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Obstet Gynecol. 2010 Feb ;115 (2, Part 1):310-316 20093904 (P,S,G,E,B,D)
From the Departments of Obstetrics and Gynecology and Urology, Loyola University Chicago, Stritch School of Medicine, Chicago, Illinois; the Department of Urology, University of Maryland, Baltimore, Maryland; the New England Research Institutes, Watertown, Massachusetts; the Birmingham VA Medical Center and the Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; the Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas; the Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania; Kaiser Permanente, San Diego, California; the Department of Urology, William Beaumont Hospital, Royal Oak, Michigan; the Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah; and the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.
OBJECTIVE:: To estimate whether prolapse severity is a major contributor to urinary incontinence severity, as measured by validated incontinence questionnaires. METHODS:: We analyzed data from two large female stress urinary incontinence (SUI) surgical cohorts: the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) study (N=655) and the subsequent Trial of Mid-Urethral Slings (TOMUS) study (N=597). All participants completed a standardized baseline assessment including validated measures of symptom severity, quality of life, objective measures of urine loss (Urogenital Distress Inventory [UDI], Medical, Epidemiologic, and Social Aspects of Aging questionnaire, Incontinence Impact Questionnaire, and pad test), as well as the Pelvic Organ Prolapse Quantification assessment. Groups were compared using the chi; test (categorical measures) or the one-way analysis of variance (continuous measures). Statistical significance was defined as P<.05. RESULTS:: The SISTEr and TOMUS samples were similar for many variables including age (52 and 53 years, respectively), nulliparity (9% and 12%), prior urinary incontinence (UI) surgery (14% and 13%), and prior hysterectomy (31% and 28%), but other differences necessitated separate analysis of the two cohorts. There was not a statistically significant difference in UDI scores according to prolapse stage in either study population. Patients with prior surgery for pelvic organ prolapse and SUI had more incontinence symptoms and were more bothered by their UI regardless of prolapse stage. CONCLUSION:: Prolapse stage is not strongly or consistently associated with incontinence severity in women who select surgical treatment of SUI. Prior pelvic organ prolapse and UI surgery is associated with worse UI severity and bother. CLINICAL TRIAL REGISTRATION:: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00064662 and NCT00325039. LEVEL OF EVIDENCE:: II.
BJU Int. 2009 Nov 12;: 19912189 (P,S,G,E,B,D)
Departments of Obstetrics & Gynecology and Urology, Loyola University, Chicago, IL, USA.
OBJECTIVE To identify predictors of self-reported discontinuation of overactive bladder (OAB) medication using a three-phase survey. PATIENTS AND METHODS In January 2005, a phase 1 survey was sent to 260 000 households in the USA to assess the prevalence of OAB symptom bother, treatment patterns and healthcare consulting behaviour. In July 2005, a detailed phase 2 follow-up survey was sent to 6577 phase 1 respondents who had used one or more OAB medications within the 12 months before phase 1; the phase 2 survey included questions about respondents' sociodemographic characteristics, general health status, OAB symptom bother, healthcare consulting behaviour, beliefs about OAB and treatment options, and medication usage. Six months later, a phase 3 survey was sent to 3387 phase-2 respondents who were persistent with OAB medication or had discontinued within <18 months of phase 2; the phase 3 survey measured the same variables as phase 2. Only phase 3 respondents who were persistent with OAB medication at phase 2 were included in the analyses reported here. Assessed were the proportions of respondents who were still persistent with OAB medication at phase 3 and who discontinued OAB medication between phases 2 and 3. The variables measured during the phase 2 survey were screened as potential predictors of discontinuation at phase 3 using univariate analysis and then assessed using multivariate logistic regression. RESULTS Among 2838 respondents at phase 3 (84% response rate), 1194 had recently discontinued and 1644 were persistent with medication at phase 2. Among phase-3 respondents who were persistent at phase 2, 1040 (66%) continued to be persistent at phase 3, 280 (18%) had discontinued between phases 2 and 3, and 261 (17%) had switched medication between phases 2 and 3; 63 respondents had missing prescription information at phase 3. Predictors of discontinuing at phase 3 included smoking (odds ratio 1.80; 95% confidence interval 1.15-2.83; P = 0.010), not knowing whether treating bladder problems requires multiple daily doses of medication (1.71, 1.10-2.67; P = 0.018), believing (2.11, 1.34-3.33; P = 0.001) or not knowing (1.76, 1.23-2.52; P = 0.002) whether adverse effects of OAB medications are often severe, and being bothered 'quite a bit or more' by a sudden urge to urinate (1.54, 1.05-2.26; P = 0.028). Respondents taking two or more medications were less likely to discontinue (odds ratio 0.45-0.58; P < 0.05). CONCLUSION Persistence with OAB medications might be improved by addressing predictors of discontinuation in the management of OAB, by proactively informing patients about the severity of antimuscarinic adverse effects, and dosing regimens. Bother associated with the key OAB symptom, urgency, is a predictor of discontinuation of treatment.
