Reliability and Validity of Pain and Urinary Symptom Severity Assessment in Urological Chronic Pelvic Pain: A MAPP Network Analysis.

PURPOSE: We assessed the reliability and validity of an efficient severity assessment for pelvic pain and urinary symptoms in urological chronic pelvic pain syndrome, which consists of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome. MATERIALS AND METHODS: A total of 578 patients were assessed using brief, empirically derived self-report scales for pelvic pain severity (PPS) and urinary symptom severity (USS) 4 times during a 1-month period and baseline clinic visit that included urological, pain and illness-impact measures. Mild, moderate and severe categories on each dimension were examined for measurement stability and construct validity. RESULTS: PPS and USS severity categories had adequate reliability and both discriminant validity (differential relationships with specific clinical and self-report measures) and convergent validity (common association with nonurological somatic symptoms). For example, increasing PPS was associated with pelvic tenderness and widespread pelvic pain, whereas USS was associated with urgency during a bladder filling test and increased sensory sensitivity. PPS and USS categories were independently associated with nonurological pain and emotional distress. A descriptive analysis identified higher likelihood characteristics associated with having moderate to severe PPS or USS or both. Lack of sex interactions indicated that the measures are comparable in interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome. CONCLUSIONS: Women and men with urological chronic pelvic pain syndrome can be reliably subgrouped using brief self-report measures of mild, moderate or severe pelvic pain and urinary symptoms. Comparisons with a broad range of clinical variables demonstrate the validity and potential clinical utility of these classifications, including use in clinical trials, health services and biological research.

Patient Reported Shared Decision Making in Urology from the Surgical Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey.

INTRODUCTION: Shared decision making balances the best available evidence with patients' preferences and values in order to make a medical decision. The use of shared decision making and its link to clinically meaningful outcomes are not well described in urology. We report the rates of shared decision making among patients undergoing urological surgery, and explore the relationship between shared decision making and patient reported surgeon ranking. METHODS: This study uses Consumer Assessment of Healthcare Provider and Systems Surgical Care Survey data from patients undergoing urological surgery between 2011 and 2013. A shared decision making composite score was created from the sum of 3 survey items. We fit an ordinal logistic regression model to evaluate factors that influence patients' overall shared decision making score. In a separate model, we evaluated how shared decision making and use of decision aid impact patients' ranking of surgeons. RESULTS: In this sample, 430 (33.8%) surveys were returned. Of respondents, 71% scored maximum points on the shared decision making composite score and 59% reported that their surgeon used a decision aid. Discussing alternative treatment options was the most often omitted step in shared decision making. Patients who report use of a decision aid had nearly double the odds of self-reported shared decision making (OR 1.84, 95% CI 1.10-3.06, p=0.02). Shared decision making or decision aid use was not associated with patient reported surgeon ranking. CONCLUSIONS: The majority of patients reported shared decision making and decision aid use during preoperative counseling. Patients reporting decision aid use had nearly double the odds of reporting shared decision making. There was no correlation between either shared decision making or decision aid use and patients' ranking of their surgeon.

Real World Performance of Sacral Neuromodulation and OnabotulinumtoxinA for Overactive Bladder: Focus on Safety and Cost.

PURPOSE: We aimed to determine the real world safety and cost of third line overactive bladder therapies, including onabotulinumtoxinA and sacral neuromodulation. MATERIALS AND METHODS: We performed an all-inclusive, population based cohort study of third line therapies of overactive bladder (sacral neuromodulation or onabotulinumtoxinA) using the statewide surgical data captured in the New York Statewide Planning and Research Cooperative System. The main outcome measures were 30-day safety events, and 1 and 3-year health care utilization costs. Propensity score matching was done to control for confounding factors and comparative analyses of safety events were also performed. RESULTS: Our cohort included 2,680 patients, of whom 1,328 underwent sacral neuromodulation and 1,352 received onabotulinumtoxinA from January 1, 2013 through December 31, 2016. Average ± SD age was 61.7 ± 16.3 years and 82.7% of the patients were female. Sacral neuromodulation implantation led to re-intervention in 15.8% of cases within 1 year and in 26.1% at 3 years. In this comparative analysis patients who received onabotulinumtoxinA therapy were at higher risk for urinary tract infection, hematuria, urinary retention and an emergency room visit compared to those treated with sacral neuromodulation. The overall cost of onabotulinumtoxinA was lower than the cost of the sacral neuromodulation device (cost at 1 year $2,896 vs $15,343 and at 3 years $3,454 vs $16,189, each p <0.01). CONCLUSIONS: Sacral neuromodulation implantation was more expensive than onabotulinumtoxinA injection. However, patients who underwent sacral neuromodulation had a lower complication rate than patients treated with onabotulinumtoxinA. A quality improvement collective database must be created to track information on onabotulinumtoxinA and sacral neuromodulation treatment. This would help generate better performance and comparative data for patient and physician decision making.

