U.S. Opportunities in the Management of Urinary Incontinence

Published January 2005 | 594 Pages | 177 Exhibits | Forecasts Through 2010


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Companies Covered

ACMI Corporation

American Medical Systems, Inc.

Boston Scientific Corporation

C.R. Bard, Inc. 

GE Healthcare

Hollister, Inc. 

Johnson & Johnson 

Karl Storz GmbH & Co. KG

Laborie Medical Technologies Corp 

Life-Tech, Inc. 

Medtronic, Inc.

Mentor Corporation 

Olympus Corporation

Pfizer, Inc.

Rochester Medical 

Siemens AG

SRS Medical Corporation

The Cooper Companies, Inc. 

Uroplasty, Inc./Cystomedix, Inc. 

Watson Pharmaceuticals, Inc. 

Yamanouchi Pharmaceutical Co., Ltd. (Astellas Pharma, Inc.)

Table of Contents



Product Markets 


Pharmacologic Therapy 

Device-Based Medical Management 

Surgical Treatment Options 

Suppliers of Incontinence Products 

End User Survey 


Summary Exhibit 1: Overview of Urinary Incontinence and Overactive Bladder 

Summary Exhibit 2: Prevalence of Significant UI by Type, U.S. Patient Forecasts, 2003-2010 

Summary Exhibit 3: Incontinence Products, U.S. Market Forecast, 2003-2010 

Summary Exhibit 4: U.S. Urinary Incontinence Patients Treated, 2003-2010 

Summary Exhibit 5: Incontinence Diagnostic Products, U.S. Market Forecast, 2003-2010

Summary Exhibit 6: Pharmacologic Therapy for Urinary Incontinence, U.S. Market Forecast Scenarios, 2003-2010

Summary Exhibit 7: Device-Based Medical Management, U.S. Market Forecast, 2003-2010

Summary Exhibit 8: SUI Surgical Procedures by Gender and Type, 2003-2010

Summary Exhibit 9: Surgical Treatments for Urinary Incontinence, U.S. Market Forecast, 2003-2010



1.1 Micturition Cycle

1.2 Pathophysiology and Etiology of UI

1.2.1 Stress Incontinence 

1.2.2 Urge Incontinence

1.2.3 Mixed Incontinence 

1.2.4 Overflow Incontinence

1.3 Risk Factors 

1.3.1 Age

1.3.2 Sex

1.3.3 Obesity

1.3.4 Conditions and Treatments 

1.3.5 Genetic Factors 

1.3.6 Other Potential Risk Factors 

1.4 Epidemiology

1.4.1 Study Challenges 

1.4.2 Demographics of Incontinence 

1.4.3 U.S. Prevalence

1.4.4 Prevalence by Type of UI 

1.4.5 Prevalence by Severity of UI 

1.5 Economic Impact 

1.6 Specialists, Providers and Sites

1.7 Patient Forecasts 

1.7.1 Factors Impacting Caseload

1.7.2 Urinary Incontinence Forecasts and Methodology Total Urinary Incontinence by Sex and Age Urinary Incontinence by Sex and Type Urinary Incontinence by Type and Severity 

1.7.3 Overactive Bladder Forecasts and Methodology


Exhibit 1-1: Micturition Cycle 

Exhibit 1-2: Overview of Major Types of Urinary Incontinence 

Exhibit 1-3: Risk Factors for Urinary Incontinence

Exhibit 1-4: Prevalence of UI, by Age, Worldwide, 1980-2002 

Exhibit 1-5: Overactive Bladder, Selected Clinical Studies 

Exhibit 1-6: Prevalence of UI, United States, 1982-1999

Exhibit 1-7: U.S. Prevalence of Overactive Bladder by Age

Exhibit 1-8: Distribution of UI by Type, Selected Epidemiological Studies

Exhibit 1-9: Distribution of Urinary Incontinence by Type, Worldwide, 1980-2002 

Exhibit 1-10: Sandvik Index, Severity of UI, 2004 

Exhibit 1-11: Prevalence of Different UI Types, by Severity, Norway, 1995-1997 

Exhibit 1-12: Economic Burden of Urinary Incontinence in U.S., Selected Studies

Exhibit 1-13: Major Factors Impacting Trends in UI and OAB in U.S.

