Urinary incontinence in Adults: Acute and Chronic Management: 1996 Update ~ NCB1 B... Page 1 of2
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`NCBI Bookshelf. A service ofihe Natioiial Library of Medicine-., National Institutes of Health.
`
`This |)llbl'iC£lI'i()l’1 is provick-.rl for historical referem.-e only and the.-. informafiun umy be out'o1"tlat.'e.
`
`Urinary Incontinence in Adults: Acute and Chronic Management:
`
`1996 Update
`
`Copyright Notice
`
`AHCPR Clinical Practice Guidelines, No. 2
`
`JA Fanti, DK Newman. and J Coiling.
`
`Rockville (MD): Agency for Health Care Policy and Research (Al-ICPR); 1996 Mar.
`Report No.1 96-0682
`
`Despite the prevalence of urinary incontinence (U1), the condition is widely underdiagnosccl and underreported. Many
`
`health care providers remain uneducated about this condition, and individuals are often ashamed or embarrassed to
`
`seek professional help. Furthermore, Ul diagnostic and treatment practices as well as associated medical costs vary
`
`widely. These factors prompted the selection of Ul in adults as a topic for guideline development. A panel of experts
`
`used an extensive review of scientific literature as well as expert judgment and group consensus to develop this
`
`guideline. Findings and recommendations are presented for (1) prevention, identification, and evaluation of U1; (2) use
`
`of behavioral. pharmacologic, and surgical treatment as well as supportive devices; (3) long—term management of
`
`chronic intractable UI; and (4) education of health professionals and the public. The panel found evidence in the
`
`literature that the treatment of U I can improve or "cure" most patients. They concluded that all patients with U] should
`
`have a basic diagnostic evaluation and that behavioral and pharmacologic therapies are usually reasonable lirst steps in
`management. in addition, vigorous efforts should be made to educate the professional and lay public.
`
`Contents
`
`[About AHCPRJ
`
`Urinary Incontinence in Adults Guideline Update Panel
`
`Guideline Development and Use
`
`Acknowledgments
`
`Foreword
`
`lixccutive Summary
`
`I. Overview
`
`incidence and Prevalence
`
`Risk Factors and Prevention
`
`Costs
`
`Purpose and Scope
`
`Methodology for Updating the Guideline
`
`Clinical Algorithm
`
`2. Identifying and Evaluating Urinary incontinence
`
`Symptoms and Subtypes
`
`lntp://www.ncbi.nlm.nih.gov/books/NBK52169/?rcport=prin1.able
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`2120/2015
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`Patent Owner, UCB Pharma GmbH — Exhibit 2033 - 0001
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`Urinary Incontinence in Adults: Acute and. Chronic Management: 1996 Update — NCBI B... Page 2 of 2
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`Identifying Urinary Incontinence
`
`General Principles of Diagnostic Evaluation
`
`Basic Evaluation
`
`Further Evaluation
`
`3. Treatment of Urinary Incontinence
`
`Behavioral Techniques
`
`Pharmacologic Treatment[a,b}
`
`Surgical Treatrnent
`
`Other Measures and Supportive Devices
`
`4. Chronic lnrractable Urinary Incontinence
`
`Prevalence and Incidence
`
`Assessment
`
`Interventions for Chronic UI
`
`Social and Organizational Milieu ofill
`
`5. Education
`
`Public Education
`
`Professional Education
`
`Abbreviations
`
`Glossary
`
`Contributors
`
`Availability of Guidelines
`
`Attachments
`
`References
`
`SUSJSJEST-9d Citation: liantl JA, Newman DK, Calling J, et al. Urinary Incontinence in Adults: Acute and Chronic
`
`Management. Clinical Practice Guideline No. 2, I-996 Update. Rockville, MD: U.S. Department of Health and Human
`
`Services. Public Health Service, Agency for Health Care Policy and Research. AHCPR Publication No. 96-0632.
`March I996.
`
`Copyright Notice
`
`Hnokshc-.lfII‘l; NBK52toq
`
`http://www.ncbi.nlm.nih.gov/books/NBK52169/?rcport=printable
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`2/20/2015
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`Patent Owner, UCB Pharma GmbH — Exhibit 2033 - 0002
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`

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`|/\bout Al*lCl’R] — Urinary incontinence in Adults: Acute and Chronic Manageinentz 1996... Page 1 oil
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`N(.‘l-ll lloul<shcll'. A servicimftlic National Lilimryof Medicine, National Institutes of licrtltli.
