Technologies for Managing Urinary

Incontinence

July 1985

NTIS order #PB85-240208
HEALTH TECHNOLOGY CASE STUDY 33

Technologies for Managing

Urinary Incontinence

JULY 1985

This case study was performed as part of OTA’S assessments:

Federal Policies and the Medical Devices Industry

and

Technology and Aging in America

Prepared for OTA by:

Joseph Ouslander, M.D.

UCLA School of Medicine

and

Robert Kane, M.D.

UCLA School of Medicine

with

Shira Vollmer

UCLA School of Medicine

and

Melvyn Menezes

School of Management, UCLA

OTA Case Studies are documents containing information on a specific medical

technology or area of application that supplements formal OTA assessments, The

material is not normally of as immediate policy interest as that in an OTA Report,

nor does it present options for Congress to consider.

CONGRESS OF THE UNITED STATES

Office of Technology Assessment

Washington, D C 20510
Recommended Citation:

Ouslander, Joseph, Kane, Robert, Vollmer, Shira, and Menezes, Melvyn, Technologies

for Managing Urinary Incontinence (Health Technology Case Study 33), OTA-HCS-33,

Washington, DC: U.S. Congress, Office of Technology Assessment, July 1985. This case

study was performed as part of OTA’S assessments of Federal Policies and the Medical

Devices Industry and Technology and Aging in America.

Library of Congress Catalog Card Number 85-600554

For sale by the Superintendent of Documents

U.S. Government Printing Office, Washington, DC 20402
Preface

Technologies for Managing Urinary Incontinence is Case Study 33 in OTA’S Health Technology Case Study Series. This case study has

been prepared in connection with two OTA projects: Federal Policies and the Medical Devices Industry and Technology and Aging in America.

The former project, conducted by the Health Program, was requested by the House Committee on

Energy and Commerce and its Subcommittee on

Health and the Environment and the Senate Committee on Finance, Subcommittee on Health. The

latter project, conducted by the Biological Applications Program, was requested by the House

Select Committee on Aging, and the Senate

Special Committee on Aging. A listing of other

case studies in the series is included at the end of

this preface, and endorsed by the House Committee on Education and Labor.

OTA case studies are designed to fulfill two

functions. The primary purpose is to provide

OTA with specific information that can be used

in forming general conclusions regarding broader

policy issues. The first 19 cases in the Health Technology Case Study Series, for example, were conducted in conjunction with OTA’S overall project

on The Implications of Cost-Effectiveness Analysis of Medical Technology. By examining the 19

cases as a group and looking for common problems or strengths in the techniques of cost-effectiveness or cost-benefit analysis, OTA was able

to better analyze the potential contribution that

those techniques might make to the management

of medical technology and health care costs and

quality.

The second function of the case studies is to

provide useful information on the specific technologies covered. The design and the funding levels of most of the case studies are such that they

should be read primarily in the context of the associated overall OTA projects. Nevertheless, in

many instances, the case studies do represent extensive reviews of the literature on the efficacy,

safety, and costs of the specific technologies and

as such can stand on their own as a useful contribution to the field.

Case studies are prepared in some instances because they have been specifically requested by

congressional committees and in others because

they have been selected through an extensive review process involving OTA staff and consultations with the congressional staffs, advisory panel

to the associated overall project, the Health Program Advisory Committee, and other experts in

various fields. Selection criteria were developed

to ensure that case studies provide the following:

●

●

●

●

●

●

●

●

examples of types of technologies by function (preventive, diagnostic, therapeutic, and

rehabilitative);

examples of types of technologies by physical

nature (drugs, devices, and procedures);

examples of technologies in different stages

of development and diffusion (new, emerging, and established);

examples from different areas of medicine

(e.g., general medical practice, pediatrics,

radiology, and surgery);

examples addressing medical problems that

are important because of their high frequency or significant impacts (e. g., cost);

examples of technologies with associated high

costs either because of high volume (for lowcost technologies) or high individual costs;

examples that could provide information material relating to the broader policy and methodological issues being examined in the

particular overall project; and

examples with sufficient scientific literature.

Case studies are either prepared by OTA staff,

commissioned by OTA and performed under contract by experts (generally in academia), or written by OTA staff on the basis of contractors’

papers.

OTA subjects each case study to an extensive

review process. Initial drafts of cases are reviewed

by OTA staff and by members of the advisory

panel to the associated project. For commissioned

cases, comments are provided to authors, along

with OTA’S suggestions for revisions. Subsequent

drafts are sent by OTA to numerous experts for

review and comment. Each case is seen by at least

30 reviewers, and sometimes by 80 or more outside reviewers. These individuals may be from

relevant Government agencies, professional societies, consumer and public interest groups, medical practice, and academic medicine. Academicians such as economists, sociologists, decision

analysts, biologists, and so forth, as appropriate,

also review the cases.

Although cases are not statements of official

OTA position, the review process is designed to

satisfy OTA’S concern with each case study’s

scientific quality and objectivity. During the various stages of the review and revision process,

therefore, OTA encourages, and to the extent

possible requires, authors to present balanced information and recognize divergent points of view.

111
Health Technology Case Study Seriesa

Case Study Case study title; author(s); Case Study Case study title; author(s);

Series No. OTA publication number b

Series No. OTA publication number b

1

2

3

4

5

6

7

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9

10

11

12

13

14

15

16

17

Formal Analysis, Policy Formulation, and End-Stage Renal

Disease;

Richard A. Rettig (OTA-BP-H-9(1))C

The Feasibility of Economic Evaluation of Diagnostic Procedures: The Case of CT Scanning;

Judith L. Wagner (OTA-BP-H-9(2))

Screening for Colon Cancer: A Technology Assessment;

David M. Eddy (OTA-BP-H-9(3))

Cost Effectiveness of Automated Multichannel Chemistry

Analyzers;

Milton C. Weinstein and Laurie A. Pearlman

(OTA-BP-H-9(4))

Periodontal Disease: Assessing the Effectiveness and Costs of

the Keyes Technique;

Richard M. Scheffler and Sheldon Rovin

(OTA-BP-H-9(5))

The Cost Effectiveness of Bone Marrow Transplant Therapy

and Its Policy Implications;

Stuart O. Schweitzer and C. C. Scalzi (OTA-BP-H-9(6))

Allocating Costs and Benefits in Disease Prevention Programs:

An Application to Cervical Cancer Screening;

Bryan R. Luce (Office of Technology Assessment)

(OTA-BP-H-9(7))

The Cost Effectiveness of Upper Gastrointestinal Endoscopy;

Jonathan A. Showstack and Steven A. Schroeder

(OTA-Bp-H-9(8))

The Artificial Heart: Cost, Risks, and Benefits;

Deborah P. Lubeck and John P. Bunker

(OTA-BP-H-9(9))

The Costs and Effectiveness of Neonatal Intensive Care;

Peter Budetti, Peggy McManus, Nancy Barrand, and

Lu Ann Heinen (OTA-BP-H-9(1O))

Benefit and Cost Analysis of Medical Interventions: The Case

of Cimetidine and Peptic Ulcer Disease;

Harvey V. Fineberg and Laurie A. Pearlman

(OTA-BP-H-9(I1))

Assessing Selected Respiratory Therapy Modalities: Trends and

Relative Costs in the Washington, D.C. Area;

Richard M. Scheffler and Morgan Delaney

(OTA-BP-H-9(12))

Cardiac Radionuclide Imaging and Cost Effectiveness;

William B. Stason and Eric Fortess (OTA-BP-H-9(13))

Cost Benefit/Cost Effectiveness of Medical Technologies: A

Case Study of Orthopedic Joint Implants;

Judith D. Bentkover and Philip G. Drew (OTA-BP-H-9(14))

Elective Hysterectomy: Costs, Risks, and Benefits;

Carol Korenbrot, Ann B. Flood, Michael Higgins,

Noralou Roos, and John P. Bunker (OTA-BP-H-9(15))

The Costs and Effectiveness of Nurse Practitioners;

Lauren LeRoy and Sharon Solkowitz (OTA-BP-H-9(16))

Surgery for Breast Cancer:

Karen Schachter Weingrod and Duncan Neuhauser

(OTA-BP-H-9(17))

a

available for sale by the Superintendent of Documents, U.S. Government

Printing Office, Washington, DC, 20402, and by the National Technical

Information Service, 5285 Port Royal Rd., Springfield, VA, 22161. call

OTA’S Publishing Office (224-8996) for availability and ordering information.

b

original publication numbers appear in parentheses.

CThe first 17 cases in the series were 17 separately issued cases in Background

Paper #2: Case Studies of Medical Technologies, prepared in conjunction

with OTA’S August 1980 report The Implications of Cost-Effectiveness Analysis of Medical Technology.

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

The Efficacy and Cost Effectiveness of Psychotherapy;

Leonard Saxe (Office of Technology Assessment)

(OTA-BP-H-9(18))d

Assessment of Four Common X-Ray Procedures;

Judith L. Wagner (OTA-BP-H-9(19))e

Mandatory Passive Restraint Systems in Automobiles: Issues

and Evidence;

Kenneth E. Warner (OTA-BP-H-15(20))f

Selected Telecommunications Devices for Hearing-Impaired

Persons;

Virginia W. Stern and Martha Ross Redden

(OTA-BP-H-16(21)) g

The Effectiveness and Costs of Alcoholism Treatment;

Leonard Saxe, Denise Dougherty, Katharine Esty,

and Michelle Fine (OTA-HCS-22)

The Safety, Efficacy, and Cost Effectiveness of Therapeutic

Apheresis;

John C. Langenbrunner (Office of Technology Assessment)

(OTA-HCS-23)

Variation in Length of Hospital Stay: Their Relationship to

Health Outcomes;

Mark R. Chassin (OTA-HCS-24)

Technology and Learning Disabilities;

Candis Cousins and Leonard Duhl (OTA-HCS-25)

Assistive Devices for Severe Speech Impairments;

Judith Randal (Office of Technology Assessment)

(OTA-HCS-26)

Nuclear Magnetic Resonance Imaging Technology: A Clinical,

Industrial, and Policy Analysis;

Earl P. Steinberg and Alan Cohen (OTA-HCS-27)

Intensive Care Units (ICUs): Clinical Outcomes, Costs, and

Decisionmaking;

Robert A. Berenson (OTA-HCS-28)

The Boston Elbow;

Sandra J. Tanenbaum (OTA-HCS-29)

The Market for Wheelchairs: Innovations and Federal Policy;

Donald S. Shepard and Sarita L. Karen (OTA-HCS-30)

The Contact Lens Industry: Structure, Competition, and Public

Policy;

Leonard G. Schifrin and William J. Rich (OTA-HCS-31)

The Hemodialysis Equipment and Disposable Industry;

Anthony A. Romeo (OTA-HCS-32)

Technologies for Managing Urinary Incontinence;

Joseph Ouslander, Robert Kane, Shira Vollmer, and Melvyn

Menezes (OTA-HCS-33)

The Cost Effectiveness of Digital Subtraction Angiography in

the Diagnosis of Cerebrovascular Disease;

Matthew Menken, Gordon H. DeFriese Thomas R. Oliver,

and Irwin Litt (OTA-HCS-34)

dBackground paper #3 to The Implications of Cost-Effectiveness Analysis of

Medical Technology.

eBackground paper #5 to The Implications of Cost-Effectiveness Analysis of

Medical Technology.

fBackground paper #l to OTA’S May 1982 report Technology and Handicapped People.

gBackground Paper #2 to Technology and Handicapped People.

iv
OTA Project Staff for Case Study #33

Roger Herdman, Assistant Director, OTA

Health and Life Sciences Division

Clyde J. Behney, Health Program Manager

Jane E. Sisk, Project Director

Judith L. Wagner, Senior Analyst

Robert Harootyan, Analyst

David McCallum, Senior Analyst

Katherine E. Locke, Research Assistant

Brad Larson, Research Assistant

H. Christy Bergemann, Editor

Ginny Cwalina, Administrative Assistant

Rebecca I. Erickson, Secretary/Word Processor Specialist

Brenda Miller, Word Processor/P. C. Specialist

Diann G. Hohenthaner, Secretary/Word Processor Specialist

Carol Guntow, Clerical Assistant

v
Advisory Panel for Federal Policies and

the Medical Devices Industry

Richard R. Nelson, Chair

Institute for Social and Policy Studies, Yale University

New Haven, CT

William F. Ballhaus Robert M. Moliter

International Numatics, Inc. Medical Systems Division

Beverly Hills, CA General Electric Co.

Ruth Farrisey

Washington, DC

Massachusetts General Hospital Louise B. Russell

Boston, MA The Brookings Institution

Peter Barton Hutt

Washington, DC

Covington & Burling Earl J. Saltzgiver

Washington, DC Foremost Contact Lens Service, Inc.

Alan R. Kahn Salt Lake City, UT

Consultant Rosemary Stevens

Cincinnati, OH Department of History and Sociology of Science

Grace Kraft

Kidney Foundation of the Upper Midwest

Cannon Falls, MN

Joyce Lashof

School of Public Health

University of Pennsylvania

Philadelphia, PA

Allan R. Thieme

Amigo Sales, Inc.

Albuquerque, NM

University of California Eric von Hippel

Berkeley, CA Sloan School

Penn Lupovich

Group Health Association

Massachusetts Institute of Technology

Cambridge, MA

Washington, DC Edwin C. Whitehead

Victor McCoy

Paralyzed Veterans of America

Technicon Corp.

Tarrytown, NY

Washington, DC

vi
Technology and Aging in America Advisory Panel*

Robert Binstock, Panel Chair

Director, Policy Center on Aging, Brandeis University

Raymond Bartus

Group Leader of Geriatrics

Medical Research Division

Lederle Laboratories

Robert Berliner

Dean

School of Medicine

Yale University

Robert N. Butler

Chairman

Department of Geriatrics and Adult Education

Mt. Sinai Medical Center

Robert Clark

Associate Professor

Department of Economics and Business

North Carolina State University

Lee L. Davenport

Senior Vice President-Chief Scientist, emeritus

GTE Corp.

Ken Dychtwald

President

Dychtwald & Associates

Caleb Finch

Professor of Biological Sciences and Gerontology

University of Southern California

Velma Murphy Hill

Director

Civil and Human Rights Division

Service Employees

Robert L. Kane

Senior Researcher

The Rand Corp.

Paul A. Kerschner

Associate Director

International Union

for Programs, Legislation

and Development

American Association of Retired Persons

Maggie Kuhn

Founder and National Convener

The Gray Panthers

Matt Lind

Vice President

Corporate Planning and Research

The Travelers Insurance Co.

Robert G. Lynch

Vice President

Marketing Planning

GTE Corp.

Mathy D. Mezey

Director

Teaching Nursing Home Program

University of Pennsylvania

Hamish Munro

Professor of Medicine and Nutrition

Tufts University

Bernice Neugarten

Professor of Education and Sociology

Northwestern University

Sara Rix

Director of Research

The Women’s Research and Education Institute

Pauline Robinson

Research Professor of Gerontology

University of Southern California

John W. Rowe

Chief of Geriatrics

Beth Israel Hospital

Bert Seidman

Director

Department of Occupational Safety, Health

and Social Security

AFL-CIO

Jacob Siegel

Senior Researcher

Center for Population Research

Georgetown University

‘Panel members’ affiliations are listed at the time the assessment began

NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the advisory panel members. The views expressed

in this OTA report, however, are the sole responsibility of the Office of Technology Assessment.

vii
Contents

CHAPTER 1: INTRODUCTION AND SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Problem of Urinary Incontinence . . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . .

Prevalence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Types and Causes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Treatments for Urinary Incontinence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Manufacturers of Incontinence Products ..,.... . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Industry Structure . . . . . . . . . . . .

Marketing . . . . . . . . . . . . . . . . . . .

Policy Implications . . . . . . . . . . . . .

Information. . . . . . . . . . . . . . . . . .

Research . . . . . . . . . . . . . . . . . . . .

Payment . . . . . . . . . . . . . . . . . . . .

Organization of This Case Study.

CHAPTER 2: THE PROBLEM OF

Prevalence of Incontinence . . . . . .

Types and Causes of Incontinence

URINARY INCONTINENCE . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Treatments for Urinary Incontinence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER 3: EFFECTIVENESS AND SAFETY OF DEVICES AND

OTHER TREATMENTS. . . . . . . . . . . . . . . . . . . . . .

Artificial Sphincters . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Electrical Stimulation . . . . . . . . . . . . . . . . . . . . . . . . . .

Catheters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Bedpads and Undergarments . . . . . . . . . . . . . . . . . . . .

Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Drug Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Training Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER 4: THE COSTS AND FINANCING OF

Costs of Incontinence . . . . . . . . . . . . . . . . . . . . . . . . . .

Payment for Urinary Incontinence . . . . . . . . . . . . . . .

INCONTINENCE . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

APPENDIX A.–INCONTINENCE PRODUCT MANUFACTURERS:

CHARACTERISTICS AND OPINIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

APPENDIX B.–INCONTINENCE PRODUCT MANUFACTURERS . . . . . . . . . . . . . . .

APPENDIX C.–INCONTINENCE PRODUCT QUESTIONNAIRE . . . . . . . . . . . . . . . .

APPENDIX D.–ARTIFICIAL SPHINCTERS: A CASE STUDY... . . . . . . . . . . . . . . . .

APPENDIX E.–GLOSSARY OF TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

APPENDIX F.–ACKNOWLEDGMENTS AND HEALTH PROGRAM

ADVISORY COMMITTEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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ix
Contents—continued

List of Tables

Table No. Page

2-1. Prevalence of Incontinence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2-2. Types of Incontinence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

2-3. Treatments for Urinary Incontinence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3-1. Sphincter Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

3-2. Electrical Stimulators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

3-3. Bedpads and Undergarments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

3-4. Drugs in Incontinence Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

4-1. Estimated Relative Costs of Treatments for Incontinence . . . . . . . . . . . . . . . . . . . . . 46

List of Figures

Figure No. Page

2-1. Treatment Options for Urinary Incontinence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
1.

Introduction and Summary
1.

Introduction and Summary

This case study describes medical devices and

other technologies used to manage urinary incontinence and reports on the firms that produce such

devices. This subject was selected for detailed

study as part of two larger OTA assessments of

Federal policies and the medical devices industry

and technology and aging in America. Urinary

incontinence represents a medical problem that

is prevalent among the elderly and has enormous

consequences for medical care costs. It is also an

area in which medical devices with widely varied characteristics are used to manage or cure the

underlying conditions. These devices complement

other approaches to the management of urinary

incontinence, and an analysis of the respective

roles of alternative strategies is useful. Although

the case study emphasizes mechanical devices over

more conventional and widely used treatments for

incontinence, such as drugs, surgery, and bladdertraining procedures, these other treatments are

also discussed. Evidence on the effectiveness and

costs of alternative treatments is presented, and

implications for public policy are discussed.

THE PROBLEM OF URINARY INCONTINENCE

Urinary incontinence is an embarrassing, potentially disabling, and costly health problem. Defined as an involuntary loss of urine sufficient in

quantity and/or frequency to be a social or health

problem, this condition disrupts the lives of 5 to

10 million Americans, their families, friends, and

caregivers. The severity of incontinence ranges

from occasional dribbling to total loss of control

over excretory functions with incontinence of both

urine and stool. It has adverse effects on physical health, psychological well-being, social functioning, and the cost of health care. When inadequately or inappropriately managed, it can lead

to skin breakdown and recurrent urinary infections. Incontinent individuals often withdraw

from their usual social activities and may subsequently become isolated and depressed. Because

it is difficult for affected individuals and their families to manage at home, incontinence often plays

a pivotal role in an individual’s decision to enter

a long-term care institution. The costs of labor,

laundry, and supplies used to manage incontinence and its complications contribute to the

growing costs of nursing-home care (111). Despite

the availability of many effective forms of treatment, incontinent persons are rarely evaluated

thoroughly to determine the precise causes of the

condition and are therefore often not treated optimally (112).

