PRACTICAL GASTROENTEROLOGY • MARCH 200312

Research Priorities for Fecal Incontinence

GUEST EDITORIAL

Nancy J. Norton

I N T R O D U C T I O N

T he topic of this paper is that of research prioritiesfor fecal incontinence from the patient’s perspec-tive. Much of the research for fecal incontinence

has been focused on improving function. Althoughimproving function is extremely important it is not theonly aspect of treatment that needs to be considered inthe healing process for people who are incontinent.There are issues that I feel should be taken into consider-ation as we move forward with strategies for the future.

There is no question that one’s quality of life isseverely compromised by fecal incontinence. Unfortu-n a t e l y, improvement in quality of life, the goal of everypatient with fecal incontinence, does not necessarilyaccompany the beneficial chances that may result fromt a rgeted medical intervention or surgical interventions.

In a recent prospective study of the long-term out-comes of pelvic-floor exercise and biofeedback for 89patients, Pager and colleagues (1) found that althoughthese interventions brought about long-term improve-ments in incontinence severity scores, as measured bythe St. Mark’s (2) and Pescatori (3) scales, there waspoor correlation between severity scores and scores onthe quality-of-life scale used in the study, the DirectQuestioning About Objectives scale (4). The researchers

write that, “Further research into the factors supportingclinical and quality-of-life improvements, and the rela-tionship of these outcomes, is important,” and they con-clude by suggesting that there are “aspects of treatmentprograms independent of the primary intervention thatare not being appropriately recognized.”

For patients, these remarks by Pager and colleaguesare crucially important. We want to be continent, buttreating incontinence is about more than containment ofurine or feces. The patients in this study reported “talk-ing about things” was the most helpful component. Theywere learning to cope with it and talking about it helped.Learning to cope is paramount. We need to work withpatients to foster the ability for self-care rather thand e p e n d e n c y.

RESEARCH PRIORITY NO. 1 Study and Clarify the Quality of Life Determinants in Fecal IncontinenceA primary research priority must be studies concerningwhat genuinely brings about and constitutes quality-of-life improvements for patients with fecal incontinence.In addition, there must be studies to elucidate the rela-tionship between fecal incontinence severity scores qual-ity-of-life scores. At the same time, quality of life scalesmust be routinely included in all studies of clinical inter-

(continued on page 14)Nancy J. Norton, President, International Foundation forFunctional Gastrointestinal Disorders, Milwaukee, WI.

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ventions aimed at improving aspects of fecal inconti-nence, and the length of intervention studies should bes u fficiently long to adequately assess changes in qualityof life associated with the intervention. In fact, interven-tion studies should be sufficiently long simply to evalu-ate the quality of the intervention. For example, severalrecent studies have suggested that results for overlappingsphincteroplasty do not persist over the long term (5years or more) (5,6).

Clarifying quality-of-life determinants for patientswith fecal incontinence would also support an essentialmoral fact about this condition: A full and humane con-sideration of quality-of-life issues like that outlined byS o ffer and Hill (7), for example—must be the startingpoint of any approach to the evaluation and treatment offecal incontinence. Because patients with this conditioncan be desperate, they and their clinicians are vulnerableto trying risky, novel, or unproved interventions. Thereare lines that need not, and should not be crossed.

RESEARCH PRIORITY NO. 2Validate and Standardize Both a Single Fecal Incontinence Severity Scale and a Single Quality of Life ScaleThere are numerous scoring systems for the severity of fecali n c o n t i n e n c e — Wexner (8), St. Mark’s (2), Pescatori (3),Rockwood (9), among others—and there are numerousscoring systems for quality of life for these patients—the36-item short Medical Outcomes Questionnaire (10), theGastrointestinal Quality of Life Index (11), and Rock-w o o d ’s specific Fecal Incontinence Quality of Life Scale(12), also among others. If research cannot determine whichamong these different sets of scales best serve patients andclinicians alike, then professional organizations like theAmerican Society of Colon and Rectal Surgeons shouldinsist on a standard adoption across institutions of a singleseverity scale and a single quality-of-life scale.

