Renée M Ward

Sling surgery for stress urinary incontinence in women: a systematic review and metaanalysis.

OBJECTIVE Understanding the long-term comparative effectiveness of competing surgical repairs is essential as failures after primary interventions for stress urinary incontinence (SUI) may result in a third of women requiring repeat surgery. STUDY DESIGN We conducted a systematic review including English-language randomized controlled trials from 1990 through April 2013 with a minimum 12 months of follow-up comparing a sling procedure for SUI to another sling or Burch urethropexy. When at least 3 randomized controlled trials compared the same surgeries for the same outcome, we performed random effects model metaanalyses to estimate pooled odds ratios (ORs). RESULTS For midurethral slings (MUS) vs Burch, metaanalysis of objective cure showed no significant difference (OR, 1.18; 95% confidence interval [CI], 0.73-1.89). Therefore, we suggest either intervention; the decision should balance potential adverse events (AEs) and concomitant surgeries. For women considering pubovaginal sling vs Burch, the evidence favored slings for both subjective and objective cure. We recommend pubovaginal sling to maximize cure outcomes. For pubovaginal slings vs MUS, metaanalysis of subjective cure favored MUS (OR, 0.40; 95% CI, 0.18-0.85). Therefore, we recommend MUS. For obturator slings vs retropubic MUS, metaanalyses for both objective (OR, 1.16; 95% CI, 0.93-1.45) and subjective cure (OR, 1.17; 95% CI, 0.91-1.51) favored retropubic slings but were not significant. Metaanalysis of satisfaction outcomes favored obturator slings but was not significant (OR, 0.77; 95% CI, 0.52-1.13). AEs were variable between slings; metaanalysis showed overactive bladder symptoms were more common following retropubic slings (OR, 1.413; 95% CI, 1.01-1.98, P = .046). We recommend either retropubic or obturator slings for cure outcomes; the decision should balance AEs. For minislings vs full-length MUS, metaanalyses of objective (OR, 4.16; 95% CI, 2.15-8.05) and subjective (OR, 2.65; 95% CI, 1.36-5.17) cure both significantly favored full-length slings. Therefore, we recommend a full-length MUS. CONCLUSION Surgical procedures for SUI differ for success rates and complications, and both should be incorporated into surgical decision-making. Low- to high-quality evidence permitted mostly level-1 recommendations when guidelines were possible.

Vaginal Estrogen for Genitourinary Syndrome of Menopause: A Systematic Review

OBJECTIVE: To comprehensively review and critically assess the literature on vaginal estrogen and its alternatives for women with genitourinary syndrome of menopause and to provide clinical practice guidelines. DATA SOURCES: MEDLINE and Cochrane databases were searched from inception to April 2013. We included randomized controlled trials and prospective comparative studies. Interventions and comparators included all commercially available vaginal estrogen products. Placebo, no treatment, systemic estrogen (all routes), and nonhormonal moisturizers and lubricants were included as comparators. METHODS OF STUDY SELECTION: We double-screened 1,805 abstracts, identifying 44 eligible studies. Discrepancies were adjudicated by a third reviewer. Studies were individually and collectively assessed for methodologic quality and strength of evidence. TABULATION, INTEGRATION, AND RESULTS: Studies were extracted for participant, intervention, comparator, and outcomes data, including patient-reported atrophy symptoms (eg, vaginal dryness, dyspareunia, dysuria, urgency, frequency, recurrent urinary tract infection (UTI), and urinary incontinence), objective signs of atrophy, urodynamic measures, endometrial effects, serum estradiol changes, and adverse events. Compared with placebo, vaginal estrogens improved dryness, dyspareunia, urinary urgency, frequency, and stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Urinary tract infection rates decreased. The various estrogen preparations had similar efficacy and safety; serum estradiol levels remained within postmenopausal norms for all except high-dose conjugated equine estrogen cream. Endometrial hyperplasia and adenocarcinoma were extremely rare among those receiving vaginal estrogen. Comparing vaginal estrogen with nonhormonal moisturizers, patients with two or more symptoms of vulvovaginal atrophy were substantially more improved using vaginal estrogens, but those with one or minor complaints had similar symptom resolution with either estrogen or nonhormonal moisturizer. CONCLUSION: All commercially available vaginal estrogens effectively relieve common vulvovaginal atrophy-related complaints and have additional utility in patients with urinary urgency, frequency or nocturia, SUI and UUI, and recurrent UTIs. Nonhormonal moisturizers are a beneficial alternative for those with few or minor atrophy-related symptoms and in patients at risk for estrogen-related neoplasia. CLINICAL TRIAL REGISTRATION: PROSPERO International prospective register of systematic reviews, http://www.crd.york.ac.uk/PROSPERO/, CRD42013006656.