`
`Fantl JA, Newman DK, Coiling J. Urinary Incontinence in Adults: Acute and Chronic Management: 1996 Update, Rockville (MD):
`Agency for Health Care Policy and Research (AH CPR); 1996 Mar. EAIICPR Clinical Practice Guidelines, No. 2.]
`
`Tliis publication is provided for l1iston'cul reference only and the information may be out ‘of date.
`
`[About AHCPR]
`
`The Agency for l-lctilth Care Policy and Research (Al ICPR) was established in December I089 under Public Law
`l0l—239 (Omnibus Budget Reconciliation Act of 1989) to enhance the quality, appropriateness, and cfiectivciicss of
`
`health care services and access to these services. AHCPR carries out its mission by conducting and supporting general
`
`health services research, including medical effectiveness research, facilitating development ofclinical practice
`
`guidelines, and disseminating research findings and guidelines to health care providers, policymakers, and the public.
`
`The legislation also established within AHCPR the Office of the Forum for Quality and Effectiveness in Health Care
`
`(the Forum). The Forum has primary responsibility for facilitating the development, periodic review, and updating of
`
`clinical practice guidelines. The guidelines will assist practitioners in the prevention, diagnosis, treatment, and
`management of clinical conditions.
`
`Guidelines are available in formats suitable for health care practitioners. the scientific community, educators, and
`
`consumers. Al lCPR invites comments and suggestions from users for consideration in development and updating of
`
`Future guidelines. Please send written comments to Director, Office ofthe Forum for Quality and Effectiveness in
`
`Health Care. Al-iCl’R, Willco Building, Suite 310, 6000 Executive Boulevard, Rockville, MD 20852.
`
`Copyright Notice
`l3ool<.shelt' IL): NBlQ;21o7
`
`http:/fwww.ncbi.nlm.nih.gov/books/NBK52167/‘?report:printable
`
`2/20/2015
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`Patent Owner, UCB Pharma GmbH — Exhibit 2033 - 0003
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`

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`Urinary Incontinence in Adults Guideline Update Panel — Urinary Incontinence in Adults:
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`Page 1 of 1
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`Nclll iionksiicll. A .~aei'vic=¢':Jflh1= National Lil-Jrz1r_v of Medicine, National institutes oflleulth.
`
`Fzmtl JA, Newman DK, Collir1g..J. Urinary Incontinence in Adults: Acute and Chronic Management: 1996 Update. Rockville (MD):
`Agency for Health Care Policy and Research [AHCPR); 1996 Mar. (AHCPR. Clinical Practice Guidelines, No. 2.)
`
`This publication is provided for historical reference only andthe information nmy be out cifdate.
`
`Urinary Incontinence in Adults Guideline Update Panel
`
`J. Andrew l-‘anti, MD (Co-Chair)
`
`Diane Kuschak Newman, RNC, MSN, FAAN (Co-Chair)
`
`Joyce Coiling, PhD, RN, FAAN
`
`John 0.1.. Delntncey, MD
`
`Christopher Keeys, Pharml)
`
`Richard Loughcry, FACHA
`
`B. Joan McDowell. PhD, RN, FAAN
`
`Peggy Norton, MD
`
`Joseph Ouslander, Ml)
`
`Jack Schnellc, Phi)
`
`David Slaskin. MI)
`
`Jeannette Tries, MS, OTR
`
`Vernon Urich, MI)
`
`Sharon ll. Vitousck, MD
`
`Barry 1). Weiss, Ml)
`
`Kristene Whitmore, MI)
`
`Copyright Notice
`
`Bcmk.-;|i¢'ll' ll): N|lK5'_*1"/J
`
`http1//www..ncbi-nln1.nih.gov/books/NBK52l 71/?report=printable
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`2/20/2015
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2033 - 0004
`
`

`
`Guideline Development and Use — Urinary Incontinence in Adults: Acute and Chronic Ma... Page 1 of 1
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`N('l3l liool<.sltt‘.ll. A service (tithe National l.i|'.n'ary of Medicine, National lttstittltos 0|" Health.
