Fear and Frustration among Women with Recurrent Urinary Tract Infections: Findings from Patient Focus Groups.

PURPOSE: We investigated the perspectives of women suffering from recurrent urinary tract infections using patient focus group discussions with an emphasis on patient attitudes toward the current prevention and treatment of urinary tract infection episodes. MATERIALS AND METHODS: Twenty-nine women with recurrent urinary tract infections were recruited from a tertiary urology practice to participate in one of 6 focus groups. Participants were asked questions related to urinary tract infection knowledge, prevention strategies, treatment and impact on quality of life. Grounded theory methods were used to analyze focus group transcripts and identify preliminary themes that describe patient attitudes toward current management strategies for recurrent urinary tract infections. RESULTS: The median age of participants was 46 years (range 20-81). The majority were Caucasian and held a college degree. The 7 preliminary themes identified during discussions fell into 2 categories: 1) negative impacts of taking antibiotics for prevention and treatment of recurrent urinary tract infections, and 2) resentment of the medical profession regarding their management of recurrent urinary tract infections. From the preliminary themes, the emergent concepts of "fear" and "frustration" became evident. CONCLUSIONS: Focus group discussions of women with recurrent urinary tract infections suggest that many women are fearful of the adverse effects of antibiotics and are frustrated with the medical profession for not addressing their fears and optimizing antibiotic stewardship. There is a need for physicians to modify management strategies to address these concerns and to devote more research efforts to improving the nonantibiotic options for prevention and treatment of recurrent urinary tract infections, as well as management strategies that better empower patients.

Pentosan Polysulfate Maculopathy: Prevalence, Spectrum of Disease, and Choroidal Imaging Analysis Based on Prospective Screening.

PURPOSE: To describe the prevalence and spectrum of disease of pentosan polysulfate (PPS) maculopathy in a large multimodal retinal imaging study and to report the results of choroidal vascularity index (CVI) analysis. DESIGN: Prospective cohort study Methods: Of 741 patients prescribed PPS within a large university database, 100 (13.4%) with any consumption agreed to participate in a prospective screening investigation. Multimodal retinal imaging including near-infrared reflectance (NIR), fundus autofluorescence (FAF), and spectral domain optical coherence tomography (SD-OCT) was performed in all patients. Characteristic findings of affected patients were identified, and affected and unaffected cohorts were compared. CVI, defined as stromal choroidal area (SCA) divided by the total choroidal area, was analyzed. RESULTS: The prevalence of PPS maculopathy was 16%. NIR illustrated punctate hyperreflective lesions with early presentation. FAF illustrated a speckled macular network of hypo- and hyperautofluorescence colocalized with multifocal hyperreflective retinal pigment epithelial lesions on SD-OCT. Advanced cases demonstrated varying degrees of atrophy. The affected cohort exhibited significantly greater mean PPS therapy duration, mean daily dosage, and mean cumulative dosage (19.5±5.5 years, 433.9±137.6 mg, 3,103.1±1,402.2 g) compared with the unaffected cohort (7.1±6.6 years, 291.6±177.6 mg, 768.4±754.8 g). SCA was significantly lower and CVI was significantly greater in the affected vs the unaffected group. CONCLUSIONS: This prospective cohort study identified a prevalence of PPS maculopathy of 15%-20% among PPS users who agreed to participate. A spectrum of findings may be observed with multimodal retinal imaging. Significant choroidal abnormalities associated with this characteristic maculopathy may provide surrogate markers of macular toxicity.

Pentosan-associated maculopathy: prevalence, screening guidelines, and spectrum of findings based on prospective multimodal analysis.