Exhibit 1-14: Historic Trend in Obesity and Diabetes in U.S.

Exhibit 1-15: Obesity and Diabetes, U.S. Population Forecasts, 2002-2010 

Exhibit 1-16: Female Urinary Incontinence (UI), Patient Forecast by Age Group, 2002-2010 

Exhibit 1-17: Male Urinary Incontinence (UI), Patient Forecast by Age Group, 2002-2010 

Exhibit 1-18: Total Urinary Incontinence in U.S., Patient Forecast, 2002-2010

Exhibit 1-19: Females by Major Type of Incontinence, 2002-2010

Exhibit 1-20: Males by Major Type of Incontinence, 2002-2010 

Exhibit 1-21: Prevalence of Significant UI by Type, Patient Forecasts, 2002-2010 

Exhibit 1-22: Overactive Bladder (OAB), Patient Forecasts, 2002-2010



2.1 Basic Urinary Incontinence Evaluation 

2.1.1 Patient History 

2.1.2 Physical Examination

2.1.3 Voiding Diary 

2.1.4 Post-Void Residual Volume 

2.1.5 Urinalysis 

2.1.6 Other Tests

2.1.7 Decision to Treat or Test

2.2 Specialized Urinary Incontinence Testing 

2.2.1 Urodynamic Studies Types and Functions Equipment and Suppliers Technology Product Trends Reimbursement Installations and Specialists Procedures Market Analysis 

2.2.2 Cystoscopy Clinical Applications Products and Suppliers Product Developments Procedures Market Analysis 

2.2.3 Imaging Technique Equipment and Suppliers Installations and Procedures Market Analysis 


Exhibit 2-1: Sample Voiding Diary 

Exhibit 2-2: Overview of Major Urodynamic Studies

Exhibit 2-3: Selected Uroflowmeters, 2005

Exhibit 2-4: Selected Urodynamic Systems, 2005

Exhibit 2-5: Medicare Reimbursement for Office Urodynamic Studies, 2005 

Exhibit 2-6: Urodynamic Studies, Procedure Forecast, 2003-2010

Exhibit 2-7: Urodynamics Products, Market Forecast, 2003-2010

Exhibit 2-8: Urodynamics Products, Supplier Shares, 2004

Exhibit 2-9: Rigid and Flexible Diagnostic Cystoscopes 

Exhibit 2-10: Selected Diagnostic Cystoscopes, 2005

Exhibit 2-11: Arthrotek InnerVue Diagnostic Scope System 

Exhibit 2-12: Diagnostic Cystoscopy, Procedure Forecast, 2003-2010 

Exhibit 2-13: Diagnostic Cystoscopes, Market Forecast, 2003-2010

Exhibit 2-14: Diagnostic Cystoscopes, Supplier Shares by Type, 2004

Exhibit 2-15: Selected Office-Based Diagnostic Ultrasound Systems 

Exhibit 2-16: Office-Based Diagnostic Ultrasound Systems, Market Forecast, 2003-2010 

Exhibit 2-17: Office-Based Diagnostic Ultrasound Systems, Supplier Shares, 2004



3.1 Urge Incontinence

3.1.1 Clinical Goals

3.1.2 Modes of Action 

3.1.3 Approved Products ALZA Indevus Pharmaceuticals Novartis Pfizer Watson Pharmaceuticals Yamanouchi/Astellas Pharma

3.1.4 Other Products 

3.1.5 Pipeline Products Antares Pharma APOGEPHA Arzneimittel Propiverine NS-8 (Nippon Shinyaku) Ardent Pharmaceuticals Barr Pharmaceuticals ICOS Kyowa Hakko Kogyo Labopharm NeuroSearch NicOx Schwarz Pharma Sepracor TAP Pharmaceutical Products 

3.2 Stress Incontinence 

3.2.1 Clinical Goals and Approaches

3.2.2 Off-Label Drug Use Alpha Adrenergic Receptor Agonists Estrogen 

3.2.3 Pipeline Products Arachnova Therapeutics Eli Lilly Roche 

3.3 Market Analysis 

3.3.1 Overactive Bladder Compliance Patient and Market Forecast Supplier Shares Generic Competition

3.3.2 Stress Urinary Incontinence (Duloxetine) 


Exhibit 3-1: FDA-Approved Pharmacologic Treatment Options for Overactive Bladder/Urge Incontinence 

