- [Show abstract] [Hide abstract] ABSTRACT: Background: Female urinary microbiota are associated with urgency urinary incontinence and response to medication. The urinary microbiota of women with stress urinary incontinence has not been described. Objective: Study the cross-sectional relationships between urinary microbiota features and demographic and clinical characteristics of women undergoing stress urinary incontinence surgery. Study design: Pre-operative urine specimens were collected from women without urinary tract infection and were available from 197 women (174 voided, 23 catheterized) enrolled in a multi-center prospective randomized trial, the Value of Urodynamic Evaluation study. Demographic and clinical variables were obtained including stress urinary incontinence and urgency urinary incontinence symptoms, menopausal status, and hormone use. The bacterial composition of the urine was qualitatively assessed by sequencing the bacterial 16S ribosomal RNA gene. Phylogenetic relatedness and microbial alpha diversity were compared to demographics and symptoms using generalized estimating equation models. Results: The majority of 197 urine samples (86%) had detectable bacterial DNA. Bacterial diversity was significantly associated with higher BMI (p=0.02), increased Medical, Epidemiologic, and Social Aspects of Aging, urge index score (p=0.04), and hormonal status (p<0.001). No associations were detected with stress urinary incontinence symptoms. Increased diversity was also associated with a concomitant lower frequency of Lactobacillus in hormone-negative women. Conclusions: Women undergoing stress urinary incontinence surgery have detectable urinary microbiota. This cross-sectional analysis revealed that increased diversity of the microbiota was associated with urgency urinary incontinence symptoms, hormonal status and BMI. In contrast, the female urinary microbiota were not associated with stress urinary incontinence symptoms.
- [Show abstract] [Hide abstract] ABSTRACT: Objective: To longitudinally assess the effect of native tissue vaginal apical prolapse repair with anti-incontinence surgery on quality of life, sexual function, and body image between uterosacral and sacrospinous suspensions. Methods: A planned secondary analysis was performed on 374 women enrolled in a randomized trial of the two types of native tissue repair for apical prolapse. Condition-specific and generic quality of life, sexual function, overall and de novo dyspareunia, and body image were assessed using validated instruments at baseline; 6, 12, and 24 months postoperatively; and changes from baseline were assessed and compared between surgical groups. General linear mixed models were used for comparisons and clinically significant differences were assessed using minimum important differences. Results: Of the women randomized, 82% had outcomes available at 2 years. Overall, clinically and statistically significant improvements in generic and condition-specific quality of life and sexual function were observed after surgery. Dyspareunia rates decreased from 25% to 16% by 24 months with only 3% of all women undergoing treatment. De novo dyspareunia occurred in 5% and 10% by 12 and 24 months, respectively. Body image scores also significantly improved from baseline. There were no clinically meaningful or statistically significant differences between groups for any of these outcomes (all P>.05). Conclusion: Native tissue vaginal prolapse surgery results in statistically and clinically significant improvements in quality of life, sexual function, and body image at 24 months with no significant differences between uterosacral and sacrospinous suspensions. One in 10 women experience de novo dyspareunia but few requested treatment. Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00597935.
- [Show abstract] [Hide abstract] ABSTRACT: Objectives: Medication adherence with urgency urinary incontinence (UUI) treatment is challenging and the best assessment methodology is uncertain. We sought to describe adherence with anticholinergic (AC) versus placebo (P) by comparing pill counts and MEMSCAP event data and to identify factors associated with adherence. Methods: The randomized controlled AC versus Botox Comparison trial of women with moderate to severe idiopathic UUI included 126 participants initiating AC plus P bladder injection and 121 receiving P pills plus Botox injection. Adherence data on 243 participants (124 AC and 119 P) were calculated by pill count and MEMSCAP data for each 2-month interval during the 6-month study that allowed for dose escalation/drug change. Overall composite adherence estimates were calculated using the average of both methods and weighted by the duration of each 2-month interval. Results: Treatment groups had no significant differences in dosing duration (P = 0.76) or mean adherence (AC, 83.3% [16.8] vs P, 84.8% [13.8]). Only 53% of women met the dichotomous outcome of more than 80% adherence during all intervals. Correlation between adherence by pill counts versus MEMSCAP decreased over time with pill counts demonstrating higher adherence than MEMSCAP (r = 0.53, 0.50, and 0.36 for each 2-month interval). Lower adherence was associated with higher baseline incontinence severity and better UUI quality of life for the AC group and with current smoking status in both groups. Conclusions: Adherence using pill counts and MEMSCAP was reasonably correlated and similar in both the AC and P groups. In the AC group, higher baseline incontinence severity and better UUI Quality of Life were associated with decreased adherence. Smokers were less adherent.