OBJECTIVE: To describe the prevalence and spectrum of multimodal imaging findings of pentosan polysulfate sodium (PPS)-associated maculopathy and to recommend dosage-related screening guidelines. DESIGN: Cross-sectional study. METHODS: Patients previously or currently treated with PPS at University of California, Los Angeles, were randomly ascertained and prospectively screened for PPS-associated maculopathy with multimodal retinal imaging. Daily and cumulative dosages of PPS exposure were calculated for each patient. Images were studied to identify the characteristic findings of toxicity. The prevalence of PPS-associated maculopathy and screening guidelines were determined. RESULTS: The prevalence of PPS-associated maculopathy in this cohort was 20% (10/50 patients). Both average duration of PPS therapy and average cumulative dosage were significantly lower in the unaffected (6.3 ± 6.6 years, 691.7 ± 706.6 g) versus the affected groups (20.3 ± 6.6 years, 3375.4 ± 1650.0 g, p < 0.001). Near-infrared reflectance (NIR) illustrated characteristic punctate retinal pigment epithelium (RPE) macular lesions early. Fundus autofluorescence (FAF) showed speckled autofluorescence in the posterior pole with peripapillary extension. Co-localization with optical coherence tomography (OCT) displayed focal RPE thickening and, in more severe cases, RPE atrophy in the macula and even the periphery. CONCLUSIONS: A prevalence of 20% in this study cohort suggests a significant risk of macular toxicity for PPS-treated patients. Characteristic alterations are best detected with FAF and NIR. More significant PPS exposure was associated with more severe atrophy. We recommend an initial baseline eye examination to include OCT and, most importantly, NIR and FAF with annual retinal imaging thereafter especially with cumulative dosages approaching 500 g. Patients exposed to greater than 1500 g of PPS are at significant risk of retinal toxicity.

Rapid diagnostic testing in the management of urinary tract infection: Potentials and limitations.

Urine culture and sensitivity (C&S) remains the gold standard diagnostic for urinary tract infections (UTI). To reduce the use of inaccurate or broad-spectrum empiric antimicrobials, rapid identification and quantification (IDQ) and antimicrobial susceptibility testing (AST) with results within 30 and 150 min, respectively, are under development. To assess the impact of rapid diagnostics, five UTI vignettes were constructed, and ninety-one United States physicians were surveyed regarding their diagnostic, management, and antimicrobial choices before and after IDQ and AST results. Rapid diagnostics increased the postponement of antimicrobial therapy pending AST results from 16% to 38% and 5% to 54% in Vignettes 1 and 2 and reduced the use of ineffective antibiotics from 41% to 0% and 69% to 0% in Vignettes 2 and 4. Rapid diagnostics increased the use of narrow spectrum agents in the five vignettes, indicating its potential to revitalize physician responsibility in antimicrobial stewardship.

Robot-assisted laparoscopic sacrocolpopexy with autologous fascia lata: technique and initial outcomes.

INTRODUCTION AND HYPOTHESIS: Pelvic reconstructive surgery is increasingly being performed with autologous grafts to avoid complications of synthetic mesh and improve the durability of a native tissue repair. Autologous fascia lata (AFL) provides a reliable source of robust connective tissue to improve surgical outcomes. We present our technique and initial experience with performing robotic sacrocolpopexy (RSC) augmented with AFL. METHODS: A retrospective review was conducted of patients who underwent RSC with AFL between January 2015 and November 2017. Outcomes evaluated include recurrence of prolapse on physical examination, prolapse symptoms, urinary incontinence, patient satisfaction based on the Patient Global Impression of Improvement (PGI-I) and complications. RESULTS: Twelve patients were identified with a median age of 68 years (range, 46-77 years) at the time of RSC with AFL. Eleven patients had a history of prior sling and/or vaginal mesh. The median operative time was 225 min (177-302 min). There were no intra- or postoperative complications. After a median follow-up of 14.7 months (5.7 to 39 months), the median PGI-I response was 2 (range, 1-3, very much to a little better). No recurrent or persistent apical prolapse was observed. Three patients (25%) reported recurrence of sensation of a vaginal bulge, which were all due to anterior vaginal wall prolapse. CONCLUSIONS: RSC can be performed with AFL and should be considered in patients with a history of mesh complications. Overall patient satisfaction was high. While these short-term outcomes are encouraging, further studies are needed to assess long-term durability of anatomic results.

Lack of uniformity among United States recommendations for diagnosis and management of acute, uncomplicated cystitis.