Exhibit 3-2: Summary Results of FDA Clinical Trials for Sanctura 

Exhibit 3-3: Summary Results of FDA Clinical Trials for Enablex 

Exhibit 3-4: Comparative Clinical Study Results Between Detrol and Ditropan XL

Exhibit 3-5: Summary Results of FDA Clinical Trials for Oxytrol

Exhibit 3-6: Summary Results of FDA Clinical Trials for Vesicare 

Exhibit 3-7: Alternative Pharmacologic Therapies for Urge Incontinence 

Exhibit 3-8: Selected Pipeline Products for Overactive Bladder/Urge Incontinence 

Exhibit 3-9: Phase IIb Results with Fesoterodine 

Exhibit 3-10: Selected Drugs Used Off-Label to Treat SUI 

Exhibit 3-11: Selected Pipeline Drugs for Stress Urinary Incontinence

Exhibit 3-12: Selected Clinical Trials of Duloxetine for Stress Urinary Incontinence

Exhibit 3-13: Frequent Adverse Events from Yentreve European Clinical Trials 

Exhibit 3-14: Overactive Bladder Drugs, Patient and Market Forecast, 2003-2010 

Exhibit 3-15: Overactive Bladder Drugs, Patient Forecast by Product, 2003-2010 

Exhibit 3-16: Overactive Bladder Drugs, Market Forecast by Product, 2003-2010

Exhibit 3-17: Overactive Bladder Drugs, Market Shares by Product, 2003-2010

Exhibit 3-18: Potential Impact of Generic Competition, Overactive Bladder Market, 2003-2010

Exhibit 3-19: Duloxetine Market Potential, 2005-2010



4.1 Behavioral Therapies 

4.1.1 Toileting Assistance

4.1.2 Bladder Training 

4.1.3 Pelvic Muscle Rehabilitation Clinical Experience Indications Adjunctive Technologies Biofeedback Devices Vaginal Exercises and Weights Pelvic Floor Electrical Stimulation Neocontrol Pelvic Floor Therapy System Treatment Protocol Clinical Experience Product Status and Pricing Reimbursement Patient Trends Market Analysis 

4.2 Incontinence Management Devices 

4.2.1 Male External Catheter Systems

4.2.2 Compression Devices

4.2.3 IntermittentSelf Catheters 

4.2.4 Urethral Prostheses and Inserts Product Function Limitations Products and Suppliers Rochester Medical Conticare Medical SRS Medical Commercial Failure of Other Products 

4.2.5 Patient Forecast

4.2.6 Market Analysis 


Exhibit 4-1: Overview of Other Medical Options for Treating Urinary Incontinence 

Exhibit 4-2: Selected Technologies Targeting Pelvic Muscle Rehabilitation 

Exhibit 4-3: Selected Biofeedback Systems for Urinary Incontinence, 2005

Exhibit 4-4: Selected Vaginal Exercisers and Weights, 2005

Exhibit 4-5: Selected Incontinence Electrical Stimulation Systems, 2005 

Exhibit 4-6: NeoControl Pelvic Floor Therapy System

Exhibit 4-7: Adjunctive Pelvic Floor Exercise Devices, Market Forecast, 2003-2010 

Exhibit 4-8: Pelvic Floor Exercise Devices, Supplier Shares, 2004 

Exhibit 4-9: Ambulatory Male External Catheter System Set Up 

Exhibit 4-10: Examples of Male External (Condom) Catheters and Collection Bags

Exhibit 4-11: Selected Male External Catheters, 2005 

Exhibit 4-12: Selected Intermittent Self Catheters, 2005

Exhibit 4-13: Selected Urethral Prostheses and Inserts, 2005 

Exhibit 4-14: Rochester Medical FemSoft Insert

Exhibit 4-15: Results of FemSoft Clinical Trial 

Exhibit 4-16: Conticare Medical ConSert Urethral Implant 

Exhibit 4-17: Factors Contributing to Failure of Urethral Prostheses and Inserts

Exhibit 4-18: Catheter-Based Incontinence Management, Patient Forecast, 2003-2010 

Exhibit 4-19: Catheter-Based Incontinence Management Products, Market Forecast, 2003-2010