This deficiency in the care of incontinent persons results from a number of factors, including:

1. lack of knowledge on the part of health-care

professionals about the underlying causes of

incontinence, appropriate methods of diagnostic evaluation, and treatment options

available (in some instances, health-care professionals even consider incontinence a normal condition in elderly patients and therefore do not evaluate or attempt to treat it);

2. reluctance on the part of affected individuals

to discuss the problem with a health-care

professional because of embarrassment and

the misconception that it cannot be treated;

and

3. the relatively small number of experts (urologists, gynecologists, neurologists, geriatricians, nurse clinicians, etc. ) available to treat

these patients, train other health-care professionals, and carry out well-designed research

on the management of this important health

problem.
4 ● Health case Study 33: Technologies for Managing Urinary Incontinence

Prevalence

Because little accurate data on the extent of urinary incontinence have been consistently maintained, estimates of its prevalence and change over

time are difficult to make. Current data indicate

that risk of urinary incontinence is strongly associated with age. From 10 to 20 percent of the community-dwelling elderly, whose median age is 72,

are incontinent to some degree. But approximately

50 percent of all elderly persons in nursing homes,

whose median age is 83, are incontinent. Not only

is the prevalence much greater among the latter

group, but the type of incontinence is also likely

to be more severe. Although these population subgroups are not directly comparable, the differences in prevalence indicate the increased risk of

urinary incontinence for persons 65 to 74 and 85

and over (85, 178). Risk of institutionalization is

increased because of urinary incontinence. Thus,

the very old (persons 85 and over) are most likely

to suffer from incontinence and to be at risk of

institutionalization.

The effects of these age-related differences will

become more relevant as the aging of the U.S.

population continues, especially within the older

population itself. During the past decade, the

elderly U.S. population has experienced a new era

of increased longevity. In contrast to earlier periods when life expectancy advances were concentrated in infants and the very young, life expectancy at age 65 and 75 has markedly increased

during the last 12 years (158). As a result, the very

old are the fastest growing segment of the population. They currently comprise 9 percent (2,4 million persons) of the total older population, but

are projected to increase to approximately 15 percent (5.1 million persons) by 2000. If present

trends continue, this growth in the very old population will be accompanied by notable increases

in the numbers and proportions of older persons

with some degree of urinary incontinence and a

higher risk of institutionalization. Technologies

that can prevent, treat, cure, manage, or reduce

the severity of urinary incontinence will help to

lessen its prevalence, minimize its impact, delay

its onset, and reduce the likelihood of institutionalization among the elderly.

Types and Causes

Incontinence can be classified into several types,

which have clinical and therapeutic differences.

Acute incontinence refers to the sudden onset of

episodes of involuntary loss of urine; it is usually associated with an acute illness or environmental factors that impair the mental or physical ability of the patient to reach a toilet or toilet

substitute in time.

Established or persistent incontinence (i.e., repeated episodes of involuntary loss of urine not

associated with an acute condition) can be divided

into four types. Stress incontinence implies leakage of urine, either in small or large amounts, as

intra-abdominal pressure increases. Urge incontinence involves leakage of varying amounts of

urine because of the inability to delay voiding long

enough to reach a toilet or toilet substitute; it can

be caused by a variety of genitourinary and neurologic disorders. Overflow incontinence is caused

by anatomic obstruction to bladder emptying

and/or inability of the bladder to contract, with

subsequent leakage of small amounts of urine.

Functional incontinence occurs in those individuals who have chronic impairments of either

mobility or mental function, are unable to toilet

themselves independently and do not have sufficient help with this task, or who, because of psychological disturbances, are unwilling to maintain continence.

TREATMENTS FOR URINARY INCONTINENCE

The most appropriate treatment for an individ- ronmental) that could cause or contribute to the

ual patient with urinary incontinence depends on condition. Most treatments discussed in this case

a thorough evaluation of all relevant factors (gen- study (e. g., sphincters, electrical stimulators,

itourinary, neurological, psychological, and envi- drugs, training procedures, and surgery) are appli-
Ch. 1—Introduction and Summary ● 5

cable for a specific type or types of incontinence

and are attempts to cure the incontinence. Thus,

a diagnostic evaluation to identify specific conditions is critical to the appropriate use of these

treatments. Some of the treatments are nonspecific

(e.g., bedpads, undergarments, and, in certain situations, catheters) and are palliative rather than

curative; they should not be used exclusively until a diagnostic evaluation has excluded treatable

conditions.

Devices for incontinence can be divided into

those that attempt to prevent or delay urine flow

and those that collect urine before or after it leaves

the bladder. Devices such as the pessary, a donutshaped piece of inert material inserted into the vagina to support the bladder outlet in women with

stress incontinence, and the external penile clamp

are used relatively infrequently at the present

time. Newer techniques such as the artificial

sphincter, which is an inflatable cuff surgically implanted around the urethra, and electrical stimulators, which contract muscles of the pelvic floor

in stress incontinence and inhibit bladder contraction in urge incontinence, have been used increasingly over the last 10 to 15 years (124).

Catheters are commonly used to manage incontinence, despite the well-known risks (e.g., infection) associated with their use (166). Probably the

most actively marketed products used to manage

incontinence are undergarments and bedpads. In

general, these products are designed with a layer

of highly absorbent material sandwiched between

layers designed to keep the patient and the bed

or clothing dry. A wide variety of techniques,

which we have labeled training procedures, have

also been described in the management of incontinence. We have categorized these training procedures into five basic techniques: pelvic floor

(Kegel) exercises, biofeedback, bladder retraining,

habit training, and behavioral modification.

Effectiveness

Few studies have systematically examined the

efficacy, safety, and long-term cost effectiveness

of the various treatments for urinary incontinence.

Most published studies are reports of case series.

The relative efficacy of various treatments has

rarely been examined.

costs

Similarly, few studies have systematically examined the costs of incontinence. A small number of reports have considered various components of the cost, such as the added costs of labor

or supplies used to manage incontinence in longterm care institutions (111). It has been estimated

that $8 billion is spent on incontinence in this

country, and urinary incontinence accounts for

one-third of costs of geriatric wards, but the basis of these estimates has not been described (20).

The costs of incontinence go far beyond economic

considerations: withdrawal from social activities,

psychological distress, burden on family and caregivers, and the subsequent predisposition to institutionalization are all important potential effects

of incontinence that are difficult to quantify.

One report has examined the overall costs of

incontinence in nursing homes in this country. If

only “first-order” costs are considered (i. e., the

costs of managing incontinence without the costs

of any complicating conditions), incontinence

adds between $3 and $11 to the daily costs of caring for a nursing home patient (111). The range

of costs is accounted for by differing costs of various techniques of management. Of the three

components of these costs (labor, laundry, and

supplies), the labor involved in managing the incontinent patient was the major contributor.

If one assumes that there are approximately

600,000 nursing home patients with some degree

of urinary incontinence and that in three-quarters

of these patients the incontinence is sufficiently

severe that catheters or other specific management

techniques are used, the yearly costs of incontinence in U.S. nursing homes can be estimated at

between $0.5 and $1.5 billion (first-order costs

only). This cost range represents between 3 and

8 percent of the total expenditure on nursing home

care in this country. The costs of incontinence in

the community are much more difficult to estimate. No studies have addressed these costs in any

detail.

Loss of productivity in those individuals afflicted with incontinence and in those caring for

the incontinent patient could be substantial. Incontinence can place physical, psychological, and
6 ● Health Case Study 33: Technologies for Managing Urinary Incontinence

economic burdens on patients and caregivers,

costs that are difficult to estimate. And as mentioned before, incontinence is often cited as a major factor in the decision to institutionalize a dependent person.

The potential cost effectiveness of evaluation

and specific treatment for incontinence has never

been systematically addressed. Although the proportion of incontinent patients that can be completely cured is unknown, many can clearly benefit from an evaluation that identifies treatable

conditions; in some instances, treatment would

lead to substantial amelioration of the incontinence. Some experts estimate that one-third of incontinent patients can be completely cured and

most others kept dry and comfortable with appropriate management (174).

THE MANUFACTURERS OF INCONTINENCE PRODUCTS

The manufacturers of urinary incontinence

products are a heterogeneous assortment, ranging from very large, diversified firms to very small

ones. The products, too, vary considerably. Some

are designed for broad consumer use; others for

very discrete types of incontinence. The latter may

have a high unit cost and require surgical implantation. Any effort to describe “the incontinence

products industry” must recognize this diversity.

To facilitate systematic collection of data from

manufacturers, a questionnaire was designed and

sent to 38 companies who had agreed to respond;

21 companies replied. (See app. C.)

Industry Structure

At least 48 companies are involved in the manufacture of one or more incontinence products.

These companies vary dramatically in their size,

the number of products manufactured, and other

corporate characteristics. In many cases, it is virtually impossible to isolate the incontinence products component of a much larger corporation.

Marketing

Companies have primarily marketed incontinence products as medical devices rather than as

consumer products, even those products with the

characteristics of consumer goods (e.g., incontinence pads).

Manufacturers distribute them through various

distributors and dealers or directly to users; 85

percent of those companies responding to a survey conducted by the authors use distributors

and/or dealers to reach the users. Most of the

manufacturers’ promotional efforts have been

directed toward physicians and others in the medical field, but the recent entry of two large paperproducts firms into the disposable incontinence

product market may herald a new marketing strategy directed toward the consumer.

An active advertising campaign designed to destigmatize incontinence can provide important information to consumers. But it can also potentially mislead the public. Because the emphasis is

on encouraging the use of an undergarment, the

consumer may be led to believe that this is the

appropriate first line of treatment. The importance

of careful evaluation to search for remediable conditions is not likely to be stressed, nor will other

techniques for managing the problem be suggested.

The incontinence-products industry is extremely competitive, and price is one of the important

mechanisms used by some companies to capture

an increased share of the market. Except for services delivered as part of an acute hospitalization,

Medicare coverage for incontinence products is

quite limited. Coverage for urinary incontinence

products under Medicaid varies from State to

State.
Ch. 1—introduction and Summary ● 7

POLICY IMPLICATIONS

As a great source of health and social cost, the

problem of urinary incontinence raises important

issues for public policy. With regard to the various urine-collection pads, pants, and sheets, a

number of competitive products are available, all

of which can greatly facilitate the management

of the incontinent patient. The difficulty seems

to lie in both patients’ and providers’ awareness

of these and other alternative treatments.

Information

Both individuals with urinary incontinence and

health professionals lack information on the variety of products and treatments available. To

date, there has been very little education through

either formal mechanisms or advertising to broaden awareness of possible options. The entry into

the disposable pad market of a second major firm

may make direct advertising to the public more

extensive.

The Government could do a great deal to destigmatize this socially unacceptable problem. Private merchandising could also influence consumer

attitudes. Once advertising taboos are broken, the

pattern of active advertising across the media, observed earlier with such previously “undiscussed”

products as sanitary pads, will likely be repeated

for incontinence products.

Health professionals should know more about

the management of incontinence than does the lay

public. At present, there is no guarantee that this

is the case. Beyond a few specialists in urology

and geriatrics, few physicians have been formally

instructed in the diagnosis, treatment, and management of incontinence. The need for better medical education about incontinence was recently

noted in the report on geriatrics and medical education by the Association of American Medical

Colleges (5). Professional education could be expanded to include more than management. Physicians could be taught to appreciate the potential for successful treatment and know-how to

evaluate patients with incontinence. Government

support for training, educational materials, and

the like might improve the likelihood that physicians would be educated about the range of incontinence products.

Research

The state of knowledge in the field is rudimentary for so prevalent a health problem. Welldesigned randomized clinical trials to test the efficacy of alternative treatment approaches have

not been conducted. Most studies to date have

weak designs; many have no control groups, despite the frequent observation of placebo effects.

Before such controlled trials are carried out, however, more precise classification of incontinent patients and rigorously defined outcome measures

need to be developed. Practical research is similarly needed. Better techniques for inexpensive

assessments are necessary if more patients are to

be properly evaluated. Diagnostic tests that are

simple to perform and could be carried out at a

patient’s bedside or in an office setting would

greatly increase the chances for better clinical

evaluations and subsequent management.

Within the Government, the appropriate focus

of responsibility for the necessary research support is unclear. The National Institutes of Health,

specifically the National Institute on Aging, has

evidenced interest in incontinence research, but

has not yet organized clinical trials of therapeutic modalities. The National Center for Health

Services Research has sponsored limited work in

this area and could potentially do more.

Specific attention needs to be directed to the

question of what types of interventions are effective with different types of patients. For example, many incontinent nursing home patients are

cognitively impaired and limited in mobility. Surgical approaches, drug treatment, and bladder

retraining (as opposed to habit training) are less

likely to be productive in this patient population.

A clinical classification of incontinence corresponding to the likelihood of effective intervention could be used as a framework for assessing

the utility of new approaches.

Reporting the consequences of incontinence has

not been systematic, The Food and Drug Administration requires records of adverse reactions

25-314 0 - 85 - 2
8 ● Health Case Study 33: Technologies for Managing Urinary incontinence

from drug treatments for incontinence, but no

agency organizes the collection of information on

the complications of untreated or undertreated incontinence. This type of data might be collected

through clinical studies sponsored by the National

Institutes of Health, or it could fall under the purview of the Centers for Disease Control.

Payment

Medicare covers the costs of diagnosis and

evaluation of incontinence and, for institutionalized persons, incontinence supplies. However,

supplies for noninstitutionalized persons are not

covered by Medicare, except for patients’ home

health services, and they are only erratically reimbursed by Medicaid. There is no clear mandate

to pay for these products. Some argue that, because incontinence is often cited as a major cause

of nursing home admission, paying for management products for ambulatory patients might be

a good investment. The debate is essentially the

same one heard for various interventions designed

to reduce nursing home use. Because we cannot

identify those at high risk of nursing home admission, there is some danger that subsidizing a

large number of incontinent persons would prevent few admissions; the cost to third-party payers such as Medicare and Medicaid is likely to be

additive rather than substitutive.

A new Medicaid reimbursement system for

nursing home care currently under development

reflects the variation in the costs of such care. Several States have developed case-mix reimbursement mechanisms that acknowledge the increased

costs associated with incontinence. However,

under such approaches, the emphasis is on the

costs of caring for such patients rather than on

encouraging treatment to improve their condition.

As with all cost-reimbursement approaches, the

worse a patient’s condition, the greater is the

reward to the caregiver. An experiment conducted

by the National Center for Health Services Research is currently underway to test the effects of

paying nursing homes an incentive to accept incontinent patients and a bonus if the institutions

are able to improve the patients’ functional condition (170).

The costs of incontinence are substantial. For

many, the use of disposable incontinence products is essentially a convenience issue and the

question of affordability is really one of willingness to spend. For others on a very limited budget,

the convenience may be financially out of reach.

These persons may be at greatest risk of nursing

home placement because of limited resources.

ORGANIZATION OF THIS CASE STUDY

The remainder of this case study provides a review of the evidence available on the safety and

background for the findings and conclusions effectiveness of alternative treatments. Finally,

summarized above, and is divided into three chapter 4 gives an overview of the costs involved

chapters. In chapter 2 the prevalence, types, and in evaluating and managing incontinence and its

causes of incontinence and alternative treatment complications.

approaches are discussed. Chapter 3 contains a
2.

The Problem of

Urinary Incontinence
2.

The Problem of Urinary Incontinence

This chapter presents information on the problem of urinary incontinence, its prevalence in the

PREVALENCE OF INCONTINENCE

Several studies have examined the prevalence

of urinary incontinence. Most of the recently published studies are summarized in table 2-1. They

vary in sample population, definition of incontinence, and methods used to collect data. Estimates

of incontinence prevalence range from less than

1 percent in young, community-dwelling persons

to greater than 50 percent in elderly populations

in long-term care institutions.

Despite the variability in study designs and estimates of prevalence, some general conclusions can

be drawn from the table. Incontinence is most

common among individuals over age 65. Between

10 and 20 percent (2 to 4 million) of communitydwelling elderly have some degree of urinary incontinence. The prevalence increases to nearly 50

percent of those elderly in nursing homes (600,000

to 700,000 people). Although incontinence is less

prevalent in younger populations, there are as

many, if not more, younger persons with the condition. Despite the dearth of studies to establish

the prevalence of incontinence in younger populations, the available data suggest that between

1 and 5 percent of those under 65 years have a

persistent problem with urinary incontinence (between 2 and 10 million people). These numbers

are probably underestimates, because individuals

often deny this problem. Moreover, these numbers reflect only those persons affected at any one

time: incontinence is a transient phenomenon in

up to one-third of affected individuals (178).

The severity of incontinence varies considerably. The frequency and amount of urinary leakage are often important considerations in the management of the condition. In younger populations,

incontinence involves either very small amounts

of urinary leakage, as would be the case in young

U.S. population, and the array of modalities

available to manage and treat the problem.

women with stress incontinence, or complete loss

of control over excretory function, usually in

younger individuals with necrologic disorders

(e.g., Spinal Cord abnormalities, multiple sclerosis, or traumatic paraplegia). Many young children also persistently wet the bed (enuresis). In

older persons, the severity of incontinence can

vary from infrequent losses of drops of urine (as

in stress incontinence) to occasional or frequent

losses of large volumes of urine (as in urge incontinence), to continuous leakage of urine and associated stool incontinence (as in people with severe

dementia or other necrologic disorders or surgical or traumatic injury to sphincter mechanisms).

Although incontinence of both urine and stool is

relatively uncommon in community-dwelling persons, close to 50 percent of those in nursing homes

who are incontinent of urine also have episodes

of fecal incontinence (67,112). Most patients with

urinary and fecal incontinence (double incontinence) have severe impairments of mental and/

or physical functioning. (The causes and treatment

of fecal incontinence are beyond the scope of this

study and are reviewed elsewhere (87). )

Other studies’ findings on the prevalence of incontinence are germane. Health professionals

commonly do not recognize the presence of incontinence or they fail to note it as a problem;

consequently they do not pursue an evaluation

(112). In addition, studies in Great Britain indicate

that incontinent individuals often do not use services available to them, such as incontinence

nurses, incontinence clinics, and laundry services

(153,160,178,179). Thus, it appears that both

health professionals and incontinent individuals

tend to underreport and underevaluate incontinence and, as a result, probably manage the condition suboptimally.

11
Table 2-1 .—Prevalence of Incontinence

Prevalence (percent)

Study Population sample Definition of Incontinence

Studies done in the community:

Yarnell and St. Leger

(1979) Random sample of community Was there any leakage of urine

elderly (over age 65) drawn m the previous 12 months? If

from two medical practices in yes; what was the frequency

South Wales (N = 388) and the time of day?