INTRODUCTION AND HYPOTHESIS: Acute, uncomplicated cystitis is one of the most common bacterial infections seen in clinical practice. Quality improvement and antibiotic stewardship efforts to optimize cystitis management rely on clinicians managing patients in a manner recommended by experts and guidelines. However, it is unclear if recent recommendations for cystitis from experts and guidelines from US medical societies that provide recommendations are well aligned. METHODS: We examined recommendations and guidelines for acute, symptomatic cystitis in women published in US medical societies' journals from January 1, 2008, to December 31, 2016, within the fields of family medicine, obstetrics and gynecology, internal medicine, female pelvic medicine and reconstructive surgery, and infectious diseases. RESULTS: All recommendations endorsed the use of symptoms and urine dipstick to diagnose cystitis. Some societies did not recommend urine dipstick in patients with recurrent urinary tract infection (UTI), classic UTI symptoms, or a lack of underlying conditions or competing diagnoses. All endorsed nitrofurantoin, trimethoprim-sulfamethoxazole, and fosfomycin as first-line agents. Some guidelines classified fluoroquinolones as second- or third-line, while others considered them first-line treatment for UTI. Avoiding use of amoxicillin and ampicillin, antibiotic agents with high prevalence of resistance in the US, was recommended by some societies. CONCLUSIONS: US recommendations differed in their approach to the treatment of acute, uncomplicated cystitis. Lack of uniformity likely contributes to clinical management variance for patients with UTI and hampers quality improvement and antibiotic stewardship efforts aimed at promoting optimal management. Our findings emphasize the need for more consistent recommendations for cystitis management.

Public Awareness of Uterine Power Morcellation Through US Food and Drug Administration Communications: Analysis of Google Trends Search Term Patterns.

BACKGROUND: Uterine power morcellation, where the uterus is shred into smaller pieces, is a widely used technique for removal of uterine specimens in patients undergoing minimally invasive abdominal hysterectomy or myomectomy. Complications related to power morcellation of uterine specimens led to US Food and Drug Administration (FDA) communications in 2014 ultimately recommending against the use of power morcellation for women undergoing minimally invasive hysterectomy. Subsequently, practitioners drastically decreased the use of morcellation. OBJECTIVE: We aimed to determine the effect of increased patient awareness on the decrease in use of the morcellator. Google Trends is a public tool that provides data on temporal patterns of search terms, and we correlated this data with the timing of the FDA communication. METHODS: Weekly relative search volume (RSV) was obtained from Google Trends using the term "morcellation." Higher RSV corresponds to increases in weekly search volume. Search volumes were divided into 3 groups: the 2 years prior to the FDA communication, a 1-year period following, and thereafter, with the distribution of the weekly RSV over the 3 periods tested using 1-way analysis of variance. Additionally, we analyzed the total number of websites containing the term "morcellation" over this time. RESULTS: The mean RSV prior to the FDA communication was 12.0 (SD 15.8), with the RSV being 60.3 (SD 24.7) in the 1-year after and 19.3 (SD 5.2) thereafter (P<.001). The mean number of webpages containing the term "morcellation" in 2011 was 10,800, rising to 18,800 during 2014 and 36,200 in 2017. CONCLUSIONS: Google search activity about morcellation of uterine specimens increased significantly after the FDA communications. This trend indicates an increased public awareness regarding morcellation and its complications. More extensive preoperative counseling and alteration of surgical technique and clinician practice may be necessary.

Clinical predictors and risk factors for vaginal mesh extrusion.

PURPOSES: Our study aims to enhance the accuracy of the clinical diagnosis in patients with vaginal mesh extrusion following transvaginal mesh placement for pelvic organ prolapse using significant clinical parameters and risk factors. METHODS: All patients who underwent vaginal mesh removal were retrospectively reviewed from January 2000 to May 2014. Eligible patients were divided into two groups according to the presence of vaginal mesh extrusion. RESULTS: A total of 862 patients, 798 were included. 357 (44.7%) had evidence of vaginal mesh extrusion, and 441 (55.3%) had no evidence of vaginal mesh extrusion. The mean age of the vaginal mesh extrusion group was slightly higher than in the group without vaginal mesh extrusion (58.7 ± 11.2 vs. 56.4 ± 11.5, respectively; p = 0.002). From multivariate analysis, the significant clinical correlations for vaginal mesh extrusion were vaginal bleeding [60 (16.9) vs. 14 (3.2%), p < 0.001], hispareunia [48 (13.5) vs. 15 (3.4%), OR = 4.163, p < 0.001], and vaginal discharge [45 (12.6) vs. 18 (4.1%), p = 0.001]. The risk factors were multiple mesh implantations [218 (67.06) vs. 175 (39.68%), p < 0.001] and menopause [314 (88) vs. 364 (82.7%), p = 0.145]. Demographic data, including BMI, sexual activity, vaginal atrophy, both local and systemic hormonal use, smoking status, and hysterectomy status, were not significantly different, as well as the clinical symptoms including dyspareunia, vaginal infection, and symptomatic vaginal bulge. CONCLUSIONS: Vaginal bleeding, hispareunia, and vaginal discharge were the most significant clinical predictors for raising suspicion of vaginal mesh extrusion. Multiple mesh implantations were a significant risk factor for extrusion.

