions). The 2002 Consensus Conference [1] highlight- ed the necessity to obtain evidence of potential bene- fits using different treatment combinations utilizing synergistic effects of combined therapies in compar- ison with a single approach. This concept remains an actuality: combination of biofeedback plus surgery vs. each alone, or combination of biofeedback plus medications vs. each alone could be useful compar- isons. SNS frequently holds a central position in the therapeutic algorithm for treating an increasing vari- ety of FI conditions (following failed behavioral ther- apies and preceding anal sphincter replacement operations); however, its role needs to be confirmed in RCTs designed in specific situations. From this perspective, it will be interesting to confirm the effec- tiveness of SNS both in FI patients with sphincter lesions already treated with overlapping sphinctero- plasty and in those with untreated sphincter tears.
This is according to the aim of future research to optimize existing therapies, improving adherence and maintenance, and evaluating long-term results of a certain approach. This pertains, in particular, to behavioral therapies [30] because they are often con- sidered first-line therapy for FI, being safe, effective, and inexpensive; it will be interesting to establish the impact for patients of changing from behavioral ther- apy to surgery.
The most intriguing aspect for future research is the development of novel treatments. Of course, efforts will be directed to noninvasive (new drugs) or minimally invasive (bulking agents, miniaturized devices) procedures [31–33]. On the other hand, establishing correct indications for available treat- ments could allow identification of the most effective surgery for each FI condition [34, 35].
Aspects Related to Specific Clinical Conditions
A wide review of FI management in specific clinical conditions is presented in the previous chapters of this book. The 2002 Consensus Conference [1] high- lighted the necessity to focus attention primarily on geriatric and pediatric patients. Concerning older subjects, it is very important to counterbalance attempts to cure with patient frailty. Therefore, physicians should identify an adequate treatment for each type of disability, including minimally invasive surgery (implant of new, effective bulking agents) and supportive measures (anal plugs). Nurse educa- tion should be directed to improving assistance to patients, both home and nursing home residents.
As to FI in pediatrics, randomized controlled studies will elucidate the value of enemas, laxatives,
and toilet training in FI and fecal soiling. Moreover, indications and use of surgical approaches should be redefined in FI patients with anorectal malforma- tions and spinal cord injury, and SNS may have a role in neurogenic FI.
Special consideration will be dedicated in the future to FI secondary to multimodal treatment (sur- gery and chemoradiotherapy) for rectal cancer in order to define the pathophysiologic contribution of the multiple factors involved and to establish correct indications to treatment.
Problems related to iatrogenic anal sphincter lesions have been widely discussed. This is a field with large perspectives toward changing the actual approach due on one hand to documentation of the possibility of sphincteroplasty failure [36, 37] and on the other hand, to success with emerging therapies, i.e., SNS. Further RCTs should determine pathophys- iological factors due to sphincter tears, surgery tim- ing (immediate or delayed), reconstruction modality (end to end or overlapping), and, importantly, indi- cations and contraindications to surgery [38–41].
Central and peripheral neuropathies (including those diseases determining nerve dysfunctions) require concentrated investigation to establish spe- cific patterns of pathophysiology useful to address treatment. In this regard, a significant decrease in aggressive treatments (sphincter replacement sur- gery) is anticipated in these conditions in the future, whereas the increasing use of therapies directly impacting pathophysiology (i.e., SNS) will be justi- fied by pathophysiological evidence.
Finally, increased integration of knowledge and cooperation between coloproctologists, urologists, and gynecologists will improve the effectiveness of treat- ment of double fecal and urinary incontinence [42–43].
This condition requires an accurate multimodal diag- nostic assessment. Treatment could provide rehabilita- tive procedures, surgery, or both: precise indications toward the behavioral approach, prosthetic/recon- structive surgery, or SNS need to be defined.
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