`
`I-‘anti JA, Newman DK. Coiling .1. Urinary Incontinence in Adults: Acute and Chronic Management: 1996 Update. Rockville (MD):
`Ag_t-.ric_\- for Health Care Policy and Research (Al-ICPR); 1996 Mar. (Al-{CPR Clinical Practice Guidelines, No. 2.)
`
`'l"l1i;-4 publication is provided for l'li5t()I'i(!Ell reference only and the i1'1f(Irmah'-on 1u.a_v be out ‘oi-‘date.
`
`Guideline Development and Use
`
`Guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health
`care for specific clinical conditions. This guideline update was developed by a private-sector panel convened by the
`
`Agency for Health Care Policy and Research (Al-ICPR). The panel employed an explicit. ‘science-based methodology
`and expert clinical judgment to develop specific statements on patient assessment and management for the clinical
`condition selected.
`
`lixtcnsivc literature searches were conducted and critical reviews and syntheses were used to evaluate empirical
`
`evidence and significant outcomes. Peer review and field review were undertaken to evaluate the validity, reliability,
`
`and utility ofthe guideline in clinical practice. The panel's recommendations are primarily based on the published
`
`scientilic literature. When the scientific literature was incomplete or inconsistent in a particular area, the
`
`recommendations reflect the prolbssional judgment of panel members and consultants.
`
`Guidclinc updates are a result ofperiodic review of the state of scientific information and technology. Updates reflect
`new research findings, experience, or technologies and provide specific recommendations in the field.
`
`"We believe that the Al-ICPR-assisted clinical practice guidelines will make positive contributions to the quality of care
`
`in the United States. We encourage practitioners and patients to use the information provided in this Climb-of i’raclic-c
`tiuideline Update. The recommendations may not be appropriate for use in all circumstances. Decisions to adopt any
`
`particular rccornmendation must be made by the practitioner in light ofavailable resources and circumstances
`
`presented by individual patients.
`
`Clifton R. (laus. ScD
`
`Administrator
`
`Agency for Health Care Policy and Research
`
`Publication of this guideline does not necessarily represent endorsement by the U.S. Department of Health and
`Human Services.
`
`Copyright Notice
`
`l'louk.sltt:ll'II): NBK52172
`
`http://www.ncbi.nlm.nih.g_ov/books/NBKL521 72/?rcport=printablc
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`2/20/2015
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`Patent Owner, UCB Pharma GmbH — Exhibit 2033 - 0005
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`

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`Acknowledgments — Urinary Incontinence in Adults: Acute and Chronic Management: 19... Page 1 of2
`
`NCBI Bookshelf. A service of the National Library of Mediflitttt, National Institutes of Health.
`
`liantl JA. Newman DK, Col1ingJ. Urinary Incontinence in Adults: Acute and Chronic Management: 1996 Update. Rockville (MD):
`Agency for Health Care Policy and Research (AHCPR); 1996 Mar. (AIICPR Clinical Practice Guidelines, No. 2.)
`
`"Fhis publication is provided for hisatorical refl-'rt:.nce only and the information ittay be out ‘of date.
`
`Acknowledgments
`
`The panel wishes to acknowledge several other consultants and technical advisers. "I"hey have provided external
`
`reviews for the combined analyses, consultation during panel meetings, and testimony during the open forum. They
`are:
`
`Consultants
`
`Patricia Burns, PhD, RN, FAAN
`
`Ananias Diokno, MD
`
`Teh-Wei llu, PhD
`
`Donna Katzman McClish, PhD
`
`Theltna Joan Wells, Phi), RN, FAAN
`
`Matthew Zack, MD, MPH
`
`Technical Advisers
`
`Jen)’ Blaivzts, MD
`
`Kari 130. Pl‘). l’”l', Phi.)