Robotic Sacrocolpopexy-Is It the Treatment of Choice for Advanced Apical Pelvic Organ Prolapse?

PURPOSE OF REVIEW: Pelvic organ prolapse (POP) is a highly prevalent condition among women that, although non-life threatening, can significantly impact daily activities and quality of life (QOL). Sacrocolpopexy (SC) has been touted by many as the "gold standard," citing superior anatomic success rates compared to transvaginal approaches for apical prolapse repair. In line with current trends throughout the surgical field, robotic-assisted laparoscopic sacrocolpopexy (RSC) has rapidly gained popularity. This review will present the most contemporary evidence examining RSC and discuss whether it has met criteria to qualify as the "treatment of choice" for advanced apical vaginal prolapse. RECENT FINDINGS: Recent findings support the superior durability of SC for apical prolapse repair compared to native tissue vaginal approaches. Recent evidence demonstrates that anatomic outcomes of minimally invasive sacrocolpopexy, including RSC, are no different than those of traditional ASC. Low quality evidence suggests lower rates of dyspareunia with SC compared to vaginal repairs. RSC may be cost-effective when compared to ASC. When compared to LSC, however, RSC is more expensive and associated with longer operating times. RSC is an excellent option for many women who desire the most durable option for definitive repair of advanced apical POP.

The Risk of Recurrent Urinary Incontinence Requiring Surgery After Suburethral Sling Removal for Mesh Complications.

OBJECTIVE: We sought to examine the risk of recurrent stress urinary incontinence (SUI) after suburethral sling mesh removal or excision. MATERIALS AND METHODS: We conducted a retrospective cohort study of patients who were continent before removal or excision of synthetic midurethral slings; this cohort of 278 subjects was much larger than seen in previous such studies. Patients with preoperative incontinence, additional vaginal mesh placements, prior mesh revision/excision, existing SUI, and prior pelvic radiation or fistula were excluded. Only patients with follow-up detailing continence status within 1 year of mesh removal were examined. RESULTS: Of 278 patients, 117 (70 retropubic and 47 transobturator) midurethral sling removals met inclusion criteria. Demographic data were comparable between groups. Presenting symptoms were also similar, with similar extrusion rates. Chronic pain was the reason for mesh removal in 80% of cases. In 1 year of follow-up, 38.6% (27/70) retropubic and 34.0% (16/47) transobturator sling removals had SUI requiring an anti-incontinence procedure. Total sling mesh removal was performed in 51.4% of retropubic vaginal mesh and 51.1% of transobturator mesh cases. CONCLUSION: In this continent population with sling complications, approximately 1/3 developed significant SUI within 1 year of mesh removal requiring anti-incontinence surgery, regardless of the amount or type of mesh removed. Total mesh removal did not increase SUI risk.

Complete Excision of Sacrocolpopexy Mesh With Autologous Fascia Sacrocolpopexy.