- [Show abstract] [Hide abstract] ABSTRACT: To assess change in overactive bladder (OAB) symptoms up to 5 years after surgery and to identify associated predictors of change from baseline. This is a secondary analysis of data from three multicenter urinary incontinence (UI) surgical trials of women with stress-predominant mixed UI assigned to Burch colposuspension, autologous fascial sling, or retropubic or transobturator midurethral slings. The primary outcome was improvement of 70% or greater from baseline in symptoms measured by the Urinary Distress Inventory-Irritative subscale. Surgical groups were compared within respective trials. Generalized linear models were fit using 1-year and up to 5-year data. Significant improvements in Urinary Distress Inventory-Irritative scores were reported by each surgical group 1 year after surgery (P<.001). Most women (50-71%) reported improvement in OAB symptoms. Improvements were similar between midurethral sling groups at 1 year (65.5% compared with 70.7%, P=.32; odds ratio [OR] 0.83, 95% confidence interval [CI] 0.57-1.20 for retropubic compared with transobturator sling) and throughout the 5-year follow-up period. More women reported OAB symptom improvement after Burch compared with pubovaginal sling (67.9% compared with 56.6%, P=.01; OR 1.59, 95% CI 1.10-2.31 for Burch compared with sling); this group difference at 1 year persisted throughout the 5-year follow-up. At 1-year, 50.0-64.3% of patients reported 70% greater improvement in UI. This proportion declined to 36.5-54.1% at 5 years (P<.001). Preoperative use of anticholinergics and urodynamic parameters was not predictive of OAB symptom change after surgery. Most women with stress-predominant mixed UI experienced significant improvement in OAB symptoms after incontinence surgery although this initial improvement diminished over time. Obesity blunted symptom improvement. II.
- [Show abstract] [Hide abstract] ABSTRACT: This study aimed to describe the incidence of fecal incontinence (FI) at 6, 12, and 24 weeks postpartum; anal incontinence (AI) and fecal urgency at 24 weeks; and identify predictors of AI in women with obstetric anal sphincter injury (OASI). Primiparous women sustaining OASIs were identified at 8 clinical sites. Third-degree OASIs were characterized using World Health Organization criteria, 3a (<50%) or 3b (>50%) tear through the sphincter. Fecal incontinence was defined as leakage of liquid/solid stool and/or mucus in the past month; AI was defined as leakage of liquid/solid stool and/or mucus and/or gas in the past month and was assessed at 6, 12, and 24 weeks postpartum using the Fecal Incontinence Severity Index. Logistic regression identified variables associated with AI. Three hundred forty-three women participated: 297 subjects sustained a third-degree OASI, 168 type 3a, 98 type 3b and 31 indeterminant; 45 had a fourth-degree OASI. Overall FI incidence at 6, 12, and 24 weeks was 7% [23/326; 95% confidence interval (CI), 4%-10%], 4% (6/145; 95% CI, 2%-9%), and 9% (13/138; 95% CI, 5%-16%), respectively. At 24 weeks, AI incidence was 24% (95% CI, 17%-32%) and fecal urgency 21% (95% CI, 15%-29%). No significant differences in FI and AI rates were noted by third-degree type or between groups with third and fourth OASI. Flatal incontinence was greater in women sustaining a fourth-degree tear (35% vs 16%, P = 0.04). White race (adjusted odds ratio, 4.64; 95% CI, 1.35-16.02) and shorter duration of second stage (adjusted odds ratio, 1.47 per 30 minute decrease; 95% CI, 1.12-1.92) were associated with AI at 24 weeks. Overall 24-week incidence of FI is 9% (95% CI, 5%-16%) and AI is 24% (95% CI, 17%-32%). In women with OASI, white race and shorter second-stage labor were associated with postpartum AI.Clinical Trial Registration: NCT01166399 (http://clinicaltrials.gov).