Method of data collection

Personal interview and

questionnaire given at home to

subject, the next of kin or

daily attendant

Thomas, et al. (1980) Individuals aged 5 and older from Leakage of urine m inappropriate

12 general practices in Britain places and at inappropriate

(N = 18,084) times, at least twice a month,

regardless of quantity

(“regular” incontinence)

Considered “occasional” if less

than twice a month

Postal questionnaire; parents

responded for children under

15

Also interviewed 237 adults with

regular incontinence (from one

general practice)

Age Female Male Overall Comments

17 11 14 Urinary Incontinence was related to a

history of cerebrovascular disease.

surgical procedures for prostatic

conditions, or utero-vaginal prolapse

One-third had incontinence for only a

short time (less than 6 months)

Nearly half those severely incontinent

preferred to buy their own supplies of

incontinence pads from their

pharmacists rather than approach their

general practitioner with the problem

Percentage with regular Prevalence m females significantly higher

incontinence than m males

Age Female Male All Prevalence of regular incontinence (as

5-14 5

opposed to occasional incontinence)

7 6

15-64 9

increased with increasing age after 35

2 5 Women who had more than four babies

65+ 11 7 10

All

were most likely to report regular

8 3 6 incontinence

Percentage with any incontinence Less than one-third were getting health or

Age Female Male All

social services for their incontinence

Those with minimal incontinence generally

5-14 16 18 17 saw no reason to seek help

15-64 27 5 16

65+ 25 15 21

All 25 9 17

Feneley, et al. (1974) One group practice in Great Involuntary excretion or leakage Postal questionnaire; parents Age Female Male All 81% has urinary incontinence only

Britain, ages 5 and older of urine in inappropriate places responded for children under 5-14 4 6 –

20% had both urinary and stool

(N = 7,000) or at inappropriate times at 15 14-64 8 2 –

incontinence

least twice a month, regardless 65+ 14 6 – 7% had stool incontinence only

of quantity All 8 3 5

Vetter, Jones, and Community elderly (age 70+) ‘‘Do you ever wet yourself if you Structured interview 18 7 14 5% were severely incontinent (daily or

Victor (1981 ) from two general practices in are unable to get to the more), 8% were less severely

South Wales (N = 1,280) lavatory as soon as you need Incontinent

to or when you are asleep at Prevalence increased with age

night or if you cough or Housebound and clinically anxious

sneeze?’ ‘‘ How often does

this happen?” “IS it a few

persons were more likely to be severely

incontinent

drops or more?’ Incontinent subjects were more likely than

continent subjects to be in contact with

family members and less likely to be

visited by friends

One-third of incontinent individuals used

no aids

36% of severely incontinent used some

type of protection, whereas only 2% of

less severely incontinent used any

protection
Table 2-l.– Prevalence of Incontinence—Continued

Prevalence (percent)

Study Population sample Definition of Incontinence Method of data collection Age Female Male Overall Comments

Wolin ( 1969) Single nursing students in the Stress incontinence = accidental Questionnaire author discussed 15% had some Incontinence, 16% had

U S. who have never borne passing of urine when intra- questions first daily Incontinence

children (ages 17-25) abdominal pressure increases, Daily stress Incontinence was related to

(N = 4,211) unrelated to voiding urinary tract infectIon but not to age or

regularity of sexual Intercourse

Yarnell, et al (1981) Random sample of women older Loss of urine on the way to the Personal innterwew by nurse using Age Female Male All Half those Incontinent had stress

than 18 in South Wales toilet or with cough, laugh, standardized questionnaire 18-64 42 NA – symptoms alone, 15% had urge only.

(N = 1,060) sneeze, etc 65-74 43 NA – 35% had both

75+ 59 NA – In most, urinary loss was small and

All 45 NA – Infrequent, 5% had to change clothes,

3% had to change clothes daily

3% felt Incontinence Interfered with social

or domestic life, but only half sought

medical advice

Studies done in both community and institutions: Involuntary excretion or leakage

Thomas, et al (1980) All those over age 15 in the of urine in inappropriate places

London boroughs short- and or at inappropriate times and

long-stay hospitals, psychiatric at least twice monthly,

wards, day-care centers. regardless of quantity

ordinary and special schools,

multiple sclerosis and spina

bifida societies; and pad and

laundry services (estimated

total population of the study

area = 359,000)

Nurses and administrators of the

institutions and community

services filled out a

questionnaire that asked for

age, sex, address, and details

about type of Incontinence of

people under their care

Age Female Male All

15-64 02 01 02

65+ 30 10 20

All 1 1 03 1.0

Feneley, et al. (1979) All those over age 15 m Bristol Involuntary excretion or leakage

who were under care of of urine in inappropriate places

general practitioners, or at inappropriate times and

community nurses, hospital at least twice monthly,

nurses, social and welfare regardless of quantity

services, or m old people’s

homes

Studies done in long-term care facilities:

Ouslander, Kane, and Patients 65+ m 7 U S nursing Any uncontrolled leakage of

Abrass (1982) homes (4 proprietary, 3 urine, regardless of amount or

nonprofit) (N = 842) frequency

Incontinent patients were

registered by general

practitioners, communtity

nurses, hospitals, old people’s

homes, and social and welfare

services over the course of a

year (details of process not

specified)

Incontinent patients identified by

nurses and verified by

interviews with patients and

nurses

Considering only community residents,

less than 1 % of those under 65 and

1 % of those over 65 were reported as

Incontinent

Overall prevalence rate of 1 % reported

50 48 50 Of those who were Incontinent, 34% had

frequent Incontinence (more than one

episode per day), 28% had occasional

Incontinence, 10% had an external

catheter, 28% had an In-dwelling

catheter

64% had concomitant fecal Incontinence

64% were Incontinent on admission to

the nursing home

Most had severe Impairments of cognitive

function and/or mobility

45% had Complications irritation,

urinary Infections)

Physicians noted or sought underlying

cause of incontinence in less than 15%
Table 2-1 .—Prevalence of Incontinence—Continued

Prevalence (percent)

Study Population sample Definition of incontinence Method of data collection Age Female Male Overall Comments

Jewett, et al. (1981) New admissions to geriatric long- Involuntary loss of urine that was Research nurse completed 36 40 38 27% had mental disorders

term care facility in Canada a social or hygienic problem questionnaire 30% could not give a history of their

(N = 277) and was objectively health status

demonstrated Urge incontinence most common

U.S. Department of 15 randomly selected patients in Involuntary loss of urine or feces Assessment form completed by 55 6% had an in-dwelling or external device

Health, Education, and each of 288 nursing homes m at least occasionally nursing-home staff

Welfare, Public Health Medicare/Medicaid program

Service (1975) (N = 4,320) Total nursing

home population = 283,914

Ouslander and Fowler All patients in 90 VA nursing- Any uncontrolled leakage of urine Survey questionnaire completed 41 Of the incontinent patients: 96% were

(1983) home care units (N = 7,853) regardless of amount or by nursing-home nurse male; 70% were age 65 or older, 22%

frequency supervisors had an in-dwelling catheter; 37% had

an external catheter (worn

continuously); only 10% had less than

one episode per day: 55% also had

episodes of fecal incontinence

SOURCE J Ouslander and R Kane, University of California at Los Angeles, 1984
Ch 2—The Problem of Urinary Incontinence ● 1 5

TYPES AND CAUSES OF INCONTINENCE

Normal urination is a complex and dynamic

process involving several anatomic structures and

the coordination of numerous physiologic processes. In addition to the structures of the lower

genitourinary tract (including the bladder itself,

the urethra, the pelvic floor musculature, and, in

men, the prostate gland), the brain, spinal cord,

and peripheral nerves are all involved in the control of urination. Disruption in the normal function of any of these anatomic components can lead

to problems with incontinence (174).

Maintaining continence depends on the normal

physiologic function of the lower genitourinary

tract, normal innervation and necrologic control

over genitourinary function, mental awareness of

the need to void, and the mental and physical capacities to reach a toilet or toilet substitute at the

appropriate time. Thus, disorders of the genitourinary tract, necrologic disorders, psychological

disturbances, and limitations in mobility or environmental factors (e. g., physical restraints or

drugs) can all contribute to the development and

persistence of incontinence.

The normal function of the lower genitourinary

tract includes two basic processes: the storage of

urine and its emptying. Problems that interfere

with these functions can cause incontinence. In

order to store urine, the bladder must accommodate increasing volumes of fluid under low pressure (i. e., it must be compliant). The sensation

of bladder fullness must be perceived at an appropriate time, the bladder must have an adequate

capacity (normally 300 to 600 ml, or about 1 pint),

and the bladder must not contract involuntarily.

In order to empty urine, the bladder must have

the capability to contract voluntarily. There must

be a coordinated lowering of resistance in the

bladder outlet as the bladder contracts, and there

can be no anatomic obstruction to urine flow.

Any condition that impairs these normal functions

of the lower genitourinary tract can cause incontinence.

Incontinence can be classified into several types

(table 2-2). From a clinical and therapeutic viewpoint, there are important differences between

causes of acute versus established (or persistent)

incontinence. Acute incontinence refers to the sudden onset of episodes of involuntary loss of urine,

which is usually associated with an acute illness

or environmental factors that impair the mental

or physical ability to reach a toilet or toilet substitute. This phenomenon is especially common

in hospitalized elderly persons. Many elderly persons have the frequent and urgent need to void

and often arrange their activities to be near a bathroom at the appropriate time. With the onset of

an acute illness, incontinence can be precipitated

by impairment of mobility (e.g., a hip fracture

or cardiovascular decompensation) or confinement to a bed with bedrails and other restraints.

Many elderly individuals also become confused

with the onset of acute illness and admission to

a hospital; their awareness of the need to void and

their ability to find a toilet may therefore be impaired. Too often, elderly hospitalized persons

who recognize the need to void but cannot obtain timely help in getting to the toilet are labeled

incontinent by their nurses and physicians.

Other factors that can precipitate acute forms

of incontinence include acute urinary tract infections with bladder inflammation, metabolic disorders (e. g., diabetes) that increase urine flow,

fecal impaction which may either mechanically

obstruct the normal emptying of the bladder or

cause reflex involuntary contraction of the bladder, and a variety of drugs. Drugs that can precipitate incontinence include diuretics which

increase urine flow, sedative, hypnotic, and antipsychotic agents which may diminish the mental

awareness required for the maintenance of continence, and drugs that influence normal lower

genitourinary functioning such as anticholinergic

drugs (which inhibit the bladder from contracting) and certain antihypertensive agents (which

decrease resistance in the bladder outlet) (14,122).

Established or persistent incontinence (i.e., repeated episodes of involuntary loss of urine not

associated with an acute condition) can be divided

into four types. Stress incontinence implies leakage of small, and sometimes large, amounts of
16 . Health Case Study 33: Technologies for Managing Urinary Incontinence

Table 2-2.—Types of Incontinence

Type Definition Causes Population(s) affected

Acute : Incontinence of sudden onset Acute illnesses associated with one or more Elderly, usually in acute

associated with an acute of the following: (a) immobility and/or hospitals

illness (and/or other factors) environmental factors that diminish the

that subsides once the acute ability to get to and use a toilet; (b)

condition has been resolved or impaired mental function that diminishes

other factors have been toileting ability; (c) fecal impaction.

removed Acute urinary tract infections

Drugs: (a) those that increase urine flow (e.g.,

diuretics); (b) those that inhibit bladder

contractions and cause urinary retention

and overflow (e.g., anticholinergics); (c)

those that decrease mental awareness

(e.g., sedatives, hypnotics)

Metabolic—increased urine flow (polyuria)

associated with poorly controlled diabetes

Established: a

Stress Leakage of small amounts of Weakened supporting tissue surrounding Women, especially

urine with increases of intra- bladder outlet and urethra associated with: those over age 40

abdominal pressure (e. g., (a) lack of estrogen in postmenopausal

coughing, sneezing, laughing, women; (b) previous vaginal deliveries; (c)

exercise) previous pelvic surgery (e.g., hysterectomy)

Urge Leakage of urine caused by Neurological diseases such as stroke, Men and women of any

inability to delay voiding long dementia, Parkinsonism, multiple sclerosis, age; most common in

enough to reach the toilet after spinal cord diseases the elderly

urge to void is felt Genitourinary disorders such as unstable

bladder (“detrusor instability”), bladder

stones, diverticuli of urethra and bladder,

atrophic urethritis, vaginitis (females),

chronic cystitis, mild outflow obstruction

(usually males)

Overflow Leakage of small amounts of Hypotonic or acontractile bladder associated Older men with

urine associated with with diabetic neuropathy; spinal cord prostatic enlargement

obstruction to urine flow injury; or drugs such as anticholinergics Diabetics

(which inhibit bladder contractions),

smooth muscle relaxants, narcotics, and

alcohol

Anatomic obstruction associated with

prostatic enlargement or urethral stricture

Functional Inability or unwillingness to Impaired mobility Elderly in acute

reach a toilet in time Impaired mental function hospitals and nursing

Inaccessible toilets (or caregivers) homes and those with

Psychological disorders such as depression, acute or severe

psychosis, anger, or hostility psychiatric illness

aincontinence is Persistent and unrelated to an acute illness.

SOURCE J Ouslander and R Kane, University of California, Los Angeles, 1984

urine with increases in intra-abdominal pressure,

such as would occur with exercise, straining,

coughing, laughing, or sneezing. This type of incontinence usually occurs in women, especially

those who have had multiple vaginal deliveries

or pelvic surgery. It is generally related to

weakened musculature of the pelvic floor and subsequent loss of resistance in the bladder outlet.

Urge incontinence involves leakage of varying

amounts of urine (usually larger volumes than in

stress incontinence) because of the inability to delay voiding long enough to reach a toilet or toilet

substitute; it can be caused by a variety of genitourinary and necrologic disorders. This type of incontinence is often (but not always) associated

with an unstable bladder (in the past referred to
Ch. 2—The Problem of Urinary Incontinence ● 1 7

by many names, including uninhibited neurogenic

bladder, detrusor hyperreflexia, and detrusor instability). The final common pathway involves

the involuntary contraction of the bladder at low

or normal bladder volumes. It is the most common abnormality found in elderly incontinent

individuals and is often responsive to drug treatment (22,32,81,174). (Drugs, however, have limitations in the management of incontinence, especially in the elderly. ) People with urge incontinence generally empty their bladder completely,

although some patients retain urine. (Urine is considered to be retained if more that 50 to 100 ml

are left in the bladder after voiding). Any condition that causes local irritation in the lower genitourinary tract, such as chronic inflammation of the

bladder or urethra, stones, tumors, or diverticula (outpocketings) of the bladder, can precipitate urge incontinence. Correcting the condition

will often cure the incontinence. Necrologic disorders that impair central nervous system and

spinal-cord control over bladder contraction (e.g.,

stroke, dementia, Parkinsonism, and multiple

sclerosis) can also cause involuntary bladder contraction and urge incontinence. Nonetheless, a

substantial proportion of individuals with urge

incontinence have no demonstrable necrologic or

genitourinary abnormality.

Overflow incontinence is caused by anatomic

obstruction to bladder emptying and/or inability

of the bladder to contract, with subsequent leakage of small amounts of urine. Most common in

older men when benign prostatic hyperplasia anatomically obstructs urine flow, it can also be related to diabetic neuropathic bladders (which contract poorly), spinal cord injuries (which impair

the innervation that causes bladder contraction),

and a variety of drugs that impair bladder contraction. This type of incontinence usually requires either the surgical removal of the anatomic

obstruction or chronic or intermittent catheter

drainage to prevent recurrent urinary tract infections and renal failure, both of which can result

from chronic urinary retention.

functional incontinence occurs in individuals

who have chronic impairments of either mobility or mental function, are unable to toilet themselves independently and do not have sufficient

help with this task, or who, because of psychological disturbances, are unwilling to maintain

continence. Functional incontinence can also be

related to a variety of iatrogenic factors such as

environmental barriers, inaccessible toilets and

caregivers, and psychotropic medication.

TREATMENTS FOR URINARY INCONTINENCE

The most appropriate treatment for a patient

with urinary incontinence depends on a thorough

evaluation of all the relevant factors (genitourinary, neurological, psychological, and environmental ) that could cause or contribute to the condition. Most treatments discussed in this case

stu dy (sphincters, electrical stimulators, drugs-,

training procedures, and surgery) are applicable

to a specific type or types of incontinence and are

attempts to cure the incontinence. Thus, a diagnostic evaluation to identify specific conditions

is critical to the appropriate use of thes e

treatments .

For the purposes of this case study, treatments

for incontinence will be divided into devices and

other treatments (fig. 2-1). Each type of treatment

is briefly described in table 2-3. Devices for incontinence can be divided into those that attempt

to prevent or delay urine flow and those that collect urine before or after it leaves the bladder. Devices such as the pessary, a donut-shaped piece

of inert material inserted into the vagina to support the bladder outlet in women with stress incontinence, and the external penile clamp are used

relatively infrequently at the present time. Newer

techniques, such as the artificial sphincter, which

is an inflatable cuff surgically implanted around

the urethra, and electrical stimulators, which contract muscles of the pelvic floor in stress incontinence and inhibit bladder contraction in urge incontinence, have been used increasingly over the

last 10 to 15 years. These devices, however, can

be used effectively only in carefully selected pa-
Figure 2-1 .—Treatment Options for Urinary Incontinence

Devices

f

Collect urine Prevent or delay urine flow

! After

Mcaga leakage External

occurs .

I

occurs c!amp (men)

ln-dwelling

catheterization

I I

NASA condom

Undergarment

I I I

Implanted Silicone-gel Periurethral

device catheter inflatable Prosthesis Teflon i

I I

(female)

‘mal e

) h r-- 1

Continuous intermittent Disposable Reusable Disposable Reusable

with

disposable

liners

.

cuff

Other treatments

I I 1

drugs Surgical procedures

I 1

Training procedures

I

I 1

I I I I I I I

strengthen inhibit Improve I

Pelvic Scheduled bladder Behavioral Biofeedback

bladder bladder bladder floor toileting retraining modification

outlet contraction emptying exercises

I 1 I I I I

Urinary Bladder neck Relief of Therapeutic Bladder Correction of Bladder neck

diversion suspension obstruction bladder denervation other GU transaction

(female) distension pathology (e.g.,

bladder tumor

r

I i I or stone)

Prostatectomy Dilitation other

{male} of stricture

SOURCE J Ouslander and R Kane University of California at Los Angeles, 1984
Type of treatment Example s

Devices; - Catheters

To collect urin e

before leakage

occurs

Table 2-3.—Treatments for Urinary Incontinence

To collect urine NASA (female )

after leakage occur s Condom catheters (male )

Bed pads

Prevent or delay Artificial sphincters

urine outflow

Silicone-gel prosthesi s

Periurethral Teflo n

Electrical stimulators

External clamp (male)

Pessary (female)

Other treatments:

Surgical procedures Bladder-neck suspension

Prostatectomy (transurethral

resection and suprapubic)

Therapeutic bladder-neck

transection

Selective bladder denervation

(cystolysis)

Therapeutic bladder

distension

Correction of other

genitourinary pathology

(e.g., bladder tumor or

stone)

Mechanism

A flexible tube is placed directly in the

bladder and drains urine into a collecting

bag. Can be used continually or

intermittently.

Outflow is trapped and drained into a

collecting bag

Pad protects individual and mattress from

contact with urine. These pads are

disposable or reusable

Inflatable cuff is surgically implanted around

urethra and inflated to prevent urine

outflow

Silicone-gel is inserted to replace existing

urethra

Teflon paste is injected into tissues

surrounding urethra

Device inserted into vagina; produces

electric impulses that; (a) cause

contraction of pelvic floor musculature; (b)

inhibit bladder contractions

Penis is clamped to prevent urine flow

Device is inserted into vagina, supporting

tissues below bladder and around urethra

.— . .

Urethra and bladder neck are restored to a

more normal intra-abdominal position

All obstructing portion of prostate is

removed

Bladder neck is surgically incised

Nerves to upper bladder are cut so that there

is no muscle control of bladder dome, but

sphincter mechanism is intact

Bladder is distended under anesthesia for at

least 2 hours to a pressure close to

systolic blood pressure

Removal of irritative or obstructive factors

Uses

Inability to empty bladder (urinary retention)

that cannot be corrected by surgical or

drug treatment. (This may or may not be

associate with overflow incontinence)

Incontinence associated with healing skin

lesions

Any type of incontinence

Any type of incontinence, especially useful

as adjunctive therapy with other treatments

Incontinence associated with sphincter -

weakness (usually stress incontinence or

post prostatectomy)

Incontinence associated with pelvic floor

muscle weakness or bladder instabiIity

All types of male incontinence

Female incontinence associated with

prolapsed pelvic structures (usually stress

incontinence) —.

