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Strikingly positive results with behavioral methods of treating UI have been reported, with some clinicians achieving an 80% reduction in incontinence |
Expanding
Options for Urinary Incontinence
A growing number of options now exist for the treatment of urinary incontinence (UI), a disorder which affects an estimated 13 million people in the U.S. alone. Treatments range from behavioral therapy (e.g., biofeedback-guided pelvic floor exercises and bladder retraining), to urethral plugs and seals, pharmaceutical agents and surgery. While these techniques can provide some measure of relief for the majority of UI sufferers, fewer than half actually seek medical help for their condition, primarily due to feelings of embarrassment or a lack of knowledge about treatment options. Although these latter two factors continue to hinder widespread diagnosis and treatment of UI, the situation is expected to improve significantly as new educational programs and dedicated continence care centers are established and a plethora of novel products become available. The largely underserved and highly fragmented nature of the current UI market adds up to a significant opportunity for both large and small competitors. Still, at the core of UI treatment remains the adult diaper and pad market, estimated at $1.5+ billion annually. A moderately incontinent consumer uses an average of about $1,200 worth of these supplies per yearan outlay that one day may, at least partially, be diverted to new products that better meet patient satisfaction requirements and produce positive outcomes. Rising Costs & Prevention Figure 27: Costs Associated with Urinary Incontinence in the
Elderly, U.S., 1995 According to the U.S. Agency for Health Care Policy and Research (AHCPR), an effective prevention program could reduce new cases of incontinence in noninstitutionalized women alone by about 50,000 per year. The American Federation for Aging Research and the Alliance for Aging Research estimate that delaying the onset of incontinence by just five years would translate into an annual savings of $8 billion. Widespread but Undertreated Figure 28: Types of Urinary Incontinence Despite the fact that existing treatment methods are effective at alleviating or even curing incontinence in the vast majority (up to 80%) of patients, studies show that fewer than half of incontinence sufferers seek medical assistance for their condition. Moreover, those who do seek care are often dissatisfied with their treatment or the recommendations of their physician. Primary care physicians in particular tend to be uninformed about the diagnosis and treatment of UI. They are often reluctant to query their patients about incontinence, and they tend to recommend low-tech solutions such as pads and diapers. According to a survey conducted by the American Foundation for Urologic Disease, only 32% of primary care physicians routinely question their female patients about incontinence, compared with nearly 80% of urologists. Continence Centers
Urology physician practice management companies (PPMCs), many of which are setting up dedicated urology ambulatory surgery centers, are also poised to play a major role in treatment expansion as well as disease management-based prevention strategies. At least five PPMCs dedicated to urology practice are already operational in the U.S. One of the newest, UROTHERAPIES (Oakbrook Terrace, IL), has plans to partner with drug and device manufacturers to facilitate adoption of the latest technology. Deficiencies in care are also being addressed by a number of government agencies, and community and physician groups, which are supporting patient and physician educational programs. In the future, incontinence care will increasingly involve a multifaceted, individualized approach, with initial treatment focused on patient-directed, noninvasive methods, possibly followed later by least-invasive procedures. Behavioral Techniques Behavioral methods are attractive to both patients and physicians because they are noninvasive, have no or minimal side effects and provide patients with control over their care. According to a recent survey conducted by the Bladder Health Council for the American Foundation for Urologic Disease, of women age 45 and older being treated for incontinence, nearly 40% received behavioral therapy, while the remainder were about evenly split between surgical treatment, medical therapy and no treatment (i.e., either the doctor did nothing or recommended absorbent pads). Strikingly positive results with behavioral methods have been reported, with some clinicians achieving an 