Exhibit 4-20: Intermittent Catheters, Market Forecast, 2003-2010 

Exhibit 4-21: Male External Catheter Systems, Market Forecast, 2003-2010 

Exhibit 4-22: Urethral Inserts, Patient and Market Forecast, 2003-2010 

Exhibit 4-23: Incontinence Management Devices, Supplier Shares, 2004



5.1 Traditional Retropubic Surgery 

5.1.1 Retropubic Urethropexy

5.1.2 Transvaginal Needle Bladder Neck Suspension 

5.1.3 Anterior Colporrhaphy and Paravaginal Repair 

5.2 Sling Procedures 

5.2.1 Traditional Pubovaginal Slings Sling Materials Products and Suppliers

5.2.2 Fixation Systems

5.2.3 Tension-Free (Midurethral) Sling Procedure Retropubic Approach Clinical Outcomes Cough Test Sling Placement Antegrade Suprapubic Approach Transobturator Approach Technique Clinical Outcomes Products and Suppliers American Medical Systems Bard Urological Boston Scientific Caldera Medical CL Médical (Uroplasty) Cook Gynecare Gyne Ideas Mentor Neomedic International Promedon Tyco Healthcare 

5.2.4 Male Perineal Sling Clinical Goals Technique Products and Suppliers American Medical Systems Neomedic International Promedon 

5.2.5 Procedure Forecast

5.2.6 Market Analysis 

5.2.7 Supplier Shares 

5.3 Radiofrequency Therapy

5.3.1 CooperSurgical Technique Clinical Experience Status

5.3.2 Novasys Medical Technique Clinical Experience Status

5.3.3 Solarant Medical 

5.3.4 Market Analysis 

5.4 Urethral Bulking Treatments 

5.4.1 Procedure 

5.4.2 Injection Techniques

5.4.3 Indications

5.4.4 Bulking Materials

5.4.5 Clinical Role in Treatment of Incontinence

5.4.6 Reimbursement 

5.4.7 Products and Suppliers Artes Medical Bard Urological Contigen Uryx/Tegress BioForm Medical Boston Scientific/Carbon Medical Technologies Contura Protein Polymer Technologies Q-Med Tissue Science Laboratories Uroplasty

5.4.8 Market Analysis 

5.5 Artificial Urinary Sphincter 

5.5.1 Current Technology (AMS 800)

5.5.2 Surgical Technique 

5.5.3 Regulatory Status/Indications 

5.5.4 Clinical Experience

5.5.5 Costs/Reimbursement 

5.5.6 New Developments Dynamic Myoplasty Technique Research Programs Continence Control Systems ICD Labs

5.5.7 Market Analysis 

5.6 Sacral Nerve Stimulation 

5.6.1 Mechanism of Action

5.6.2 Approaches 

5.6.3 Indications and Contraindications

5.6.4 Complications 

5.6.5 Clinical Experience

5.6.6 Products and Suppliers Boston Scientific/Advanced Bionics CystoMedix (Uroplasty) FineTech/NDI Medical Medtronic Victhom Human Bionics

5.6.7 Market Analysis 

5.7 Other Emerging Therapies

5.7.1 Adjustable Continence Therapy (Uromedica) Clinical Experience Status

5.7.2 Botulinum Toxin Injections Clinical Uses for Botulinum Toxin Potential Uses for Urge Incontinence Differences Among BTX Serotypes Procedural Techniques and Concerns Products and Suppliers

5.7.3 Cell Therapy InnovaCell Biotechnology Cook MyoSite ITL Laboratories 

5.7.4 Spiral Salvage Sling


Exhibit 5-1: Selected Surgical Treatment Options to Treat Urinary Incontinence

Exhibit 5-2: Cure and Improvement Rates for Selected SUI Surgical Procedures

Exhibit 5-3: Complications of Selected SUI Surgical Procedures

Exhibit 5-4: Comparison of Sling Materials 

Exhibit 5-5: Selected Sling Products and Suppliers, 2005

Exhibit 5-6: Selected Sling Fixation Systems, 2005

Exhibit 5-7: Comparison of Tension-Free Sling Procedures 

Exhibit 5-8: Selected Clinical Outcomes of Tension-Free Sling Procedures 

Exhibit 5-9: Comparative Clinical Studies of SPARC vs. TVT Systems

Exhibit 5-10: Anatomical Comparison of Transobturator and Retropubic Tension-Free Sling Placement 