- [Show abstract] [Hide abstract] ABSTRACT: AimsTo examine treatment options selected for recurrent stress urinary incontinence (rSUI) in follow-up after Burch, autologous fascial and synthetic midurethral sling (MUS) procedures.Methods We performed a secondary analysis of the SISTER and ToMUS trials of participants who underwent primary stress urinary incontinence (SUI) treatment (without prior SUI surgery or concomitant procedures). Using Kaplan–Meier analysis, retreatment-free survival rates by initial surgical procedure were compared. Mean MESA (Medical Epidemiologic and Social Aspects of Aging) stress index was also compared between those retreated for rSUI compared to those not retreated.ResultsHalf of the women in the SISTEr trial met inclusion criteria for this analysis (329/655, 174 Burch and 155 fascial sling), as did 444/597 (74%) of subjects in ToMUS (221 transobturator midurethral sling (TMUS), and 223 retropubic midurethral sling (RMUS). Types of surgical retreatment included autologous fascial sling (19), synthetic sling (1), and bulking agent (18). Five-year retreatment free survival rates (and standard errors) were 87% (3%), 96% (2%), 97% (1%), and 99% (0.7%) for Burch, autologous fascial sling, TMUS, and RMUS groups respectively (P < 0.0001). For all index surgery groups, the mean MESA stress index at last visit prior to retreatment for those retreated (n = 23) was significantly higher than mean MESA stress index at last visit for those not retreated (n = 645) (P < 0.0001).Conclusion In these cohorts, 6% of women after standard anti-incontinence procedures were retreated within 5 years, mostly with injection therapy or autologous fascial sling. Not all women with rSUI chose surgical retreatment. Neurourol. Urodynam. © 2015 Wiley Periodicals, Inc.
- [Show abstract] [Hide abstract] ABSTRACT: We conducted a genome-wide linkage analysis to identify pelvic organ prolapse (POP) predisposition genes using a resource of high-risk POP pedigrees. Cases are defined as women who reported bothersome symptoms of POP based on standardized symptom questions (Pelvic Floor Distress Inventory (PFDI), moderately or quite bothered), and/or received treatment for POP documented in medical records. Our complete pedigree resource contains 299 familial POP cases in 83 high-risk pedigrees. Genotype data were obtained from Illumina HumanHap550, 610Q, the Human1M-Duo, Human Omni1-Quad, or the Human Omni 2.5 platforms. A set of single nucleotide polymorphism (SNP) markers common to all platforms was identified and markers in high linkage disequilibrium were removed. We performed a genome-wide linkage analysis under general dominant and recessive models using a Markov Chain, Monte Carlo linkage analysis method implemented in MCLINK software. Because 70 individuals in 32 pedigrees were used in a previously published linkage analysis for a phenotype of POP requiring treatment/surgery, we also performed linkage only including the 225 newly recruited and genotyped cases in 61 pedigrees. Linkage analysis using our complete pedigree resource for the loosened criteria of bothersome POP showed evidence for significant genome-wide linkage on chromosome 10q24-26 (recessive model, max HLOD 3.4); suggestive evidence was identified on chromosomes 6, 17, and an additional region on chromosome 10. In the subset of only the newly recruited familial POP cases, significant evidence for genome-wide linkage was observed on chromosome 17q25 (recessive model, max HLOD 3.3), and suggestive evidence for linkage was observed on chromosomes 10 and 11. Neither analysis duplicated the previously published linkage evidence for the POP-requiring-treatment/surgery phenotype observed on chromosome 9. While the etiology of this common condition is unknown, this study provides evidence that loci on chromosomes 10q and 17q may contribute to POP etiology. Copyright © 2014 Elsevier Inc. All rights reserved.