`
`Carol Brink, MPI I, RN
`
`Chetyl Gartley
`
`Linda Cardozo, MD
`
`Alan Cottenden, l-’hD
`
`Molly Dougherty, PhD, RN, FAAN
`
`Shelia Fiers, RN, BSN, CETN
`
`Katherine Jeter, EdD
`
`Rhonda Kotarinos, MS, PT
`
`Deborah l.ekan-Rutledge, MSN, RN, C
`
`Christine Norton, RN
`
`Mary H. Palmer, RNC. PhD, FAAN
`
`Neil Resnick, MD
`
`Carolyn Sampsclle, Phi), RN, FAAN
`
`Alan Wcin. Ml)
`
`Many other organizations and individuals also made significant contribution during“ the development of this guideline.
`Although they are too numerous to mention here, the Contributors section, which appears later in this docutnent, lists
`
`http://www.nobi.nlm.nih.gow’books/NBK52174/?rcport=printable
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`2/20/20] 5
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`Patent Owner, UCB Pharma GmbH — Exhibit 2033 - 0006
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`

`
`Acknowledgments — Urinary Incontinence in Adults: Acute and Chronic Management: 19... Page 2 012
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`individual consultants, peer reviewers, and support staff. Publication ofthis guideline would not have been possible
`without their collaborative efforts.
`
`Copyright Notice
`
`Bnuk.~;l1:~.lf 1 D: NBK52174
`
`http://www.ncbi.n1m.nih.gov/books/NBK52l74/‘?1'cport=pri11table
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`2/20/201 5
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`Patent Owner, UCB Pharma GmbH — Exhibit 2033 - 0007
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`

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`Foreword — Urinary Incontinence in Adults: Acute and Chronic Management: 1996 Updat... Page 1 of l
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`NCBI liookshelf. A service of the National Lib:-nry of MLdicirtc, National Institutes ofllealth.
`
`I-‘anti JA. Newrnan DK, Coiling J. Urinary Incontinence in Adults: Acute and Chronic Management: 1996 Update. Rockville (M D):
`Agency for Health Care Policy and Research [AtlCPR); 1996 Mar. (AI-ICPR Clinical Practice Guidelines, No. 2.)
`
`This publication is provided for historical reference only and the information may be out of date.
`
`Foreword
`
`Urinary incontinence (Ul) affects approximately 13 million Americans in community and institutional settings.
`Despite its prevalence. and an estimated annual cost ofmore than $15 billion, most affected individuals do not seek
`
`help for incontinence, primarily because of'embarras'sment or because they are not aware that help is available. When
`
`individuals do seek help, evidence exists that practitioners are hesitant or ill prepared to discuss, diagnose, or treat the
`problem.
`
`A ‘number of Federal and private organizations have provided research funding for the study of U I. Data from these
`
`studies indicate that treatment of U1 is effective in most people, but there is an increased need for efforts to inform and
`
`educate the public and health care providers about the condition. Furthermore, there are wide variations in the actual
`
`costs and methods of providing care for U1, in the actual costs per procedure, and the charges within each diagnostic
`group.
`
`it is expected that Ul will continue to be a signilic-ant health care problem in the elderly and institutionalized
`
`populations, and will increase as the population of America continues to age.
`
`This ('l:‘rz.r'ca[ Practice Guideline Update addresses major evaluative, diagnostic, treatment, and management issues of
`
`U1. It was developed under the sponsomhip of the Agency for Health Care Policy and Research (AHCPR), Public
`
`Health Service, U.S. Department ofl-lealth and Human Services. To develop the guideline, AHCPR convened a
`multidisciplinary, e..‘<pcrl panel of physicians, nurses, other allied health care providers, and consumers. The panel lirst
`undertook an extensive and interdisciplinary clinical review ofcurrent needs, therapeutic practices and principles, and
`
`emerging, let.'hnologies for diagnosis and treatment of U]. Second, the panel conducted a comprehensive review of the
`
`lield to define the existing knowledge base and critically evaluate the assumptions and common wisdom in the field.
`
`Third. the panel initiated peer review ofguidelinc drafts with intended users in clinical sites. Comments from these
`
`reviews were assessed and used in developing the guideline.
`
`This is an update of the (.'!:'m'cat' Prac!:'ce Gm'det'ine on lfrinary lnc'onlr'nenc'e in Adults. first published in March I9‘-)2.
`
`This update reilccts new research findings and experience with emerging technologies for U1 diagnosis and treatment,
`
`and provides specific recommendations for diagnosing and managing adult patients with U l.