RESEARCH PRIORITY NO. 3Link Diagnostic Tests with Predictive Outcomesand Strategies for Patient ManagementThe summary article of the April 1999 Consensus Con-ference on Treatment Options in Fecal Incontinence (13)listed eight research priorities for fecal incontinence,

three of which in particular merit renewed emphasisfrom the patient perspective. One 1999 priority wasresearch evaluation of the utility of specific diagnostictests in predicting treatment outcomes and in setting oraltering treatment strategies. There is a multitude ofobjective tests of rectoanal function (14)—from analmanometry to rectal balloon manometry, from anorectalelectromyography (EMG) to imaging studies—but therelationship between the objective “results” and patient-management strategies remains unclear.

Meanwhile, some of the current tests, like anorectalEMG, which involves placing standard concentric nee-dles into four quadrants of the sphincter, are not onlyextremely painful but appear to be user dependent interms of the desired result: insight into the integrity of thesensory and motor innervation of the rectoanal region. Ifsuch a diagnostic test does not offer additional informa-tion that factors positively into a patients plan of care andoutcome the test should not be performed.

RESEARCH PRIORITY NO. 4Develop New Drug Treatments for Fecal IncontinenceAnother 1999 priority was development of new drugcompounds for fecal incontinence. The importance of thispriority for patients has been underscored by the recentsuccessful patient advocacy for the renewed availabilityof alosetron (Lotronex) in the US marketplace. Marketingapproval for alosetron, indicated for the treatment of diar-rhea-predominant irritable bowel syndrome (IBS), waswithdrawn by the U.S. Food and Drug Administration inNovember 2000 because of concerns about safety (15).On June 7, 2002 the FDA announced the approval of asupplemental New Drug Application (sNDA) that per-mits the marketing of alosetron with restrictions. Up to20% of IBS patients experience fecal incontinence (16),and for many, alosetron was a life-altering intervention.The patient advocacy for alosetron also served to makeincontinence part of the IBS dialogue.

RESEARCH PRIORITY NO. 5Provide Explanations for Fecal Incontinence and Study How Prevention is PossibleA third 1999 research priority was better understanding

GUEST EDITORIAL

Research Priorities for Fecal Incontinence

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GUEST EDITORIAL

Research Priorities for Fecal Incontinence

of the etiology of fecal incontinence. Patient acceptanceof the condition is supported by clear explanations andfurthered by the understanding that clinical knowledge isleading to preventive measures of benefit to others. Forexample, it is known that the risk of fecal incontinence isincreased by use of forceps or vacuum extraction, byhigh infant birth weight, and possibly by episiotomy(17). What is the risk of the development of fecal incon-tinence associated with these procedures compared withrisks arising from an elective Cesarean delivery?

Mellgren and colleagues (18) studied the long-termcost of fecal incontinence secondary to obstetric injuries.Their study result demonstrated that there is a substantialeconomic cost, as well as a tremendous psychologicalburden on incontinent patients and their families becauseof the disability and treatment that is not always suc-cessful. Editorial commentary to the article suggestedthat, “the best solution would seem to be prevention ofdisease rather than subsequent evaluation and treatment.Prevention of sphincter injury during childbirth shouldbe an achievable goal.” Prevention is always more coste ffective than is subsequent attempted cure. There needsto be a greater dialogue between the colorectal commu-nity and the obstetric community.

