Report From the 24th Annual Scientific Meeting of the
American Urogynecology Society
September 11-13, 2003; Hollywood, Florida
Medscape Ob/Gyn & Women's Health 8(2), 2003. © 2003 Medscape
The Annual Scientific Meeting of the American Urogynecologic Society (AUGS) was held in Hollywood, Florida, September 11-13, 2003. This annual meeting provides a forum for the discussion of important new advances in research related to the pathophysiology, evaluation, and management of pelvic floor disorders.
This year the program included 39 scientific papers, 39 oral poster presentations, and 42 traditional poster presentations. In addition, there were several invited lectures and panel discussions.
Some highlights of the scientific sessions are summarized in this report. The topics included in this review are:
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Epidemiologic studies have suggested an association between hysterectomy and urinary incontinence. This observation has led to concerns that hysterectomy might cause urinary symptoms, possibly as a result of the neurologic and mechanical changes associated with removal of the uterine cervix. Thus, a logical question is whether supracervical hysterectomy (SCH) might reduce post-hysterectomy urinary incontinence.
Dr. Holly Richter of the University of Alabama, Birmingham, presented the results of an important multicenter randomized trial, the Total Or Supracervical Hysterectomy (TOSH) study. At 4 clinical sites, 135 women with uterine leiomyomata or abnormal bleeding (refractory to medical management) were randomized to either SCH or total hysterectomy (TAH). The average age of participants was 42 years, and 78% were African American. The investigators compared preoperative data with 2-year post-hysterectomy data. Gynecologists will be pleased to know that both groups demonstrated significant improvements in a number of urinary symptoms, including urinary urgency, pelvic pressure, vaginal bulging, urinary urgency, incomplete voiding, frequency, and nocturia. More importantly, the women did not worsen with respect to any of the urinary symptoms investigated. The TAH group demonstrated significant improvement in symptoms of stress and urge incontinence. (The TOSH trial also examined changes in sexual function, which will be the subject of an upcoming publication.)
The most important finding of this study was that there were no differences between the SCH and TAH groups with respect to the postoperative improvements in urinary symptoms. Women planning hysterectomy for uterine fibroids or abnormal bleeding should find the results of this study reassuring. These results are similar to a recent British study[1] of SCH and TAH. That study also demonstrated improved urinary symptom after both surgeries, with no significant differences between groups.
Dr. Maria Paraiso and colleagues from Cleveland Clinic (Cleveland, Ohio) presented data from a randomized trial of laparoscopic Burch vs TVT for treatment of stress incontinence with hypermobility. A rationale for this study is provided by a recent multicenter study[2] demonstrating similar cure rates at 6 months for these procedures.
Investigators randomized 61 women to laparoscopic Burch or TVT and followed them for 6-43 months. Women were excluded from this trial if they had undergone prior surgery for incontinence, had a well-supported urethra, or had prolapse of the anterior vaginal wall past the hymen. All participants underwent preoperative urodynamic studies to confirm urodynamic stress incontinence, and the authors eliminated women with leak point pressures less than 60 cm water or detrusor overactivity. Operative times were shorter for TVT. Three of 33 laparoscopic Burch procedures were converted to laparotomy. One TVT patient developed a mesh erosion. At the time of follow up, the groups were similar in terms of most bladder symptoms and measures of bladder function. However, there was a higher objective (urodynamic) cure rate in the TVT group (96.8% vs 81.2%). Also, women in the TVT group were less likely to have detrusor overactivity and less likely to require anticholinergic medications for symptoms of overactive bladder. Overall, the authors concluded that the TVT offers a greater objective cure for stress incontinence. Unfortunately, this study was stopped early because of slow recruitment and, therefore, the power of this study to detect other differences was limited.
An important area of research for reconstructive surgeons is the impact of such surgery on sexual function. Dr. Rebecca Rogers presented research from the University of New Mexico in Albuquerque and several other centers regarding the sexual function of women undergoing surgery for incontinence. The participants in this research were undergoing a variety of surgeries for prolapse (77%) and incontinence (82%). Their mean age was 47 years, 47% were Caucasian, and two thirds were premenopausal. Surgery included hysterectomy in 55% and bilateral salpingo-oophorectomy in 28%. A disturbing finding was that at 3 and 6 months after surgery, sexual function was worse than before surgery. Specifically, there was an increase in problems with sexual desire, arousal, and orgasm. The percentage of women reporting overall dissatisfaction with sexual function increased from 3% before surgery to 38% after surgery. These results are of great concern to pelvic surgeons and our patients. Further research is needed to determine whether certain surgical approaches are more likely to preserve or restore sexual function.
There were several presentations regarding pessary use. The overall theme was that only two thirds of women who agree to a pessary trial become long-term pessary users. Also, only 40% to 60% of women presenting with pelvic organ prolapse are willing to try pessary use in the first place.