Female stress incontinence

Male overflow incontinence associated with

anatomic obstruction

Urge incontinence associated with bladder

instability

Urge incontinence associated with bladder

instability

Urge incontinence

Urge incontinence associated with bladder

instability

Overflow incontinence associated with

outflow obstruction
20 ● Health Case Study 33: Technologies for Managing Urinary incontinence

u

r

.—

3

u

(n(/3
Ch. 2— The Problem of Urinary Incontinence ● 2 1

tier-its. In addition, only a limited number of health

care professionals are knowledgeable in their use,

and, therefore, only a few patients have been

treated with them.

Catheters are commonly used to manage incontinence, despite the well-known risks associated

with their use, such as urinary tract infections,

penoscrotal abscess and epididymitis in men,

sepsis, and death (91,98,120,144,166). Continuous in-dwelling catheterization is justified for the

short-term management of incontinence in acutely ill individuals, in those undergoing genitourinary surgical procedures, in patients with skin

breakdown needing protection from incontinent

urine, and in patients with urinary retention that

cannot be corrected surgically or pharmacologically or managed by intermittent catheterization.

The technique is inappropriately used for the longterm management of a substantial proportion of

institutionalized incontinent individuals (98, 110).

Intermittent catheterization can be used in carefully selected patients and may prevent the frequent infectious complications of continuous indwelling catheterization (92). External catheters

(condom catheters) are most commonly used in

elderly male incontinent patients; these devices

require frequent changing by nursing staff or other

caregivers and can result in serious complications

(especially local skin irritations). Except for devices currently under development, only one female external-urine-collection device has been described in the literature (59).

Other treatments for urinary incontinence include surgical procedures, drugs, and a group of

techniques that can be broadly labeled training

procedures. As with the treatments mentioned

above, surgical procedures are most useful if the

nature of the underlying genitourinary pathology

is understood. The most common surgical procedure used for incontinence is bladder neck suspension, which is used in women with stress incontinence (124). Other procedures, such as bladder

denervation and bladder distention for the management of unstable bladder, are much less commonly used (44,114).

Drugs are most commonly used in the treatment of the unstable bladder, a common condition in patients with urge incontinence (14,109,

122). A variety of pharmacologic agents can inhibit bladder contraction and therefore are useful

in the therapy for unstable bladder. Other drugs

can strengthen the bladder outlet and can be used

in the management of stress incontinence in females. Drugs used to treat stress incontinence are

potentially toxic, especially in elderly women, and

are generally less effective than surgical procedures (see table 2-3). Drug treatment to promote

bladder contraction is used in the treatment of urinary retention with overflow incontinence.

Probably the most actively marketed products

used to manage incontinence are undergarments

and bedpads. In general, these products are designed with a layer of highly absorbent material

sandwiched between layers designed to keep the

patient and the bed or clothing dry (152). The

majority of bedpads are disposable. Although several U.S. manufacturers offer reusable pads, the

only specially designed reusable bedpad (the Kylie

pad) has been developed and marketed in Australia, but is not yet available in the United States

(24).

Several kinds of incontinence undergarments

are currently marketed in this country (17,18).

Some are completely disposable and resemble diapers; others have a launderable pant fitted with

disposable liners. Although they are useful as adjuncts to other, more specific types of treatments

and can help incontinent individuals remain dry,

comfortable, and involved in social activities,

these undergarments should be considered only

as aids to management for incontinence until the

patient has been evaluated and specific conditions

and their treatments identified.

A wide variety of techniques, which we have

labeled training procedures, have also been described in the management of incontinence (74,

171 ). Although the nomenclature for these procedures remains confusing (74), we have categorized the procedures into five basic techniques

(fig. 2-1): pelvic floor (Kegel) exercises, biofeedback, bladder retraining, habit training, and behavioral modification. However, when one reads

the literature on bladder training, especially that

pertaining to nursing homes and other institutional settings, it becomes clear that most of these

techniques have nothing to do with training the

bladder; they generally involve training the staff

to get the patient to the toilet on time (110).
3.

Effectiveness and Safety of

Devices and Other Treatments
`3 ■

Effectiveness and Safety of

Devices and Other Treatments

Few studies have systematically examined the

efficacy and long-term cost effectiveness of the various treatments for urinary incontinence. Most

published studies are reports of case series. The

relative efficacy of various treatments has rarely

ARTIFICIAL SPHINCTERS

Several types of artificial sphincters have been

developed and tested over the last two decades.

The historical development of and the mechanisms by which these devices maintain continence

are described in detail later in this case study. The

most extensively tested types of sphincters are

surgically implanted cuffs, which fit around the

urethra and are controlled externally by the patient. Earlier models such as the AS 721, manufactured by American Medical Systems, required

patients to both inflate and deflate the cuff. Later

models, such as the AS 791 and AMS 800 TM,

manufactured by American Medical Systems, require patients to deflate the cuff only when they

desire to urinate; the cuff automatically inflates

gradually after urination. These devices are implanted primarily for weakness or total dysfunction of the bladder outlet and urethral sphincter

mechanisms. Patients with unstable bladders or

urinary retention (secondary to anatomic obstruction of urine flow or an inadequately contracting bladder) are not appropriate candidates for

an implantable sphincter and therefore must be

excluded by preoperative urologic evaluation. In

addition, candidates for artificial sphincters must

be mentally and physically capable of managing

the device and be motivated to do so (or have a

caregiver available who will manipulate the device for them ).

As shown in table 3-1, all published reports of

artificial sphincters have been case series, not conbeen examined. In this chapter, we review in detail

the published reports of the effectiveness of treatments for urinary incontinence, focusing especially on devices.

trolled clinical trials. Most commonly, artificial

sphincters have been tested in males with incontinence following prostate surgery, in women with

stress incontinence (many of whom have had previous unsuccessful surgical procedures to correct

incontinence), and in children with spinal-cord abnormalities (myelomeningocele).

As the table demonstrates, artificial sphincters

appear to improve or cure incontinence in 40 to

80 percent of patients. The duration of followup

has ranged from a few months to longer than 3

years. Many patients developed complications

from the procedure—primarily erosion of the

sphincter cuff into the urethra. This was often a

very serious and irreversible complication, occurring in up to one-quarter of treatment failures.

Other complications included persistent infection

and mechanical failure requiring removal and/or

replacement of the device. A newer technique (primary deactivation), designed to minimize cuff erosion, involved leaving the cuff deflated for up to

3 months after the implantation to allow tissue

healing.

In addition to the surgically implantable devices, other approaches to the artificial sphincter

have been developed. A prosthesis made of a silicone gel has been implanted in patients with postprostatectomy incontinence. In the fewer than 200

cases reported, approximately 70 percent benefited from the prosthesis over a 1- to 2-year

2 5
Table 3-1 .—Sphincter Devices

Sphincter device Reference - “

-

Study design

—.-

Diagnosis Criteria for Improvement Results Comments

AS 721 Scott Bradley and Case Series (N = 5 1 m 4 neurologic disorder Radiologlc office 100% success, all dry

Timm (1973) 4 fe) 10-day follow-up examination urodynamics and void freely, voiding

tissue acceptance flow rates as good as or

better than preoperative

results, no discomfort

after 10 days

.—. - ----

AS 721

- .—

HaId, Bystrom, and Case Series (N = 8, 6 m

——. . .

5 neurogenic bladder, Continence “- - 6 continent ‘“

.—————— .—.

Alfthan (1975) 2 fe) 2-10 month follow-up 3 postsurgery

AS 721 Furlow ( 1976) Case Series (N = 31. 29 m. Most post-prostate surgery, Continence 68% success Major complications,_ 3 Infections around

2 fe) Ages 22-78, 24-month 6 pelvic trauma prosthesis, 2 urethral erosions, 1 vesical

follow-up neck erosion, 1 vesicorectal fistula, 1

defective cuff

9/26 continent patients required more

than one revisit to maintain device

function

AS 761 Balloon Sphincter Clinical Case Series (N = 82) Continence 57% successful lnitially, Failures from mechanical complications

Study Group (1977) 2% Improved, 41 % (e g , valve failure), surgical failure (e g

failed Infection), patient selection (e g ,

uninhibited bladder contractions)

As 742 balloon Sphincter Clinical Case series (N = 90) continence 68% success, 5% Failures from surgical error (11), patient

Study Group (1978) improved, 27% failed selection (3), mechanical failure (1)

AS 721

AS 742

Scott (1978) Case series (N = 41) Most past-prostate surgery, Patient should not require Success rate = AS 721, Success rate = 100% for incontinence

10 pelvic fracture bedpad, be continent with 59%, AS 742, 92%, resulting from urethral surgery or

stress. and be able to Overall, 78% following radical prostatectomy

urinate easily Success rate = 50% for those with

pelvic fracture causing disruption to

membranous urethra

6/41 required removal of prostheses

because of surgical contamination and

Infection

742 A,B. C Bruskewitz, et al (1980) Case Series comparing AS Most post-prostate surgery, Excellent = none or slight

742A with AS 742B or C 2 female stress Incontinence Incontinence

Group I (N = 21, 19 m Improved = Improvement

2 fe) Ages 7-83 but still moderate

incontinence

Group II (N = 17) Ages Most post-prostate surgery, Failure = unimproved

9-81 15 had neurologlc disorders,

2 pelvic trauma

14% excellent, 2 4 % Failures associated with cuff erosion

Improved, 62% failure (24%), Infection (24%) patient’s inability

to operate the device and continued

Incontinence (24%)

44% excellent, 6% Failures associated with cuff erosion

Improved, 50% failure (33%), infection (11 %), continued

Incontinence (6%)

The higher balloon pressures in 742B and

C were associated with increased rates of

erosion

AS 742 A,B,C Furlow (1981) Case Series (N = 47, 41 m, 17 radical prostatectomy 13 Continence 81% continent, 19% Device malfunction was not a significant

6 fe) Ages = 6-81, mean neurogenic bladder, 4 female erosion cause of failure, half the failures were

= 55 stress incontinence corrected by cuff replacement and

deactivation

AMS 791 /792 Scott, et al (1981) Case Series (N = 203, 129 88 neurological disorders, 68 Failure = complications or 85% success rate Mechanical failures (26) mainly caused by

m, 74 fe) Ages 5-84: postoperative, 47 others persistent Incontinence cuff failure: 96 percent chance of success

27-month follow-up after first 6 months

r’d

m

●

L

L. .
Table 3-1 .—Sphincter Devices—Continued

Sphincter device Reference Study design Diagnosis Criteria for Improvement

AS 742 Lindner, Kaufman, and Nonrandomized comparison Most post-prostate surgery

Raz (1983) of primary activation with

delayed activation (N = 78,

76 m, 2 fe) Ages 6-83,

mean = 60

Follow-up Group I mean =

268 months, Group II mean

= 92 months

AMS 791/792 -

Reimenschneider and Case Series (N = 16) 2-12 Most post-prostate surgery

Moon (1983) month follow-up

Rosen prostheses Rosen (1978) Case Series (N = 23) Most post-prostatectomy

Dry

Minimal stress Incontinence

Failure

Patient dry between voidingresidual under 100 cc;

unchanged or Improved

upper urinary tracts, no

complications for more than

90 days

Continence

Results

Primary activation (N =

53), 40% dry, 15%

minimal: 45% failed

Delayed activation 58%

dry, 7% minimal, 35%

failed

8 success, 3 failure, 5

unknown (follow-up less

than 90 days)

77% success

Rosen prosthesis Rosen (1978) Case Series (N = 16) 14 post-prostate surgery Cured = continent most of 11

the time

Comments —.— .

Reasons for failure, Group I erosion

19%, Incontinent 13%, infection, 11 %

tube leaked, 2%, Group 11 erosion 24%

Incontinent 12%

Best results occurred in patients with

normal bladders and Incompetent

sphincters

Urethral erosion was major complication

8 patients had second operation 3 had

device successfully changed 5 had

device removed because of infection (4)

or urethral damage ( 1 )

Five failures included failure of scrotal

reserve, urethral and Derineal fistula,

persistent perineal pain, persistent

incontinence

Rosen prosthesis Augspurger (1981) Case Series (N = 17) Post-prostate surgery Proper prosthesis function 53% success ‘-

Half of failures (4) had a possibility of

O-26 month follow-up regardless of number of replacement (e. g mechanical failure),

operations other half caused by perineal pain (2)

and multiple complications (2), 15

patients had major complications requiring

another operation with replacement or

removal of prosthesis

Silicone-gel Kaufman (1978) Case Series (N = 184) 168 post-prostate surgery Excellent = patient 169 excellent or good 11‘Yo had major complications (mostly prosthesis 6-1 2-month follow-up satisfaction and no pads 15 failure used urethral erosions)

Good = patient uses fewer After 1 year with one or more injection

than four pads a day for 33% excellent, 28% good, 390/0 failure

stress incontinence Overall, 69% benefit

Failure = no Improvement or

patient uses more than four

pads a day

Silicone-gel Confer and Bean (1981) Case Series (N = 8) Post-prostate surgery Continence without 100% success One patient required a second injection

prosthesis 30-month follow-up Complications regardless of 2’/2 years later

number of injections

-—. —._—

Periurethral Teflon Politano (1978) Case Series (N = 125, 77 75 post-prostate surgery, Excellent = total continence 70% good/excellent -

Injection m, 43 fe) Ages 6-84 variety of other conditions with no protective device

Good = collecting device not

necessary

Poor = little or no

Improvement

Periurethral Teflon Lim, Ball, and Feneley Case Series (N = 28) Ages All Incontinent, 26 had Cured = total continence 21% cured, 54% -

‘Patients with weak sphincters and stable

injection (1983) 20-84, Mean = 569, 3-12 previous surgery to relieve Temporary Improvement = temporary Improvement, bladders responded best

month follow-up incontinence good control of continence 2570 no Improvement

with only minimal leakage
Table 3-1 .—Sphincter Devices—Continued

Sphincter device Reference Study design Diagnosis criteria for Improvement

..——

Results Comments

Four recent studies a

..—

Light Case Series (N = 58) Ages All spinal cord Continence without 70%

12-67, 3-36 month follow-up complications

Diokno Case Series (N = 23) Continence without 70% 6 failures from tissue erosion 1 from

Follow-up mean = 35 years complications infection

Mulcahy Case Series (N = 70)

Barnett Case Series (N = 262)

(N = 30)

Continence without 89% Complications Included 11 cuff erosion

complications tubing kinks 3 cuff leaks 3 pump

erosions

All had previous surgery for Continence without 50%

incontinence complications

None had previous surgery 95%

for Incontinence

-. -.

apresented at the 1983 Annual Meeting of the American Urological Association and reported in Hager 1983

SOURCE J Ouslander and R Kane University of California at Los Angeles 1984

4
Ch. 3– Effectiveness and Safety of Devices and Other Treatments . 2 9

period. Some of the patients required repeated injections, and urethral erosion (similar to complications described with artificial sphincters)

occurred in a few patients (38,88).

In addition to the silicone-gel prosthesis, a

method of periurethral injection of Teflon has

been developed (31 ). This procedure is quite simple and requires only local anesthesia and the injection of a Teflon paste around the urethra. As

with the silicone-gel prosthesis, fewer than 200

ELECTRICAL STIMULATION

Several different approaches involving electrical impulses for the treatment of incontinence

have been tested over the last 20 years (149). In

the earliest investigations, electrodes were implanted into the pelvic floor musculature and electrical current was used to stimulate muscle contraction and maintain continence in patients with

stress incontinence. Difficulties with mechanical

failure and migration of the surgically implanted

electrodes led to the development of external electrical stimulation. External techniques include anal

plugs and pessary-like devices with electrodes.

Electrical stimulation has been used for both

acute and chronic conditions. In acute situations,

the maximum voltage that does not produce discomfort is used to stimulate for periods of approximately 30 minutes. Stimulation can be repeated

on several occasions over the course of a few

weeks. In chronic situations, the device is left in

place for most of a 24-hour period and the pelvic

floor musculature is intermittently stimulated as

the current is turned on and off for several seconds

at a time.

Scandinavian studies done in cats and humans

have shown that these devices can be used for

both stress incontinence and incontinence associated with bladder instability (.50,51,53,54). In

stress incontinence, stimulation appears to work

by causing contraction of the pelvic floor musculature through stimulation of the nerves that

innervate (i. e., control) the muscles. For bladder

instability, the device stimulates sensory nerve

cases have been reported; approximately 70 percent achieved favorable results. Experiments with

dogs have indicated that the Teflon particles can

migrate: They have been found in the dogs’ lungs

and other major organs (97’). Thus, before this

technique can be widely instituted, larger sized

Teflon particles may have to be developed to prevent migration and any potential long-term adverse effects of these articles in various areas of

the body.

fibers, which then cause reflex relaxation of the

bladder, mediated by the spinal cord.

These different effects occur at different frequencies of stimulation. Thus, it appears that optimal design of the device involves the ability to

vary the stimulation frequency. Because the effects are mediated by nerve fibers, the electrodes

must be placed and maintained in the proper position for nerve stimulation to be effective. Recently

developed electrical stimulators are inflated in the

vagina to minimize electrode movement.

Patient selection is important in the success of

these devices. Urologic examination must be performed to determine the type of incontinence and

rule out abnormalities treatable by other means.

Patients with stress incontinence must have intact

pelvic floor musculature to be eligible. Patients

with unstable bladders must have an intact nervous reflex arc. Patients with disorders that have

completely destroyed the peripheral nerves or

lower spinal cord are not appropriate candidates.

In addition, patients must be willing and able to

use and manage this device on an acute or chronic

basis.

Results of several reported case series (shown

in table 3-2) vary, depending on the nature of the

electrical stimulation. In general, between .50 and

80 percent of individuals derive some short-term

benefit from the treatment. A much smaller proportion of patients enjoy long-term benefits. Although there were few serious complications re-
Table 3.2—Electrical Stimulators

Electrical stimulator

device Reference Study design Diagnosis Criteria for improvement

. .