OBJECTIVE: To evaluate the safety and short-term efficacy of complete sacrocolpopexy mesh excision with concomitant autologous fascia sacrocolpopexy. METHODS: A retrospective cohort study of patients undergoing complete sacrocolpopexy mesh excision and concomitant autologous fascia sacrocolpopexy from March 2013 to September 2016 was conducted. The primary objective was assessment of perioperative outcomes including complications within 60 days of surgery. The secondary outcome measure was surgical success defined as no need for retreatment by either surgery for apical prolapse or pessary. RESULTS: Nineteen patients were identified. Median patient age was 56 years old (range 35-78). Median time from mesh placement to surgical excision was 4.5 years (0-13). Indications for mesh excision included refractory pelvic pain in 18 patients (95%), symptomatic mesh exposure in 8 patients (42%), and bilateral ureteral obstruction with ureterovaginal fistula in 1 patient (5%). Median operative time, estimated blood loss, and length of hospital stay were 228 minutes (133-362), 200 mL (50-1000), and 5 days (2-9), respectively. The rate of minor and major complications within 60 days was 36.8% and 5.3%, respectively. There were no cases of bladder or bowel injury. At a median follow-up of 9.9 months (2.4-39) no patient required secondary surgery for apical vaginal prolapse or retreatment with pessary. CONCLUSION: Complete sacrocolpopexy mesh excision with concomitant autologous fascia sacrocolpopexy can be accomplished safely with a low rate of major complications. These are short-term findings and longer follow-up of anatomic and functional outcomes is needed.

Comparison of Times to Ureteral Efflux after Administration of Sodium Fluorescein and Phenazopyridine.

PURPOSE: There is currently a national shortage of indigo carmine. In efforts to identify the most efficient aid for visualizing ureteral efflux intraoperatively we investigated the time to excretion of phenazopyridine vs a newly identified alternative, sodium fluorescein. MATERIALS AND METHODS: We analyzed prospectively collected data on a cohort of women who underwent pelvic reconstructive surgery in 2015. Per provider preference patterns a number of patients were administered 200 mg phenazopyridine orally with a sip of water 1 hour prior to the start of operative time. Other patients were given 0.5 ml 10% sodium fluorescein intravenously in the operating room. In all cases time was measured between the administration of the agent and the visualization of color changes consistent with agent efflux in an indwelling catheter, which was placed at the start of the operation. Differences in excretion times between the groups were compared with the Wilcoxon rank sum test. RESULTS: Seven women received phenazopyridine and 5 received sodium fluorescein. Mean excretion time was significantly longer in the phenazopyridine group compared to the sodium fluorescein group (81.9 vs 5.1 minutes, p = 0.0057). Median excretion time for phenazopyridine was 70 minutes (range 59 to 127) and for sodium fluorescein it was 5 minutes (range 3 to 9). CONCLUSIONS: Sodium fluorescein is excreted significantly faster in the operating room compared to phenazopyridine. Depending on the cost of these agents at an institution, in addition to the desire to decrease operative time, this may impact practice patterns and agent selection.

Risk Factors for Microscopic Hematuria in Women.

OBJECTIVES: The objective of this study was to determine the risk factors that may contribute to the diagnosis of microscopic hematuria (MH) in women. METHODS: This multicenter case-control study reviewed cases of women presenting to Female Pelvic Medicine & Reconstructive Surgery sites with MH from 2010 to 2014. Microscopic hematuria was defined as 3 or more red blood cells per high power field in the absence of infection as indicated in the American Urologic Association guidelines. Controls were matched to cases in a 1:1 ratio and chart review of 10 risk factors was performed (urethral caruncle, pelvic organ prolapse, vaginal atrophy, personal or family history of nephrolithiasis, prior prolapse or incontinence surgery, past or current smoking, chemical exposure, family history of urologic malignancy, prior pelvic radiation, and prior alkylating chemotherapy). Odds ratios were performed to assess risk factors. RESULTS: There were 493 cases and 501 controls from 8 Female Pelvic Medicine & Reconstructive Surgery sites. Current smoking, a history of pelvic radiation, and a history of nephrolithiasis were all significant risk factors for MH (P < 0.05). Vaginal atrophy, menopausal status, and use of estrogen were not found to be risk factors for MH (P = 0.42, 0.83, and 0.80, respectively). When stratifying the quantity of MH, women with increased red blood cells per high power field were more likely to have significant findings on their imaging results. CONCLUSIONS: Our findings suggest that the risk factors for MH in women are current smoking, a history of pelvic radiation, and a history of nephrolithiasis.