80% reduction in UI using a combination of techniques. Biofeedback and pelvic floor stimulation (PFS) devices for the treatment of UI are available from at least 13 U.S. manufacturers. Among those displaying products at the American Urogynecologic Society meeting, held last September in Tucson, AZ, were AMERICAN IMEX (Irvine, CA), INCARE MEDICAL PRODUCTS (Libertyville, IL), SRS MEDICAL SYSTEMS (Redmond, WA), VERIMED INTERNATIONAL (Coral Springs, FL) and EMPI (Minneapolis, MN). The latter, a leading provider of electrical stimulation systems for both incontinence and pain management, showcased its new InnoSense PFS system, which combines surface electromyography (sEMG) biofeedback and electrical stimulation in a low-cost, battery-powered device. In addition to the recently launched InnoSense product, EMPI has been granted FDA approval to market Minnova, a new device developed to simplify and lower the cost of pelvic floor stimulation in treating both stress and urge UI. Minnova addresses the need for low-cost continuation therapy for patients in the home setting. Additional competitors in PFS and biofeedback include BIOSONICS (Fort Washington, PA), which will begin marketing its Cystotron PFS device in the U.S. this year, and INFLUENCE (San Francisco, CA), which is developing In-Bio, a wireless system that combines biofeedback and electrical stimulation. Growth & Reimbursement Figure 29: Incontinence Management Devices, U.S. Market Forecast,
1997E & 2001E Implantable Stimulators The first fully implantable electrical stimulator for severe, refractory urge incontinence is MEDTRONICs (Minneapolis, MN) Interstim. The device, which received FDA marketing approval last September, is about the size of a pacemaker and is implanted near the spinal cord where it delivers electrical pulses to the sacral nerves to control bladder contractions. Cost of the unit is about $10,000, plus an additional $15,000 for the implant surgery. In clinical testing, the device "cured" about 47% of patients, and cut leakage in half in another 28%. However, 35% of patients reported long-term pain from the device and required additional surgery to reposition the implant. Disappointing Performances Contigen has been up against disappointing physician acceptance. Sales have been relatively flat ($30-$40 million per year) since the product was introduced in 1993. Manufactured by COLLAGEN (Palo Alto, CA) and marketed by BARD, Contigen is an injectable, collagen-based urinary sphincter bulking agent for the treatment of stress incontinence due to intrinsic sphincteric deficiency, which affects about 15% of stress UI sufferers. However, it does not work well for male incontinence (only 40% of men attain dryness when treated with the product). For women, there is uncertainty about the dosage required per treatment, and many need repeated treatments, at a cost of about $1,800 each, to achieve complete dryness. New Inserts, Patches & Caps |
Poor patient or physician acceptance of UI treatment devices or less than optimal long-term efficacy have often resulted in disappointing sales performance |
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Periurethral bulking agents hold much promise as lower-cost, less-invasive alternatives to surgery for patients with intrinsic sphincter deficiency |
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Figure
30: Current & Future Treatment Options for Urinary Incontinence![]() *In development in the U.S. **Also see Figure 31, Note: UI = urinary incontinence; ISD = intrinsic sphincter deficiency Sources: UBS Securities; Medical Data International (Based on information from two newly released MDI Reports: #RP-191112, "U.S. Markets for Urological Products" and #RP-611335, "U.S. Womens Health Products and Markets" [table of contents for both reports available upon request]) |
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Drugs can benefit some patients with UI but they often have troublesome side effects |
Last month,
the company announced its intention
to decrease its investment in the
consumer-oriented continence
care business by securing
marketing partners to sell
and distribute Impress.
The firm, which will concentrate its
efforts on hospital-based products,
has also been diversifying its product
line in order to reduce its dependence
on the incontinence market.
Late last year, UROMED received
FDA marketing clearance
for CaverMap,
a unique nerve-locating device
that has proven valuable in preventing impotence
during prostate removal surgery; its BreastCheck
and BreastExam battery-powered
tactile sensor devices for detecting breast
lumps are scheduled to begin clinical
testing this year.