`
`U rinnry Incontinence in Adults Guideline Update Panel
`
`Copyright Notice
`
`l‘itJuk:iht'lF ll): NHK521(53
`
`http://www..nebi.nlm.nih.gov/books/NBK52163/?report=printable
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`2/20/201 5
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`Patent Owner, UCB Pharma GmbH — Exhibit 2033 - 0008
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`

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`lixecutive Summary — Urinary Incontinence in Adults: Acute and Chronic Management: 1... Page l 012
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`Ntflsl lsoolcslu-It". A service of the National Library of Medicine, National Institutes of Health.
`
`Fantl .lA, Newman I) K, Col1ingJ. Urinary Incontinence in Adults: Acute and Chronic Management: 1996 Update, Roekvillc (MD):
`Agency for Health Care Policy and Research (Al-ICPR); 1996 Mar. (AHCPR Clinical Practice Guidelines, No. 2.)
`
`This f.!ll1'1liC11ififll‘| is provided for laistrrricai reference only and the informaition n1a,v be out of date.
`
`Executive Summary
`
`Urinary incontinence (Ul) plagues 10-35 percent of adults and at least halfofthe 1.5 million nursing home residents in
`the United States. Because of the social stigma of‘ U1, many sufferers do not even report the problem to a health care
`provider. in addition, when it is reported, many physicians and nurses, who need to be educated in this area, fail to
`
`pursue investigation ofUl. As a result, this medical problem is vastly underdiagnosed and undcrrcpotted.
`
`The prevalence oflll, its toll on physical and psychological health, large variations in U] care practices and costs, and
`the urgent need to educate health care providers and the public about this condition prompted the selection ol‘U| as a
`clinical guideline topic.
`
`The purpose otthis guideline is to improve reporting, diagnosis. and treatment of U1; reduce variations in clinical
`
`practice; educate health care providers and consumers about this condition; and, finally, encourage further biomedical,
`
`clinical. and cost research on Ul. The guideline should help clinicians, caregivers, patients, and patients‘ families
`
`understand the assessment, management, and treatment of U1 in adults. Specific reimbursement issues are not
`addressed.
`
`The guideline recommendations apply to the diagnosis and treatment of acquired incontinence in ambulatory and
`nonambulatnry patients in outpatient, inpatient, and long—term care settings. Not addressed are extraurethral Ul, which
`
`is involuntary loss of urine through channels other than the urethra, U] in children, and U l due to no-uropathic
`conditions.
`
`To develop and update the guideline AHCPR convened a multidisciplinary. private—seetor panel ofphysicians. nurses,
`
`allied health professionals, and health care consumers. The panel conducted extensive literature reviews of U1 in
`
`adults, heard public testimony at national hearings, and examined information gathered from consultants. It studied the
`
`cttcctivcness and appropriateness ufdiagnostie and treatment procedures for U1, how they affect outcomes important
`
`to patients, their benefits and adverse consequences, and costs incurred from their use.
`
`The panel "found evidence in the literature that the treatment of Ul can improve or "cure“ most patients. It determined
`
`that U1 in the adult requires a comprehensive approach by health professionals in the initial evaluation -and treatment
`
`with behavioral and pharrnacologic interventions and requires specialists for further diagnostic evaluation and surgical
`intervention.
`
`The guideline provides practice recommendations in three areas:
`
`- Prevention, identification, and evaluation. Specific risk factors For incontinence can be both identified and
`
`remediated with targeted interventions and prevention programs. The identification and documentation of'Ul
`
`can be improved with more thorough medical history taking, physical examination, and rccordkeeping. Routine
`
`tests. oflower urinary tract function should be performed For initial identification of Ul. Situations that require
`further evaluation by qualified specialists include uncertain diagnosis, lack of correlation between symptoms
`
`and clinical findings, failure to respond to adequate therapeutic trial, hematuria without infection, presence of
`
`other comorbid conditions, and confirmation of diagnosis of incontinent patients being considered for surgical
`
`therapy. The specialized tests recommended for further diagnosis are detailed.
