BB&T Contributing Writer

CHICAGO – the 19th Annual Postgraduate Course for Advanced Gynecologic Surgery was held here once again with practically standing room only: who would have thought that hundreds would come to Chicago in December? There was clearly no global warming evident but instead a global interest in providing the best care for women using data driven, minimally invasive methods. Topics from alternatives to hysterectomy to mini-slings and robots were all discussed in an interactive, evidence-based format to encourage practicing gynecologic surgeons to provide the best care possible for their patients based on data. In a specialty that has undergone mass transformation due to changes in available technologies and advancements in understanding, the practicing gynecologic surgeon is challenged to stay abreast of the latest information that may change his approach to treating his patients.

The Society of Gynecologic Surgery (SGS) sponsors of this annual symposium, advocates using the results of past clinical trials to shape current practice patterns. To that end, Linda Brubaker, MD, Professor, Department of Obstetrics and Gynecology and Urology, Loyola University Medical Center, (Maywood, Illinois) outlined key clinical trials and encouraged physicians to join in any that they can because “they are capable of generating the highest level of evidence for clinical practice.“ Brubaker reviewed current clinical trials such as the Trial of Mid-Urethral Slings (TOMUS) that has just been completed and whose results will be presented at both the American Urological Association (Linthicum, Maryland) and American College of Obstetricians and Gynecologists (Washington) meetings this spring along with publication of a journal article in the New England Journal of Medicine. The primary aim of TOMUS is to compare treatment success for two minimally invasive surgical procedures that treat stress urinary incontinence in women; the TVT from Ethicon Women's Health (Somerville, New Jersey) and the TOT from American Medical Systems (Minnetonka, Minnesota). The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and the need for other treatments after surgery. This trial is not just comparing two different companies' competing products, but rather the surgical approach (inside out vs. outside in) utilized with each of the products. Unless the outcomes have significant differences, most surgeons feel that the best approach is “that which you are comfortable with and good at.“

The VALUE trial is an ongoing study randomizing women with uncomplicated, primary stress incontinence to basic office evaluation and pre-operative urodynamic testing vs. basic office evaluation only. The patients then go on to stress incontinence surgery. Urodynamic testing is typically performed prior to incontinence surgery. There is no dominant player in the urodynamics equipment and urodynamics supplies market. Some larger U.S. and international urodynamics equipment manufacturers include: Laborie (Williston,Vermont), C.R.Bard (Murray Hill, New Jersey), Gyrus ACMI (Southborough, Massachusetts), CooperSurgical (Trumbull, Connecticut), and Ethicon Women's Health Care. Urodynamic studies are expensive, time-consuming, and uncomfortable diagnostic investigations. The intent of this clinical trial is to check to see if the urodynamic testing is of value (is it worth it?). Key research questions related to urodynamic testing are: 1) Do physicians alter clinical decision-making based on results of urodynamic testing? and 2) Do alterations in clinical decisions made in response to urodynamic testing results improve the clinical outcomes? The results of this trial could potentially have an economic impact on the industry since many insurance carriers require urodynamic testing prior to stress incontinence surgery.

Another interesting trial is the OPUS trial, or Outcomes following vaginal Prolapse repair and mid Urethral Sling. Pelvic organ prolapse (POP) is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some women develop stress urinary incontinence (SUI) after surgery. A prior randomized trial (CARE) has shown that use of a Burch sling (native tissue) at the time of an abdominal sacrocolpopexy decreases the risk of urinary incontinence; however, the benefit of adding an anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal approach is unclear. Thus, the objective of the OPUS trial is to determine whether prophylactic treatment with Tension-free Vaginal Tape (TVT), manufactured by Ethicon Women's Health, at the time of prolapse surgery done via a vaginal approach is effective in preventing urinary incontinence. This study should influence many surgeons who are on the fence as to whether or not add a prophylactic SUI procedure at the same time as the anterior repair for prolapse surgery.

Although the randomized controlled trial comparing Botox 200 units to placebo in women with refractory urge incontinence had to be stopped due to higher than expected rates of urinary retention; there is a new trial anticipated to begin enrollment imminently that will study Botox used at only 100 units. Some urogynecologists have reported good results injecting Botox into the bladder for women with refractory urge incontinence—it will be better accepted once a trial has shown similar results.

Brubaker concluded by advising audience members to check www.clinicaltrials.gov regularly to see if they can participate in a trial as well as to see what is being studied (See Table 1).

With the results of completed clinical trials as a backdrop, the speakers at this meeting offered advice as to how to incorporate the findings into their practice patterns. In a plea to his fellow gynecologists, Melvin Gerbie, MD, Professor Emeritus, Department of Obstetrics and Gynecology, Northwestern University, (Chicago) asked that hysterectomy be performed only on those who truly need their uterus removed; and then by means other than what is currently being done: open abdominal surgery. In his presentation “Alternatives to Hysterectomy“ he pointed out “the vast majority of hysterectomies are being performed for benign conditions. Of the approximately 602,000 hysterectomies performed annually in the U.S., 539,000 were for benign conditions. In addition, it is the only surgical procedure where the majority of cases are still being performed as an open procedure rather than a minimally invasive one.“

Gerbie implied disappointment in these statistics because not only is there a less invasive laparoscopic choice for hysterectomy, there is also a completely scarless technique by going through the vagina (See Table 2).