ROCHESTER MEDICAL (Stewartville, MN) began clinical trials early last year of its FemSoft insert, a lubricated, fluid-filled device that conforms to the natural contours of the urethra, providing more comfort and less irritation than more rigid devices like Reliance, according to the company. Another new product, the FemAssist urethral cap developed by INSIGHT MEDICAL (Bolton, MA), has exhibited some promising early clinical results. The soft, silicone device is fitted over the external urethral meatus and is held in place by mild suction and an adhesive sealant ointment. It is removed for urination, cleaned with soap and water, and reapplied, with a single device worn for up to one week. A recent study found that the device was well tolerated and effective in reducing female stress, urge or mixed incontinence. According to the company, the FemAssist will cost about $40 for a one-month supply (i.e., four devices plus ointment). Bulking Products
Evolve MENTOR (Santa Barbara, CA) is seeking FDA approval for its silicon-based product, Urithryn. In addition, CONVATEC (Princeton, NJ; a division of BRISTOL-MYERS SQUIBB) is conducting clinical trials of a bulking agent incorporating calcium hydroxylapatite granules; while BIOMATRIX (Ridgefield, NJ) recently received FDA approval to begin clinical trials of a hyaluronan-based viscoelastic gel, Hylagal Uro. Another firm, PROTEIN POLYMER TECHNOLOGIES (San Diego, CA), has begun preclinical studies of biocompatible polymer bulking agents (the companys technology platform is also applicable to surgical adhesives and sealantssee article 1). A new entry in the periurethral bulking agent market is GENYX MEDICAL (Laguna Niguel, CA), a recent spinoff of MICRO THERAPEUTICS (San Clemente, CA; also see article 5) which has licensed the latters EMBOLYX bulking agent for urologic/gynecologic uses. The product, which has been renamed URYX, is an injectable biocompatible polymer of ethylene vinyl alcohol and contrast material that forms a solid mass once inside the body. In addition to urethral bulking, GENYX also hopes to use the material for reversible male (and possibly female) sterilization procedures. A number of products are under development in Europe, as well. UROPLASTY (The Netherlands) has developed a novel hydrogel sphincter implant in Europe (see MedPro Month VII[1]:5, 1997); QVESTOR, a Swedish company, is in clinicals with Deflux, an implant composed of sodium hyaluronate and dextranomer microspheres; and U.K.-based UROCOL is pursuing a ceramic bead bulking product. A different approach has been taken by UROSURGE. The companys Self-Detachable Balloon System, in Phase II clinical testing, is intended to provide a bulking system that, unlike collagen and similar products, poses no risk of systemic absorption and possible side effects. It is administered during a 15-minute cystoscopic procedure in which a catheter is used to position and deliver three microballoons (one at a time) into the submucosal layer at the site of the sphincter muscle. The balloons are inflated with hydrogel, detached from the catheter, and subsequently seal themselves. In Phase I trials, 63% of women treated with the system achieved dryness, while 89% reported subjective improvement. Drug Solution?