Results Comments

Implantable pelvic Merrill, Conway,

floor stimulate? and DeWolf Case Series (N = 14; 9 Most had necrologic Dry for at least 3 hours 3 cured; 4 Improved No surgical complications; procedure

(1975) m, 5 fe) Ages 3-70 disorders; 6 postoperative for several days in a row uniformly unsuccessful for those

with lower motor neuron lesions or I

meningomyelocoele: equipment !

failures (fractured antenna leads (4);

faulty power supply (2)) occurred In

43% of failures

Implanted

electrical Alexander (1976) Case Series (N = 22 fe) Stress incontinence, usually Cure =continence 8 cured after surgery without Relapses associated with Influenza, ~.

stimulators 3-24 month follow-up with coexisting urge Improved = subjects using implant, 13 Improved gallbladder surgery, bladder 2

incontinence relieved but not totally with surgery and Implant uncomfortable, blow on the abdomen, y

continence stimulation domestic strife -.

x

Transrectal external Merrill, Conway, and Case Series (N = 6 fe) Stress, congenital iatrogenic Continence

n

50% Abdominal cramps and mild diarrhea <

pelvic floor DeWolf (1975) postoperative incontinence occurred during stimulation: no

stimulator

````````````````````2

equipment failure $

Transrectal Merrill (1979) Case Series (N = 20) 5-12 Urinary incontinence and Cure = continence without O cured: 4 benefited Patient Instructed to activate device .

stimulator month follow-up detrusor hyperreflexia stimulator

-.

continually except when voiding, 3/4 2

Benefit = symptoms less successes after frost day 3

than before Implant

nm

External stimulating Doyle, et al. (1974) Case Series (N = 120) 104 sphincter weakness Success = continence 370/o success Success rate highest in young,

device 12 bladder dysfunction 42% success nulliparous patients who had not had

4 both 75% success surgery and was lowest in older patients

who had had pregnancies and previous

surgery

Maximal perineal Glen, et al (1976) Case Series (N = 19) Urinary incontinence, 17 Subjective O reported benefit

stimulation poor urethral pressure

profiles

Chrome electrical Godec, Cass, and Case series (N = 72; 34 m, 38 hyperreflexive bladder; 12 Cured = dry when off 17 cured, 49 Improved, 6 Failures caused by urethral stricture (2):

stimulation Ayala (1976) 38 fe) pelvic floor weakness: 16 device one month failure

both

urinary tract infection (2), radiation

Improved = less wet than 12% success rate overall cystitis (l), mental retardation (1)

before stimulation

Acute electrical Godec and Cass Nonrandomized study of 8 stress incontinence, most relief = dry Overall 1 7/20 relief or

stimulation (1978) different types (N = 29, 8 others had necrologic Improved =- less wet improvement, 5/17 relapsed,

m, 21 fe) 4-17 month disorders requiring repeat treatment

follow-up
o

co

u-l

I

Table 3-2.—Electrical Stimulators-Continued

Electrical stimulator

device Reference Study design Diagnosis Criteria for Improvement Results Comments

Maximal electrccal “ Plevnik and Janez Case Series (N = 98) 37 mixed stress and urge Success = continence Overall 7% cured, 50% In some patients, 3 MES sessions

stimulation (M ES) (1979) Incontinence, 11 postprostate Improved, 43% no effect resulted in sustained Improvements

surgery, remainder had

various types of neurogenic

bladder

Electronic pessary Harrison and Case Series (N = 21 fe) 15 stress Incontinence, 5 Symptoms cured or Improved 11 success

Paterson (1970) Ages 37-70 urge Incontinence, 1

dribbling incontinence

(duration of symptoms = 9

mo to 38 yrs)

Electric pessary HiII, et al (1968) Case Series (N = 5 fe) 12 2 stress incontinence, 1 urge Continence 4 Improved

week follow-up incontinence, 1 postsurgical

Incontinence —.-

Intravaginal electrical Erlandson, Fall, and Case Series (N = 50 fe) 24 stress incontinence, 22 Urethral pressure profile 20-50 Hz for 15 mins was Carefully selected positions of electrodes

stimulation (IVS) Sundin (1977) Ages 19-82 urgency with or without used to determine effect of most effective for urethral and proper frequency of electrical Impulse

incontinence electrical stimulation on closure were necessary for optimal urethral

urethral closure response

Ivs Fall, et al. (1977) Case Series (N = 17 fe) Idiopathic urinary urgency Bladder capacity increase Bladder capacity less than

Ages 27-60, mean = 46 without incontinence before urination 300 ml 7/9 Increased, 2/9

decreased

Bladder capacity more than

300 ml 3/8 Increased, 5/8

decreased

Long-term IVS Fall, et al (1977) Case Series (N = 24 fe) 9 urge incontinence, 9 stress Cured, free from symptoms Urge incontinence

(4-9 months) Ages 30-60, mean = 46, incontinence; 6 both or marked improvement, no 1/9 cured, 8/9 Improved

2-8 month follow-up Improvement Stress Incontinence

3/9 cured, 4/9 improved,

2/9 not Improved

Both types

1/6 cured,

a

Not defined

SOURCE J Ouslander and R Kane, University of California at Los Angeles 1984

5/6 Improved

I
32 * Health Case Study 33: Technologies for Managing Urinary Incontinence

ported with these devices, the long-term effects

of chronic electrical stimulation are unknown.

Several reports indicated that patients simply refused to use the device for a long period of time.

Several features of the case series reviewed in

table 3-2 should be emphasized. Many of these

series were done before information on optimal

frequencies and durations of stimulation for the

different types of incontinence were known. Thus,

the success rate using optimal parameters of stimulation is unknown. Unlike the situation for artificial sphincters, which requires a sham operation

CATHETERS

There are three basic types of catheter techniques used to manage incontinence: chronic indwelling catheterization, intermittent bladder

catheterization, and external catheters (for men).

Chronic in-dwelling catheterization involves the

placement of a catheter in the bladder, held in

place by an inflated balloon. The catheter is attached to plastic tubing, draining urine into a

drainage bag, which is emptied at regular intervals. The drainage bag can be strapped to the leg

and hidden beneath clothing to avoid embarrassment. Despite improved techniques of chronic indwelling catheterization, this type of treatment

is associated with several potentially severe complications and is probably overused in the management of incontinence (especially for elderly patients in long-term care institutions) (98,110,

120,166).

Continuous in-dwelling catheterization is appropriate for managing established incontinence

in only a limited number of patients. They include

individuals with urinary retention (caused by either anatomic or functional obstruction or poor

bladder emptying) that cannot be relieved surgically, pharmacologically, or by intermittent catheterization, and patients with skin conditions that

are worsened by contact with urine. Surveys of

long-term care institutions in this country and

Canada indicate that 10 to 30 percent of incontinent individuals are managed by continuous indwelling catheterization (85,98,111,120). This

number probably far exceeds the number of pato design a true controlled trial, a controlled trial

of intravaginal electrical stimulation to test possible placebo effects is much more feasible. Despite the possibility, no controlled studies have

been reported. Comparing the effects of the functioning intravaginal electrical stimulator with the

effects achieved by simply placing the device without the electrical stimulation would be of great

interest in light of reports in which patients had

prolonged cures after single treatments or claimed

success when batteries were malfunctioning.

tients with the above-mentioned conditions, but

catheters are probably used for staff convenience

and because of cost considerations (if one ignores

the costs of treating complications that result from

catheterization). The cost implications are discussed later in this study.

The primary risk of chronic in-dwelling catheterization is urinary tract infection. Virtually all

patients with in-dwelling catheters for periods

over 2 weeks will have urinary tract infections;

however, not all these patients will become symptomatic and require treatment (166). Urinary catheterization has been shown to be the major cause

of nosocomial infections in acute care hospitals

(77,144) and are associated with increased mortality in this setting (116).

Studies over the last two decades have shown

that maintaining a closed drainage system and

adeptly handling the catheter and draining its bag

are critically important in preventing infection

(68,177). Other techniques, such as one-way

valves in the catheter tubing to prevent backflow

of urine and separate ports added to the catheter

for urine sampling, have also decreased the risk

of infection. Prophylactic antibiotic therapy, either directly instilled into the bladder or taken

orally, does not prevent urinary infections and,

in fact, appears to predispose to infection with

more resistant bacteria (70,91,106,165). Frequent

cleaning of the area of catheter entry with antimicrobial substances increases rather than decreases the incidence of infection (26). Thus it
Ch. 3—Effectiveness and Safety of Devices and Other Treatments ● 3 3

appears that techniques involving frequent manipulation of the catheter or breaking of the draining system increase the risk of infection and should

be avoided. A few recent reports indicate that

antimicrobial substances, such as peroxide and iodine solutions, instilled regularly into the drainage bag, diminish the incidence of infection (39,

96,143). The ability of these techniques to prevent symptomatic infections to patients continuously catheterized for years is still unproven.

An alternative approach to continuous indwelling catheterization is intermittent self-catheterization. This technique has been applied mainly

in younger individuals with paraplegia or other

necrologic disorders (e. g., spina bifida) whose

bladders do not contractor empty properly (92).

It is also applicable for patients with other causes

of chronic urinary retention such as a diabetic

neuropathic bladder. These patients are taught to

catheterize themselves at regular intervals. The

procedure involves no special equipment except

a catheter, which is kept in an antiseptic solution

between catheterizations. This technique has been

shown to reduce the incidence of infection and

other complications compared with continuous

in-dwelling catheterization in younger patients

(92). Intermittent catheterization is less often used

BEDPADS AND UNDERGARMENTS

Most acute care hospitals and long-term care

institutions use “blue pads” for managing incontinence, despite their relatively poor absorbency

and lack of odor control. A variety of other products are available for keeping patients’ bedding,

clothing, and furniture dry in these settings. Specially designed incontinence undergarments and

bedpads have been used for several years in Great

Britain, other European countries, and Australia,

but only over the last 2 to 3 years have several

of these products been marketed intensely in the

United States.

Ideally, an incontinence bedpad or undergarment should be highly absorbent, nonallergenic,

and relatively easy for patients or caregivers to

change. It should control odor, not wrinkle

(which predisposes to skin irritation and impairs

in the elderly incontinent patient; however, it

would be applicable in those whose incontinence

is associated with urinary retention not correctable by other means. Either the patient or the caregiver must be trained in the technique. Because

complications with this technique might be more

frequent in this patient population than in others,

studies comparing the efficacy of chronic in-dwelling versus intermittent catheterization in the elderly population would be of value.

External catheters (condom catheters) are used

exclusively in men. Although this technique is

thought to diminish the risk of urinary tract infection, no studies have confirmed this impression. External catheters require changing every 24

to 48 hours, and they frequently fall off, requiring reapplication. Certain types of catheters and

application techniques reduce the frequency with

which the catheter falls off. A substantial proportion of patients develop skin irritation on the penis

(balanitis), which precludes the use of these

catheters; the patient then requires an in-dwelling

catheter until the skin lesions heal. External

catheters, like intermittent catheterization, require

either the patient or, more commonly, a caregiver

to be available and

ment techniques.

trained in the proper managehealing of pressure sores), and require fewer

changings than simply using drawsheets or other

types of padding (152,171). The most innovative

bedpad is the Kylie pad, which was developed in

Australia. This pad is launderable, has a porous

top layer that allows urine to pass freely into a

more absorbent middle layer, and a moistureresistant backing that keeps the bed dry. Unlike

other types of bedpads, the Kylie pad’s special design helps keep both the patient and the bed or

furniture dry (24,175).

Incontinence undergarments come in many

shapes and forms. Some are completely disposable; others are launderable briefs into which a

disposable pad is inserted. An increasing number

of these products is being marketed in this country. Most are designed along the lines of the Kylie
34 ● Hea/th Case Study 33: Technologies for Managing Urinary Incontinence

bedpad, with a permeable layer close to the patient, a highly absorbent middle layer or pad

(which generally contains a polymer with tremendous absorptive capacity), and an outer layer,

which prevents soiling of clothing.

Several small-scale studies have examined the

impact of these products on patient comfort and

health (table 3-3). Most of the studies are uncontrolled and do not account for patient cross-overs

between treated and untreated groups.

As might be expected, most patients responded

favorably. A few studies suggested that costs decreased because the reduced amounts of clothing

and bedding required decreased the laundry and

labor needs, thus lowering costs. These types of

products can clearly make life more comfortable

SURGERY

Surgical treatment is essential in the management of certain types of incontinence and effective, but not essential, for other types. For those

patients with overflow incontinence caused by an

anatomic obstruction to urine flow (e. g., an enlarged prostate in men or a urethral stricture), surgery is necessary to relieve the obstruction. Although this type of surgery may not always cure

the incontinence (in fact, in some instances, the

incontinence may persist or even worsen), urinary

obstruction cannot be left untreated. Continuous

retention of urine will predispose the patient to

recurrent urinary tract infections and could eventually lead to renal failure and death. In some patients, pathologic conditions in the lower genitourinary tract, which irritate the bladder or urethra

and cause incontinence, can be corrected surgically. Examples of such conditions include bladder tumors, bladder stones, and diverticuli of the

bladder or urethra, as well as several other, less

common conditions.

DRUG TREATMENT

for incontinent persons and diminish the burden

on their caregivers by keeping the affected individuals dry and more mobile and by enhancing their ability to interact socially. However,

carefully designed, controlled studies with objective outcomes that compare these products with

other strategies to manage incontinence would be

of great value, especially in the incontinent population now in long-term care institutions, No

studies have carefully assessed the effectiveness

of these products in diminishing such complications of incontinence as skin irritation and urinary

tract infection. Studies that examine the effectiveness of these products in diminishing the burden

on caregivers of community-dwelling elderly and

in delaying or preventing institutionalization

would also be of great interest.

The most common surgical procedure for incontinence is bladder-neck suspension. In this

operation in women with stress incontinence, the

bladder neck and urethra are repositioned. Several modifications of the original bladder-neck

suspension procedure have been developed, and

the procedure can now be done in less than an

hour, under local or spinal anesthesia (124). Hospital stays can be as short as 3 days. Because

women with symptoms of stress incontinence can

also have other abnormalities of genitourinary

tract function (e.g., bladder instability and urinary

retention), careful preoperative evaluation and appropriate patient selection are critical to success.

Most published series have shown a 70 to 90 percent success rate (99,123,124,146). No prospective, randomized, controlled study has been done

to compare bladder-neck suspension to other treatments for stress incontinence—e.g., electrical

stimulation or drug treatment—in similar groups

of patients.

Drugs can be used to treat overflow, stress, and der contraction (rather than anatomical obstrucurge incontinence (14,109,122). For those patients tion to urine flow), cholinergic drugs that promote

with overflow incontinence caused by poor blad- bladder contraction can be used. The most com-
Table 3-3.— Bedpads and Undergarments

Device Reference Study design Diagnosis Criteria for Improvement Results Comments

Launderable bed pad Broughten (1979) Nonrandomlzed crossover

(Kylie) study of drawsheet and 85% incontinent of urine, Nurses’ reactions, patient’s Kylie pads decreased odor, Estimated cost savings per patient per

disposable pads vs Kylie 50% incontinent of urine and reactions, skin condition and made patients more night = $2420

pad (N = 18), age = stool costs comfortable, Improved skin

6 5 + conditions, reduced laundry

by 45%

Launderable bed pad Smith (1979) Uncontrolled (N = 8) age All Incontinent of urine at Nurses’ assessments of Kylie

(Kylie) = 65+ night and prone to pressure pad’s ability to absorb large

sores volume of urine, retain

moisture under pressure,

keep patient’s skin dry, keep

bed dry reduce risk of bed

sores, avoid wrinkling; give

patient comfort, reduce odor,

be economical

Kylie pads allowed patients Study performed m two acute-care

to sleep better, saved time, hospitals

saved linen, decreased cost

by $1.25 per patient per

night

Launderable bed pad Williams, et al Comparison of disposable Most had neurologlc disorder Skin dryness, lack of Kylie pads reduced skin

(Kylie) (1981) bed pads and Kylie with causing incontlnence creasing, less need to wetness, creased less often,

crossover design (N = 36: change bed hnen; less odor, decreased bed changes,

11 m, 25 fe) Ages = male cost savings Improved odor; reduced cost

52-87, mean = 73; female 39% ($1 25 per patient per

34-101, mean = 77 day)

Launderable Shepherd and Each subject wore each Necrologic disorders Subject’s opinion of garment Kanga was most satisfactory; Most subjects were Iiving in homes and

undergarments with Blannin (1980) garment for a month (N = Molnlyche was difficult to attended by a community nurse

disposable pads 20; 2 m, 18 fe) Ages 4-84 handle, Sandra was

(Kanga, Molnlyche, associated with skin

and Sandra pants) Irritation, sweating, and

discomfort

Launderable Silberberg (1977) Randomized comparison of Urinary and stool Lack of skin moisture, skin Groups with pads had less Subjects Iiving in long-term care ward

bedsheet (Kylie pad) absorbent pad, pad and incontinence inflammation, creasing or skin irritation (77% vs.

antimicrobial agent, and wrinkling of pad; odor 37%), dryer skin (750/976

drawsheet (N = 32) vs. 387/1046): less

wrinkling (14% vs. 41%),

less odor (5% vs. 27%)

Disposable Beber (1980) Randomized comparison of Persistent incontinence (3 or Nursing staff rate skin 40/53 staff judged patient’s All were nursing-home patients; reduced

undergarments Attends and disposable more uncontrolled urinations conditions and quality of life quality of life as Improved patient changes, gave some patients

(Attends) bedpads, no crossover per day) (based on social activities greater mobility and less embarrassment:

(N = 276) Age = 65+ and expressed confidence Improved odor, appearance, and mood of

with Attends) ward

Launderable brief Watson (1980) Uncontrolled (N = 54; 15 22 “heavy’ incontinence; Patient comfort, acceptance, Reduced staff workload, Subjects in chronic hospital; estimated

with disposable pad m, 39 fe) Age 60-99 17 “moderate”, 8 “slight”, and effect on skin laundry, odor; increased 90% cost savings for all wards, increase

(Molnlyche pant) 21 also had stool patient dignity, response to in visitors

incontinence toilet training

SOURCE J Ouslander and R Kane, University of California at Los Angeles, 1984

T

●

h

h
36 . Health Case Study 33: Technologies for Managing urinary Incontinence

monly used drug, bethanechol (Urecholine), stimulates bladder contraction and emptying, prevents

recurrent urinary tract infections caused by urinary retention, and, in theory, helps resolve the

overflow incontinence. In many patients, especially in the elderly age group, this type of treatment

may worsen incontinence by creating urinary frequency and urgency. In addition, bethanechol has

several adverse side effects, including gastrointestinal cramping, diarrhea, and increased bronchial

secretions. Thus, intermittent catheterization may

be a better alternative for many of these patients.

Drugs that promote contraction of the smooth

muscle around the bladder outlet have been used

to treat stress incontinence. These drugs include

pseudoephedrine and phenylopropanolamine,

both found in over-the-counter cold preparations.

No carefully designed studies have been done to

compare the effectiveness and risks of drug versus

surgical therapy for stress incontinence. Drugs for

stress incontinence must be used carefully, especially in elderly women in whom they can exacerbate hypertension and cardiovascular disease.

Topical or oral estrogens are frequently chosen

to treat stress incontinence in elderly women. Although estrogens strengthen the tissues around the

bladder outlet, few studies have objectively documented that this physiologic effect results from

estrogen therapy alone, and estrogens do carry

the risk of exacerbating hypertension and thromboembolic disease, as well as an increased risk of

endometrial cancer (86,169). They are probably