Exhibit 5-11: Selected Clinical Outcomes of Transobturator Sling Procedures

Exhibit 5-12: Comparison Studies of Transobturator and Retropubic Tension-Free Sling Procedures 

Exhibit 5-13: Selected Tension-Free Sling Products and Suppliers, 2005 

Exhibit 5-14: American Medical Systems’ Tension-Free Sling Products 

Exhibit 5-15: Bard Urological's Tension-Free Sling Portfolio

Exhibit 5-16: Boston Scientific's Advantage-Mesh Tension-Free Sling Portfolio 

Exhibit 5-17: Caldera Medical's T-Sling System 

Exhibit 5-18: Gynecare's TVT Products

Exhibit 5-19: Gyne Ideas' Minitape RP

Exhibit 5-20: Neomedic International's Remeex System

Exhibit 5-21: Selected Clinical Outcomes with the Remeex Sling System

Exhibit 5-22: Promedon's Safyre Sling System: 

Exhibit 5-23: Selected Clinical Outcomes with the IVS Tunneler 

Exhibit 5-24: Selected Clinical Outcomes of Male Sling Procedures 

Exhibit 5-25: U.S. Sling Procedures, 2003-2010

Exhibit 5-26: U.S. Urethral Sling Market, 2003-2010

Exhibit 5-27: U.S. Sling Market, Supplier Shares by Segment, 2003-2004

Exhibit 5-28: Selected Radiofrequency Therapy Systems, 2005

Exhibit 5-29: Radiofrequency Therapy, Procedure and Market Forecast, 2003-2010 

Exhibit 5-30: Comparison of Bulking Agent Injection Techniques 

Exhibit 5-31: Periurethral and Transurethral Injection of Bulking Agents

Exhibit 5-32: Clinical Studies of Bulking Agents in the Treatment of Urethral Hypermobility 

Exhibit 5-33: Comparison of Bulking Agent Materials

Exhibit 5-34: Selected Urethral Bulking Agents, 2005 

Exhibit 5-35: Uryx Effectiveness Results at 12 Months

Exhibit 5-36: Adverse Events in Uryx FDA Clinical Trials

Exhibit 5-37: Zuidex Improvement in Urine Leakage Compared to Baseline 

Exhibit 5-38: Comparison of Permacol and Macroplastique Pad Weight Loss

Exhibit 5-39: Macroplastique Clinical Outcomes at 12 and 24 Months

Exhibit 5-40: U.S. Urethral Bulking Agents, Procedure and Market Forecast, 2003-2010

Exhibit 5-41: U.S. Urethral Bulking Agents, Supplier Shares, 2003-2004 

Exhibit 5-42: AMS 800 Urinary Control System 

Exhibit 5-43: New Developments in Artificial Urinary Sphincters

Exhibit 5-44: Artificial Urinary Sphincters, Procedure and Market Forecast, 2003-2010

Exhibit 5-45: Possible Mechanisms of Action of Sacral Nerve Stimulation 

Exhibit 5-46: Indications and Contraindications for Sacral Nerve Stimulation 

Exhibit 5-47: Selected Sacral Nerve Stimulation Devices for Urinary Incontinence, 2005

Exhibit 5-48: Advanced Bionics' Bion Device

Exhibit 5-49: CystoMedix' Urgent PC Device 

Exhibit 5-50: Selected Clinical Outcomes of Peripheral Sacral Nerve Stimulation

Exhibit 5-51: Vocare Bladder System

Exhibit 5-52: Medtronic InterStim Device and Placement 

Exhibit 5-53: Selected Clinical Trials of InterStim Device 

Exhibit 5-54: Sacral Nerve Stimulation, Procedure and Market Forecast, 2003-2010

Exhibit 5-55: Sacral Nerve Stimulation, Supplier Shares, 2004

Exhibit 5-56: Emerging Incontinence Therapies, 2005 

Exhibit 5-57: Uromedica’s Adjustable Continence Therapy (ACT) Implants 

Exhibit 5-58: Selected Clinical Outcomes of Adjustable Continence Therapy

Exhibit 5-59: Clinical Trials of Botulinum Toxin for Overactive Bladder/Urge Incontinence

