Anthony G. Visco

Hysterectomy rates in the United States, 2003.

OBJECTIVE: To estimate hysterectomy rates by type of hysterectomy and to compare age, length of stay, and regional variation in type of hysterectomy performed for benign indications. METHODS: We conducted a cross-sectional analysis of national discharge data using the 2003 Nationwide Inpatient Sample. These data represent a 20% stratified sample of U.S. hospitals. Women aged 16 years or older who underwent a hysterectomy were identified by International Classification of Diseases, 9th Revision, Clinical Modification procedure codes. We extracted data regarding age, race, diagnoses codes, length of stay, and hospital characteristics. Using 2000 National Census data and weighted data analysis for cluster sampling, we calculated hysterectomy rates. RESULTS: In 2003, 602,457 hysterectomies were performed, for a rate of 5.38 per 1,000 women-years. Of the 538,722 hysterectomies for benign disease (rate 4.81 per 1,000 women-years), the abdominal route was the most common (66.1%), followed by vaginal (21.8%) and laparoscopic (11.8%) routes. Mean ages (±standard deviation) differed among hysterectomy types (abdominal 44.5±0.1 years, vaginal 48.2±0.2 years, and laparoscopic 43.6±0.3 years, P<.001). Mean lengths of stay (±standard deviation) were also different (3.0±0.03 days, 2.0±0.03 days, 1.7±0.03 days, respectively, P<.001). The hysterectomy rate was highest in the South (5.92 per 1,000 women-years) and lowest in the Northeast (3.33 per 1,000 women-years). CONCLUSION: Despite a shorter length of stay, vaginal and laparoscopic hysterectomies remain far less common than abdominal hysterectomy for benign disease. LEVEL OF EVIDENCE: III

Sexual function in women with urinary incontinence and pelvic organ prolapse

OBJECTIVE To compare sexual function in women with urinary incontinence and pelvic organ prolapse and to determine the effects of therapy on sexual function. METHODS 343 community‐dwelling women older than 45 years with urinary incontinence or advanced prolapse were recruited into a multi‐armed clinical trial. Women with incontinence were stratified to receive estrogen therapy, behavioral therapy, or surgical therapy. Women with prolapse were enrolled in a randomized surgical trial. All women completed a standardized urogynecologic evaluation and a sexual function questionnaire at baseline and after therapy. RESULTS Women with prolapse or detrusor instability were more likely to cite pelvic floor symptoms as a reason for sexual inactivity than were women with other conditions. One third of patients with prolapse reported that their pelvic floor condition affected their ability to have sexual relations “moderately” or “greatly” significantly more than did other groups. Patients with genuine stress incontinence who underwent surgical or behavioral therapy were less likely to report being worried about urine leakage during intercourse after therapy than at baseline. After surgery, women with prolapse were less likely to report that their symptoms affected their ability to have sexual relations compared with baseline. Overall sexual satisfaction was the same at baseline and remained unchanged in all therapeutic groups at 6 months. CONCLUSION Prolapse is more likely than urinary incontinence to result in sexual inactivity and to be perceived as affecting sexual relations. However, overall sexual satisfaction appears to be independent of diagnosis of or therapy for urinary incontinence or prolapse.

Refractory Idiopathic Urge Urinary Incontinence and Botulinum A Injection

PURPOSE We compared 200 U intradetrusor botulinum toxin A vs placebo in women with refractory idiopathic urge incontinence. MATERIALS AND METHODS This institutional review board approved, multicenter registered trial randomized women with refractory urge incontinence, detrusor overactivity incontinence and 6 or greater urge incontinence episodes in 3 days to botulinum toxin A or placebo at a 2:1 ratio. Refractory was defined as inadequate symptom control after 2 or more attempts at pharmacotherapy and 1 or more other first line therapies for detrusor overactivity incontinence. The primary outcome measure was time to failure, as evidenced by a Patient Global Impression of Improvement score of 4 or greater at least 2 months after injection, or changes in treatment (initiation or increase) at any time after injection. Safety data, including increased post-void residual volume, defined as more than 200 ml irrespective of symptoms, was obtained at specified time points. RESULTS Approximately 60% of the women who received botulinum toxin A had a clinical response based on the Patient Global Impression of Improvement. The median duration of their responses was 373 days, significantly longer than the 62 days or less for placebo (p <0.0001). In the botulinum toxin A group increased post-void residual urine (12 of 28 women or 43%) and urinary tract infection in those with increased post-void residual urine (9 of 12 or 75%) exceeded expected ranges. Further injections were stopped after 43 patients were randomized, including 28 to botulinum toxin A and 15 to placebo. CONCLUSIONS Local injection of 200 U botulinum toxin A was an effective and durable treatment for refractory overactive bladder. However, a transient post-void residual urine increase was experienced in 43% of patients. Botulinum toxin A for idiopathic overactive bladder is still under investigation.

Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse

IMPORTANCE More than 225 000 surgeries are performed annually in the United States for pelvic organ prolapse (POP). Abdominal sacrocolpopexy is considered the most durable POP surgery, but little is known about safety and long-term effectiveness. OBJECTIVES To describe anatomic and symptomatic outcomes up to 7 years after abdominal sacrocolpopexy, and to determine whether these are affected by concomitant anti-incontinence surgery (Burch urethropexy). DESIGN, SETTING, AND PARTICIPANTS Long-term follow-up of the randomized, masked 2-year Colpopexy and Urinary Reduction Efforts (CARE) trial of women with stress continence who underwent abdominal sacrocolpopexy between 2002 and 2005 for symptomatic POP and also received either concomitant Burch urethropexy or no urethropexy. Ninety-two percent (215/233) of eligible 2-year CARE trial completers were enrolled in the extended CARE study; and 181 (84%) and 126 (59%) completed 5 and 7 years of follow-up, respectively. The median follow-up was 7 years. MAIN OUTCOMES AND MEASURES Symptomatic POP failure requiring retreatment or self-reported bulge; or anatomic POP failure requiring retreatment or Pelvic Organ Prolapse Quantification evaluation demonstrating descent of the vaginal apex below the upper third of the vagina, or anterior or posterior vaginal wall prolapse beyond the hymen. Stress urinary incontinence (SUI) with more than 1 symptom or interval treatment; or overall UI score of 3 or greater on the Incontinence Severity Index. RESULTS By year 7, the estimated probabilities of treatment failure (POP, SUI, UI) from parametric survival modeling for the urethropexy group and the no urethropexy group, respectively, were 0.27 and 0.22 for anatomic POP (treatment difference of 0.050; 95% CI, -0.161 to 0.271), 0.29 and 0.24 for symptomatic POP (treatment difference of 0.049; 95% CI, -0.060 to 0.162), 0.48 and 0.34 for composite POP (treatment difference of 0.134; 95% CI, -0.096 to 0.322), 0.62 and 0.77 for SUI (treatment difference of -0.153; 95% CI, -0.268 to 0.030), and 0.75 and 0.81 for overall UI (treatment difference of -0.064; 95% CI, -0.161 to 0.032). Mesh erosion probability at 7 years (estimated by the Kaplan-Meier method) was 10.5% (95% CI, 6.8% to 16.1%). CONCLUSIONS AND RELEVANCE During 7 years of follow-up, abdominal sacrocolpopexy failure rates increased in both groups. Urethropexy prevented SUI longer than no urethropexy. Abdominal sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00099372.

Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy.

OBJECTIVE: To compare short-term outcomes of robotic sacrocolpopexy with abdominal sacrocolpopexy for vaginal vault prolapse. METHODS: We conducted a retrospective cohort study comparing robotic to abdominal sacrocolpopexy with placement of permanent mesh. The primary outcome was vaginal vault support on 6-week postoperative pelvic organ prolapse quantification (POP-Q) system examination. Secondary outcomes included blood loss, operative time, length of stay, blood transfusion, pulmonary embolus, gastrointestinal or genitourinary tract injury, ileus, bowel obstruction, postoperative fever, pneumonia, wound infection, and urinary retention. RESULTS: The analysis included 178 patients (73 robotic and 105 abdominal sacrocolpopexy). There were no differences in age, race, or body mass index. Robotic sacrocolpopexy showed slight improvement on POP-Q “C” point (–9 compared with –8, P=.008) when compared with abdominal sacrocolpopexy and was associated with less blood loss (103±96 mL compared with 255±155 mL, P<.001), longer total operative time (328±55 minutes compared with 225±61 minutes, P<.001), shorter length of stay (1.3±0.8 days compared with 2.7±1.4 days, P<.001), and a higher incidence of postoperative fever (4.1% compared with 0.0%, P=.04). There were no differences in other secondary outcomes. Operative time remained significantly greater in the robotic group (P<.001), and estimated blood loss remained lower (P<.001) when controlling for possible confounders. CONCLUSION: Robotic sacrocolpopexy demonstrated similar short-term vaginal vault support compared with abdominal sacrocolpopexy, with longer operative time, less blood loss, and shorter length of stay. Long-term data are needed to assess the durability of this new minimally invasive procedure. LEVEL OF EVIDENCE: II