In a study from Albert Einstein College of Medicine (Bronx, New York), Dr. Ken Powers reported that 20 of 32 (63%) women with stage 3-4 prolapse were successful with pessary use (mean follow-up, 11 months). Younger women were less likely to report success. At that center, only 42% of women with severe prolapse were willing to consider pessary use, so the successful users represent only 26% of all women evaluated for severe prolapse. Another important finding was that 15% to 17% of women using pessaries had erosions or problems with vaginal discharge.
Dr. Jeff Clemons reported on a prospective study of pessary use at Brown University (Providence, Rhode Island). Among 67 women who were successful pessary users 2 months after pessary fitting, only 43 (64%) continued use 1 year later, 6 (9%) were lost to follow-up, and the remaining 18 discontinued pessary use. Dr. Clemons compared those who continued pessary use with those who elected surgery. Factors associated with ongoing pessary use were age over 65, stage 3-4 prolapse of the posterior vaginal wall, women classified as "poor surgical risk," those who had initially desired surgery, and those who were sexually active.
Several researchers presented important new information about the relationship between childbirth and pelvic floor disorders. In a presentation that won the Prize Paper Award, Kuo-Cheng Lien of the University of Michigan in Ann Arbor presented a computer model of pelvic floor stretch during parturition. In this simulated computer model, a sphere (fetal vertex) descended through a model of the levator ani muscles, with fibers oriented to conform to known muscle origin and insertion. This computer simulation suggested that the greatest stretch occurs in the medial pubococcygeus muscle. This region of the levator ani was stretched to more than 3 times its resting length by the descending sphere. Future research will determine whether that region of the levator ani is most likely to be injured during vaginal delivery.
Several researchers independently presented new information about pelvic floor symptoms after childbirth. Dr. Kathryn Burgio from the University of Alabama at Birmingham reported on 523 women who were followed for 1 year after delivery. Eleven percent had urinary incontinence at 1 year. Factors associated with incontinence included cigarette smoking, increased duration of breastfeeding, vaginal delivery, forceps delivery, and body mass index. Women who reported incontinence during pregnancy were more likely to report incontinence 1 year after delivery. There was no association between incontinence and age, race, episiotomy, parity, or pelvic muscle exercises. This raises important questions about the obstetric management. For example, what should physicians advise women who report incontinence during pregnancy? Is there an intervention that would reduce the likelihood of persistent postpartum incontinence? Should we advise incontinent women to stop breastfeeding? More research is needed in this important area.
Dr. Rebecca Rogers reported on the results of the Function After Childbirth Trial (FACT). In this study, women were followed for 3 months after delivery. Participants were assessed for urinary tract symptoms, fecal incontinence, and sexual function. Urinary incontinence was reported by 39% at 3 months. Fecal incontinence was reported by 27%. (These relatively high prevalence rates may be related to a relatively broad definition of these symptoms.) By 3 months, 83% of women had resumed intercourse. Participants reported a deterioration in sexual function after delivery. At three months postpartum, 15% found intercourse less satisfying, 17% had increased discomfort with intercourse, and 27% reported difficulty in achieving orgasm. Because follow-up did not extend beyond 3 months, we don't know whether those complaints were sustained in the long term. Prior studies have suggested that postpartum sexual complaints decrease substantially over time.[3]
Finally, Dr. Patrick Culligan of the University of Louisville (Louisville, Kentucky) presented a decision-analysis model to examine the question of whether a woman who has experienced an obstetric anal sphincter laceration should undergo cesarean delivery for a subsequent pregnancy. Although the assumptions of the model were challenged by some attendees, Dr. Culligan's results suggest that elective cesarean is appropriate. He estimates that this strategy would cost $15,400 per case of anal incontinence averted. The findings from this analysis provide a strong argument for research on this topic, such as a randomized trial of cesarean delivery vs vaginal delivery for women with a history of sphincter laceration.
Dr. Marie-Andree Harvey from the University of Ottawa (Ottawa, Ontario, Canada) reported some early results from a trial of 380 primiparas (mean age 28.7 years) examined 6 months postpartum. This research provides an estimate of the prevalence of prolapse among young women. Prolapse was described using the pelvic organ prolapse quantification (POP-Q) system. In this cohort, she found that 4% had stage 0 prolapse, 87% had stage 1 prolapse, and 8% had stage 2 prolapse. All stage 2 prolapse was localized to the anterior vaginal wall.