Exhibit 5-60: Selected Cell Therapy Programs for Stress Urinary Incontinence 



6.1 Survey Design, Format and Sample Size

6.2 Patients Seen Weekly by Severity of Incontinence 

6.3 Diagnostic Protocols 

6.4 Ownership of Urodynamic Equipment 

6.5 Importance of Clinical Factors in OAB Drug Selection

6.6 Factors Causing Patients to Discontinue OAB Drug Therapy

6.7 Potential Impact of Generic Ditropan XL

6.8 Current and Planned Prescribing of OAB Drugs by Type

6.9 Limitations of OAB Drugs

6.10 Off-Label Prescribing of Duloxetine 

6.11 Effectiveness of Non-Pharmacologic SUI Treatments 

6.12 Midurethral Sling Products 

6.13 Radiofrequency Bladder Neck Suspension

6.14 Quality of Suppliers' Sales Representation


Exhibit 6-1: Survey Respondents

Exhibit 6-2: Incontinence Patients Seen Weekly 

Exhibit 6-3: Frequency of Use of Selected Incontinence Diagnostic Tools 

Exhibit 6-4: Current Ownership of Urodynamic Equipment

Exhibit 6-5: Respondents Planning Purchases of Urodynamics Equipment 

Exhibit 6-6: Current & Planned Urodynamic Equipment Ownership by Manufacturer 

Exhibit 6-7: Importance of Clinical Factors in Drug Selection for Overactive Bladder 

Exhibit 6-8: Contribution of Specific Factors to Patient Discontinuation of Drug Therapy for Overactive Bladder 

Exhibit 6-9: Share of Patients Discontinuing Drug Therapy for Overactive Bladder Due to Specific Factors

Exhibit 6-10: Share of Detrol LA Patients Expected to Shift to Generic Ditropan XL Upon Availability

Exhibit 6-11: Reasons for Switching from Detrol LA to Generic Ditropan XL

Exhibit 6-12: Respondents' Plans to Increase Prescribing for Patients with OAB When Generic Ditropan XL Becomes Available

Exhibit 6-13: Share of Patients on Various OAB Drugs At Present and at End of 2005 

Exhibit 6-14: Major Limitations of Detrol LA 

Exhibit 6-15: Major Limitations of Ditropan XL 

Exhibit 6-16: Major Limitations of Oxytrol Patch

Exhibit 6-17: Major Limitations of Vesicare 

Exhibit 6-18: Major Limitations of Enablex

Exhibit 6-19: Major Limitations of Sanctura 

Exhibit 6-20: Respondents Likely to Prescribe Duloxetine Off-Label

Exhibit 6-21: Reasons for Prescribing and Not Prescribing Duloxetine Off-Label

Exhibit 6-22: Rating of Non-Pharmacologic Stress Urinary Incontinence Treatments

Exhibit 6-23: Current Use of Midurethral Sling Products 

Exhibit 6-24: Planned Use of Midurethral Sling Products

Exhibit 6-25: Reasons for Current & Planned Use of Selected Midurethral Sling Products 

Exhibit 6-26: Performance of Radiofrequency Bladder Neck Suspension

Exhibit 6-27: Quality of Incontinence Suppliers' Sales Representation



7.1 ACMI Corporation

7.2 American Medical Systems, Inc.

7.3 C.R. Bard, Inc. 

7.4 Boston Scientific Corporation

7.5 The Cooper Companies, Inc. 

7.6 GE Healthcare

7.7 Hollister, Inc. 

7.8 Johnson & Johnson 

7.9 Laborie Medical Technologies Corp 

7.10 Life-Tech, Inc. 

7.11 Medtronic, Inc.

7.12 Mentor Corporation 

7.13 Olympus Corporation

7.14 Pfizer, Inc.

7.15 Rochester Medical 

7.16 Siemens AG

7.17 SRS Medical Corporation

7.18 Karl Storz GmbH & Co. KG

7.19 Uroplasty, Inc./Cystomedix, Inc. 

7.20 Watson Pharmaceuticals, Inc. 

7.21 Yamanouchi Pharmaceutical Co., Ltd. (Astellas Pharma, Inc.) 



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