Fecal and urinary incontinence in primiparous women

OBJECTIVE: To prospectively investigate the relationship between anal sphincter tears and postpartum fecal and urinary incontinence. METHODS: The Childbirth and Pelvic Symptoms study was a prospective cohort study performed by the Pelvic Floor Disorders Network to estimate the prevalence of postpartum fecal and urinary incontinence in primiparous women: 407 with clinically recognized anal sphincter tears during vaginal delivery, 390 without recognized sphincter tears (vaginal controls), and 124 delivered by cesarean before labor. Women were recruited postpartum while hospitalized and interviewed by telephone 6 weeks and 6 months postpartum. We assessed fecal and urinary incontinence symptoms using the Fecal Incontinence Severity Index and the Medical, Epidemiological, and Social Aspects of Aging Questionnaire, respectively. Odds ratios were adjusted for age, race, and clinical site. RESULTS: Compared with the vaginal control group, women in the sphincter tear cohort reported more fecal incontinence (6 weeks, 26.6% versus 11.2%; adjusted odds ratio [AOR] 2.8, 95% confidence interval [CI] 1.8–4.3; 6 months, 17.0% versus 8.2%; AOR 1.9, 95% CI 1.2–3.2), more fecal urgency and flatal incontinence, and greater fecal incontinence severity at both times. Urinary incontinence prevalence did not differ between the sphincter tear and vaginal control groups. Six months postpartum, 22.9% of women delivered by cesarean reported urinary incontinence, whereas 7.6% reported fecal incontinence. CONCLUSION: Women with clinically recognized anal sphincter tears are more than twice as likely to report postpartum fecal incontinence than women without sphincter tears. Cesarean delivery before labor is not entirely protective against pelvic floor disorders. LEVEL OF EVIDENCE: II-3

Two-Year Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence

OBJECTIVES: To report anatomic and functional outcomes 2 years after sacrocolpopexy in stress-continent women with or without prophylactic Burch colposuspension. METHODS: In the Colpopexy and Urinary Reduction Efforts (CARE) trial, stress-continent women undergoing sacrocolpopexy were randomized to receive or not receive a Burch colposuspension. Outcomes included urinary symptoms, other pelvic symptoms, and pelvic support. Standardized pelvic organ prolapse quantification examinations and validated outcome measures including the Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire were completed before surgery and at several postoperative intervals, including at 2 years. RESULTS: This analysis is based on 302 of 322 randomized participants. Most were Caucasian (94%), with a mean age of 62±10 years (mean±standard deviation). Two years after surgery, 32.0% and 45.2% of women in the Burch and control groups, respectively, met the stress incontinence endpoint (presence of symptoms or positive cough stress test or interval treatment for stress incontinence, P=.026). The apex was well supported (point C within 2 cm of total vaginal length) in 95% of women, and this was not affected by concomitant Burch (P=.18). There was a trend toward fewer urgency symptoms in the Burch group (32.0% versus 44.5% no Burch, P=.085). Twenty participants experienced mesh or suture erosions. CONCLUSION: The early advantage of prophylactic Burch colposuspension for stress incontinence that was seen at 3 months remains at 2 years. Apical anatomic success rates are high and not affected by concomitant Burch. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, ClinicalTrials.gov, NCT00065845 LEVEL OF EVIDENCE: I