Dr. Steven Swift of the Medical University of South Carolina in Charleston reported on a study of over 1000 women seen for annual gynecologic care at several centers. This study also employed the POP-Q system. The goal was to estimate the prevalence of prolapse in a cross-section of adult women. The cohort was 43% Caucasian, 29% Hispanic, and 24% African American. They found stage 0 prolapse in 24%, stage 1 prolapse in 38%, stage 2 prolapse in 36%, and stage 3 prolapse in 2%. Older women were more likely to have stage 2 prolapse. Ninety-five percent of women had prolapse at or above the hymen. Dr. Swift suggested this finding supports the need to re-examine our staging and nomenclature for pelvic organ prolapse. His data suggest that only 5% of "normal" women have prolapse beyond the hymen. Therefore, "prolapse" within the vagina may be a normal finding in many cases. Further research is needed to clarify the relationship between prolapse stage, symptoms, and prognosis.
Dr. Victoria Handa from Johns Hopkins (Baltimore, Maryland) presented research on the incidence rate of prolapse after menopause and the risk of progression of mild prolapse. This research was based on data from 1 site of the Women's Health Initiative (WHI). Women enrolled in the estrogen/progestin vs placebo trial of the WHI underwent annual gynecologic examinations. More than 400 women were examined for 2-8 years. Among women who did not have prolapse at the time of enrollment, the incidence of cystocele, rectocele, and uterine prolapse were 9.3, 5.7, and 1.5 women per 100 women per year. Incident prolapse was strongly associated with parity and waist circumference. Another interesting finding was the apparent spontaneous resolution of prolapse. For example, among women with grade 1 cystocele examined 1 year later, 23% had resolved, 10% had progressed (to grade 2-3), and the remainder demonstrated no change. Spontaneous resolution of higher-grade prolapse was less common. Nevertheless, prolapse to or beyond the introitus resolved completely over 1 year of observation in 9.3% of women with cystocele and 3.3% of women with rectocele. Further studies are needed to clarify the prognosis for mild prolapse and to explain the risk factors and biologic mechanism for progression and regression.
Finally, Dr. Matt Barber from the Cleveland Clinic reported on a related question. He investigated the relationship between prolapse stage and symptoms among 162 women presenting with various pelvic floor complaints. In this cohort, 20% had stage 2 prolapse, 25% had stage 1 prolapse, 23% had stage 2 prolapse, 26% had stage 3 prolapse, and 6% had stage 4 prolapse. He compared the stage of prolapse to women's answers to items on the pelvic floor distress inventory. There was a relatively weak correlation between symptoms of pelvic pain and pressure with severity of prolapse. Symptoms of bulging and heaviness were more strongly correlated with stage. For example, among women with prolapse to the hymen, more than 50% reported a sensation of bulging. When the prolapse reached 1 cm beyond the hymen, more than 50% reported they could see or feel a bulge. The only other symptom that correlated with prolapse stage was the need to splint for voiding or defecation, but the correlation was weak.
Dr. G. Buchsbaum of the University of Rochester (Rochester, New York) presented data to suggest that the development of prolapse may be in part genetic and in part acquired. She studied 27 nulliparous postmenopausal women and their parous sisters. The mean ages of these 2 groups were similar, as were other demographic characteristics. The parous sisters had mean parity of 3.7. All of the women underwent pelvic examinations, with prolapse described according to the POP-Q system. Comparing pairs of sisters, the majority had identical staging of prolapse. In 26% there was a discordance of at least 2 stages. In 85% of cases of these discordant pairs, the more advanced prolapse was found in the parous sister. This suggests 2 important findings. First, the strong concordance within sister pairs suggests that prolapse severity may be familial or genetic. Second, the increased prolapse among the parous sisters in discordant pairs suggests an impact of childbirth in the genesis of prolapse. Dr. Buchsbaum's research is in progress, and we look forward to further important information from this study.
There were numerous presentations about new and future medications for urinary incontinence. Dr. Linda Cardozo of Kings College Hospital in London, who receives research support from Eli Lilly, reported on duloxetine treatment for urodynamic stress incontinence. While awaiting surgery for stress incontinence, women were treated with duloxetine (40-60 mg twice daily) or placebo. More women in the placebo group completed the study; women in the duloxetine group were more likely to report nausea (45% vs 13%) and headache (27% vs 6%). Compared with women in the placebo group, women in the duloxetine group who completed the study were more likely to report improvement in incontinence (60% vs 27%) and reduction in pad use. The investigators did not report whether any women became "dry" with duloxetine.
Dr. C.R. Chappele, who receives support from the European YM905 Study Group, reported on a trial of solifenacin (Vesicare), tolterodine (Detrol), or placebo for treatment of overactive bladder. Both solifenacin and tolterodine improved urinary frequency and functional bladder capacity when compared with placebo. Solifenacin (but not tolterodine) was associated with a greater improvement in urinary urgency and incontinence. Of the patients incontinent at baseline, continence was achieved by 51% with solifenacin, 48% with tolterodine, and 37% with placebo. Dry mouth was reported by 14% to 21% with various solifenacin doses, 19% with tolterodine 2 mg twice daily, and 5% with placebo.