`
`- Selection of appropriate therapy. The guideline provides an informed framework for selecting appropriate
`behavioral, pharmacologic, and surgical treatments and supportive devices that can be used to manage U]. The
`
`panel concluded that behavioral techniques such as bladder retraining and pelvic muscle rehabilitation arc
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`http://www.ncbi .nlm.nih.gov/’boo ks/NBK52 l 78/?report=printabl.e
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`2/20/2015
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`Executive Summary — Urinary incontinence in Adults: Acute and Chronic Management: 1... Page 2 M2
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`effective. |ow»risl-; interventions that can reduce incontinence significantly in varied populations. The guideline
`outlines ‘what drugs can be used effectively for certain types of incontinence, including dosages and possible
`
`side effects. The panel recognizes the effectiveness ofsurgical interventions in well-selected cases. Behavioral
`
`and pharmacologic treatments may reduce the need for surgical interventions and may be considered in the
`
`initial management. A new chapter on long—term management of chronic intractable Ul has been added to the
`
`updated chapters from the 1992 guideline. Specilic recommendations on management of patients with this
`condition are provided.
`
`- Education of health professionals and the public. Finally, the guideline calls for continued efforts to educate
`
`health care providers about this condition so that they are sufficiently knowledgeable to diagnose and treat it. it
`recommends that the public be advised to report incontinence problems once they occur and be informed that
`
`incontinence is not inevitable or shameful but is a treatable or at least manageable condition.
`
`This is an update of the guideline, Urinary Incorzlinence in Adulis first published in March i992. This update reflects
`
`new research findings and experience with emerging technologies and innovative approaches for Ul assessment and
`
`relief. The Agency for Health Care Policy and Research and the guideline development panel welcome comments and
`
`suggestions regarding the current guideline. Please address written comments to: Director, Office oi‘ the Forum For
`Quality and }'£t'feclivencss in Health Care, Agency for Health Care Policy and Research, 6000 Executive Boulevard,
`Suite 3l0, Rockville, MD 20852.
`
`Copyright Notice
`llotflcslnrif ID: NHK5217!-i
`
`http://www.ncbi.nlm.nih..gov/books/NBK52l 78/‘?report--printable
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`2/20/2015
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`Patent Owner, UCB Pharma GmbH — Exhibit 2033 - 0010
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`

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`Overview — Urinary incontinence in Adults: Acute and Chronic Management: 1996 Updat... Page l of6
`
`Nt.‘Bl liookslieli. A service ofthc National Library of Medicine, National ]ns|it11te_~;utI[enJth_
`
`Fantl JA. Newman DK, Coiling .1. Urinary Incontinence in Adults: Acute and Chronic: Management: I996 Update. Rockville (MD):
`r\geI1c:»' for Health Care Policy and Research (AHCPR); 1996 Mar. (AHCPR Clinical Practice Guidelines. No. 2.)
`
`This publication is prm-ittezd for historical reference. only and the information may be out ofdnte.
`
`1 Overview
`
`incidt-me-c and Prevalence
`
`Ul affects approximately 13 million Americans, with the highest prevalence in the elderly in both community and
`institutional settings (National Kidney and Urologic Diseases Advisory Board, 1994). The high prevalence of U1 and
`its significant adverse physical, psychological, and financial effects clearly justify more aggressive efforts to identity,
`evaluate, ‘and treat U1 in all settings. Growing evidence indicates that appropriate management can reduce the
`morbidity and cost of U1, particularly in institutionalized populations (0uslander, Palmer, Rovner, at al., 1993).
`
`Although the prevalence of U1 increases with age. Ul should not be considered a normal part of the aging process.
`Rt:poI‘led prevalence rates oftll vary considerably. depending on the population studied, the definition of U1, and how
`
`the information is obtained (Diokno, Brock, Herzng, et al., 1990). Among the population between 15 and 64 years of
`
`age, the prevalence of U] in men ranges from 1.5 to 5 percent and in women from 10 to 30 percent (Burgio, Matthews,
`
`and lingel, |99|; Harrison and Mcmel, I994). Although Ul is usually regarded as a condition affecting older
`mulliparous. women, it is also common in young, nulliparous women, particularly during physical activity (Bo,
`
`Maehlum, Oseid, et al., 1989; Nygaard. Thompson, Svengalis, ct al., 1994)
`
`For noninstitutionalized persons older than 60 years of age, the prevalence of U1 ranges from 15 to 35 percent, with
`
`women having twice the prevalence of men. Between 25 and 30 percent of those identified as incontinent have
`frequent incontinence episodes. usually daily or weekly (Burgio, Matthews, and [Inge], I991; Diokno. Brock, Brown,
`t-:tal.. I986).