- [Show abstract] [Hide abstract] ABSTRACT: To identify genetic variants associated with urgency urinary incontinence (UUI) in post-menopausal women. A two-stage genome wide association analysis was conducted to identify variants associated with UUI. The Women's Health Initiative-Genomics & Randomized Trials Network (GARNET) sub-study with 4,894 genotyped post-reproductive white women was randomly split into independent discovery and replication cohorts. Genome-wide imputation was performed using IMPUTE2 with the 1000-Genomes-ALL-Phase-I integrated variant set as a reference. Controls reported no UUI at enrollment or follow-up; cases reported monthly or greater UUI and leaked sufficiently to wet/soak underpants/clothes. Logistic regression models were used to predict UUI case versus control status based on genotype, assuming additive inheritance. Age, obesity, diabetes and depression were included in the models as covariates. Following quality control, 975,508 single nucleotide polymorphisms (SNPs) in 2,241 cases (discovery=1,102, replication=1,133) and 776 controls (discovery=405, replication=371) remained. Genotype imputation resulted in 9,077,347 SNPs and insertions/deletions with minor allele frequency >0.01 available for analysis. Meta-analysis of the discovery and replication samples identified six loci on chromosomes 5, 10, 11, 12 & 18 associated with UUI at p<10(-6). Three of the loci were within genes, the zinc finger protein 521 (ZFP521) gene on chromosome 18q11, the ADAMTS16 gene on chromosome 5p15, and the CIT gene on chromosome 12q24. The other three loci were intergenic. Although environmental factors also likely contribute, this first exploratory Genome-Wide Associated Study (GWAS) for UUI suggests that genetic variants in the ZFP521, CIT, and ADAMTS16 genes might account for some of the observed heritability of the condition. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
- [Show abstract] [Hide abstract] ABSTRACT: Introduction and hypothesis: Understanding the clustering of pelvic floor disorders (PFDs) within families is important because it may suggest underlying risk factors that may be environmental, genetic or both. The objective of this study was to describe clinical characteristics observed in familial cases with PFDs and compare them with strictly defined controls. Methods: Women evaluated and treated for PFDs were recruited as part of a larger genetic study. Here, we define familial cases as those with bothersome symptoms or treatment for a PFD (pelvic organ prolapse [POP], stress urinary incontinence [SUI], and overactive bladder [OAB]) and who had a first-degree relative with bothersome symptoms or treatment for the same pelvic floor defect. We assigned clinical characteristics to probands and their relatives using standardized symptom questions (PFDI), examination, and review of treatment records, if any. Results: We identified 126 familial POP cases, 183 familial SUI cases, and 101 familial OAB cases. Familial cases were more likely to have bothersome symptoms for more than one PFD. Among familial POP cases, bothersome SUI (71 %), OAB (54 %), and a combination of all three disorders (48 %) were common. Among familial SUI cases, bothersome OAB (60 %), POP (59 %), and combinations of all disorders (40 %) were common. Among familial OAB cases, bothersome SUI (88 %), POP (66 %), and combinations of all three disorders (59 %) were common. Conclusions: Familial cases of POP, SUI, and OAB are more likely to have more than one pelvic floor defect. It is likely that underlying genetic factors contribute to more than one pelvic floor defect.
- [Show abstract] [Hide abstract] ABSTRACT: Objectives: Urological chronic pelvic pain syndrome includes interstitial cystitis/painful bladder syndrome (IC/PBS), a chronic bladder pain condition of unknown etiology. Interstitial cystitis/painful bladder syndrome can co-occur with a number of associated conditions such as irritable bowel syndrome and fibromyalgia. The purpose of this study was to estimate the heritability of approximately 20 associated conditions in first-degree relatives (and if appropriate, second- and third-degree relatives) of patients with IC/PBS to identify shared genetic contributions for the disease combinations. Methods: We used the Utah Population Database, a unique population-based genealogical database that has been linked to electronic health records for the University of Utah Health Sciences Center back in 1994. Interstitial cystitis/painful bladder syndrome probands were identified by the International Classification of Diseases, Ninth Revision code for chronic interstitial cystitis and had genealogy information for 12 of their 14 immediate ancestors. We calculated excess risk of an associated condition in relatives of patients with IC/PBS using relative risk estimates. Results: We identified 248 IC/PBS probands. We found that 2 associated conditions, myalgia and myositis/unspecified (fibromyalgia) as well as constipation, were in significant excess in the patients with IC/PBS themselves, their first-degree relatives, and their second-degree relatives. The excess risk among relatives between IC/PBS and these associated conditions also held in the converse direction. Excess risk of IC/PBS was observed in the first- and second-degree relatives in probands with myalgia and myositis/unspecified (fibromyalgia) and in probands with constipation. Conclusions: These results suggest that myalgia and myositis/unspecified (fibromyalgia) as well as constipation are likely to share underlying genetic factors with IC/PBS.