Intracellular Bacterial Communities: A Potential Etiology for Chronic Lower Urinary Tract Symptoms.

Patients with persistent lower urinary tract symptoms and negative urine cultures are often difficult to treat. Infection may go undetected in these patients because the concentrations of bacteria in their urine are beneath the threshold of standard urine culture techniques. Empiric treatment may result in temporary relief, followed by recurrent symptoms. Occult and recurrent urinary tract infection may be due to both invasion of the bladder wall by uropathogenic Escherichia coli and the formation of biofilm-like intracellular bacterial communities. This review examines emerging evidence for a role of intracellular bacterial communities in human infection.

Sacral neuromodulation for refractory overactive bladder, interstitial cystitis, and painful bladder syndrome.

Various pelvic floor conditions, including overactive bladder syndrome and chronic pelvic pain, have been successfully managed with the neuromodulation of sacral nerves. Sacral neuromodulation is a minimally invasive procedure involving the implantation of a programmable pulse generator that delivers low-amplitude electrical current via quadripolar tined leads through the S3 foramen. Durable efficacy has been demonstrated in retrospective studies, but questions regarding ideal patient candidacy and optimal technical considerations remain unanswered.

Expanding the Role of Neuromodulation for Overactive Bladder: New Indications and Alternatives to Delivery.

From the time that it was granted US Food and Drug Administration approval, neuromodulation has secured a firm position in the treatment algorithm for overactive bladder. With neuromodulation, physicians were able to bridge the gap between the two ends of the treatment spectrum (medical therapy and open surgery). Sacral nerve stimulation has been the most widely used form of neuromodulation. Recent modifications to its design, namely the development of the tined lead and the launching of the refined InterStim II (Medtronic, Minneapolis, MN), have made sacral nerve simulation even less invasive and more effective. While InterStim is maintaining a level of success with these advancements, peripheral means of neuromodulation are being explored. The current literature takes a closer look at posterior tibial and pudendal nerve stimulation as alternatives to sacral nerve stimulation. The field of neuromodulation is also expanding in terms of the target patient population, as it is being used to treat children, patients with neurological disease, and others. As the role of neuromodulation increases, we must continue to assess its efficacy, safety, and cost-effectiveness in comparison to other therapeutic options.

Contrasting the percutaneous nerve evaluation versus staged implantation in sacral neuromodulation.

Sacral neuromodulation is increasingly used for the treatment of voiding dysfunction, pelvic pain syndromes, and gastrointestinal disorders. While increased use of this technology has led to a greater understanding of its potential as well as its limitations, difficulty persists in identifying the patients that will benefit most. Either of two trial stimulation techniques is performed before placement of a permanent neuromodulator: the monopolar percutaneous nerve evaluation and the tined quadripolar staged trial. The preponderance of recent literature asserts the superior sensitivity of the staged trial over percutaneous nerve evaluation. However, the techniques offer disparate advantages, and other issues, such as cost-effectiveness, remain largely unexplored. The role of sacral neuromodulation will continue to expand as physicians and patients become increasingly aware of its therapeutic potential. Widespread adoption of this clinically superior technique will most rapidly help the greatest number of patients.

Is robotic sacrocolpopexy a marketing gimmick or a technological advancement?

PURPOSE OF REVIEW: Robot-assisted laparoscopic sacrocolpopexy (RALS) is a new surgical technique for the treatment of symptomatic vaginal vault prolapse that is rapidly gaining popularity among both urologists and gynecologists. This article will summarize the available published data to assess the potential advantages and disadvantages of this new procedure and its current role in female pelvic floor reconstruction. RECENT FINDINGS: The literature on RALS is limited mainly to single-institution retrospective studies, which suggest minimal morbidity, technical feasibility, and short-term efficacy comparable to open abdominal sacrocolpopexy. What remains uncertain is whether this approach will be superior to the other established minimally invasive transvaginal and laparoscopic approaches in terms of subjective and objective outcomes and quality of life. Other relevant issues, such as overall cost-effectiveness and extended application for multicompartment defects and uterine-sparing procedures, remain largely unexplored. SUMMARY: The use of RALS will likely continue to expand secondary to increased access and the popularity of the robotic apparatus among both surgeons and patients. Well designed large randomized multicenter comparative studies based on validated measurement instruments are needed to evaluate its advantage over conventional approaches, including open abdominal sacrocolpopexy and various transvaginal and laparoscopic techniques.