Urological Surveillance and Medical Complications in the United States Adult Spina Bifida Population.

OBJECTIVE: To evaluate urologic follow-up and prevalence of medical complications among adult patients in the United States with myelomeningocele (MMC) who are Medicare beneficiaries. METHODS: We performed a retrospective study using a 5% Medicare sample from 2007 to 2010. We defined acceptable minimum follow-up criteria as patients receiving all of the following: serum creatinine, upper urinary tract imaging, and a urologist evaluation within a 2-year period. We queried associated diagnoses and relevant complications using International Classification of Diseases, Ninth Revision codes, graded based on clinical impact. A regression model identified factors associated with evaluation completeness as well as with increased prevalence of medical complications. RESULTS: We identified 825 patients with MMC, predominantly Caucasian (85.1%) and female (61.3%), with a mean age of 51.2 ± 17.2 years. Only 33.5% of the patients met the minimum acceptable follow-up criteria. Forty-four percent saw a urologist within the 2-year period. Most complications observed were mild, observed in 27.6% of patients. Moderate and severe complications were observed in 17.0% and 6.6% of patients, respectively. The most common complications were cystitis (16.4%), pressure ulcers (7.1%), chronic kidney disease (4.4%), and pyelonephritis (3.7%). Logistic regression indicated that younger age, male gender, and adequate follow-up were associated with increased prevalence of complications. CONCLUSION: Despite high prevalence of complications in patients with MMC, most are not receiving the minimum recommended follow-up. The 33.5% of patients who received adequate surveillance were diagnosed with more complications, likely secondary to improved disease ascertainment. Prospective studies are needed to look at follow-up strategies and how these can improve outcomes for patients with MMC.

Patterns of medical management of overactive bladder (OAB) and benign prostatic hyperplasia (BPH) in the United States.

AIMS: Overactive bladder (OAB) and benign prostatic hyperplasia (BPH) are highly prevalent conditions that place a large burden on the United States (US) health care system. We sought to analyze patterns of prescription medication usage for incident OAB in men and women, and for incident BPH in men using US health insurance claims data. MATERIALS AND METHODS: This study used Truven Health MarketScan® Commercial and Medicare Supplemental Research databases. The data were pooled from diverse points of care. BPH subjects included men age 18+ with the first and last two diagnoses of BPH ≥30 days apart and no BPH diagnosis for 1 year prior. OAB subjects included men and women age 18+, who were diagnosed similarly with incident OAB. The type of medication, medication continuation (persistence), and switching to a different medication were analyzed through September 30, 2013. RESULTS: Medication persistence was much higher overall for BPH than OAB (56% vs 34%, respectively, P < 0.0001), and was highest among men with BPH age 65+ (62%). Patients age 18-64 were less likely to continue medication than older adults (age 65+) for both BPH and OAB. A 9.4% of patients in the OAB cohort and 6.9% of men with BPH switched from one medication to another. CONCLUSIONS: Persistence was higher with BPH than OAB medications overall, whereas switching rates were higher in the OAB group. The lower persistence of OAB medication may be due to less efficacy or tolerability. The possibility of under treatment of OAB also warrants future investigations.

The Role of the Surgeon on Outcomes of Vaginal Prolapse Surgery With Mesh.