BJU Int. 2009 Nov 12;: 19912188 (P,S,G,E,B,D)
IMS Health, Falls Church, VA, USA.
OBJECTIVE To evaluate patient-reported reasons for discontinuing antimuscarinic prescription medications for overactive bladder (OAB). PATIENTS AND METHODS A phase 1 screening survey was sent to a representative sample of 260 000 households in the USA to identify patients using antimuscarinic agents for OAB. A detailed phase-2 follow-up survey was sent to 6577 respondents with one or more antimuscarinic prescriptions for OAB in the 12 months before the phase 1 survey. The follow-up survey included questions about demographics, clinical characteristics, antimuscarinic use, beliefs about OAB, treatment expectations, OAB symptom bother, and pre-coded reasons for discontinuation. Patients who reported discontinuing one or more OAB medication during the 12 months before phase 2 were grouped by reason, using latent class analysis (LCA); the Lo-Mendell-Rubin likelihood statistical test was used to determine the number of classes. Conditional probabilities of reasons for discontinuation were calculated for each class. Multivariable logistic regression was used to assess the influence of demographic and clinical characteristics on class assignment. RESULTS In all, 162 906 (63%) and 5392 (82%) useable responses were returned in phases 1 and 2, respectively; the demographics were similar in respondents and nonrespondents in both phases. In all, 1322 phase 2 respondents (24.5%) reported discontinuing one or more antimuscarinic drugs during the 12 months before phase 2. LCA identified two classes (Lo-Mendell-Rubin statistic, P = 0.01) based on reasons for discontinuation. Most respondents (89%) reported discontinuing OAB medication primarily due to unmet treatment expectations and/or tolerability; many respondents in this class switched to a new antimuscarinic agent. A smaller group (11%) indicated a general aversion to taking medication. Age, sex, race, income, and history of incontinence were not predictive of class assignment. CONCLUSIONS Expectations about treatment efficacy and side-effects are the most important considerations in discontinuing OAB medications for most patients. Interventions to promote realistic expectations about treatment efficacy and side-effects might enhance adherence.
Neurourol Urodyn. 2009 Sep 21;: 19771598 (P,S,G,E,B,D)
Division of Female Pelvic Medicine and Reconstructive Surgery, Departments of Obstetrics and Gynecology and Urology, Loyola University Stritch School of Medicine, Maywood, Illinois.
INTRODUCTION & HYPOTHESIS: Determine if treatment of urge incontinence with tolterodine results in changes in bladder and/or urethral sensation using Current Perception Threshold (CPT) testing. METHODS: Women with >/=1 incontinence episode on 7-day diary were treated with 4 mg of long-acting tolterodine for 2-months. At baseline and 2-months, participants had CPT testing of the urethral and bladder at 3 frequencies 2000, 250, and 5 Hz. Baseline and post-treatment measures were compared using Wilcoxon Signed Rank Test. RESULTS: Seventeen women underwent baseline CPT testing. Four discontinued medication due to side effects and did not have repeated testing. Urethral CPT at 250 Hz was lower after treatment (median 1.3 [Interquartile range .69--2.1] and .75 [.45--1.2], p =.003) and at 5 Hz trended toward a significant decrease (1.1 [1--1.9] and .84 [.32--1.1], p =.06). CONCLUSIONS: Urethral sensitivity improves after 2-months of tolterodine, suggesting it may restore urethral sensory nerves in addition to known motor effects. Neurourol. Urodynam.(c) 2009 Wiley-Liss, Inc.
Keywords:
Obstet Gynecol. 2009 Sep ;114 (3):600-609 19701041 (P,S,G,E,B,D)
From the 1Obstetrics, Gynecology, and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio; 2Departments of Obstetrics & Gynecology and Urology, Loyola University Chicago, Illinois; 3Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah; 4Department of Obstetrics and Gynecology, University of Alabama-Birmingham, Birmingham, Alabama; 5Department of Obstetrics and Gynecology, University of Texas-Southwestern, Dallas, Texas; 6Data Coordinating Center, University of Michigan, Ann Arbor, Michigan.