Validating the incontinence symptom severity index: a self-assessment instrument for voiding symptom severity in women.

PURPOSE: Most voiding symptom self-assessment instruments assess either symptom bother or effect on quality of life. The Incontinence Symptom Severity Index is an instrument for self-assessment of severity of female urinary storage and voiding symptoms, rather than symptom bother or effects of symptoms on quality of life. We assessed the validity of the Incontinence Symptom Severity Index for female voiding symptom self-assessment. MATERIALS AND METHODS: The Incontinence Symptom Severity Index assesses 8 symptom domains, including emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity and pad use. Three separate cohorts of women with a mean age of 59, 60 and 63 years, respectively, who underwent evaluation for urinary complaints associated with incontinence and vaginal prolapse were analyzed. Internal consistency was assessed via item-total correlations and Cronbach's alpha. Concurrent validity against the Urogenital Distress Inventory and Pelvic Floor Distress Inventory-Short Form were studied by correlating similar symptom domains of the Incontinence Symptom Severity Index with both instruments. We assessed criterion validity by comparison with the objective measures of post-void residual urine, voiding logs and self-reported pad use. Response to change was assessed by comparing pretreatment and posttreatment Incontinence Symptom Severity Index scores. RESULTS: Significant item total correlations were seen for each Incontinence Symptom Severity Index item and Cronbach's alpha was 0.69. All Incontinence Symptom Severity Index items significantly correlated with similar items of the Urogenital Distress Inventory and Pelvic Floor Distress Inventory-Short Form. Significant posttreatment reductions were also observed for all 8 Incontinence Symptom Severity Index items. Progressively higher post-void residual urine was noted for the 4 severity scores of Incontinence Symptom Severity Index item 1 (emptying) (p = 0.07). Incontinence Symptom Severity Index items 3 (nocturia) and 4 (daytime frequency) showed significantly increasing nighttime and daytime voids with worsening severity scores for each (p <0.0001 and <0.0041, respectively). Incontinence Symptom Severity Index items 5 to 8 (stress incontinence, urge incontinence, leakage with activity and pad use) showed significantly increasing trends in mean daily pad use (p <0.0001, 0.022, <0.0001 and <0.0001, respectively) among the 4 severity scores for each. CONCLUSIONS: The Incontinence Symptom Severity Index demonstrates good reliability and validity. It is a useful instrument for assessment of female incontinence and voiding symptom severity in clinical and research settings.

Trends in surgical management of stress urinary incontinence among female Medicare beneficiaries.

OBJECTIVES: To identify patterns in the surgical treatment of women with stress urinary incontinence in the United States from 1992 to 2001. METHODS: As a part of the Urologic Diseases in America Project, we analyzed data from a 5% national random sample of female Medicare beneficiaries aged > or =65 years. The data were obtained from the Centers for Medicare and Medicaid Services carrier and outpatient files from 1992, 1995, 1998, and 2001. Women in the sample with a diagnosis of urinary incontinence were identified using the International Classification of Diseases, 9th edition, codes. Surgical procedures were identified using the Current Procedural Terminology, 4th edition, codes. The patterns of care were then analyzed during the 10-year period. RESULTS: The overall number of surgical procedures increased from 18 820 to 32 480 during the 10-year period, likely owing to the growing population of Medicare beneficiaries. Needle suspension was the most commonly performed incontinence procedure in 1992 and 1995. Collagen injections gained rapid popularity and became the most common procedure by 1998. A drastic increase in the numbers and rates of sling placements occurred from 1995 to 2001. CONCLUSIONS: A rapid shift occurred in the surgical management of stress urinary incontinence in the 1990s. The rapid increase in the use of sling procedures corresponded with a decrease in the use of the many other available anti-incontinence procedures. As in previous years, we identified a trend toward minimally invasive approaches to surgery, without the presence of randomized controlled clinical trials to support these trends. We anticipate that the analysis of Medicare claims from 2004 onward will demonstrate an additional increase in the use of sling procedures.