Antibiotic prophylaxis for selected gynecologic surgeries

Antibiotic prophylaxis for surgery is commonly used and is recommended by multiple organizations.

Pelvic mesh complications in women before and after the 2011 FDA public health notification.

Objectives On July 13, 2011, the US Food and Drug Administration (FDA) released a public health notification with concerns regarding vaginal mesh for the treatment of pelvic organ prolapse. Our study compares the frequency and type of mesh complications related to female pelvic floor disorders presenting to our center before and after this notification. Methods We performed a retrospective cohort study comparing the percentage of women found to have mesh complications related to pelvic floor disorders for the year preceding and the 6 months following the FDA notification. The 2011 International Urogynecological Association/International Continence Society (IUGA/ICS) guidelines were used to classify mesh complications. Results We identified 109 women in the 12 months before and 98 women in the 6 months after the FDA notification who presented for new consultation with a history of pelvic mesh placement. Of the women with prior mesh, a higher percentage had a mesh complaint after the FDA notification (31.2% before vs 45.9% after notification; P = 0.029). There was no difference in the frequency of diagnosed mesh complications (38.5% before vs 43.9% after notification; P = 0.435) or the types of complications seen as classified by the IUGA/ICS guidelines. The rate of complications among women with a prior sacral colpopexy (35%) or midurethral sling (30%) was higher than expected for both time periods. Conclusions Whereas the number of patient-perceived mesh complications increased after the FDA notification, neither the frequency, type, or location of complications changed. The complications were not limited to transvaginal mesh, and an unexpectedly high proportion of the complications were related to sacral colpopexy and midurethral sling procedures.

Genetic epidemiology of pelvic organ prolapse: a systematic review

Given current evidence supporting a genetic predisposition for pelvic organ prolapse, we conducted a systematic review of published literature on the genetic epidemiology of pelvic organ prolapse. Inclusion criteria were linkage studies, candidate gene association and genome-wide association studies in adult women published in English and indexed in PubMed through Dec. 2012, with no limit on date of publication. Methodology adhered to the PRISMA guidelines. Data were systematically extracted by 2 reviewers and graded by the Venice criteria for studies of genetic associations. A metaanalysis was performed on all single nucleotide polymorphisms evaluated by 2 or more studies with similar methodology. The metaanalysis suggests that collagen type 3 alpha 1 (COL3A1) rs1800255 genotype AA is associated with pelvic organ prolapse (odds ratio, 4.79; 95% confidence interval, 1.91-11.98; P = .001) compared with the reference genotype GG in populations of Asian and Dutch women. There was little evidence of heterogeneity for rs1800255 (P value for heterogeneity = .94; proportion of variance because of heterogeneity, I(2) = 0.00%). There was insufficient evidence to determine whether other single nucleotide polymorphisms evaluated by 2 or more papers were associated with pelvic organ prolapse. An association with pelvic organ prolapse was seen in individual studies for estrogen receptor alpha (ER-α) rs2228480 GA, COL3A1 exon 31, chromosome 9q21 (heterogeneity logarithm of the odds score 3.41) as well as 6 single nucleotide polymorphisms identified by a genome-wide association study. Overall, individual studies were of small sample size and often of poor quality. Future studies would benefit from more rigorous study design as outlined in the Venice recommendations.

The impact of multichannel urodynamics upon treatment recommendations for female urinary incontinence.

The aim of this study was to evaluate whether multichannel urodynamic testing changes a physician’s treatment recommendations when managing women with urinary incontinence. In this prospective reader study, four fellowship-trained urogynecologists reviewed 39 abstracted cases of urinary incontinence on two occasions: first without and subsequently with urodynamic data. Treatment recommendations were made for each case after each review. The probability of urodynamic data modifying treatment recommendations was estimated for each reader and for the population of readers using a random effects logistic regression to account for reader variability. The overall probability that urodynamic data would change treatment was 26.9% (95% confidence interval (CI), 18.6%, 37.2%) for medical treatments and 45.5% (95% CI, 37.8%, 53.4%) for surgical treatments. Reader-to-reader differences accounted for 3% and <1% of the total variance for medical and surgical treatments, respectively. Multichannel urodynamic evaluations are significantly associated with changes in medical and surgical treatment recommendations in a referral population.

Recurrent Thigh Abscess with Necrotizing Fasciitis from a Retained Transobturator Sling Segment

A woman who underwent transobturator sling surgery for urinary incontinence experienced early vaginal mesh erosion, and underwent a partial sling removal. Several months later, she developed recurrent right thigh and groin abscesses and necrotizing fasciitis. The source of the infection, a retained segment of mesh in the obturator space, was identified only after several operative procedures and referrals. This case illustrates several of the areas of concern with the introduction of new surgical materials and techniques.