Gerbie did note that there is a trend showing decreasing total abdominal and increasing laparoscopic hysterectomies, one that he hopes will continue. He cited the lack of enough vaginal hysterectomy training in residency, along with patients' misunderstanding of their post-operative sexual function, as key reasons contributing to the amount of abdominal hysterectomies. He said, “Currently the decision to have a hysterectomy is patient driven but in the near future it should be physician driven with patient education, which should lead to better choices being made.“ He reminded the audience that in the 1980's hysterectomy was the only available treatment for dysfunctional uterine bleeding and symptomatic fibroids, the two major benign conditions leading to a hysterectomy. In the 1990's both ablation of the uterus for dysfunctional bleeding and embolization of the uterine artery for fibroids were introduced as alternatives to hysterectomy for these conditions. In the 2000's there are a variety of non-surgical means to treat both of these disease states: from hormones, to uterine artery embolization, hormone-impregnated IUDs, focused ultrasound, hysteroscopic myomectomy, and others in development (See Table 3). He posed the question “Do we now have more methods than indications?“ but quickly added that having a multitude of choices allows each surgeon to select what is best for that specific patient. Dr. Gerbie concluded his lecture with a quote “Having a doctor say you need a hysterectomy is like a waiter saying you must have the steak. A good doctor should give you a menu of choices.“ It is all right for the doctor to say “But we do have a special that I think will be best for you.“

Dee Fenner, MD, Furlong Professor of Women's Health, University of Michigan, (Ann Arbor) presented “Robotic Applications in Gynecologic Surgery.“ Fenner is currently performing all sacrocolpopexies with the robot and cited a study done at the Mayo Clinic (Rochester, Minnesota) that compared open abdominal with robotically assisted sacrocolpopexy that found “the robot assisted laparoscopic sacrocolpopexy accomplishes the identical repairs as that of the open transabdominal technique but with reduced morbidity for the patient, low complications, and high patient satisfaction.“ Fenner finds it also helpful for node dissection in cancer cases, and all other cases that meet her criteria for use of the robot (Table 4). She offered examples of surgeries that meet her criteria in other specialties, such as cardiac valve replacement, pancreatic surgery, and gastric bypass–all complex procedures requiring a lot of suturing that would reap the benefits of the robot. She is opposed to using it for routine hysterectomies and said “We should not be performing open abdominal hysterectomies; but neither should we go to the other extreme and perform robotic hysterectomies either. It is best to stay with the least invasive method, vaginal hysterectomy, as long as there are no other complicating issues.“ She also feels that “it is important to do a steady number of robotic procedures for the surgeon, as well as the team, to develop and maintain their skill level. Most importantly, the success in complex abdominal surgery is dependent on the knowledge of three things: the history of the disease process, the details of the anatomy and the principles of surgery“ whether or not the robot is being used. Overall, she concluded, “the robot makes surgery easier to learn, to perform, and to teach.“

After a show of hands, she determined that “about 25% of the audience is using the robot, more than 50% present have one at their hospital but are not using it, and half of those are thinking about using it. While urologists have taken over the robot as their primary surgical mode, when and why should we (gynecologists) use the robot?“ Fenner, who said she has no connections to Intuitive Surgical (Sunnyvale, California), the makers of the Da Vinci robot, clearly identified why and when to use the robot for gynecologic procedures. She described the benefits (why) of using the robot for gynecologic surgery; then she suggested when to use the robot.

The evidence for using mesh kits (See Table 5) for POP procedures remains controversial and under investigation in clinical trials. Fenner, in a panel presentation, addressed this issue by asking the audience “What is the utility of the mesh, or, is it worth it? What is the risk vs. the benefit for the specific case and how big is the risk? Are we talking death or discomfort? Even meshes that worked well in other parts of the body do not necessarily perform well in the vagina—it is a different environment. Meshes used in the vagina must have a pore size not so small that it traps bacteria but large enough to attract tissue ingrowth. It can't be too stiff as it must accommodate sexual activity.“ The concern with finding the right mesh for use in vaginal surgeries is that of risk of erosion that causes discomfort and can eventually lead to necrotizing fasciitis; but at the least requires another trip to the OR to remove the offending mesh. “So far, there is little data that says POP outcomes using mesh are better compared to traditional repairs,“ Fenner claimed. “Although surgery for urinary incontinence has been significantly improved with polypropylene suburethral slings, polypropylene mesh in prolapse surgery is not the panacea it was for urinary incontinence. There may be a role for mesh in the anterior wall, but we still need data!“ Fenner warned that one must be careful in assessing the risk: is it better for the patient to have a reoccurrence (as with using native tissue) or complications (found with synthetic mesh)? Both require a trip back to the OR: one for treating the complication, the other for a re-do. Fenner, along with the rest of the panel of experts, feels that all information should be discussed with the patient pre-operatively and a fully informed joint decision be made between the surgeon and the patient.