Dr. N. Zinner, of Western Clinical Research, Inc. (Torrance, California), reported on a trial of tropium chloride vs placebo for the treatment of overactive bladder. This trial involved 523 subjects enrolled at 51 centers. Compared with the placebo group, the treatment group demonstrated a significant improvement in frequency after only 3 days of therapy. The treatment group also experienced a more significant reduction in urge incontinence and in severity of urgency. The percentage of subjects who became continent was not reported. The most common side effects were reported more often by subjects in the treatment group, including dry mouth (22% vs 7%) and constipation (10% vs 4%).
These studies suggest 3 overall themes. First, the pharmaceutical industry has identified incontinence as a potentially lucrative market, and promising new products are being aggressively pursued. Clinicians and patients will ultimately benefit from a greater number of effective treatment options. Second, compared with placebo, most of the available medications and the drugs in development are more effective but associated with higher rates of side effects. For example, according to the Cochrane database,[4] anticholinergic agents are associated with cure of or improvement in overactive bladder symptoms, decrease in leakage episodes, and decrease in voiding frequency. However, anticholinergic drugs are also associated with higher residual volumes and 2-3 times the rate of dry mouth. Finally, it is not always apparent that the newer products are dramatic improvements over existing surgeries (for stress incontinence) or medications (for overactive bladder). As more data emerge regarding new products, clinicians will have to determine the role for each in the management of incontinence.
Dr. Alf Bent of the Greater Baltimore Medical Center (Baltimore, Maryland) discussed the findings of a large collaborative group investigating Uryx. This product is an injectable liquid solution of ethylene vinyl alcohol in DMSO that solidifies after injection. This material can be delivered via trans- or peri-urethral injection as a bulking agent for stress incontinence. The investigators treated 253 women with either Uryx or Contagen. Participants had urodynamic stress incontinence with leak point pressure less than 100 cm water. Although data collection continues in this trial, results of the participants who are at least 12 months from treatment suggest that 47% of women treated with Uryx and 20% of women treated with Contagen are "dry or improved" at 1 year.
The authors concluded that women treated with Uryx are more likely to remain "dry" at 1 year. However, the interpretation of these results is complicated by a relatively high drop-out rate, particularly in the Uryx group. Also of note is a post-treatment complication unique to Uryx: "material exposure" in the urethra. In some cases, the exposed Uryx material required transurethral excision (although the material re-epithelialized in other cases). The incidence of this complication was reduced from 15% to 6% by limiting injection volumes. Further useful information will be obtained as more subjects in this trial reach the 12-month follow-up point and more outcomes become available for analysis.
Dr. Andrew Sokol of the Cleveland Clinic presented animal research regarding the prevention of vesicovaginal fistulae. Cautery injuries to the bladder were created at the time of laparoscopic hysterectomy in dogs. Various techniques of 2-layer closure were compared. There were no cases of fistulae observed with any of the 2-layer closure techniques. (By contrast, their prior research had demonstrated 2 fistulae among 8 dogs whose cystotomies were closed with only a single layer.) These researchers observed 1 bladder rupture after a simple double-layer closure but no ruptures after the other 2 techniques (closure with resection of tissue around the thermal injury and closure that involved the interposition of an omental flap) were performed. However, the power of this study was limited, and the authors were unable to conclude that any of the double-layer closure techniques were superior. Nevertheless, surgeons could consider this research an argument for a double-layer closure rather than a single-layer closure of cautery injuries of the bladder during hysterectomy.
Dr. Robert Harris, Chair of the AUGS Committee on Coding and Nomenclature, made some important announcements regarding new CPT codes for reconstructive surgery. This information is of great interest to practicing gynecologists and other reconstructive pelvic surgeons. The AUGS Coding and Nomenclature Committee has been advocating on behalf of improved coding for pelvic surgery. As a result, Dr. Harris anticipates several new codes in the CPT 2005. First, the code for sacrospinous suspension (57282) will be redefined as "colpopexy, vaginal, extraperitoneal approach." Thus, this code will include iliococcygeus suspension and other related procedures. A new code (5728x) will be introduced for the "intraperitoneal approach," such as a uterosacral suspension. Also, the Committee anticipates a decision in favor of unbundling abdominal sacropexy and total abdominal hysterectomy. Surgeons who perform hysterectomy with sacropexy have long argued that these procedures should be unbundled. The Committee is also addressing a code for insertion of graft in colporrhaphy, although some attendees (including outgoing AUGS President Linda Brubaker) questioned the wisdom of developing a code for procedures that are currently of unproven benefit to our patients.