RESEARCH PRIORITY NO. 6Understand—and Analyze How Education CanCounter—the Societal Metaphor of “Incontinence”F i n a l l y, we must explore how our culture understandscontinence and incontinence—metaphorically as well asl i t e r a l l y. A social stigma attaches to incontinence, sug-gestive of an impaired identity; in one way or another,patients with the condition are liable to being consideredb l a m e w o r t h y. Such current attitudes are devastating,and they foster a state of secrecy about the condition.With secrecy comes misunderstanding—and the dia-logue that is perpetuated correlates incontinence withi n f a n c y, dependence, and ultimately loss. The words wechoose have significance. For example, Random Housedescribes a diaper as a piece of absorbent material wornas underpants by a baby not yet toilet trained. Suff e r e r sof incontinence are not infants, but rather are contribut-ing members of society who seek a positive and sup-portive environment. Changing our dialogue to off e radult patients “protective undergarments,” not “dia-

pers,” can have a profound affect on an individual’sw e l l - b e i n g .

With understanding and openness, societal attitudescan change. Indeed, witness how the stigmatization thatwas once associated with “cancer” has yielded to knowl-edge and candor over the last 20 years. We can accom-plish a similar transformation of consciousness withrespect to incontinence.

I have a personal interest in the future of incontinentpatients and what is or isn’t happening with research. Ihave lived with fecal incontinence for seventeen years.When I say, “lived with” I mean just that. As an inconti-nent person I must find a way to live with it and not let itconsume my life. It will certainly do that if one does nothave the strength and support to take control of it. Onedoes not escape incontinence; it is even in our dreams.

Incontinence is a symptom of something that hasgone wrong—disease, injury or neglect. Whatever thecause, the ramifications of incontinence in and of itselfare life altering. We are in a unique position to change thefuture for incontinent people. We have the opportunity tocontinue our work together and build on the knowledgeand technology that have brought us this far. ■

R e f e r e n c e s1. Pager CL, Solomon MJ, Rex J, Roberts RA. Long-term outcomes

of pelvic floor exercise and biofeedback treatment for patients withfecal incontinence. Dis Colon Rectum, 2002; 45:997-1003.

2. Lunniss PJ, Kamm MA, Phillips RK. Factors affecting continenceafter surgery for anal fistula. Br J Surg, 1994; 8l:1382-1385.

3. Pescatori M, Anastasio G, Bottini C, Mentasti A. New grading andscoring system for anal incontinence: evaluation of 335 patients. D i sColon Rectum, 1 9 9 2 ; 3 5 : 4 8 2 - 4 8 7 .

4. Tillinger W, Mittermaier C, Lochs H, Moser G. Health-related qual-ity of life in patients with Crohn’s disease: influence of surgicaloperation—a prospective trial. Dig Dis Sci, 1 9 9 9 ; 4 4 : 9 3 2 - 9 3 8 .

5. Malouf AJ, Norton CS, Engel AF, et al. Long-term results of over-lapping anterior anal-sphincter repair for obstetric trauma. L a n c e t,2 0 0 0 ; 3 3 5 : 2 6 0 - 2 6 5 .

6. Halverson AL, Hull TL. Long-term outcome of overlapping analsphincter repair [letter]. Dis Colon Rectum, 2 0 0 2 ; 4 5 : 3 4 5 - 3 4 8 .

7. Soffer EE. Hull T. Fecal incontinence: a practical approach to eval-uation and treatment. Am J Gastroenterol, 2 0 0 0 ; 9 5 : l 8 7 3 - 1 8 8 0 .

8 . Jorge JMN, Wexner SD. Etiology and management of fecal incon-t i n e n c e . Dis Colon Rectum, 1 9 9 3 : 3 6 : 7 7 - 9 7 .

9 . Rockwood TH, Church JM, Fleshman JW, et al. Patient and sur-geon ranking of the severity of symptoms associated with fecalincontinence: the fecal incontinence severity index. Dis Colon Rec -tum, 1 9 9 9 : 4 2 : 1 5 2 5 - 1 5 3 2 .

1 0 . Ware JE, Sherbourne CD. The MOS 36-item Short-Form HealthSurvey (SF-36). I. Conceptual framework and item selection. M e dC a r e , 1 9 9 2 ; 3 0 : 4 7 3 - 4 8 3 .

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