Sling surgery for stress urinary incontinence in women: A systematic review and meta-analysis

Traditional treatment options in women with stress urinary incontinence (SUI) include Burch urethropexy or pubovaginal slings. These procedures have become much less popular and less frequently performed with the development and increased use of synthetic midurethral slings (MUSs). These trends in practice have not been associated with dramatic improvements in outcomes, however, and up to a third of women require repeat surgery. Therefore, it is important to understand the comparative effectiveness of competing surgical repair procedures. The primary aim of this systematic review and meta-analysis was to compare objective and subjective cure rates in adult women with SUI treated with different surgical procedures. A systematic review was performed using the MEDLINE and Cochrane Central Register for Controlled Trials databases to obtain English-language comparative studies, cohort studies, and systematic reviews published from 1990 through April 2013 comparing a sling procedure for SUI to another sling or to Burch urethropexy. For evaluation of outcomes, only peer-reviewed randomized controlled trials with at least 12 months of follow-up were included. The minimum requirement for meta-analysis was at least 3 randomized controlled trials that compared the same surgeries for the same outcome and provided adequate efficacy and adverse event data. A random-effects model meta-analysis was used to estimate pooled odds ratios (ORs). Comparison ofMUS vs Burch urethropexy (open or laparoscopic):Meta-analysis of objective cure showed no significant difference between these 2 procedures (OR, 1.18; 95% confidence interval [CI], 0.73–1.89). There was also no difference between these 2 surgeries for outcomes of subjective cure, quality of life, or sexual function. Either an MUS or Burch procedure can be used. The choice should be based on potential adverse events and planned concomitant surgeries. Comparison of pubovaginal sling vs Burch urethropexy: Because the evidence favored pubovaginal slings for both subjective and objective cure, the authors recommended use of pubovaginal slings to maximize cure outcomes. Comparison of pubovaginal slings vs MUS: Meta-analysis of subjective cure favored MUS (OR, 0.40; 95% CI, 0.18–0.85). A meta-analysis for objective cure could not be performed because of inadequate data. Based on the subjective evidence for better cure, the authors recommended MUS. www.obgynsurvey.com | 586 Copyright

Phenotyping clinical disorders: lessons learned from pelvic organ prolapse.

Genetic epidemiology, the study of genetic contributions to risk for disease, is an innovative area in medicine. Although research in this arena has advanced in other disciplines, few genetic epidemiological studies have been conducted in obstetrics and gynecology. It is crucial that we study the genetic susceptibility for issues in womens health because this information will shape the new frontier of personalized medicine. To date, preterm birth may be one of the best examples of genetic susceptibility in obstetrics and gynecology, but many areas are being evaluated including endometriosis, fibroids, polycystic ovarian syndrome, and pelvic floor disorders. An essential component to genetic epidemiological studies is to characterize, or phenotype, the disorder to identify genetic effects. Given the growing importance of genomics and genetic epidemiology, we discuss the importance of accurate phenotyping of clinical disorders and highlight critical considerations and opportunities in phenotyping, using pelvic organ prolapse as a clinical example.

Genetic determinants of pelvic organ prolapse among African American and Hispanic women in the Women's Health Initiative

Current evidence suggests a multifactorial etiology to pelvic organ prolapse (POP), including genetic predisposition. We conducted a genome-wide association study of POP in African American (AA) and Hispanic (HP) women from the Women’s Health Initiative Hormone Therapy study. Cases were defined as any POP (grades 1–3) or moderate/severe POP (grades 2–3), while controls had grade 0 POP. We performed race-specific multiple logistic regression analyses between SNPs imputed to 1000 genomes in relation to POP (grade 0 vs 1–3; grade 0 vs 2–3) adjusting for age at diagnosis, body mass index, parity, and genetic ancestry. There were 1274 controls and 1427 cases of any POP and 317 cases of moderate/severe POP. Although none of the analyses reached genome-wide significance (p<5x10-8), we noted variants in several loci that met p<10−6. In race-specific analysis of grade 0 vs 2–3, intronic SNPs in the CPE gene (rs28573326, OR:2.14; 95% CI 1.62–2.83; p = 1.0x10-7) were associated with POP in AAs, and SNPs in the gene AL132709.5 (rs1950626, OR:2.96; 95% CI 1.96–4.48, p = 2.6x10-7) were associated with POP in HPs. Inverse variance fixed-effect meta-analysis of the race-specific results showed suggestive signals for SNPs in the DPP6 gene (rs11243354, OR:1.36; p = 4.2x10-7) in the grade 0 vs 1–3 analyses and for SNPs around PGBD5 (rs740494, OR:2.17; p = 8.6x10-7) and SHC3 (rs2209875, OR:0.60; p = 9.3x10-7) in the grade 0 vs 2–3 analyses. While we did not identify genome-wide significant findings, we document several SNPs reaching suggestive statistical significance. Further interrogation of POP in larger minority samples is warranted.