useful in women with stress incontinence in whom

there are no major contraindications to their use

and should be used cyclically in the lowest doses

possible. Some experts recommend that they be

used in a topical vaginal cream in combination

with a progestational agent taken orally to diminish the risk of complications, although topiTRAINING PROCEDURES

Several techniques, broadly labeled here as

“training procedures, ” have been reported as successful in managing various types of incontinence

(71,74). These techniques include pelvic floor

exercises, biofeedback bladder retraining, habit

training, and behavioral modification.

cal intravaginal estrogens are absorbed to pharmacologic blood levels, and the relative safety of

this mode of administration remains unclear (86).

The most common and effective drug treatment

is that for urge incontinence (122,174). Various

drugs have been tested for their ability to diminish bladder contractility and thereby improve

symptoms associated with bladder instability (table 3-4). Most studies have shown these drugs to

be effective in over 50 percent of the patients.

Several caveats are important. The majority of

studies have been either uncontrolled or placebo

controlled without adequate concern for patient

cross-overs between treatments. The patients,

their genitourinary abnormalities, their presenting symptoms, and the specific outcomes of treatments have generally been poorly defined. Interestingly, several of the studies mentioned that

symptomatic improvement does not always correlate with objective changes in lower genitourinary

function (as measured by urodynamic techniques).

Most studies did not control for other simultaneous interventions that can also affect outcomes,

such as instructions to delay the urge to void, to

schedule toileting, and to restrict fluid intake. Finally, most of the drugs used to treat bladder

instability have bothersome side effects, including dry mouth, constipation, and blurred vision

(122,174).

Several newer classes of drugs, such as prostaglandin inhibitors and calcium antagonists, have

also been studied in small numbers of patients.

Carefully controlled studies of newer drugs, studies comparing drug treatment to other forms of

treatment for detrusor instability, and the development of new pharmacologic agents for this condition would be of great value.

Repetitive contraction of muscles of the pelvis

and vaginal wall (Kegel exercises) have been used

for several decades in the management of stress

incontinence in females (89). Although these exercises are often not curative and can only be used

by patients with adequate cognitive function, in-
Table 3-4.—Drugs in Incontinence Treatment

Drug

Criteria for

Reference Study design Diagnosis Improvement Results Comments

Diminish bladder contractions:

Propantheline 30 mg orally Tulloch (1978) Uncontrolled (N = 33), Unstable detrusor Symptoms 2 symptomatic Improvements 14/20 needed long-term therapy to

aid or more ages = 14-79, mean = 62 maintain Improvement

Propantheline 60 mg IV Diokno, et al (1972) Uncontrolled (N = 11) Uninhibited bladder Urodynamic Propantheline abolished

Imipramine 25-75 mg IM contractions uninhibited bladder contractions,

Imipramine did not

Propantheline 15 mg orally Thompson and Double-blind: placebo Uninhibited neurogenic Urodynamic Both delayed reflex contractions, Oxybutinin was better than

weeks Lauvetz (1976) controlled (N = 14) bladder Increased bladder volume at first propantheline, had fewer side effects

Oxybutinin 5 mg orally 4-6 contraction, and subjectively over 4-6 week period

weeks decreased urge incontinence

Propantheline 30 mg po Kohler and Morales Double-blind, no placebo 21 bladder spasticity Urodynamic Both raised bladder capacity 2 No change In Intra-ocular pressure

Flavoxate 200 mg PO (1968) (N =, 23 m, 2 fe) 4 flaccid bladder hours after dose, 13/21

flavoxate, 8/21 propantheline

Propantheline 30 mg orally Badley and Cazort Double-blind; no placebo Urinary symptoms Symptoms Both Improved symptoms 11 urinary Infection, 25 cystitis, no

qid 7 days (1970) (N = 46; 18 m, 28 fe) change m ocular pressure

Flavoxate 200 mg orally qid

7 days

Propantheline 15 mg orally Beck, Aruusch, and Uncontrolled (N = 82) Detrusor overactivity, Symptoms 76% of 64 propantheline, 67%

qid 3 weeks King (1976) stress Incontinence Urodynamic of 18 dicyclomine Improved or

Dicyclomine 10 mg orally 3 cured

weeks

Propantheline 15 mg orally Beck, Aruusch, and Placebo; controlled Detrusor overactivity; Symptoms 75% of 15 propantheline, 62%

qid 3 weeks King (1976) (N = 51) stress inactivity of 13 dicyclomine; 15% of 15

Dicyclomine 10 mg orally placebo Improved

qid 3 weeks

Propantheline 15 mg orally Brocklehurst and Uncontrolled; All subjects Incontinence Incontinence charts, Combination of propantheline and Total of 13 drug combinations

Atropine 0,6 mg IM Dillane (1967) elderly urodynamics orphenadrine gave best clinical Clinical Improvement did not correlate

Ephedrine 15 mg orally

Orphenodrine 50-100 mg

and urodynamic improvement with urodynamic changes

orally

Others

Propantheline 15 mg orally Fliegner and Uncontrolled (N = 258) Urge and stress incontinence Symptoms 90% with urge Incontinence Not all subjects received both drugs;

combined with Imipramine Glenning (1979) Improved some received other agents

25 mg qid orallv “1 .

Propantheline 15 mg adults Blaivas, et al. Uncontrolled (N = 42, 9 m, Uninhibited detrusor Urodynamic 79% positive response to No patient who failed to respond to

IM, 7.5 mg children IM (1980) 33 fe) ages = 5-79, contractions propantheline, 50% urinary parenteral medication had favorable

mean = 62 retention response to drug when administered

orally

Emepronium bromide 50 mg Brocklehurst, Placebo controlled, crossover Incontinence Nursing records Small reduction In Incontinence

orally qid 2-4 weeks Armetage, and unblinded (N = 43) ages = with active drug

Jouhar (1972) 57-90; mean = 82

Emepronium bromide 200 mg Nordling, et al. Uncontrolled (N = 38) ages 30 uninhibited contractions Symptoms 66% Improved

orally qid for one month (1979) = 18-90, mean = 51

Emepronium bromide 50 mg Ritch, et al (1977) Uncontrolled (N = 9, 6 m, Established Incontinence, Urodynamic Only IM decreased contractions

IM dose 200 mg orally qid 3 fe) ages = 71-94, uninhibited contractions and a raised bladder capacity

7-10 days mean = 82 and had little effect on

urodynamics

●

L

w
Table 3.4.—Drugs in Incontinence Treatment—Continued

Criteria for

Drug Reference Study design Diagnosis Improvement Results Comments

Emepronwm bromide 200 mg Stanton (1973) Double-blind randomized Urinary symptoms and Symptoms Flavoxate better for relief of 38% showed no clinical effect from

qid orally crossover, no placebo Incontinence Urodynamlc symptoms, no change m urethral either drug

Flavoxate hydrochloride 200 (N = 38; 6 m, 32 fe) pressure profiles

mg orally qid mean age = 47

Emepronium bromide 200 mg Williams, Double-blind placebo Organic brain disease; Symptoms No significant difference between

orally qid 21 days Prematalake, and controlled (N = 30, 8 m, functional psychiatric placebo and emepronium

Palmer (1981) 22 fe) mean age = 74 disorder; incontinence

Emepronium bromide 200 mg Gaudenz and Weil Placebo controlled (N = 70) Motor urge incontinence Symptoms Emepronium bromide, 34% Uninhibited detrusor contractions

tld (1980) Urodynamic excellent; flavoxate, 50% persisted

Propantheline 3 x 30 mg for excellent; propantheline, 15%

12 weeks excellent; placebo, O%

Emepronium bromide 200 mg Walter, et al. (1982) Double-blind crossover Urinary incontinence and Symptoms No statistically significant

tid OR placebo in two 4-week (N = 20; 8 m, 12 fe) frequency Urodynamic

periods

difference between effects of

ages = 64-88; emepronium bromide and

mean = 74 placebo; overall subjective cure

rate = 7 9 %

Emepronium bromide 200 mg Meyhoff, Double-blind crossover Motor urge incontinence Subjective 79% claimed good effects from

qid OR Gerstenberg, and (N = 20) ages = 22-79, without bladder suspension one or more drugs; 47%

Flavoxate chloride 200 mg Nordling (1983) median = 51 defect preferred placebo

qid OR Only placebo had statistically

Placebo significant decrease m frequency

of voidings, incontinence, and

nocturia

NO differences demonstrated

between emepronium bromide

and flavoxate chloride

Flavoxate 100 mg IV 200 mg Briggs, Castleden, Uncontrolled (N = 6; 2 m, Uninhibited contractions Symptoms No consistent effect on symptoms

orally qid 7 days and Asher (1980) 4 fe) ages = 72-84 Urodynamic or urodynamic parameters

Flavoxate 200 mg IV Cardozo and Stanton Uncontrolled (N = 15) Detrusor instability Urodynamic Emepronium significantly

Emepronium bromide 50 mg (1979) Improved urodynamic parameters;

IM flavoxate and imipramine had no

Imipramine 50 mg IM significant effect

Flavoxate 50 mg orally qid Hebjorn (1977) Double-blind crossover, no Multiple sclerosis; Symptoms as 27/32 had improved symptoms, 9 chronic urinary infection, patient

14 days placebo (N = 34; 8 m, 26 incontinence; detrusor recorded m a patient 18/27 preferred methanteline satisfaction did not correlate well with

Methanteline 50 mg orally fe) ages = 23-65; hyperreflexia diary urodynamic changes

qid 14 days mean = 47 Urodynamic

Meiadrazine 150 mg orally

aid 14 days

Flavoxate 200 mg qid Younglove, Newman, Uncontrolled (N = 25) Unstable bladder Symptoms 21 cured

and Wall (1980)

Methanteline 50 mg orally Walter (1978) Uncontrolled (N = 54) Uninhibited contractions Symptoms 27/53 Improved or free of Only half those Improved had

qid 6 months ages = 29-82, mean = 54 Urodynamic symptoms increased bladder by cytometry, no

other urodynamic changes

Dicyclomine 20 mg IM 20 Awad, et al. (1977) Uncontrolled (N = 27; Uninhibited neurogenic Symptoms Most had increased bladder No significant side effects;

mg orally tid 8 weeks 14 m, 13 fe) ages = 10-90 bladder Urodynamic capacity with oral or IM; 26 improvement started at 7-10 days

increased bladder capacity an and continued after 4 weeks, females

average of 21 see, 24 had had more symptomatic Improvement

symotomatic improvement

Dicyclomine 20 mg orally Fischer, et al Uncontrolled (N = 14; 6 m, Uninhibited neurogenic Urodynamic 17% excellent; 7% good, 22% No complications

(1978) 8 fe) bladder fair

●

b

b. .
Table 3-4.—Drugs in Incontinence Treatment—Continued

Drug

Crlterla for

Reference Study design Diagnosis Improvement Results

Imipramine 50-100 mg orally Cole and Fried Uncontrolled (N = 9) Spinal cord injury or disease Symptoms 6 improved continence

in divided doses 1-2 weeks (1971) and neurogenic bladder Urodynamic

. —

Imipramine 50-150 mg for up Castelden, et al – Uncontrolled (N = 10, 2 m, Detrusor instability Symptoms 6 became continent

to 2 weeks (1981) 3 fe) ages = 63-88, Urodynamic urodynamics Improved

mean = 88

Oxybutinin Moisey, Stephenson, Double-blind placebo Detrusor- instability Symptoms 69% had symptomatic

and Brenoler (1980) controlled crossover Urodynamic Improvement, 40% had

(N = 26; 10 m, 13 fe) urodynamic Improvement

Oxybutinin

ages = 20-79

Younglove, Newman, Uncontrolled (N = 3)

—

Unstable bladder Symptoms 100% improved

and Wall (1980)

Oxybutinin

(a) 5 mg oral dose Diokno and Lapides Uncontrolled (N = 8) Uninhibited bladder Symptoms 7 had decreased frequency or

(1972) contractions Urodynamic amplitude of uninhibited

contractions

(b) 5 mg orally bid or tid Improved symptoms

7-14 weeks

Strengthen bladder outlet:

Norephedrine 100 mg orally Ek, et al (1978) Double-blind placebo Stress incontinence Symptoms 12/22 Improved, 2 became

bid controlled crossover Urodynamic continent, urethral pressure

(N = 25) Increased in erect and supine

mean age = 54 positions

Norephedrine 100 mg orally Obrink and Bunne Uncontrolled (N = 10) Stress incontinence Symptoms 1 Improved, no change in

bid 3 weeks (1978) ages = 33-67, mean = 52 Urodynamic bladder or urethral pressure

Comments

3 with urodynamic follow UP had

Increased bladder capacity

2 had symptomatic postural

hypotension no correlation with

plasma drug levels

8% placebo response, Symptomatic

improvement not correlated with

urodynamic changes, dry mouth

common side effect

3 given 15 mg propantheline orally in

separate trial this also decreased

contractions

Urodynamic changes correlated with

symptomatic Improvement

7 got headaches, all subjects on

estrogens , / .

Norephedrine 75-100 mg Ek, Andersson and Uncontrolled (N = 6) Stress incontinence Urodynamic Urethral pressure increased in all 2 got headaches, mean blood

orally 1 dose Ulmsten (1978) ages = 39-66, mean = 55 subjects pressure Increased from 130/83 to

178/96

Ephedrine 25 mg orally bid Rashbaum and Uncontrolled (N = 82) Incontinence Symptoms 41% of 68 improved, 40% of 68 52 had previous pelvic surgery

1-18 mos Mandlebaum (1948) ages = 41-70 cured

Ephedrine 44-200 mg orally Diokno and Taub Uncontrolled (N = 38, Incontinence Symptoms 27 good to excellent response

in divided doses for 1-17 (1975) 20 m, 18 fe) ages = 7-77

mos

Ephedrine 15-30 orally 3 x Castleden, et al Uncontrolled (N = 24, 8 m, Unstable detrusor Symptoms

.-—

32% Continent, 55% improved, Urodynamic Improvement did not

daily 2-6 weeks (1982) 16 fe) ages = 68-90, contractions Urodynamic 13% same reach statistical significance, tralnlng

mean = 79.5 techniques also used

Phenypropanalamine 50 mg Montague and Uncontrolled (N = 12) Stress incontinence Urodynamic

-—

11 had at least 20% Increase in

orally (1 spansule Ornade) Stewart (1979) urethral pressure

Chlorpheniramine maleaxe Younglove, Newman, Uncontrolled (N = 14) Unstable bladder Symptoms

—.-

~~ cured

and phenylpronolamine and Wall (1980)

(twice daily

Phenylpropanalamine 50 mg Stewart, Banowsky, Uncontrolled (N = 88, Females–stress Incontinence symptoms 59% females and 27% males

orally bid (1 spansule and Montague 11 m. 77 fe) (documented in 32), had significant Improvement

Ornade) for 3 mos to 3 yrs (1976) males–prostatectomy

incontinence

Phenylpropanalamine 50 mg Awad, et al (1978) Uncontrolled (N = 20, Females–stress Symptoms 11 females improved or became

orally bid for up to 4 weeks 7 m, 13 fe) incontinence, males—post- Urodynamic continent, 6 men Improved, all

prostatectomy Incontinence with urodynamic follow up had

Increased urethral pressure
Table 3-4.— Drugs in Incontinence Treatment—Continued

Criteria for

Drug Reference Study design Diagnosis Improvement Results Comments

Estrogen therapy:

Estradiol 2 mg + estradiol 1 Walter, et al. (1978) Double-blind controlled, no All postmenopausal stress Symptoms 8 cured (of these 1 had No one experienced side effects:

mg daily crossover (N = 29) ages = Incontinence but no detrusor Urodynamic placebo), no significant significant difference betwen placebo

56-69, mean = 56 hyperreflexia urodynamic changes and estrogen, demonstrated influence

of estrogen on urethral and vaginal

mucosa

Estriol 2 mg day for 2-4 Faber and Controlled (N = 41) All postmenopausal with Urodynamic 95% had significant urodynamic No patient maintained complete

months Heidenreich (1977) stress incontinence grades II Symptoms Improvement, 34% subjective continence

and Ill (clinical categories Improvement

after lngelman-Sundberq)

Estradiol Benzoate Salmon, Walter, and Uncontrolled (N = 16) 10 stress incontmence, 6 Symptoms 12 had relief over 4-month Symptoms returned 6 weeks to 9

4,000-10,000 RU 2-3-wk Geist (1941) ages = 57-72 urinary frequency follow-up months after treatment, recurrent

Estradiol Deproplonate 1-2 symptoms responded to estrogen

mg 3/wk IM therapy

Estradiol 2 mg/day for 3 Ek, et al (1980) Uncontrolled (N = 16) All postmenopausal stress Urodynamic No statistical urodynamic change,

wks then 1 mg/day ages = 38-71; mean = 61 incontinence Symptoms 1 /13 improved, 10/13 no

change, 2/1 3 got worse

Estradiol 2 mg/day for 3 Rud (1980) Uncontrolled (N = 30) 27 postmenopausal Subjective 17/24 Improved, no significant

wks OR ages = 37-78; mean = 61 24 stress incontinence Urodynamic

Estriol 8 ma/dav for 3 wks

change m urodynamic parameters

Estriol rejection 80 mg every BeIsland, Fossberg, Uncontrolled (N = 14) Urinary incontinence from Symptoms 8 good. 4 improved No serious side effects

4 wks with and Sander (1981 ) ages = 54-94; mean = 77 recomplete urethral closure Good = continent

phenylpropanolamine 50 mg mechanism Improved =

twice daily continent

occasionally

Unchanged

Other drugs:

Baclofen 5 mg orally per day Taylor and Bates Double-blind, placebo- Unstable bladder Symptoms Improved symptoms Some Improvement also noted with

for 28 days (1979) controlled crossover (N = placebo

40, 13 m, 27 fe)

Nifedipine 10-20 mg orally Rud. Andersson, Uncontrolled (N = 10) Urge incontinence Symptoms All had symptomatic

bid for 1 week and Ulmsten (1979) ages = 9-63, mean = 33 Urodynamic improvement; uninhibited

contractions abohshed

Methyldopa 250-2,000 mg Raz, et al (1977) Uncontrolled (N = 50) Neurogenic bladder with Symptoms 19/38 Improved, 5/12 Improved,

day m divided doses for up residual urine: 38 upper Urodynamic urodynamics unchanged after one

to SIX months motor neuron (mostly week

multiple scleroses), 12 lower

motor neuron

Bromocriptine up to 25 mg Cardozo and Stanton Single-blind crossover Detrusor instability Symptoms More symptomatic Improvement Prominent side effects with both

orally bid (1980) (N = 40) mean age = 53 with inmdomethacm drugs

Indomethacin up to 100 mg

orally bid

Bromocriptine 5 mg/day Farrar and Osborne Urlcontralled (N = 24, 7 m, Detrusor instability Symptoms 14 benefited Of 10 studied, 5 had marked side

(1976) 17 fe) ages = 17-22 effects

Bromocriptine 5 mg/day Farrar and Osborne Double-blind (N = 10) Detrusor mstabdity Symptoms Too small for statistical analysts

(1976) but those on placebos

subsequently improved on

Bromocriptine
Drug

Table 3-4.—Drugs in Incontinence Treatment—Continued

.-— —

Reference Study design

Criteria for

Diagnosis Improvement Results Comments

Bromocriptine 75 mg/day Abrams and Dunn Double-blind (N = 51, 6 m, Bladder instability Symptoms No significant Improvement in

OR (1979) 45 fe) ages = 20-68) Urodynamic either symptoms or urodynamic

placebo in a six-week period findings seen in bromocriptine

compared to control group ——

Flurbiprofen 50 mg orally ‘Cardozo, et al Double-blind placebo, Detrusor instability, 27 Symptoms Significant symptomatic 43% side effects (mostly minor)

bld for 2 wks (1980) controlled crossover idiopathic, 3 multiple Urodynamic Improvement, increased bladder

(N = 30) ages = 21-74, sclerosis volume at first contraction, 6

mean = 49 cured symptomatically and

urodynamically —

Flunarazine 20 mg Palmer, et al (1981) Double-blind placebo Detrusor Instability Symptoms 11 symptomatic cure with active No correlation between symptomatic

controlled crossover Urodynamics drug, no significant urodynamic and urodynamic change

(N = 14) ages = 35-81 change

KEY IM = By Intramuscular injection

—.- .—. -—. .-. -——

qid = Four times a day

PO = by mouth orally

tid = three times a day

OR = operating room

SOURCE J Ouslander and R Kane University of California at Los Angeles 1984

Y’

m~

n

- .

cm

xmWI

u)

●
4.? . Health Case Study 33: Technologies for Managing Urinary incontinence

tact pelvic-floor musculature, and motivation to

perform them, they can be useful adjuncts to other

forms of therapy, such as surgery, drugs, or electrical stimulation.

Biofeedback has been used in the treatment of

both urge and stress urinary incontinence, as well

as in fecal incontinence (49,168,172). This procedure involves placing pressure transducers in

the bladder or rectum and having the patients try

to either inhibit bladder contraction or contract

pelvic-floor musculature, depending on the nature of the condition being treated. The pressure

transducers can supply both visual and auditory

feedback on these physiologic processes. The

treatments are performed repeatedly over several

weeks and require specialized equipment and personnel and well-motivated patients with adequate

cognitive function.

Bladder retraining refers to techniques that help

restore normal voiding pattern and continence.

These techniques are generally useful after bladder function has been acutely altered. For patients

who have had over-distention injuries from acute

urinary retention, techniques to stimulate voiding (e.g., running tap water and stroking the lower

abdomen and inner thigh) and to help complete

bladder emptying (e.g., bending forward and

pressing on the lower abdomen) are used, often

in combination with intermittent catheterization,

until the patient can void properly on his or her

own. For those patients who have urge incontinence from a shrunken, inflamed bladder (such

as might occur after removal of an indwelling

catheter), bladder retraining involves having the

patient attempt to delay voiding as long as possible and gradually extend the intervals between

voiding. This technique (sometimes referred to in

the literature as “bladder drill”) has also been used

to treat urge incontinence. For bladder retraining

to be successful, the patient must have adequate

cognitive and physical function, and both the patient and staff must be sufficiently motivated.

Habit training is most useful for patients with

functional incontinence, although the techniques

may also be useful for those with urge and stress

incontinence. In contrast to bladder retraining,

the primary objective of habit training is to avoid

incontinent episodes, rather than to restore a completely normal pattern of voiding. The procedure

involves a toileting schedule modified by the patient’s responses and may include techniques for

stimulating or inhibiting voiding and complete

bladder emptying (similar to bladder retraining).

Unlike bladder retraining, habit training can be

successful in patients with impaired mental and

physical function and is more dependent on the

motivation of the staff performing the procedure.

It is referred to in the literature as “bladder training, ” “habit retraining, ” and “scheduled toileting. ”

Behavioral modification involves procedures

similar to habit training with the addition of positive and negative reinforcers. This technique has

been used mainly in children with persistent bedwetting and in chronically mentally impaired patients (37,119).

Carefully controlled studies of training procedures are exceedingly difficult to perform. Several clinical series using training procedures have