`
`Survey data from caregivers of the elderly show that approximately 53 percent of the homebound elderly are
`incontinent (Noelker, 1987). A random sampling of hospitalized elderly patients identified‘ l
`I percent as having
`
`persistent Ul at admission and 23 percent at discharge (Palmer, McCormick, Langford, ct al., 1992).
`
`U1" is generally recognized as one ofthe major causes of institutionalization ofthe elderly. Among the more than 1.5
`
`million nursing, facility residents, the prevalence of U1 is 50 percent or greater, with the majority ofnursing home
`residents having frequent Lil (Ouslander, Kane, and Abrass, I982; Palmer, German, and Ouslander, 199] ). The annual
`
`incidence of U] in nursing home residents who are admitted continent was recently reported to be 27 percent and is
`
`higher in males; it is strongly associated with dementia, fecal incontinence, and inability to walk and transfer
`
`independently (()uslander, Kane, and Abrass, 1982; Palmer. German, and Ouslander, 1991). Additional information
`
`about the prevalence ol'Ul in nursing home residents and homebcund persons is provided in Chapter 4.
`
`Quality of Life
`
`lll imposes a significant psychosocial impact on individuals, their families, and caregivers. Ul results in a loss ol'self-
`
`esteem and a decrease in ability to maintain an independent lifestyle. Dependence on caregivers for activities of daily
`
`life increases as incontinence worsens. Consequently, excursions outside the home. social interaction with friends and
`
`family, and sexual activity may be restricted or avoided entirely (Crrimby. Milsom, Molander, et al., 1993', Harris,
`
`1986; Noelker. I987). Quality—of—life and symptom distress questionnaires for women with U1 have been validated for
`use (Shumaker, Wyman, Uebersax, et al., 1994; Uebersax, Wyman, Shurnaker, et al., 1995).
`
`Unclerreportinglundertreatment
`
`Fewer than half ofindividuals with U1 living in the community consult health care providers about the problem
`
`(Burgio, Ives. Lochcr. et al., 1994). The reasons for this could be the availability ofabsorbent products, low
`
`htlp://www.ncbi.nlm_nih.gov/b0oksfN BK52176/'?rep0rt=printable
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`2/20/2015
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`Patent Owner, UCB Pharma GmbH — Exhibit 2033 - 0011
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`

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`Overview — Urinary Incontinence in Adults: Acute and Chronic Management: 1996 Updat... Page 2 off)"
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`expectations of benefit from reporting the condition to health care providers, and lack of information regarding
`
`management options. There is a lack "of understanding about U1, especially among men, those age 85 or older, and
`those with lower levels of education Branch, Walker, Wetle, ct a!., I994}.
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`Studies show significant variation in perfonnance of adequate examination. assessment, and management of U]. U l is
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`often undetected and underreported by hospital and nursing home personnel, masking its true extent and clinical
`impact and reducing the opportunity for effective management. Assessment tools with cue words for continence Status
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`significantly improve identification of U] in nursing homes andincreasc the opportunity for effective management
`(Palmer, McCormick, Langford, et al.. I992).
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`Risk Factors and Prevention
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`The incidence of incontinence is su fficicntly high that the development of an effective prevention program would
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`reduce new cases of incontinence in community-dwelling women alone by approximately 50,000 cases annually (Siu,
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`Beers. and Morgenstern, I993). There is good evidence that specific risk factors for incontinence can be both
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`identified and remediated with targeted interventions. However, no controlled clinical trial data exist showing that
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`these interventions reduce incontinence incidence, severity, or prevalence. Table 1 provides a summary ofrisk factors
`associated with incontinence that have been documented in the literature. Some of the risk factors for U1 are discussed
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`further in Chapter 2. Only one reference has been listed for each risk factor, although in most cases multiple studies
`have described the same factor. Several ofthe studies described interventions that have moditied these risk factors
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`successfully.