- [Show abstract] [Hide abstract] ABSTRACT: Aims: Urodynamic studies (UDS) are generally recommended prior to surgical treatment for stress urinary incontinence (SUI), despite insufficient evidence that it impacts treatment plans or outcomes in patients with uncomplicated SUI. This analysis aimed to calculate the cost incurred when UDS was performed as a supplement to a basic office evaluation and to extrapolate the potential savings of not doing UDS in this patient population on a national basis. Methods: This is a secondary analysis from the Value of Urodynamic Evaluation (ValUE) trial, a multicenter non-inferiority randomized trial to determine whether a basic office evaluation (OE) is non-inferior in terms of SUI surgery outcomes to office evaluation with addition of urodynamic studies (UDS). All participants underwent an OE; those patients who randomized to supplementary UDS underwent non-instrumented uroflowmetry, filling cystometry, and a pressure flow study. Costs associated with UDS were calculated using 2014 U.S. Medicare allowable fees. Models using various patient populations and payor mixes were created to obtain a range of potential costs of performing UDS in patients undergoing SUI surgery annually in the United States. Results: Six hundred thirty women were randomized to OE or OE plus UDS. There was no difference in surgical outcomes between the two groups. The per patient cost of UDS varied from site to site, and included complex cystometrogram $314-$343 (CPT codes 51728-51729) plus complex uroflowmetry $16 (CPT code 51741). Extrapolating these costs for US women similar to our study population, 13-33 million US dollars could be saved annually by not performing preoperative urodynamics. Conclusion: For women with uncomplicated SUI and a confirmatory preoperative basic office evaluation, tens of millions of dollars US could be saved annually by not performing urodynamic testing. In the management of such women, eliminating this preoperative test has a major economic benefit. Neurourol. Urodynam. 9999:1-4, 2014. © 2014 Wiley Periodicals, Inc.
- [Show abstract] [Hide abstract] ABSTRACT: The objectives of this study are (1) to describe the presenting symptoms, findings, and treatment and (2) to describe the self-reported improvement and function at least 6 months after presentation in women presenting to 1 urogynecology division for complications associated with synthetic vaginal mesh. Women evaluated between 2006 and 2011 were identified by diagnostic codes. We abstracted information from the medical record and attempted to contact all women to complete a follow-up telephone survey questionnaire consisting of several validated instruments. A total of 111 women were evaluated for complications associated with synthetic vaginal mesh. The mean interval from index surgery was 2.4 years. Of these, 84% were referred from outside hospitals. Index surgeries included vaginal mesh kits/vaginally placed mesh (47%), midurethral mesh slings (37%), abdominally placed vaginal mesh (11%), and vaginal mesh kit with concomitantly placed mesh sling (5%). The most common complications were extrusion (65%), contraction (17%), and chronic pelvic pain (16%). A total of 98 women underwent some type of treatment (85 surgical) by urogynecologists, pelvic pain specialists, or physical therapists. Eighty-four (76%) provided follow-up information at mean interval since presentation of 2.3 years. At follow-up, the mean (SD) Pelvic Floor Distress Inventory score was 98 (67), the mean (SD) EQ-5D index score was 0.69 (0.23), and 22% reported vaginal discharge, 15% vaginal bleeding or spotting, and 45% sexual abstinence due to problems related to mesh. A total of 71% reported being overall better, whereas 29% were the same or worse. Two years after tertiary care level multidisciplinary treatment of vaginal mesh complications, many women still report symptoms that negatively impact their quality of life.