INTRODUCTION: Adverse outcomes after surgery for pelvic organ prolapse (POP) with mesh are often attributed to the mesh material with little attention paid to the influence of surgeon factors. We used a national data set to determine whether surgeon case volume and specialty influenced vaginal prolapse surgery outcomes with mesh. MATERIALS AND METHODS: Public Use File data on a 5% random national sample of female Medicare beneficiaries were obtained from the Centers for Medicare and Medicaid Services. Women with a diagnosis of POP who underwent surgery with mesh between 2007 and 2008 were identified by relevant International Classification of Diseases, 9th Revision, Clinical Modification and Current Procedural Terminology, 4th Edition procedure codes. Outcomes were compared by surgeon case volume and specialty. RESULTS: From 2007 to 2008, 1657 surgeries for POP were performed with mesh. Low-, intermediate-, and high-volume surgeons performed 881 (53%), 408 (25%), and 368 (22%) of the cases with mesh, respectively. The cumulative reoperation rates for low-, intermediate-, and high-volume providers were 6%, 2%, and 3%, respectively. The difference in reoperation rates between low and intermediate and low- and high-volume surgeons was statistically significant (P = 0.007 and 0.003, respectively). There was no significant difference in reoperation rates between gynecologists and urologists when vaginal mesh was implanted for POP surgery. CONCLUSIONS: Low-volume surgeons performed most of the vaginal prolapse repairs with mesh and had significantly higher reoperation rates. Surgeon experience must be a consideration when reporting mesh-related complications of POP surgery.

Outcomes of Sacral Neuromodulation in a Privately Insured Population.

OBJECTIVE: In this study, we analyzed claims data from the Ingenix data base to analyze outcomes of sacral neuromodulation with respect to both provider and patient factors. MATERIALS AND METHODS: We used the Ingenix (I3) data base to determine demographic, diagnosis, and procedure success information for years 2002-2007 for privately insured patients. Demographic information was obtained, as were the diagnoses given and procedures performed, based on ICD-9 diagnosis codes and Current Procedural Terminology procedure codes. Multivariate analysis was performed to identify specific predictors of success, as measured by progression to implantation of a pulse generator. RESULTS: Overall success, as defined by battery placement, was 49.1%. Fifty-one percent of staged procedures were followed by battery placement compared with 24.1% of percutaneous cases (p < 0.0001). Among the patient variables analyzed, women were more likely than men to progress to battery placement. After Stage I testing, patients treated by urologists were overall more likely than gynecologists to proceed to battery placement (I3: 54% vs. 47%, p < 0.0001). Unlike previous findings in other claims-based data sets, we did not observe a provider-volume relationship in the i3 data set. CONCLUSIONS: Success of sacral neuromodulation, as defined by proceeding to battery placement, was much better after formal staged procedures, which leads us to question the utility of percutaneous techniques. Outcomes were also better among female patients and among those treated by a urologist. Specialty differences will likely diminish over time as more gynecologists adopt sacral neuromodulation.

Incidence and Management of Uncomplicated Recurrent Urinary Tract Infections in a National Sample of Women in the United States.

OBJECTIVE: To determine the incidence and characteristics of women with uncomplicated recurrent urinary tract infections (UTIs) and to explore whether the use of culture-driven treatment affects rates of UTI-related complications and resource utilization. MATERIALS AND METHODS: Using MarketScan claims from 2003 to 2011, we identified UTI-naive women ages 18-64 with incident-uncomplicated recurrent UTIs. Recurrent UTIs were defined as 3 UTI visits associated with antibiotics during a 12-month period. Cases were excluded if they had a UTI in the preceding year, or if they had any complicating factors (eg, abnormality of the urinary tract, neurologic condition, pregnancy, diabetes, or currently taking immunosuppression). We next assessed use of urine cultures, imaging, and cystoscopy, and performed propensity score matching with logistic regression to determine whether having a urine culture associated with >50% of UTIs affected rates of complications and downstream resource utilization. RESULTS: We identified 48,283 women with incident-uncomplicated recurrent UTIs, accounting for an overall incidence of 102 per 100,000 women, highest among women ages 18-34 and 55-64. Sixty-one percent of these women had at least 1 urine culture, 6.9% had imaging, and 2.8% had cystoscopy. Having a urine culture >50% of the time was associated with fewer UTI-related hospitalizations and lower rates of intravenous antibiotic use, whereas demonstrating higher rates of UTI-related office visits and pyelonephritis. CONCLUSION: The incidence of uncomplicated recurrent UTIs increases with age. Urine culture-directed care is beneficial in reducing high-cost services including UTI-related hospitalizations and intravenous antibiotic use, making urine cultures a valuable component to management of these patients.

Urological Surveillance and Medical Complications after Spinal Cord Injury in the United States.

