BBI Contributing Editor
SAN FRANCISCO, California The 23rd annual scientific meeting of the American Urogynecologic Society (AUGS; Washington), held here in mid-October, achieved record attendance with 900 attendees of the 1,000 total members. AUGS fosters research on the diagnosis and management of pelvic floor disorders, including such areas as urinary incontinence, fecal incontinence and pelvic organ prolapse.
James Scott, MD, former chairman of obstetrics and gynecology at the University of Utah (Salt Lake City, Utah) and the current editor of Obstetrics and Gynecology, set the tone of the meeting in his keynote lecture, "Show Me the Evidence." He stressed the importance of good research using meta-analysis to eliminate bias, noting that standardized analyses often include state-of-the-art reviews and statistics that can lead to subjective assumptions. Meta-analysis is an analytical strategy for combining data from multiple small studies to reach a definitive conclusion. Scott touted the benefits of using the Cochrane library, which holds hundreds of meta-analysis reviews and reminded the audience of the purpose of research medicine: to generate and publish medical knowledge. He de-emphasized the importance of intuition, experience and opinion while emphasizing the value of evidence and outcomes.
Much of the research at this meeting centered on stress urinary incontinence (SUI), with two poster presentations demonstrating the growth in SUI procedures. S.H. Boyles, MD, of Ohio State University (Columbus, Ohio), found that the rate and number of incontinence surgeries has nearly doubled since 1979. In another poster presentation from the University of California at Davis (Davis, California), a group of researchers found that the rate of incontinence surgery increased by 50% in the last 10 years and that in 1998, of the 135,000 incontinence surgeries performed, 68% had a concomitant surgery.
Addressing this opportunity were three "sweethearts" of those visiting the exhibit area each targeting stress urinary incontinence. Eli Lilly and Co. (Indianapolis, Indiana) showcased its soon-to-be-approved drug that will be the only oral medication that can treat stress urinary incontinence. Duloxitene HCL works on the central nervous system as an alpha blocker on the external urethral sphincter. Unlike bulking agents that puff up the internal urethral sphincter to fill space, this drug would activate the external sphincter, causing it to close. Duloxitene HCL could be on the market within 18 months.
Genyx (San Diego, California) exhibited its urethral bulking agent, Uryx, for the first time in the U.S. Mickey Karram, MD, of Good Samaritan Hospital (Cincinnati, Ohio), presented an oral poster, "Multicenter Randomized controlled study to evaluate Uryx urethral bulking agent in treating female stress urinary incontinence." Uryx is an ethylene vinyl alcohol copolymer dissolved in DMSO for injection and upon contact with tissue mucosa, converts into a single spongy mass. The study compared Uryx to Contigen, manufactured by C.R. Bard (Murray Hill, New Jersey), and found that Uryx patients demonstrated "dry" outcomes more often that Contigen patients. In the study, 236 patients were treated with either Uryx or Contingen and several different parameters were measured. At the six-month mark there was only a slight advantage with Uryx, but by 12 months the improvements of Uryx patients over Contigen patients were significant. Uryx is CE-marked in Europe and is selling there. FDA approval is anticipated this year.
The Novasys Medical (Newark, California) booth was among the busiest, generating interest and enthusiasm from both physician and nurse attendees. Novasys is testing a new, non-incisional, transurethral treatment for women with genuine SUI that requires no visualization (neither cystoscopy nor fluoroscopy). The device is inserted into the urethra and is accurately positioned in a manner much like inserting a Foley catheter. The treatment takes less than 10 minutes and requires no general anesthesia, allowing it to be performed in an outpatient or office setting.
The treatment directly alters the dynamic compliance of the bladder neck and proximal urethral by using radiofrequency energy to heat submucosal tissue to collagen remodeling temperatures (as opposed to higher ablation temperatures, which produce gross tissue shrinkage and cell destruction). These minute regions of renatured collagen reorganize in a significantly more compact, less-compliant architectural pattern, resulting in reduced dynamic compliance (that is, less urethral distensibility in the face of increased intra-abdominal pressure). Novasys said it believes that re-treatment would be a safe possibility if necessary, and that the treatment would not preclude other treatment modalities or surgery in the future if required.
A 10-site trial, led by Rodney Appell, MD, of the Baylor College of Medicine (Houston, Texas), and involving urogynecologists, urologists and gynecologists, included more than 170 women with SUI. Novasys will be collecting treatment safety and efficacy data on these women over the next year and expects that their unique treatment as a first-line approach to SUI will provide an alternative to women uninterested in surgical therapy.