- [Show abstract] [Hide abstract] ABSTRACT: Purpose: Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings. Materials and methods: Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort. The primary outcome, treatment success, was defined as no re-treatment or self-reported stress incontinence symptoms. Secondary outcomes included urinary symptoms and quality of life, satisfaction, sexual function and adverse events. Results: Of 597 women 404 (68%) from the original trial enrolled in the study. Five years after surgical treatment success was 7.9% greater in women assigned to the retropubic sling compared to the transobturator sling (51.3% vs 43.4%, 95% CI -1.4, 17.2), not meeting prespecified criteria for equivalence. Satisfaction decreased during 5 years but remained high and similar between arms (retropubic sling 79% vs transobturator sling 85%, p=0.15). Urinary symptoms and quality of life worsened with time (p <0.001), and women with a retropubic sling reported greater urinary urgency (p=0.001), more negative impact on quality of life (p=0.02) and worse sexual function (p=0.001). There was no difference in the proportion of women experiencing at least 1 adverse event (p=0.17). Seven new mesh erosions were noted (retropubic sling 3, transobturator sling 4). Conclusions: Treatment success decreased during 5 years for retropubic and transobturator slings, and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit. However, satisfaction remained high in both arms. Women undergoing a transobturator sling procedure reported more sustained improvement in urinary symptoms and sexual function. New mesh erosions occurred in both arms over time, although at a similarly low rate.
- [Show abstract] [Hide abstract] ABSTRACT: Objective To estimate the effect of Burch and fascial sling surgery on out-of-pocket urinary incontinence (UI) management costs at 24 months post-operatively and identify predictors of change in cost among women enrolled in a randomized trial comparing these procedures. Methods Resources used for UI management (supplies, laundry, dry cleaning) were self-reported by 491 women at baseline and 24 months post-surgery and total out-of-pocket costs for UI management (in 2012 US dollars) were estimated. Data from the two surgical groups were combined to examine change in cost for UI management over 24 months. Univariate and bivariate changes in cost were analyzed using Wilcoxon signed rank test. Predictors of change in cost were examined using multivariate mixed models. Results At baseline mean (±SD) age of participants was 53±10 years, and frequency of weekly UI episodes was 23±21. Weekly UI episodes decreased by 86% at 24 months (P<0.001). Mean weekly cost was $16.60±$27 (median $9.39) at baseline and $4.57±$15 (median $0.10) at 24 months (P<0.001), a decrease of 72%. In multivariate analyses, cost decreased by $3.38±$0.77 per week for each decrease of 1 UI episode per day (P<0.001) and was strongly associated with greater improvement in UDI and IIQ scores (P<0.001) and decreased 24-hour pad weight (P<0.02). Conclusion Following Burch or fascial sling surgery, UI management cost at 24 months decreased by 72% ($625 per woman per year) and was strongly associated with decreasing UI frequency. Reduced out-of-pocket expenses may be a benefit of these established urinary incontinence procedures.
- [Show abstract] [Hide abstract] ABSTRACT: AimsThe Blaivas–Groutz nomogram defines voiding obstruction in women using Qmax from the NIF and the maximum detrusor pressure (Pdetmax) from the PFS. The aim of this study was to understand the relationship between NIF and PFS maximum flow rates in women with stress incontinence.Methods We analyzed the UDS of 597 women with stress-dominant urinary incontinence. Each subject underwent a NIF and then a PFS. Mixed model was used to test the hypothesis that the relationship between flow rates and voided volume (VV) were similar for NIF and PFS.ResultsThere were 452 subjects with both NIF and PFS studies that met the inclusion criteria and had max flow rate (Qmax) for both NIF and PFS. The mean age was 53. Overall, higher VV were observed during PFS compared to NIF and subjects had higher Qmax with NIF compared to PFS. The relationship between Qmax and VV was significantly different between NIF and PFS (P < 0.004). At 200 ml, NIF Qmax was 14% higher than PFS Qmax and this difference increased to 30% at 700 ml.Conclusion The difference between PFS Qmax and NIF Qmax increases as VV increase. As a result, values from PFS and NIF cannot be used interchangeably as has been suggested in the Blaivas–Groutz nomogram for obstruction in women. Neurourol. Urodynam. © 2014 Wiley Periodicals, Inc.
University of Utah
Salt Lake City, Utah, United States
- Department of Obstetrics and Gynecology