OBJECTIVE: To evaluate the national patterns of urologic follow up after spinal cord injury (SCI) and the occurrence and predictors of urological complications. MATERIALS AND METHODS: This retrospective cohort study used a 5% sample of Medicare data 2007-2010. The minimum adequate urologic surveillance was defined as a urologist visit, serum creatinine evaluation, and upper urinary tract imaging study within the 2-year period. Patients were classified to their most severe complication in a multivariate linear regression model. RESULTS: Among the 7162 patients with SCI, the majority were functionally paraplegic (82.4%) and Caucasian (80.9%). Among them, 4.9% received no screening studies over the 2-year period; 70.5% received some, but not all screening; and 24.6% received all three screening tests. Patients traveled a mean of 21.3 ± 27.5 miles to receive care. A total of 35.7% of patients saw a urologist during the 2-year period; 48.6% had some form of upper tract evaluation, with the majority being computed tomography scans; and 90.7% had serum creatinine evaluation. Of all patients, 35.8% had a minor complication during their 2-year follow up, 17.1% had a moderate complication, and 8.0% had a severe complication. In our prediction model, patient factors that correlated with increased complications included male gender, African American race, paraplegia, and receiving some or all of the neurogenic bladder recommended screening. Patients' distance of travel to their treating physician (urologist or physiatrist) did not affect the rate of complications. CONCLUSION: Urological complications are common in patients with SCI who receive Medicare. Most of these patients with SCI are not receiving even the minimum recommended surveillance for these urological complications.

Physician Use of Sacral Neuromodulation Among Medicare Beneficiaries With Overactive Bladder and Urinary Retention.

OBJECTIVE: To identify physician-level factors associated with high rates of sacral neuromodulation testing. MATERIALS AND METHODS: We performed a retrospective cohort study using a 20% sample of national Medicare claims to identify physicians who performed sacral neuromodulation procedures between 2005 and 2010. Physician-level rates of device testing were determined based on the number of patients seen for overactive bladder and urinary retention diagnoses in the office in each calendar year. These rates were then used to fit a Poisson model to examine factors associated with high rates of device testing. RESULTS: The number of physicians performing test procedures increased 4-fold from 2005 to 2010. Average rates of test procedures increased from 4.0 to 6.4 procedures per physician per year (P <.001), whereas rates of device implantation remained stable (P = .23). Physicians who had higher rates of device testing were associated with lower rates of device implantation (estimate, -1.76, P <.01). Other predictors of physicians with higher test rates included more recent calendar year, testing done in any setting other than an ambulatory surgery center, gynecology subspecialty, and geographic location in the South and West (all P values <.01). CONCLUSION: Over time, physicians are testing more patients but are not implanting more devices. Additionally, there is an inverse relationship between rates of device testing and implantation, suggesting opportunities to improve efficiency and resource utilization.

Trends in management of pelvic organ prolapse among female Medicare beneficiaries.

OBJECTIVE: In the last decade, many new surgical treatments have been developed to achieve less-invasive approaches to prolapse management. However, limited data exist on how the patterns of care for women with pelvic organ prolapse (POP) may have changed over the last decade, and whether mesh implantation techniques have influenced the type of specific compartment repair performed. We used a national data set to analyze the temporal trends in patterns of care for women with POP. STUDY DESIGN: Data were obtained from Public Use Files from the Centers for Medicare and Medicaid Services for a 5% random sample of national beneficiaries with an International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis of POP from 1999 through 2009. Current Procedural Terminology, 4th Edition and International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes were used to evaluate nonsurgical and surgical management trends for this cohort. Types of surgery were categorized by prolapse compartment and combinations of repairs. After 2005, when applicable codes became available, mesh or graft repairs were also analyzed. RESULTS: Over the study time period, the number of women with a diagnosis of POP in any 1 year in our 5% sample of Medicare beneficiaries remained relatively stable (range, 21,245-23,268 per year). Rates of pessary insertion were also consistent at 11-13% over the study period. Of the women with a prolapse diagnosis, 14-15% underwent surgical repair, and there was little change over time in surgical management patterns based on compartment. Most commonly, multiple compartments were repaired simultaneously. There was a rapid increase in mesh use such that in 2009, 41% of all women who underwent surgery (5.8% of the total cohort) had mesh or graft inserted in their repair. Hysterectomy rates for prolapse decreased over time. Rates of vault suspension at the time of hysterectomy for prolapse were low; however, they showed a relative increase over time (22% in 1999 to 26% in 2009). CONCLUSION: Patterns and rates of prolapse repairs remained relatively unchanged from 1999 through 2009, with an exception of a rapid rise in mesh use. These data suggest that the majority of mesh techniques were used for augmentation purposes only, but did not result in an increase in apical repairs performed in the United States. There remains a disappointingly low rate of vault suspension repairs concomitantly at time of hysterectomy for POP.