OBJECTIVES:: To describe pelvic organ prolapse surgical success rates using a variety of definitions with differing requirements for anatomic, symptomatic, or re-treatment outcomes. METHODS:: Eighteen different surgical success definitions were evaluated in participants who underwent abdominal sacrocolpopexy within the Colpopexy and Urinary Reduction Efforts trial. The participants' assessments of overall improvement and rating of treatment success were compared between surgical success and failure for each of the definitions studied. The Wilcoxon rank sum test was used to identify significant differences in outcomes between success and failure. RESULTS:: Treatment success varied widely depending on definition used (19.2-97.2%). Approximately 71% of the participants considered their surgery "very successful," and 85.2% considered themselves "much better" than before surgery. Definitions of success requiring all anatomic support to be proximal to the hymen had the lowest treatment success (19.2-57.6%). Approximately 94% achieved surgical success when it was defined as the absence of prolapse beyond the hymen. Subjective cure (absence of bulge symptoms) occurred in 92.1% while absence of re-treatment occurred in 97.2% of participants. Subjective cure was associated with significant improvements in the patient's assessment of both treatment success and overall improvement, more so than any other definition considered (P<.001 and <.001, respectively). Similarly, the greatest difference in symptom burden and health-related quality of life as measured by the Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire scores between treatment successes and failures was noted when success was defined as subjective cure (P<.001). CONCLUSION:: The definition of success substantially affects treatment success rates after pelvic organ prolapse surgery. The absence of vaginal bulge symptoms postoperatively has a significant relationship with a patient's assessment of overall improvement, while anatomic success alone does not. CLINICAL TRIAL REGISTRATION:: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00065845. LEVEL OF EVIDENCE:: II.
Ecology. 2009 Jul ;90 (7):1788-801 19694128 (P,S,G,E,B)
College of Forest Resources, Box 352100, University of Washington, Seattle, Washington 98195-2100, USA. lbru@u.washington.edu
Interactions between vegetation and fire have the potential to overshadow direct effects of climate change on fire regimes in boreal forests of North America. We develop methods to compare sediment-charcoal records with fire regimes simulated by an ecologica model, ALFRESCO (Alaskan Frame-based Ecosystem Code) and apply these methods to evaluate potential causes of a mid-Holocene fire-regime shift in boreal forests of the south-central Brooks Range, Alaska, U.S.A. Fire-return intervals (FRIs, number of years between fires) are estimated over the past 7000 calibrated 14C years (7-0 kyr BP [before present]) from short-term variations in charcoal accumulation rates (CHARs) at three lakes, and an index of area burned is inferred from long-term CHARs at these sites. ALFRESCO simulations of FRIs and annual area burned are based on prescribed vegetation and climate for 7-5 kyr BP and 5-0 kyr BP, inferred from pollen and stomata records and qualitative paleoclimate proxies. Two sets of experiments examine potential causes of increased burning between 7-5 and 5-0 kyr BP.(1) Static-vegetation scenarios: white spruce dominates with static mean temperature and total precipitation of the growing season for 7-0 kyr BP or with decreased temperature and/or increased precipitation for 5-0 kyr BP.(2) Changed-vegetation scenarios: black spruce dominates 5-0 kyr BP, with static temperature and precipitation or decreased temperature and/or increased precipitation. Median FRIs decreased between 7-5 and 5-0 kyr BP in empirical data and changed-vegetation scenarios but remained relatively constant in static-vegetation scenarios. Median empirical and simulated FRIs are not statistically different for 7-5 kyr BP and for two changed-vegetation scenarios (temperature decrease, precipitation increase) for 5-0 kyr BP. In these scenarios, cooler temperatures or increased precipitation dampened the effect of increased landscape flammability resulting from the increase in black spruce. CHAR records and all changed-vegetation scenarios indicate long-term increases in area burned between 7-5 and 5-0 kyr BP. The similarity of CHAR and ALFRESCO results demonstrates the compatibility of these independent data sets for investigating ecological mechanisms causing past fire-regime changes. The finding that vegetation flammability was a major driver of Holocene fire regimes is consistent with other investigations that suggest that landscape fuel characteristics will mediate the direct effects of future climate change on boreal fire regimes.
