BBI Contributing Editor
HOLLYWOOD, Florida This year's annual meeting of the American Urogynecology Society (AUGS; Washington) had a preponderance of presentations on pelvic organ prolapse (POP), but the exhibit hall was filled with a virtual menu of incontinence therapies, including "slings du jour," with almost every company offering a unique twist to the tension-free sling popularized by Gynecare (Somerville, New Jersey), a unit of Johnson & Johnson (J&J; New Brunswick, New Jersey).
The 24th annual scientific sessions of AUGS attracted about 60% of the society's 1,000 members. This specialty group of gynecologists and urologists focuses on research and treatment for female pelvic organ disorders, including but not limited to: POP, incontinence and sexual dysfunction.
With 33 million Americans suffering from some form of incontinence, it was not surprising that a majority of vendor exhibit booths concentrated on demonstrating the latest in treatments.
Incontinence is categorized as urge, stress or mixed and the causes and therapies for each are different (Table 4). For the one-third of incontinent Americans that have urge incontinence the only type that can be treated with pills the first line of defense is medication: either with Detrol, Ditropan or Oxytrol (oral or patch). Eli Lilly and Co. (Indianapolis, Indiana) expects final approval for Duloxitene, which will be the first pill for treatment of stress incontinence, late this year or early next. Yamanouci (Tokyo) reported that its new molecule for treatment of overactive bladder should be FDA-approved in the near future, having submitted its premarket approval application in December 2002.
Following drugs, non-invasive therapies are attempting to reach those patients who may not be compliant with pill-taking, who are not surgical candidates or who just don't want surgery. This group of patients often tries biofeedback or pessaries, but if these methods don't work, there is not much of an alternative left for them but surgery. Novasys Medical (Newark, California) is gaining interest among physicians looking for a non-invasive approach for the millions of women not wanting surgery. Novasys is awaiting the results of its pivotal, multi-center randomized controlled trial in the U.S. In the meantime, its 12 month-Mexico data, presented at the International Continence Society's annual meeting in Florence, Italy, demonstrated durability from the six-month results, with 70% to 82% of women reporting an improvement in quality of life. If the U.S. clinical trials prove efficacy, Novasys may have the only non-invasive procedure available that bridges the gap between medical management and surgery.
Although stress incontinence affects 12 million American women, surgery as a treatment option has been held to a bare minimum, as evidenced by less than 100,000 surgical procedures performed until recently. The conventional surgical technique was difficult, invasive, required hospitalization, and the results were often less than acceptable. In 1997, J&J's Gynecare unit presented a radically new way of performing the same surgery in a minimally invasive manner, introducing a novel "blind" insertion that many said would never be adopted. To the contrary, the procedure became so well adopted that it now rivals the conventional Burch procedure for consideration as the "gold standard" for urinary stress incontinence surgery.
Because the technique is minimally invasive, has superior long-term clinical results, requires no hospitalization, and allows the patient to return to work quickly, the number of procedures is growing. Although the number of sling procedures grew only to a modest 140,000 procedures in the U.S. in 2002, it is thought that most of those surgeries were performed using a tension-free sling, cannibalizing the conventional Burch procedure.
It is predicted that word of mouth from patients, along with more physicians trained in the technique, will boost tension free sling procedures to well over 260,000 procedures worldwide and growing. Following the success of Gynecare's TVT tension-free sling and the intensifying market growth, almost every company serving urogynecology has developed an approach for minimally invasive tension free slings. (Table 5).
Boston Scientific (Natick, Massachusetts) introduced two second-generation products at the AUGS meeting its improved Durasphere, a bulking agent, and Advantage, a sling kit that utilizes a transvaginal approach to place its new sling material that maintains its width under pressure. The second-generation Durasphere injectable bulking agent was just approved by the FDA recently and allows for an easier injection with smoother flow due to suspending smaller beads in solution.
In past AUGS meetings, several presentations were made on bulking agents; however, at this conference only two presentations discussed them. A paper by Dr. A. Bent of Greater Baltimore Medical Center (Baltimore, Maryland), titled "Multicenter Randomized Controlled Study to Evaluate Uryx Urethral Bulking Agent in Treating Female Stress Urinary Incontinence," found that Uryx had improved outcomes over Contigen, with 58% of the patients dry or improved at one year and only 15% having an early exposure of the bulking agent through the urethral mucosa, requiring surgical extraction of the material. No other complications or adverse effects were reported. The absence of other papers on bulking agents may have been due to new agents still in clinical trials with no new information available.
A newly formed, privately held company, Caldera Medical (Thousand Oaks, California), was showing its new tension-free sling, Centrasorb, which has a central absorbable section that is totally resorbed by the body in 100 days, leaving no synthetic portion of the sling touching the urethra. Caldera offers Stamey needles that can be reused 30 times as a cost saving alternative to kits. The price of its sling plus needles, although each can be purchased separately, is $650, the lower end of the $650-to-$800 price range for tension-free sling kits.
Because the Canadian healthcare system was refusing to allow many TVT procedures to be performed due to cost, Dr. A. Gill, MD, of the Memorial University of Newfoundland (St. John's, Newfoundland) performed a cost outcome study titled "A Randomized Control Trial Comparing Modified TVT Using Reusable Pubovaginal Sling Device in Treatment of Urinary Stress Incontinence." He studied 50 patients, half of whom received the Gynecare TVT product and half who received his modified system, which consisted of a stainless-steel needle with jaw handle that he designed, and a slice of hernia mesh that he cut into strips and sterilized. His modified system cost the hospital $10, while the TVT kit cost $675.
All patients were operated on under general anesthesia and followed for six months. There was no difference between the groups in operative time at 25 minutes. The cure rates were comparable with 84% cure in the TVT group and 88% in the modified TVT group. The overall total cost was significantly less with the modified group at $997 compared to $1,712 in the TVT group. Gill said that the technique of modified TVT is as effective as the standard TVT and that the total cost is approximately half that of a standard TVT. This may spur other physicians to try something similar, especially outside of the litigious U.S., possibly creating a trend toward price erosion of sling kits.
A presentation made by Dr. R. Rogers, MD, of the University of New Mexico (Albuquerque, New Mexico) on the "Sexual Function after Surgery for Stress Urinary Incontinence" indicated that following surgery for SUI in 103 women, it was found that their sexual function worsened and sustained that lesser level for six months independent of age, type of surgery, postoperative complication or hormonal status. Follow-up questionnaires were not able to determine why this occurred, but conjecture is that patients, or their partners, may feel fearful that intercourse could reverse the effects of the surgery. In the discussion that followed, some physicians felt compelled to disclose this fact to potential candidates for incontinence surgery when counseling them.
From presentations made at this year's meeting, it is clear that the trend is toward performing more tension-free sling procedures, on more and broader patient populations, and with surmounting clinical evidence that supports the safety and efficacy of this procedure.