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`Costs
`
`A recent estimate of the direct costs of caring for persons of all ages with incontinence is $1 1.2 billion annually in the
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`community and $5.2 billion in nursing homes (based on I994 dollars) Hu, 1994). This cost estimate is more than 60
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`percent greater than a previous estimate (Irlu, I990), an increase greater than that for the cost of services in the medical
`care sector. Data show that costs of providing care for U1 vary widely (Baker and Blue, 1995; Hu, Gabelko, Weiss, et
`21].. I994).
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`The guideline does not address specific reimbursement issues, which are being evaluated by other groups (National
`Kidney and Urologic Diseases Advisory Board, 1994.).
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`Purpose and Scope
`
`The original (.’/iru't'r.'l' !’r'acrice Gm'n'ct'l'ne on Urinarjv fm.'(m!i'nerIce in /ldu/t.s' was published in March i992. The
`purpose and scope ofthe I992 guideline and the methodology for its development are outlined below. The process
`used for updating the original guideline, which resulted in the publication of this Clirt-that Pr'¢ic't:'ce Guide-line Update
`on Urinary Incontinence in Adults: Acute and Chronic Management is also outlined.
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`1992 Guideline
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`The original U1 guideline panel defined Ul as involuntary loss ofurine that is sufficient to be a problem. The panel
`agreed that the guideline. which sought to improve the care of incontinent adults, should be directed toward acquired
`incontinence in ambulatory and nonambulatory patients in outpatient, inpatient, home care, and long-term care
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`settings. Extraurethral Lil, which is involuntary loss of urine through channels other than the urethra, was not
`addressed in the document. The guideline was targeted to all practitioners who encounter U l, with the primary
`outcome ofelimination or reduction of Ul.
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`The original panel also agreed on the components of the evaluation and management of U1, which were considered to
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`be the management model for the guideline. The original guideline made seven broacl—based recommendations, as
`lbl lows:
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`http://www.nchi.nlm.nih.gov!boo ks/NBK52 1 76%‘?report'"—"printable
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`2/20/2015
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`Patent Owner, UCB Pharma GmbH — Exhibit 2033 - 0012
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`lmprove the education and dissemination ofUl diagnosis and treatment alternatives to the public and to health
`care providers.
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`liducatc t.he consumer to report incontinence problems once they occur.
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`Improve the detection and documentation of U] through better medical histories and health care recordkeeping.
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`4. Establish appropriate basic evaluation and criteria for further evaluation.
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`5. Delincate the steps of appropriate management.
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`6. Where appropriate, reduce variations among health care providers, while maintaining flexibility to individualize
`treatment to individual patients.
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`7. Encourage further biomedical and clinical research on prevention, diagnosis, and treatment of Ul in adults and
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`encourage further research into the costs ofU[ diagnosis and treatment and the cost benefit ofprevention
`programs.
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`The original panel conducted an extensive literature review on Ul in adults, heard public testimony at a national
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`hearing. and reviewed information from consultants. It also sought further evidence of the costs of U1, variations in
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`practice and payments, the prevalence of incontinence in hospitals. and the incidence of U] in outpatient,
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`rehabilitation, and home settings. Previous research data and expert opinions helped to provide insight into the
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`problem within communities, acute care facilities, and nursing homes. The draft guideline was also extensively peer-
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`reviewed by individual experts and representatives of the various professional and public organizations, and many of
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`their recommendations were incorporated into the document.
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`The panel Found evidence that treatment ofLll is effective in most people; however, the condition was underreported,
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`services were improperly or poorly documented, and major variations in diagnosis and treatment were identified as
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`significant problems.
`
`The original Ul panel also recommended that review of the guideline respond to new developments in Ul research,
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`training, product developments, practice, and patient participation. Because ofthe magnitude of literature produced
`each year, the panel recommended that the guideline be updated annually.
`
`Updating the Guictel-lne
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`Because the recommendations were so broad—based, AHCPR recommended updating the guideline to include recent
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`literature and to provide specific recommendations for managing Ul in adults. AHCPR Ptovidcd the general
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`parameters for this update ofthe guideline. An update can be in the form of amendments to the guideline or a more
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`complete update and reprinti