Short-term outcomes of vaginal mesh placement among female Medicare beneficiaries.

OBJECTIVE: To compare short-term outcomes between prolapse repairs with and without mesh using a national data set. Mesh use in surgical treatment of pelvic organ prolapse has gained wide popularity. However, mesh complications have increased concomitantly with its use. METHODS: Public Use File data were obtained for a 5% random national sample of female Medicare beneficiaries aged 65 years and older. Women who underwent prolapse surgery were identified using Current Procedural Terminology Coding System, Fourth Edition (CPT-4) codes. Because the code for mesh placement was effected in 2005, we separated patients into 3 cohorts as follows: those who underwent prolapse repairs from 1999 to 2000 (presumably without mesh), those who underwent repairs from 2007 to 2008 (presumably without mesh), and those with mesh (based on CPT-4 code 57267) from 2007 to 2008. One-year outcomes were identified using International Classification of Diseases, Ninth Revision diagnosis and procedure codes and CPT-4 procedure codes. RESULTS: A total of 9180 prolapse repairs without mesh were performed from 1999 to 2000, 7729 without mesh from 2007 to 2008, and 1804 prolapse repairs with mesh from 2007 to 2008. Prolapse reoperation within 1 year of surgery was higher in nonmesh vs mesh cohorts (6%-7% vs 4%, P <.02). Mesh removal rates were higher in mesh vs nonmesh group (4% vs 0%-1%, P <.001). Mesh use was associated with more dyspareunia, mesh-related complications, and urinary retention, even when controlling for concomitant sling. CONCLUSION: Mesh to treat pelvic organ prolapse and stress urinary incontinence was associated with a small decrease in early reoperation for prolapse. This decrease came at the expense of increased rates of pelvic pain, retention, mesh-related complications, and mesh removal.

Affordable Care Act: implications in female pelvic medicine and reconstructive surgery.

The Patient Protection and Affordable Care Act (PPACA) of 2010 marks an important milestone in redefining how healthcare will be practiced in the United States for decades to come. This review article will outline the basic concepts associated with the PPACA, including value-based purchasing, pay for performance, accountable care organizations, bundled payments, and patient-centered medical homes, and will discuss how each of these components of the PPACA will impact the subspecialty of Female Pelvic Medicine and Reconstructive Surgery (FPMRS).

The effect of sacral neuromodulation on anticholinergic use and expenditures in a privately insured population.

OBJECTIVES: Sacral neuromodulation is Food and Drug Administration approved for many types of voiding dysfunction. Goals of treatment often include cessation of anticholinergic therapy. With the goal of understanding the impact of sacral neuromodulation on anticholinergic use, we analyzed patterns of care using a national claims-based dataset. MATERIALS AND METHODS: The Ingenix (i3) data base contains insurance claims, including utilization and cost data, for 75 large employers. De-identified patients who underwent sacral neuromodulation between 2002 and 2007 were identified by the unique current procedural terminology-4 procedure code for pulse generator implantation, code 64590. The number and costs of anticholinergic prescriptions were compared before and after treatment. RESULTS: There were 266 percutaneous and 794 two-staged procedures performed from 2002 to 2007 in the i3 dataset. A total of 484 pulse generator implantations were performed, representing 46% of the test procedures. During the year prior to pulse generator placement, each patient purchased an average of 2.1 prescriptions for an anticholinergic agent (SD 3.5). During the year after neuromodulation, each patient purchased an average of 1.0 prescription (SD 2.3, p < 0.0001 by t-test). Prescription charges were $241.31 per patient before and $103.52 after neuromodulation, a statistically significant cost difference (p < 0.0001 by t-test). During the year before the procedure, 50% of patients filled anticholinergic prescriptions. This decreased to 23% after the procedure (p < 0.0001 by chi-square test). CONCLUSIONS: Sacral neuromodulation was associated with a significant decrease in the use of anticholinergic medication. Cost-effectiveness analyses that take into account patient quality-adjusted life years are needed to determine the true cost-benefit ratio of sacral neuromodulation.

Predictors of implantable pulse generator placement after sacral neuromodulation: who does better?