A Survey of Pessary Use by Members of the American Urogynecologic Society

Objective To describe trends in pessary use for pelvic organ prolapse. Methods An anonymous survey administered to the membership of the American Urogynecologic Society covered indications, management, and choice of pessary for specific support defects. Results The response rate was 48% (359 of 748). Two hundred fifty surveys were received at the scientific meeting and 109 were returned by mail. Seventy-seven percent used pessaries as first-line therapy for prolapse, while 12% reserved pessaries for women who were not surgical candidates. With respect to specific support defects, 89% used a pessary for anterior defects, 60% for posterior defects, 74% for apical defects, and 76% for complete procidentia. Twenty-two percent used the same pessary, usually a ring pessary, for all support defects. In the 78% who tailored the pessary to the defect, support pessaries were more common for anterior (ring) and apical defects (ring), while space-filling pessaries were more common for posterior defects (donut) and complete procidentia (Gellhorn). Less than half considered a prior hysterectomy or sexual activity contraindications for a pessary, while 64% considered hypoestrogenism a contraindication. Forty-four percent used a different pessary for women with a prior hysterectomy and 59% for women with a weak pelvic diaphragm. Ninety-two percent of physicians believed that pessaries relieve symptoms associated with pelvic organ prolapse, while 48% felt that pessaries also had therapeutic benefit in addition to relieving symptoms. Conclusion While there are identifiable trends in pessary use, there is no clear consensus regarding the indications for support pessaries compared with space-filling pessaries, or the use of a single pessary for all support defects compared with tailoring the pessary to the specific defect. Randomized clinical trials are needed to define optimal pessary use.

The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Reduction Efforts (CARE) randomized surgical trial

The aim of this study is to describe results of reduction testing in stress-continent women undergoing sacrocolpopexy and to estimate whether stress leakage during urodynamic testing with prolapse reduction predicts postoperative stress incontinence. Three hundred twenty-two stress-continent women with stages II–IV prolapse underwent standardized urodynamics. Five prolapse reduction methods were tested: two at each site and both performed for each subject. Clinicians were masked to urodynamic results. At sacrocolpopexy, participants were randomized to Burch colposuspension or no Burch (control). P-values were computed by two-tailed Fisher’s exact test or t-test. Preoperatively, only 12 of 313 (3.7%) subjects demonstrated urodynamic stress incontinence (USI) without prolapse reduction. More women leaked after the second method than after the first (22% vs. 16%; p = 0.012). Preoperative detection of USI with prolapse reduction at 300ml was pessary, 6% (5 of 88); manual, 16% (19 of 122); forceps, 21% (21 of 98); swab, 20% (32 of 158); and speculum, 30% (35 of 118). Women who demonstrated preoperative USI during prolapse reduction were more likely to report postoperative stress incontinence, regardless of concomitant colposuspension (controls 58% vs. 38% (p = 0.04) and Burch 32% vs. 21% (p = 0.19)). In stress-continent women undergoing sacrocolpopexy, few women demonstrated USI without prolapse reduction. Detection rates of USI with prolapse reduction varied significantly by reduction method. Preoperative USI leakage during reduction testing is associated with a higher risk for postoperative stress incontinence at 3 months. Future research is warranted in this patient population to evaluate other treatment options to refine predictions and further reduce the risk of postoperative stress incontinence.

Risk factors for mesh/suture erosion following sacral colpopexy

OBJECTIVE The purpose of this study was to identify risks for mesh/suture erosions following abdominal sacral colpopexy (ASC). STUDY DESIGN We analyzed demographic, perioperative variables, and erosion status in 322 participants in the Colpopexy and Urinary Reduction Efforts study 2 years after sacral colpopexy. RESULTS The predominant graft used was synthetic mesh: woven polyester (Mersilene; Ethicon, Inc, Somerville, NJ) (42%) or polypropylene (48%). Twenty subjects (6%) experienced mesh/suture erosion. Unadjusted risk factors for mesh/suture erosion were expanded polytrafluroethylene (ePTFE) mesh (ePTFE 4/21 [19%] vs non-ePTFE 16/301 [5%]; odds ratio [OR], 4.2), concurrent hysterectomy (OR, 4.9), and current smoking (OR, 5.2). Of those with mesh erosion, most affected women (13/17) underwent at least 1 surgery for partial or total mesh removal. Two were completely resolved, 6 had persistent problems, and 5 were lost to follow-up. No resolution was documented in the 4 women who elected observation. CONCLUSION Expanded PTFE mesh should not be used for sacral colpopexy. Concurrent hysterectomy and smoking are modifiable risks for mesh/suture erosion.