been reported; however, many have not carefully

defined the training procedure, and few have been

adequately controlled. Most have involved some

type of bladder retraining or habit training for

urge incontinence, with 50 to 80 percent of subjects cured or substantially improved (35,48,56,

63,74 ,82,83,84,95,115,150). Studies that would

carefully define training interventions and compare them to other treatments in patients with

similar types and degrees of incontinence could

lead to better patient selection and more effective

treatment.
4

The Costs and Financing

of Incontinence
4

The Costs and Financing of Incontinence;

As a prevalent health problem, urinary incon- information on the current costs of treating intinence is costly to the health care system, to pa- continence and the ways in which these costs are

tients, and to their families. This chapter presents met through the health care payment system.

COSTS OF INCONTINENCE

Few studies have systematically examined the

costs of incontinence, although some have considered various components of the cost, such as

the added costs of labor or supplies used to manage incontinence in long-term care institutions.

The U.S. Surgeon General has estimated that $8

billion is spent on incontinence in this country

(2o); others have estimated that incontinence accounts for up to one-third of the cost of care in

geriatric wards in Great Britain (27). The bases

for these estimates, however, have not been detailed. The costs of incontinence go far beyond

monetary considerations: withdrawal from social

activities, psychological distress, burden on family

and caregivers, and subsequent predisposition to

institutionalization are all important potential effects of incontinence that are difficult to quantify

(105).

One report has examined the overall costs of

incontinence in nursing homes in this country

(111). Several specific assumptions were used to

arrive at the cost estimates; however, the figures

reported in that study generally concur with the

limited data available from the other reports. If

only “first-order” costs are considered (i. e., the

costs of managing incontinence without the costs

of any complicating conditions), in 1983, incontinence added between $3 and $11 to the daily

costs of caring for a nursing home patient. The

range of costs is accounted for by differing costs

of various techniques of management. Blue pads,

launderable diapers and bedpads, disposable diapers and catheters were the four methods of management considered in the analysis cited. Of the

three components of these costs—labor, laundry,

and supplies—the labor involved in managing the

incontinent patient was the major contributor.

Interestingly, the first-order costs were calculated to be lowest for patients managed with indwelling catheters. However, “second-order” costs

(those associated with managing complications of

incontinence and its treatment) are highest with

in-dwelling catheters because of the high incidence

of urinary tract infections associated with this

treatment. Although the precise incidence of urinary tract infections requiring specific treatment

in chronically catheterized nursing home patients

is not known, a conservative estimate of these

second-order costs of incontinence is between

$2,000 and $3,000 per patient per year. Thus,

when one considers total costs, the costs of catheter management are comparable to those of other

techniques with lower risks of morbidity. If methods of preventing morbidity from in-dwelling

catheters could be developed, such as adding an

antibacterial substance to the drainage bag

(39,96,143), these devices might then be less costly

than other types of incontinence management in

the nursing home setting. The National Institute

on Aging is currently funding a study addressing

these methods (164).

The total costs of incontinence in long-term care

institutions may or may not be covered by different sources of third-party reimbursement. In general, although Medicaid reimbursement covers the

costs of managing incontinence, nursing homes

may have inadequate incentives to care for incontinent patients because they represent a relatively

costly condition. Given present fixed reimbursement rates in most States, the first-order costs of

incontinence (up to $11 per day) represent close

to one-third of the daily per diem for nursing

home patients provided by Medicaid (about $37

per day in California). The result is often nurs45
—

46 ● Health Case Study 33: Technologies for Managing Urinary Incontinence

ing home reluctance to accept incontinent patients. The second-order costs, such as the costs

of hospitalization to treat skin breakdown and urinary tract infections, are often covered by Medicare or other third-party payers. Thus, the nursing home administrator may be less concerned

with these types of costs. However, several States

have developed, or are developing, case-mix reimbursement strategies that recognize the increased

costs of incontinence (142).

Assuming that there are approximately 600,000

nursing home patients with some degree of urinary incontinence and that in three-quarters of

these patients the incontinence is of sufficient

severity that catheters or other specific management techniques are used, the yearly costs of inTable 4-1 .—Estimated Relative Costs

continence in U.S. nursing homes can be estimated

at between $0.5 and $1.5 billion (first-order costs

only). This represents between 3 and 8 percent

of the total expenditure on nursing home care in

this country (111).

The costs of incontinence in the community are

much more difficult to estimate. No study has addressed these costs in any detail. Table 4-1 summarizes some of the major direct costs for various approaches to treatment.

Loss of productivity y in both those afflicted with

incontinence and those caring for the incontinent

patient could be substantial. Incontinence can

place physical, psychological, and economic burdens on patients and caregivers—costs that are

difficult to estimate. In addition, incontinence is

of Treatments for Incontinence (1983)

Treatment cost Components and methods of estimate

. . . . . . . Intravaglnal electrical

stimulator . . . . . . . . . . . . . . . .

Artificial sphincter . . . . . . . . . .

Periurethral Teflon injection . .

Silicone-gel prosthesis . . . . . .

Bladder-neck suspension . . . .

In-dwelling catheter . . . . . . . . .

Disposable pads . . . . . . . . . . . .

Disposable diapers

Long-term+ are (LTC)

institution. . . . . . . . . . . . . .

Community . . . . . . . . . . . . . .

Reusable pads or diapers

LTC institution . . . . . . . . . . .

Community . . . . . . . . . . . . . .

Drug treatment:

Urge incontinence

Ditropan (oxybutinin) . . . .

Tofranil (imipramine) . . . .

Urispas (flavoxate) . . . . . .

Stress incontinence

Sudafed (ephedrine) . . . . .

Premarin (estrogen)

Vaginal cream . . . . . . . .

Oral . . . . . . . . . . . . . . . . .

$ 600’

3,500

1,050’

3,900a

3,800’

1 ,059’ b

2,522 b

1,836b

821

1,583b

425

240a c

46’ c

175’ c

142’ c

4 8

a c

47’ c

Suggested retail price of device; can also

be rented for $95 per month

Device and surgical fee = $2,300

Four hospital days = 1,20 0

Surgical fee . 450

Two hospital days = 600

Surgical fee = 2,700

Four hospital days = 1,20 0

Surgical fee = 2,00 0

Six hospital days = 1,800

Includes supplies, labor, and laundry (see

Ouslander and Kane, 1984)

Includes supplies, labor, and laundry

Yearly cost of three diapers per day

(“Attends) at $0.75 per diaper

(See Ouslander and Kane, in press.) Yearly

cost of four undergarments (“Dignity

Pants”) at $15 per garment and

disposable pads at $1 per day

5 mg three times daily

25 mg three times daily

200 mg three times daily

60 mg three times daily

1 g three times weekly

0.3 mg daily

aDoes not include the cost of urologic diagnostic evaluation generally necessary before instituting treatment (Up to $600).

bMinimum estimate of daily cost in a nursing-home setting. Does not include costs of managing secondary Complications

related to treatment and/or incontinence (Ouslander and Kane).

ccost of a year’s supply; includes $2.00 monthly pharmacist’s fee.

SOURCE: J. Ouslander, R. Kane, S. Vollmer, and M. Menezes, University of California at Los Angeles, 1984.
Ch, 4—The Costs and Financing of Incontinence . 47

often cited as a major factor in the decision to institutionalize a dependent person. Although no

empirical data precisely define the role of incontinence in precipitating admission to long-term

care institutions, certain suggestive data (in addition to the commonly quoted anecdotal information ) indicate that incontinence plays a major

role in nursing home admission. In one study of

stress in caregivers of frail, elderly, communitydwelling persons, difficulties with toileting and

incontinence were highly correlated with caregiver

burden (10.5). Most incontinent patients in nursing homes are admitted to the nursing home at

a time when they are already incontinent (112).

Thus, from the limited data available, it would

appear that incontinence is an important factor

in the decision to institutionalize dependent

persons.

A critical question, and one that has never been

systematically addressed, is the potential cost effectiveness of evaluation and specific treatment

for incontinence. It appears that few (less than 5

percent) incontinent patients in the nursing home

setting have any specific evaluation of their incontinence (112). Although the proportion of incontinent patients that can be completely cured

is unknown, many can clearly benefit from an

evaluation that identifies treatable conditions; in

most instances, this treatment will lead to substantial amelioration of the incontinence, Some

experts estimate that one-third of incontinent patients can be completely cured and most others

kept dry and comfortable with appropriate management (32,81, 174 ). From a purely economic perspective, even extensive evaluation may be a costeffective intervention overall (111). Moreover, improvements in the quality of life of incontinent

patients and their caregivers likely far outweigh

the purely monetary benefits of evaluation and

specific treatment for incontinence.

The cost of a typical extensive urologic evaluation for incontinence is approximately $600

(111). The components of such an evaluation include: consultation for history and physical examination ($150); urinalysis and culture ($5o);

voiding cystourethrogram ($40), cystoscopy ($100);

urodynamic tests, including cystometrics, urine

flowmetry, and urethral pressure profile ($225);

and a followup visit ($35) (111).

However, many treatable conditions can be

identified by a much less extensive, less expensive, and less invasive evaluation (87). The role

of urodynamic testing in the diagnosis and management of incontinence is especially controversial, particularly in the geriatric population. If

properly performed and interpreted, these tests

can clearly identify genitourinary conditions that

underlie incontinence and that require specific

treatment (2,15). However, the testing requires

specialized equipment and highly trained personnel, which are available in only a few medical

centers; it is relatively expensive and invasive (requiring repeated bladder catheterizations); and it

is uncomfortable and inconvenient—especially for

frail elderly patients.

Some investigators state that most patients can

be properly diagnosed and treated using an algorithmic approach without urodynamics (81);

others feel that treating an incontinent patient

without urodynamics is like treating a cardiac arrhythmia without an electrocardiogram (32). Because most treatments are used for specific conditions, some type of diagnostic evaluation should

be carried out before the treatments are instituted.

Identifying the most practical and cost-effective

strategies for diagnosing different types of incontinent patients should be a major area of future

research.

PAYMENT FOR URINARY INCONTINENCE

Except for services delivered as part of an acute or function. Thus, sphincters would qualify, but

hospitalization, Medicare coverage for inconti- catheters and pants or diapers would not. Medinence products is quite limited. Part B of the pro- care’s home-health program will permit reimgram pays for a prosthetic device that replaces bursement to a home-health agency for supplies

a permanently inoperative internal body organ ordered by a physician and deemed reasonable
48 . Health Case Study 33: Technologies for Managing Urinary Incontinence

and necessary for the treatment of the patient, but

only a small proportion of incontinent persons

will be covered by the constrained Medicare

home-health benefit, because it is available only

to those patients requiring skilled nursing care.

Thus, Medicare does not pay for most urinary incontinence pads and pants used outside the

hospital.

Medicare will pay for inpatient hospital care

associated with incontinence in the same way that

it pays for all hospital care. Medicare coverage

of acute care hospital costs changed dramatically

with the introduction of prospective payment in

October 1983 (Public Law 98-21). The prospectively set price per admission does not vary with

the use of a given incontinence device, just as it

is insensitive to all inpatient services.

Coverage for urinary incontinence products under Medicaid varies from State to State. Coverage is available in such States as New York, California, Florida, Illinois, and Michigan, but not in

other States. Even in those States in which Medicaid covers the products, the type and extent of

coverage vary considerably. Additionally, the

States’ requirements for coverage and payments

change frequently. In California, for example, disposable diapers, pants, disposable pant liners, disposable underpads, and urinary drainage/irrigation supplies are covered under Medicaid. However,

these are subject to requirements such as quantity limitations (two pants per prescription), prior

authorization and prescription documentations,

and patient age limitations (age 5 or older).
.

Appendixes
Appendix A.— Incontinence Product Manufacturers:

Characteristics and Opinions

This appendix examines the characteristics and opinions of manufacturers of incontinence products. It includes data collected directly from manufacturers of

the devices and from various secondary sources such

as the Medical Devices Register of the Food and Drug

Administration. As would be expected from the wide

range of devices available for treatment of incontinence, urinary incontinence products are made by a

heterogeneous assortment of firms. Some incontinence

products are designed for broad consumer use; others

are designed for very discrete types of incontinence,

have a high unit cost, and require surgical implantation. Any effort to describe “the incontinence products industry” must recognize this diversity. Two approaches to this dilemma were used: a survey of a

representative sample of manufacturers and a more

detailed description of a highly specialized product,

the artificial sphincter (see app. D).

To facilitate systematic collection of data from manufacturers, a questionnaire was designed and pretested

in telephone discussions with a small number of manufacturers. A careful search through various secondary sources, supplemented by discussions with some

manufacturers, was used for compiling a list of manufacturers of urinary incontinence products. In all, 48

companies were identified. Most of them were contacted by telephone to seek their consent to participate in this survey. Questionnaires were sent to 38

companies that agreed to respond. Frequent telephone

followup was required to obtain an acceptable response rate. Twenty-one companies replied, giving a

response rate of approximately 55 percent. A copy of

the questionnaire is shown in appendix C. The analysis based on this survey has a number of limitations.

The most significant include:

● Potential selection bias among those who responded to the survey. It is possible that companies responding to the survey may have differed

significantly and systematically from those not responding. If they did differ, the analysis would

suffer from some biases.

● Variations in quality and quantity of responses.

Although many of the questions were answered

by only a few respondents, the analysis of the importance of the physician’s role, the promotional

tools used, the relative use of advertising and samples, and the obstacles to growth are based on all

21 responses. The question on barriers to entry

was answered by 19 companies (90 percent of respondents), However, the question on proportion

of incontinence products purchased by different

segments of the population was answered by only

12 companies (57 percent of respondents), and the

question on cost of research and development was

answered by only 6 companies (28 percent of respondents). The confidence in the analysis of the

last two questions is therefore very limited.

● Variations in respondents. The questionnaire may

have been completed by people at different levels

and positions in the companies surveyed. This

could have caused some differences in the perspectives of the respondents.

These survey limitations must be kept in mind while

reviewing the analyses in this appendix.

Industry Structure

The substantial size of the incontinence product

market appears to have attracted numerous companies

into this field. Although it is difficult to pinpoint the

exact number, at least 48 companies are involved in

the manufacture of one or more incontinence products. A list of these companies is provided in appendix B.

These companies vary dramatically in their size, the

number of products manufactured, etc. In many cases,

it is virtually impossible to isolate the incontinence

component of a much larger corporation. For example, O. M., Inc., employs only seven people and has

a total sales volume of $50,000. Proctor & Gamble,

on the other hand, employs 25,000 people, and the

sales volume of its “Attends” disposable pants was said

to be $100 million in 1982. of these 48 companies, 26

are small (1 to 100 employees), 13 are medium 101 to

1,000 employees), and 9 are large (more than 1,000

employees). Most of the companies manufacture more

than one type of incontinence product. The most common combination is pants and pads. Of the 20 companies that manufacture pants, 16 (80 percent) also

manufacture pads. Of the 24 companies that manufacture pads, 16 (67 percent) also manufacture pants.

● Pants: The disposable and reusable pants market

has as many as 20 manufacturers. Despite the

number of manufacturers, the market is dominated by a few large companies such as Proctor

& Gamble, Bard Home Health, Kimberly-Clark,

Dundee, and Whitestone Products. The impressive record of the disposable baby diaper industry in the United States is expected to be dwarfed

51
52 . Health Case Study 33: Technologies for Managing Urinary Incontinence

●

●

●

●

by the $6 billion in sales of adult incontinent pants

projected by the year 2000 (140).

Pads: Some 24 companies manufacture disposable or reusable pads. Once again, a few large

companies dominate: Kendall Co., Bard Home

Health, Johnson & Johnson, Dundee, and Whitestone Products.

Catheters: At least 17 companies manufacture either in-dwelling or condom catheters. The large

companies in this category are Seamless Hospital Products, American V. Mueller, and Bard

Home Health.

Electrical Stimulators: Only two companies manufacture electrical stimulators: Mentor Corporation, a small company in Minneapolis that employs 85 people and Myodynamics, Inc., a privately owned company in Carson, CA.

Artificial Sphincters: American Medical Systems

is the leading company for this product, ‘which

is described in greater detail in the case history

(app. D).

Table A-1 summarizes the companies in the incontinence-product market.

Costs of Research and Development

The amount of time and money spent on research

and development (R&D) varies considerably from one

product type to another. Accurate information on

R&D costs is difficult to obtain from manufacturers,

but it is clear that both the time involved and the costs

associated with R&D for pads and pants are considerably less than those associated with R&D for the other

product types. For example, typical R&D for pads and

pants takes about 6 months to 1 year and costs approximately $6,000 to $100,000. For catheters, on the

other hand, typical R&D takes 1 to 3 years and costs

approximately $100,000 to $500,000.

Other sources of R&D support might come from

public funds, such as Government research agencies.

The National Institute on Aging has shown recent interest in urinary incontinence and supports research

on the topic but has not funded the development of

specific devices. The National Center for Health Services Research might be considered a potential source

of support for tests of efficacy but has not funded such

work in incontinence.

Marketing and Distribution

Companies historically have marketed incontinence

products as medical devices rather than as consumer

products. Most companies (85 percent) reported on the

survey that they use distributors and /or dealers to

reach the users. Three companies that do not use distributors or dealers, and three companies that do, sell

directly to the users. Thus, only six companies (29 percent) sell directly to users,

Most brands are available throughout the United

States; however, some brands are available only in certain regions. Over time, these companies can be expected to begin national distribution. The previous

lack of retail distribution, despite the large number of

incontinent people in the community, may be attributable to the social stigma attached to incontinence.

This situation is changing as new marketing strategies

focus on the consumer. The marketing situation has

been comparable to that of feminine sanitary products

about 40 to sO years ago. At that time, the subject was

not discussed, despite the fact that a huge demand existed for the product, Feminine sanitary products were

sold by some pharmacists but were wrapped in plain

paper and never displayed. Now these products are

commonly sold in supermarkets and advertised on television.

Mail order has become an increasingly effective

channel of distribution for many different products in