OBJECTIVES: Numerous studies have documented a relationship between provider variables, including surgeon volume and specialty, and outcomes for surgical procedures. In this study we analyzed claims data from a Medicare database to analyze outcomes of sacral neuromodulation (SNM) with respect to both provider and patient factors. MATERIALS AND METHODS: A 5% random sample of Medicare beneficiaries from 1997 to 2007 was the data source. Data retrieved included demographic information, ICD-9 diagnosis codes, and CPT procedure codes. Multivariate analysis was performed to identify predictors of progression to implantable pulse generator (IPG) implantation. RESULTS: After stage I testing, urologists were more likely than gynecologists to proceed to IPG placement (Center for Medicare and Medicaid Services: 49% vs. 43%, p < 0.0001). After percutaneous testing, gynecologists were more likely than urologists to proceed to battery placement (63% vs.44%, p = 0.005). Among the patient variables analyzed, women were more likely than men to progress to battery placement. Patients treated by high-volume providers had higher rates of IPG placement after formal stage I trials (71% vs. 33%, p < 0.0001). CONCLUSIONS: The rate of IPG implantation after SNM was greater among high-volume providers. Women had better outcomes than men. Further research may better define the relationship between outcomes of sacral neuromodulation and specific etiology of voiding dysfunction.

Outcomes of vaginal prolapse surgery among female Medicare beneficiaries: the role of apical support.

OBJECTIVE: Recurrent pelvic organ prolapse (POP) has been attributed to many factors, one of which is lack of vaginal apical support. To assess the role of vaginal apical support and POP, we analyzed a national dataset to compare long-term reoperation rates after prolapse surgery performed with and without apical support. METHODS: Public use file data on a 5% random national sample of female Medicare beneficiaries were obtained from the Centers for Medicare and Medicaid Services. Women with POP who underwent surgery during 1999 were identified by relevant International Classification of Diseases, 9th Revision, Clinical Modification, and Current Procedural Terminology, Fourth Edition codes. Individual patients were followed-up through 2009. Prolapse repair was categorized as anterior, posterior, or anterior-posterior with or without a concomitant apical suspension procedure. The primary outcome was the rate of retreatment for POP. RESULTS: In 1999, 21,245 women had a diagnosis of POP. Of these, 3,244 (15.3%) underwent prolapse surgery that year. There were 2,756 women who underwent an anterior colporrhaphy, posterior colporrhaphy, or both with or without apical suspension. After 10 years, cumulative reoperation rates were highest among women who had an isolated anterior repair (20.2%) and significantly exceeded reoperation rates among women who had a concomitant apical support procedure (11.6%; P<.01). CONCLUSION: Ten years after surgery for POP, the reoperation rate was significantly reduced when a concomitant apical suspension procedure was performed. This analysis of a national cohort suggests that the appropriate use of a vaginal apical support procedure at the time of surgical treatment of POP might reduce the long-term risk of prolapse recurrence. LEVEL OF EVIDENCE: II.

Effectiveness of mesh compared with nonmesh sling surgery in Medicare beneficiaries.

OBJECTIVE: To assess the effectiveness of mesh compared with nonmesh slings placed in different surgical settings as measured by the frequency of complications within 1 year. METHODS: We performed a retrospective cohort study of Medicare beneficiaries undergoing sling surgery from 2006 to 2008 in hospital outpatient departments and hospital-based ambulatory surgery centers. Slings were identified and categorized according to the use of mesh by Healthcare Common Procedure Coding System codes and temporary "C" Healthcare Common Procedure Coding System codes. Patients were followed for 1 year after each procedure to identify complications. Logistic models were fit to assess relationships among sling type, surgical setting, and various complications. RESULTS: We identified 6,698 Medicare beneficiaries who underwent mesh sling procedures and 445 Medicare beneficiaries who underwent nonmesh sling procedures. The overall frequency of complications was similar between the two groups at 69.8% and 72.6% in the mesh and nonmesh groups, respectively (P=.22). Infectious complications were the most common complication at 45.4% and 50.1% of the mesh and nonmesh groups, respectively (P=.06). Patients undergoing mesh procedures were less likely than patients undergoing nonmesh procedures to require management for bladder outlet obstruction (13.9% compared with 19.3%, adjusted odds ratio [OR] 0.66, 95% confidence interval [CI] 0.52-0.85) and were less likely to have a subsequent sling removal and revision or urethrolysis (2.7% compared with 4.7%, adjusted OR 0.56, 95% CI 0.35-0.89). CONCLUSION: Frequencies of most complications were similar regardless of the use of mesh except for the management of bladder outlet obstruction. These results did not differ based on the surgical setting where the sling procedure was performed. LEVEL OF EVIDENCE: II.