Figure 31: Urinary Dysfunction Drugs in Clinical Trials New Catheter Devices ROCHESTER is also developing a valved catheter for female patients. Valved catheters are the newest innovation for patients with chronic, refractive stress or overflow UI, providing a more convenient and potentially safer alternative to intermittent catheterization. Inserted into the urethra by a physician and left in place for up to a month at a time, the devices block urine flow until the patient opens the valve for urination, usually via a remote device. In addition to ROCHESTER, valved catheters are under development by INFLUENCE, IMAGYN MEDICAL TECHNOLOGIES (Newport Beach, CA; merged with UROHEALTH SYSTEMS in 1997) and UROQUEST (Salt Lake City, UT). The latter is conducting clinical trials of its On-Command magnetically activated valved catheters for both men and women (the firm has a development agreement with B. BRAUN [Germany]). ROCHESTER plans to begin clinical trials this year of its FemSoft female valved catheter, designed to be replaced every day, while both the 29-day INFLUENCE In-Flow valved-pump catheter for overflow incontinence and the IMAGYN RelaX valved devices are undergoing clinical testing (INFLUENCE expects to file a PMA this year for its device, which is marketed in Europe). Another device worth mentioning is HK MEDICALs (San Antonio, TX) Autocath 100 intraurethral sphincter prosthesis for female stress UI due to ISD. This product received European market approval in October and is undergoing clinical testing in the U.S. The Autocath 100 is inserted in a nonsurgical, 10- minute procedure in which it is suspended on the bladder floor from a X-shaped spring. It is designed to hold the sphincter muscle closed until the patient uses abdominal pressure to open the device for urination. Advances in Urodynamics Figure 32: Urodynamic Measurements, U.S. Procedural Forecast,
1996-2001 Recent developments in urodynamic products include new office-based systems with complex capabilities, the introduction of diagnostic database management systems as well as highly sophisticated video urodynamic equipment and devices that can also perform gastroenterology studies (e.g., manometry or rectal pressure studies). Manufacturers include BARD UROLOGICAL (Covington, GA), LABORIE MEDICAL TECHNOLOGIES (South Burlington, VT), LIFE-TECH (Houston, TX), and several others. An estimated 5,500-6,000 urodynamic installations currently exist in the U.S., the majority operated by urologists. In 1996, these installations performed over 1 million urodynamic studies, 85% of which took place at office-based or freestanding sites. Although urodynamic studies are still largely underutilized in the U.S., the growing incontinence caseload is leading to greater utilization and an increasing number of specialists offering urodynamic analysis. One of the drawbacks to wider use of these systems is cost and reimbursement. The average patient undergoes three urodynamic studies during the course of an evaluation, at a cost which typically ranges from $100 to $300 or more each (only partially paid for by insurance). Surgical Techniques Evolve In 1997, the American Urological Association released treatment guidelines which strongly recommend the use of surgery as a first line of treatment for female stress UI. According to the guidelines, there is strong evidence to suggest that surgery provides an effective long-term cure for most patients, with retropubic suspensions and sling procedures offering better results than transvaginal suspensions (although the former also have higher complication rates). The evolution of laparoscopically assisted and incisionless techniques may eventually improve transvaginal success rates. Bone Anchors Gain
Figure 33: Bone Anchor Systems, U.S. Market Forecast, 1997E
& 2001E The broadening popularity of bone anchors for UI surgery has prompted many manufacturers to introduce products (some of which were originally designed for orthopedic uses) to this market, including MICROVASIVE/ BOSTON SCIENTIFIC (Natick, MA), MENTOR, AMS/PFIZER, ETHICON (Somerville, NJ), INFLUENCE, INNOVASIVE DEVICES (Marlborough, MA)/UROMED and WRIGHT MEDICAL (Arlington, TN). MICROVASIVE/BOSTON SCIENTIFIC is the market leaderits Vesica procedure (and products) is marketed as a way for physicians to achieve more reproducible results than can be obtained with other methods and products. Other manufacturers, including INFLUENCE and MENTOR, are planning to introduce additional components to their bone anchor lines, such as bone locators and sling material, but unlike the Vesica kit, these manufacturers will market each component separately, a strategy intended to give physicians greater flexibility in their choice of products. INFLUENCE is the only company to offer products for incisionless, transvaginal bladder neck suspension or sling procedures, which take place under local anesthesia and can be performed in as little as 20 minutes. Due to the shorter procedural time, these products have caught the attention not only of urologists, who have readily embraced bone anchoring systems, but also of urogynecologists (and gynecologists performing incontinence surgery) who are generally more experienced in laparoscopic suturing and have thus far tended to avoid the use of expensive bone anchors. New Market Entrants |
The broadening popularity of bone anchors for UI surgery has prompted many manufacturers to introduce products to this market |
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Copyright © 1998 Medical Data International This article was published in the March
1998 issue of MedPro Month, Medical Data International's monthly |