the United States, including urinary incontinence products. Catalog sales of incontinence products by Sears

Roebuck and Montgomery Ward, for example, include

a wide range of product types and have grown rapidly. This channel of distribution is especially useful for

Table A“l.—lncontinence-Product Industry Structure

Company size . .

l-l00 101-1,000 1,000 +

Product employees employees employees Total

Pads . . . . . . . . . . . . . . . . . . . . . . 7 6 24

Pants. . . . . . . . . . . . . . . . . . . . . . ; : 7 3 20

Catheters . . . . . . . . . . . . . . . . . . 8 5 4 17

Electrical stimulators. . . . . . . . 1 1 2

Artificial sphincters ... , . . . . . 1 1

Others. . . . . . . . . . . . . . . . . . . . . 1 2 3

SOURCE: J. Ouslander and R. Kane, University of California at Los Angeles, 1984,
App. A—Incontinence Product Manufacturers: Characteristics and Opinions • 53

stigmatized products because people can purchase the

product without disclosing their problem.

Pricing

Price is one of the important mechanisms used by

some companies to capture an increased share of the

market. Although one would therefore expect prices

to be fairly uniform within a given product type, this

is not the case. Some companies have not used pricing as a major tool. Instead, they have opted for product differentiation so that they can charge a different

price and consequently have greater sales, greater prof -

itability, or both. This product differentiation is accompanied by considerable price variation, even

within a product type, For example, the price of reusable pants sold by Sears Roebuck varies from 57.49

(nylon fabric with vinyl coating) to $8.49 (viny] brief

with cotton-flannel lining) to $10.49 (vinyl coated nylon tricot with cotton-flannel lining).

The typical wholesale price range in 1983 for each

product is given below:

Pants:

Disposable SO. 46 0.80 each

Reusable $7.00 $14.00 each

pad s

Disposable $O.12 $O.70 each

Reusable $7.00 $1O.00 each

Catheters $1.00 $2.00 each

Intravaginal electrical

stimulaters $6OO. 00 eac h

Artificial sphincters $2,450 each
Appendix B.— Incontinence Product Manufacturers

American Heyer-Schulte Corp.

American Medical Systems, Inc.

American V. Mueller

Amira Products, Inc.

ATCO Surgical Supports Co., Inc.

Bard Home Health

Bell-Horn

Chasten Medical & Surgical Products

Chesebrough-Pond’s Inc.

Coast Clinical Co.

Davol

DiaMed Division

Dri-Pride Division of Weyerhauser

Dundee Professional Health Care

Duro-Med Industries, Inc.

GMG International

Gericare Products

Graham-Field Surgical Co., Inc.

Greenwalk Surgical Co., Inc.

Harvy Surgical Supply Corp.

Hermitage Hospital Products

Hollister, Inc.

HowMedica, Inc.

Humanicare

Inmed Corp.

Intermed Associates, Inc.

Kendall Co.

Kimberly-Clark Corp.

Leylor National Hospital Supply Corp.

Mary Clark Products

Mark One Hospital Products

Medical Disposable Co., Inc.

Medical Marketing Group, Inc.

Medicine Industries, Inc.

Mentor Corp.

Minneapolis Society for the Blind, Inc.

Molyncke

Myodynamics, Inc.

O. M., Inc.

Principle Business Enterprises, Inc.

Proctor & Gamble

Rusch, Inc.

Salk, Murray, Inc.

Seamlers Hospital Products Co.

Stanford Professional Products Corp.

TLC Co., Inc.

United Surgical Co.

UroCare Products, Inc.

Wal-Jan Surgical Products, Inc.

Whitestone Products

Johnson & Johnson Products, Inc.

54
Appendix C.— Incontinence Product Questionnaire

1. Which of the following urinary incontinence products do you manufacture?

(please check ) For each, please indicate the year introduced and whethe r

FDA approval is required.

Product Year Introduced FDA Approval

Product Manufactured? Into Market Required?

Pants, disposabl e

Pants . reusabl e

Pads. disposabl e

Pads . reusabl e

Catheters . simple

Catheters . condom

Artificial sphincter s

stimulators , electrica l

Othe r ( S p ecify )

2. In what geographical areas do you sell the products ?

Across the U.S.

In only some regions of the U.S.

3. What modes of distribution do you use? (check all that apply)

Direct to user s

Exclusive distributor s

Various distributor s

Dealer s

Others (specify )

55
56 ● Health Case Study 33: Technologies for Managing Urinary h-continence

4. Do you have your own salesmen or do YOU use distributorst .salesmen or

independent salesmen?

Own salesmen

Distributors’ salesme n

Independent salesmen

5. How do you promote the product (check all that apply)

Advertising in professional magazine s

Advertising in general magazine s

Advertising in newspaper s

Advertising on televisio n

Samples

Salesmen

6. What proportion of your product(s) is (are) purchased by nursing homes ,

private individuals, home-care agencies , Veterans Administration and othe r

institutions ?

Percentage* purchased by

Nursing Privat e Home-Care VA and Other

Product Home Individual Agencies Institutions

*Use range if easier

7. What are the list prices of your products?

Product Price (indicate unit)

$ Per

$ P e r
App. C—Incontinence Product Questionnaire • 57

8. To your knowledge , in which States is each of your products covered under

Medicaid?

9. What was the cost of research and development and how long did it take to

develop each product?

Product cost Time

10. What are the major obstacles to growth of business with respect to these

products? (check all that apply)

Competitors

Government policies

Consumer awareness

Cost of product

Inadequate distribution

Other (Specify: )

11. Do your products have patents?

All

None

Some (Specify which:

)
58 ● Health Case Study 33: Technologies for Managing Urinary Incontinence

12. What were the company’s sales of these products in thousands of dollars :

Product 1977 1978 1979 1980 1981 1982

Pants, disposable

Pants. reusable

Pads. disposable

Pads. reusable

Catheters, condom

Artificial sphincters

Stimulators. electrical

13. What were the company’s sales of these products in thousands of units :

Product 1977 1978 1979 1980 1981 1982

Pants, disposable

Pants. reusable

Pads. disposable

Pads. reusable

Catheters. condom

Artificial sphincters

Stimulators , electrica l

14. What was your market share for each product in the most recent year?

Year

Product Share

Pants. disposabl e

Pants . reusabl e

Pads. disposabl e

Pads. reusabl e

Catheters . condom

Artificial sphincter s

Stimulators . electrica l
App. C—Incontinence Product Questionnaire ● 5 9

15. What do you estimate is the total 1983 market for each of the following

product types?

Thousands of Thousands of

Product Dollars Units

Pants, disposable

Pants, reusable

Pads. disposable

Pads. reusable

Catheters, condom

Artificial sphincters

Stimulators, electrical

16. What is the role of the physician in determining the product and

manufacturers’ brand to be used? (check one in each column)

Manufacturer’s

Product Brand

Unimportant

Moderately important

Important

Extremely important

17. Do government policies affect product development and introduction?

Yes , facilitate development and introduction

Yes, hamper development and introduction

No effect on development and introduction

If you feel government policies facilitate or hamper development and

introduction, please explain why:
60 ● Health Case Study 33: Technologies for Managing Urinary Incontinence

18. Did your company delay between first considering and finally entering the

field of incontinence products ?

Ye s

No

If yes, what factors were responsible for this hesitation? (check all tha t

apply)

Cost of research and development

Initial costs of start-u p

Rate of retur n

Delays and difficulties getting product approva l

Consumer resistance

Physician resistanc e

Other (specify )
Appendix D.—Artificial Sphincters: A Case Study

This appendix presents a case study of the development of the artificial sphincter, a surgically implantable device designed to treat urinary incontinence.

Marketing efforts for this device are directed toward

a small group of specialists: urologists. Primary concerns are with performance, success in accomplishing

the prosthetic task, and minimizing complications.

The use of artificial sphincters is limited to the few

conditions characterized by incompetence of the urinary sphincter. Since the device must be surgically implanted, it is relatively costly to use and its adoption

depends on the enthusiasm of physicians, usually urologists.

In 1973, a totally implantable, externally controllable, artificial sphincter was developed by Scott and

his colleagues (136). The original idea came from Foley

(62), who in 1947 first introduced the concept of external urethral compression using an inflatable cuff.

Using a syringe-like mechanism, Foley inflated a cuff

around the penis of incontinent males. This device

never received widespread acceptance by the medical

profession.

The device developed by Scott was made of silicon

rubber and marketed by American Medical Systems

(Minneapolis) as the AS 721 in the mid-1970s. Unlike

Foley’s device, this prosthesis could be used in both

sexes and the cuff was surgically implanted to surround

the urethra. The reservoir used to inflate the cuff was

placed in the abdominal cavity. The two pumping

mechanisms, implanted in the scrotum in males and

the labia in females, were inflated and deflated by the

patient. Each pumping mechanism consisted of a bulb

and two valves. The valves controlled the direction

of fluid flow inside the prosthesis and were designed

to set the precise cuff pressure. The B4 valve was critical to controlling the pressure applied to the urethra.

The valve ensured that regardless of the number of

times the inflating bulb was squeezed, the cuff could

reach a predetermined pressure equilibrium but avoid

high, potentially harmful pressures.

The major problem with the AS 721 was valve failure. To increase mechanical reliability of the system,

Model AS 761 was introduced in 1976. AS 761 eliminated the critical dependence on the valve through a

pressure-regulating balloon. However, after testing the

device, the Balloon Sphincter Clinical Study Group

(10) found that 50 percent of the failures resulted from

mechanical complications, so production was stopped.

The next model, AS 742, differed substantially from

the previous devices. Rather than requiring manual inflation, the cuff of the newer model automatically inflated by fluid forced through a resistor set at a controlled rate by a pressure-regulating balloon. As a

result, the patient operated only a deflating bulb. Results have shown a higher success rate (70 versus 50

percent ) and fewer mechanical failures with this than

with previous models. In addition, the device has been

easier to implant and simpler to operate. The success

of the AS 742 has depended on a balloon that maintains a low-pressure reservoir. High pressures around

the urethra have been the main causes of urethral erosion, a very serious and often irreversible complication of sphincter implantation. The low-pressure balloon reservoir has reduced the number or urethral

erosions but has not eliminated them completely. A

major problem with the AS 742 has been the requirement that the cuff be inflated while tissue was healing

in the immediate period after implantation.

Primary deactivation is a newer technique designed

to reduce the rate of urethral erosion. With primary

deactivation, the cuff is kept deflated after the sphincter is inserted, allowing the tissues to heal after the

operation. The sphincter is activated several weeks

later. Thus the newer sphincters (AS 791/792) resolve

the problem of maintaining constant pressure under

all circumstances with the AS 742 and are especially

useful for high-risk patients (those who already have

weak tissues from prior surgical procedures).

The most recent sphincter developed by American

Medical Systems (AMS Sphincter 800TM) allows the

initial activation of the device to be carried out without a second surgical procedure (which is sometimes

necessary for AS 791 /792). Studies of this new model

have not been published in the medical literature.

Studies of the older models have shown a 40 to 85

percent success rate (see above and table 3-l). According to data presented in a marketing brochure published by American Medical Systems, 4,000 children

and adults have been helped by their artificial sphincters since they were first produced in 1972. Their data

on the 486 implants of model AS 791/792 indicate that

74 percent were implanted in males; 32 percent in patients aged 20 or younger, 35 percent in patients aged

21 to 60; and 32 percent in patients older than 60.

Thirty-five percent of these sphincters were implanted

for post-prostate surgery (radical prostatectomy, 19

percent, and transurethral resection, 16 percent); 26

percent for myelomeningocele; 9 percent for spinal

cord injuries; and the remainder for a miscellaneous

group of conditions (generally involving necrologic

abnormalities) (4).

An alternative sphincter was developed by Michael

Rosen (128). This device was also made of silicon rubber and has a three-armed clamp that fits across the

61
62 ● Health Case Study 33: Technologies for Managing Urinary Incontinence

urethra. One arm carries a balloon attached to a salinefilled reservoir bulb (positioned in the scrotum) and

a release bulb. Compressing the reservoir bulb inflates

the balloon, which partially increases the urethral resistance to maintain continence. To void, the release

valve is pressed, which deflates the balloon. The advantages of this device are its relative simplicity, lack

of circumferential compression, and the relatively

short urethral dissection needed to implant the device.

Clinical studies in approximately 60 male patients

demonstrated a 50 to 75 percent success rate (table 3-

1), but some of the patients required more than one

operation. Failures were most commonly caused by

mechanical malfunction and infection. The longest

functioning prosthesis lasted 26 months.

In summary, the artificial sphincter appears to be

a treatment option for those patients with severe urinary incontinence caused by dysfunction of the bladder outlet and/or urethral closure mechanisms. This

would include young patients with neurological disorders (e. g., myelomeningocele ), women with stress

incontinence who have not been helped by standard

surgical correction procedures, and men with postprostatectomy incontinence from sphincter damage,

Thus, patients who are appropriate candidates for

sphincters represent only a small proportion of the incontinent population. Improved mechanical properties of the sphincters and techniques of surgical implantation are likely to increase the success rate and

diminish complications of these devices (75).
Appendix E.— Glossary of Terms

Acute incontinence: The sudden onset of episodes of

involuntary loss of urine. Usually associated with

an acute illness or environmental factors that impair the mental or physical ability of the patient to

reach a toilet or toilet substitute on time.

Algorithmic approach: In incontinence testing, a stepby-step procedure used to diagnose incontinence.

Bladder neck suspension: An operation performed on

women with stress incontinence in which the bladder neck and urethra are repositioned; the most

common surgical procedure for incontinence.

Case-mix reimbursement: A hospital and nursing

home payment plan which considers both the relative frequency of admissions of various types of patients and the severity of their condition.

Catheterization: With respect to the urinary system,

the passage of a small tubular instrument into the

bladder for the purpose of urinary management.

Cholinergic drugs: Drugs which are activated by choline and associated with the synaptic transmission

of nerve impulses; promotes bladder contraction.

Diabetic neuropathic bladder: A functional disturbance of the bladder which can be found among persons with diabetes; marked by the bladder’s poor

ability to contract.

Established incontinence: Repeated episodes of involuntary loss of urine not associated with an acute

condition.

External catheterization: With regard to urinary functions, a catheter applied to the penis; requires frequent changing and may result in local skin irritations or other complications.

Fecal incontinence: Involuntary excretion of stool sufficient in frequency to be a social or health problem.

Relatively uncommon in community-dwelling persons, but more prevalant among persons in nursing homes.

First-order costs: Costs assessed without consideration

of complicating conditions. With regard to incontinence, the immediate costs of labor, laundry, and

supplies.

Functional incontinence: Leakage of urine caused by

chronic impairments of either mobility or mental

function, marked by the inability or unwillingness

of the patient to toilet himself or herself independently and a lack of sufficient help with this task.

Iatrogenic factors: Aspects of the attending physician’s

activity which inadvertently result in an adverse

condition for the patient.

In-dwelling catheter: With respect to the urinary system, a catheter that is held in position in the bladder by a device resembling an inflated balloon. Infectious complications may arise with long-term

use.

Intermittent catheter: A catheter which may be inserted at regular intervals; use by selected patients

may prevent risks of infections associated with the

in-dwelling catheter.

Kegel exercises: A series of repetitive contractions of

muscles of the pelvis and vaginal wall for the purpose of vaginal health; also used in the management

of stress incontinence in females.

Nosocomial infections: Infections which originate in

a hospital or institution.

Overflow incontinence: Leakage of small amounts of

urine caused by anatomic obstruction to bladder

emptying and ‘or inability of the bladder to

contract.

Palliative treatments: Treatment designed to provide

relief from a condition, but not to cure that condition.

Pessary: A donut-shaped piece of inert material inserted into the vagina to support the bladder outlet in women with stress incontinence.

Placebo effect: An improvement in condition that occurs in response to treatment, but cannot be considered a result of the specific treatment used.

Prophylactic antibiotic therapy: Therapy designed to

ward off disease through the use of antibiotics taken

in a preventative manner.

Prostatic hyperplasia: The abnormal multiplication in

the number of normal cells in normal arrangement

in the prostate gland.

Sham operation: An operation which the patient believes was performed, but actually was not performed for the purpose of creating a control group

for experimental measure.

Sphincter: In the genitourinary system, the ringlike

band of muscular fibers around the urethra that

through its constriction regulates the flow of urine.

Stress incontinence: Leakage of urine, either in small

or large amounts, as intra-abdominal pressure increases.

Urge incontinence: Leakage of varying amounts of

urine because of the inability to delay voiding long

enough to reach a toilet or toilet substitute. Can be

caused by a variety of genitourinary and necrologic

disorders.

Urinary incontinence: An involuntary loss of urine sufficient in quantity and/or frequency to be a social

or health problem.

Urodynamic testing: Testing which pertains to the flow

and motion of urine in the urinary tract.

63
Appendix F. —Acknowledgments and

Health Program Advisory Committee

Robert N. Butler

Mt. Sinai Medical Center

New York, NY

Nancy B. Cummings

National Institute of Arthritis, Diabetes, Digestive

and Kidney Diseases

National Institutes of Health

Bethesda, MD

Dr. Annais Diokno

University of Michigan

School of Medicine

Ann Arbor, MI

Marie A. Dray

Pharmaceutical Manufacturers Association

Washington, DC

Bernard T. Engel

National Institute on Aging

Gerontology Teaching Center

Baltimore, MD

Cheryl Gartley

Simon Foundation

Wilmett, IL

Tony Geglys

Humanicare

East Brunswick, NJ

Anthony M. Grimaldi

E.I. du Pent de Nemours & Co., Inc.

Wilmington, DE

Mike Jensen

Proctor & Gamble

Cincinnati, OH

Kathryn Jetter

Union, SC

Ellen Jividen

Daniel J. Edelman & Associates

Chicago, IL

Sidney Katz

Brown University

Providence, RI

Glenn Morris

Research Triangle Institute

Research Triangle Park, NC

Bernice Neutgarten

Northwestern University

Evanston, IL

James J. O’Connor

Kimberly Clark Corp.

Neenah, WI

Adrian Ostfeld

Yale University

New Haven, CT

Neil Resnick

Beth Israel Hospital

Boston, MA

Doris Rouse

Research Triangle Institute

Research Triangle Park, NC

Thelma Wells

University of Michigan

Ann Arbor, MI

T. Franklin Williams

National Institute on Aging

National Institutes of Health

Bethesda, MD

64
App, F—Acknowledgements and Health Program Advisory Committee ● 65

HEALTH PROGRAM ADVISORY COMMITTEE

H. David Banta

Deputy Director

Pan American Health Organization

Washington, DC

Rashi Fein

Professor

Department of Social Medicine and Health Policy

Harvard Medical School

Boston, MA

Harvey V. Fineberg

Dean

School of Public Health

Harvard University

Boston, MA

Patricia King

Professor

Georgetown Law Center

Washington, DC

Joyce C. Lashof

Dean

School of Public Health

University of California-Berkeley

Berkeley, CA

Sidney S. Lee, Committee Chair

President, Milbank Memorial Fund

New York, NY

Robert Oseasohn

Associate Dean

University of Texas-San Antonio

San Antonio, TX

Nora Piore

Senior Fellow and Advisor to the President

United Hospital Fund of New York

New York, NY

Dorothy P. Rice

Regents Lecturer

Department of Social and Behavioral Sciences

School of Nursing

University of California-San Francisco

San Francisco, CA

Richard K. Riegelman

Associate Professor

George Washington University

School of Medicine

Washington, DC

Alexander Leaf

Professor of Medicine

Harvard Medical School

Massachusetts General Hospital

Boston, MA

Frederick Mosteller

Professor and Chair

Department of Health Policy and Management

School of Public Health

Harvard University

Boston, MA

Walter L. Robb

Vice President and General Manager

Medical Systems Operations

General Electric Co.

Milwaukee, WI

Frederick C. Robbins

President

Institute of Medicine

Washington, DC

Rosemary Stevens

Professor

Department of History and Sociology of Science

University of Pennsylvania

Philadelphia, PA

Norton Nelson

Professor

Department of Environmental Medicine

New York University Medical School

New York, NY
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