Comparative outcomes of open versus laparoscopic sacrocolpopexy among Medicare beneficiaries.

INTRODUCTION AND HYPOTHESIS: Since the first reported laparoscopic sacrocolpopexy in 1991, a limited number of single-center studies have attempted to assess the procedure's effectiveness and safety. Therefore, we analyzed a national Medicare database to compare real-world short-term outcomes of open and laparoscopically assisted (including robotic) sacrocolpopexy in a United States sample of patients. METHODS: Public Use File data for a 5% random national sample of all Medicare beneficiaries aged 65 and older were obtained from the Centers for Medicare and Medicaid Services for the years 2004-2008. Women with pelvic organ prolapse were identified using ICD-9 diagnosis codes. CPT-4 procedure codes were used to identify women who underwent open (code 57280) or laparoscopic (code 57425) sacrocolpopexy. Individual subjects were followed for 1 year post-operatively. Outcomes measured, using ICD-9 and CPT-4 codes, included medical and surgical complications and re-operation rates. RESULTS: Seven hundred and ninety-four women underwent open and 176 underwent laparoscopic (including robotic) sacrocolpopexy. Laparoscopic sacrocolpopexy was associated with a significantly increased rate of re-operation for anterior vaginal wall prolapse (3.4% vs 1.0%, p = 0.018). However, more medical (primarily cardiopulmonary) complications occurred post-operatively in the open group (31.5% vs 22.7%, p = 0.023). When sacrocolpopexy was performed with concomitant hysterectomy, mesh-related complications were significantly higher in the laparoscopic group (5.4% vs 0%, p = 0.026). CONCLUSION: Laparoscopic sacrocolpopexy resulted in an increased rate of reoperation for prolapse in the anterior compartment. When hysterectomy was performed at the time of sacrocolpopexy, the laparoscopic approach was associated with an increased risk of mesh-related complications.

Battery explantation after sacral neuromodulation in the Medicare population.

AIMS: To determine sacral neuromodulation battery life and the patient and provider risk factors for early explantation in a population-based sample. METHODS: A 5% sample of Medicare beneficiaries from 1997 to 2007 served as the data source. All patients who had a sacral neuromodulation device implanted in that time period were included. Variables included in a multivariate analysis of risk factors for removal included gender, age, race, diagnosis, type of test phase, provider specialty, and volume. The number of device reprogramming events was also recorded in this time period. RESULTS: Mean follow-up was 60.5 months. Patients on average had 2.15 reprogramming episodes in their first year, with that number decreasing over subsequent years. Out of the 558 batteries implanted 63 (11.3%) were explanted. Of the 19 implanted individuals who carried the diagnosis of interstitial cystitis (IC), 11 (57.9%) had the battery removed. This was the only variable that predicted early removal, with an odds ratio of explantation of 10.5 (95% CI: 3.9-28.4). CONCLUSION: Very few sacral neuromodulation batteries, once implanted, are removed prematurely. Patients with IC, however, are at very high risk of requiring premature battery removal.

Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline.

PURPOSE: The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of non-neurogenic overactive bladder (OAB). MATERIALS AND METHODS: The primary source of evidence for this guideline is the systematic review and data extraction conducted as part of the Agency for Healthcare Research and Quality (AHRQ) Evidence Report/Technology Assessment Number 187 titled Treatment of Overactive Bladder in Women (2009). That report searched PubMed, MEDLINE®, EMBASE and CINAHL for English-language studies published from January 1966 to October 2008. The AUA conducted additional literature searches to capture treatments not covered in detail by the AHRQ report and relevant articles published between October 2008 and December 2011. The review yielded an evidence base of 151 treatment articles after application of inclusion/exclusion criteria. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate) or C (low). Additional treatment information is provided as Clinical Principles and Expert Opinions when insufficient evidence existed. RESULTS: The evidence-based guideline statements are provided for diagnosis and overall management of the adult with OAB symptoms as well as for various treatments. The panel identified first through third line treatments as well as non-FDA approved, rarely applicable and treatments that should not be offered. CONCLUSIONS: The evidence-based statements are provided for diagnosis and overall management of OAB, as well as for the various treatments. Diagnosis and treatment methodologies can be expected to change as the evidence base grows and as new treatment strategies become obtainable.