Urology. 2009 Aug 4;: 19660800 (P,S,G,E,B,D)
Mayo Clinic, Rochester, Rochester, Minnesota.
OBJECTIVES: To determine whether Zuidex using a non-cystoscopy mid-urethral injection technique produces as good a result (i.e. was not inferior) as Contigen injected endoscopically at the bladder neck in the treatment of urinary stress incontinence secondary to intrinsic sphincter deficiency in adult women. METHODS: A prospective 2:1 randomized trial of mid-urethral injections of Zuidex-Implacer vs proximal urethral cystoscopic injections of Contigen was performed in 344 women with intrinsic sphincter deficiency at 23 North American sites, and followed up for >1 year from last treatment. RESULTS: Outcomes at 12 months from last treatment failed to demonstrate that mid-urethral injected Zuidex was equivalent to cystoscopically injected Contigen in primary and secondary outcome variables. The primary outcome, the proportion of women who achieved a 50% reduction in urinary leakage on provocation testing, was achieved in 84% of Contigen-treated women vs 65% of Zuidex-treated women. CONCLUSIONS: Confounding multiple variables inherent in the study design make a detailed analysis of study outcomes difficult.
Contemp Clin Trials. 2009 Jul 24;: 19635587 (P,S,G,E,B,D)
Department of Reproductive Medicine, University of California, San Diego, San Diego, CA; Corresponding author. University of California, San Diego Medical Center, Mail Code 0974, 9350 Campus Point Dr, Ste 2A, La Jolla, CA 92037-1300. Tel.:+1 858 657 8435; fax:+1 858 657 6828.
BACKGROUND AND PURPOSE: Urodynamic studies (UDS) are routinely obtained prior to surgery for stress urinary incontinence (SUI) despite a lack of evidence that UDS information has an actual impact on outcome. The primary aim of this non-inferiority randomized clinical trial is to determine whether women with symptomatic, uncomplicated SUI who undergo only a basic office evaluation (BOE) prior to SUI surgery (No UDS arm) have non-inferior treatment outcomes compared to women who have BOE and UDS (UDS arm). Secondary aims are: 1) to determine how often physicians use preoperative UDS results to alter clinical and surgical decision-making, 2)to compare the amount of improvement in incontinence outcomes, and 3) to determine the incremental cost and utility of performing UDS compared with not performing UDS METHODS: After an initial basic office evaluation, women planning surgery for uncomplicated SUI who consent to study participation will be randomized to receive preoperative UDS or No UDS. Treatment will be planned and performed by the surgeon utilizing all the data available to them. We will compare results from the basic office evaluation (No UDS) with results from the basic office evaluation and preoperative UDS. RESULTS: The primary outcome will be measured at 12months using responses to the Urogenital Distress Inventory and the Patient Global Index - Improvement. CONCLUSIONS: Randomized trials comparing the effects of different diagnostic alternatives on treatment outcomes pose study design challenges. A non-inferiority design is appropriate when comparing a less invasive and less expensive alternative with a standard of care approach.
J Magn Reson Imaging. 2009 Jul 23;30 (2):344-350 19629987 (P,S,G,E,B,D)
University of South Florida, College of Medicine, Division of Urogynecology and Pelvic Reconstructive Surgery, Tampa General Hospital, Urogynecology Division, Tampa, Florida.
PURPOSE: To describe inter- and intraobserver reliability of 3D measurements of female pelvic floor structures. MATERIALS AND METHODS: Twenty reconstructed MR datasets of primiparas at 6-12 months postpartum were analyzed. Pelvic organ measurements were independently made twice by three radiologists blinded to dataset order. A "within-reader" analysis, a "between-reader" analysis, and the intraclass correlation (ICC), and standard deviation ratio (SDR) were computed for each parameter. Fifteen continuous variables and one categorical variable were measured. RESULTS: Eight continuous parameters showed excellent agreement (ICC >0.85 / SDR <0.40), five parameters showed relatively good agreement (ICC >0.70 / SDR >/=0.40,<0.60). Two parameters showed poor agreement (ICC </=0.70 and/or SDR >/=0.60). The categorical variable showed poor agreement. CONCLUSION: Agreement was best where landmark edges were well defined, acceptable where more "reader judgment" was needed, and poor where levator defects made landmarks difficult to identify. Automated measurement algorithms are under study and may improve agreement in the future. J. Magn. Reson. Imaging 2009;30:344-350.(c) 2009 Wiley-Liss, Inc.
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