Female Pelvic Medicine and Reconstructive Surgery最新文献

Patient-reported outcomes (PRO) are important for measuring quality of care, particularly for interventions aimed at improving symptom bother such as procedures for pelvic organ prolapse. We aimed to create a concise yet comprehensive PRO measurement tool to assess pelvic organ prolapse care in high-volume clinical environments.

Methods: The relevant concepts to measure prolapse treatment quality were first established through literature review, qualitative interviews, and a patient and provider-driven consensus-building process. Extant items mapping to these concepts, or domains, were identified from an existing pool of patient-reported symptoms and condition-specific and generic health-related quality of life measures. Item classification was performed to group items assessing similar concepts while eliminating items that were redundant, inconsistent with domains, or overly complex. A consensus meeting was held in March 2020 where patient and provider working groups ranked the remaining candidate items in order of relevance to measure prolapse treatment quality. After subsequent expert review, the revised candidate items underwent cognitive interview testing and were further refined.

Results: Fifteen relevant PRO instruments were initially identified, and 358 items were considered for inclusion. After 2 iterative consensus reviews and 4 rounds of cognitive interviewing with 19 patients, 11 final candidate items were identified. These items map 5 consensus-based domains that include awareness and bother from prolapse, physical function, physical discomfort during sexual activity, pain, and urinary/defecatory symptoms.

Conclusions: We present a concise set of candidate items that were developed using rigorous patient-centered methodology and a national consensus process, including urogynecologic patients and providers.

Importance: The U.S. Food and Drug Administration uses the Manufacturer and User Facility Device Experience database to evaluate the safety of urogynecologic meshes; however, reports on individual meshes have not been characterized.

Objective: The aim of the study was to compare complications among available urogynecologic meshes reported to the Manufacturer and User Facility Device Experience database.

Study design: This study is a cross-sectional analysis of medical device reports (MDRs) of urogynecologic mesh from January 2004 to March 2019, using the Reed Tech Navigator (LexisNexis), which codes MDRs. The percentage of reports containing specific complaints (not an adverse event rate) were compared with χ 2 tests with Dunn-Sidak correction. Correlations with time on market, mesh weight, stiffness, and porosity were determined.

Results: The 34,485 reports examined included 6 transvaginal meshes, 4 sacrocolpopexy meshes, and 10 midurethral slings. Most reported events were pain, erosion, and infection. For transvaginal prolapse, less than 10% of Uphold Lite (Boston Scientific) reports contained pain or erosion versus greater than 90% of Prolift/Prolift+M (Ethicon, P < 0.001). For sacrocolpopexy mesh, greater than 90% of Gynemesh (Ethicon; Prolift in vaginal form) reports included erosion and pain versus less than 60% for Artisyn (Ethicon), Restorelle (Colpoplast), and Upsylon (Boston Scientific, P < 0.0001). For slings, Gynecare TVT Obturator had the highest proportion of erosion and pain complaints. Heavier sling meshes had more reports. When Ascend (Caldera Medical), an outlier with only 5 reports, was excluded, transvaginal mesh stiffness correlated strongly with number of reports. For transvaginal meshes, number of reports correlated with time on market (ρ = 0.8, P = 0.04).

Conclusions: Individual meshes have different properties with different complication profiles, which should inform mesh development and use. Gynemesh MDRs included pain and erosion more frequently than others. Comprehensive registries are needed.

Importance: Urinary tract infections (UTIs) are one of the most common bacterial infections and more frequently affect women than men.

Objectives: Our objective was to determine clinical characteristics associated with a positive urine culture in women seeking treatment for symptoms of UTI.

Study design: In this prospective cohort study, women seeking treatment for UTI symptoms were administered the Urinary Tract Infection Symptom Assessment questionnaire at baseline and at the time of culture results. Participants were grouped by history of recurrent UTI (rUTI) based on chart review. Our primary outcome was the proportion of "positive" urine cultures (≥10 3 colony-forming units) compared between rUTI groups. Characteristics were compared and the relative odds of a positive culture were calculated with a logistic regression model.

Results: Analyses included 152 women, 79 (52%) with rUTI and 73 (48%) with no history of rUTI. Overall, 90 (59.2%) had a positive culture. Participants with a positive culture were more likely to report history of rUTI ( P = 0.01). There was a 2.45-fold increased adjusted odds of a positive culture in those with a history of rUTI (adjusted odds ratio [aOR], 2.45; 95% confidence interval [CI], 1.34-5.03; P = 0.01) when controlling for confounding variables, including scores on the Urinary Tract Infection Symptom Assessment for frequency (aOR, 0.59; 95% CI, 0.40-0.91), dysuria (aOR, 1.53; 95% CI, 1.10-2.12), and age (aOR, 1.02; 95% CI, 1.01-1.05).

Conclusions: In a cohort of women seeking care for UTI symptoms, older women, those with a history of rUTI and those presenting with dysuria are more likely to have a positive urine culture compared with those with urinary frequency.

Importance: Antibiotics are commonly used to treat and prevent urinary tract infection (UTI), but resistance is growing. Nonantibiotic prophylaxis such as methenamine hippurate (MH) shows clinical promise, but its impact on bladder factors influencing recurrent UTIs (rUTIs) is not well described.

Objective: The aim of the study was to examine the effect of MH on bladder inflammation and barrier function in aged mice and women with rUTI.

Study design: This study included urine samples from an experimental study involving aged female mice with and without methenamine treatment as well as women with rUTI who received either no prophylaxis, MH alone, vaginal estrogen therapy and/or d-mannose alone, or MH in addition to vaginal estrogen therapy and/or d-mannose. We performed a comprehensive cytopathological analysis, which included enzyme-linked immunosorbent assay for immunoglobulin A (IgA), interleukin 6 (in human samples), and fluorescein isothiocyanate-conjugated-dextran permeability assay (in mice) to assess for urothelial permeability.

Results: In the aged mice model, there was a decreased urothelial permeability (as seen by retention of fluorescein isothiocyanate-conjugated-dextran fluorescence in superficial cells) and increased urinary IgA in mice treated with MH compared with controls. There was no significant difference in urothelial shedding (P > 0.05). In human samples, there was significantly increased urinary IgA in those taking MH alone compared with no prophylaxis (830.1 vs 540.1 ng/mL, P = 0.04), but no significant difference in interleukin 6.

Conclusions: Methenamine hippurate seems to enhance barrier function as evidenced by decreased urothelial permeability and increased urinary IgA levels, without worsening inflammation. This may reflect another beneficial mechanism by which MH helps prevent rUTI.

Importance: Pessaries are an important conservative therapy for stress urinary incontinence (SUI), but few studies have comprehensively evaluated their utility.

Objective: The objective of this study is to evaluate the existing evidence on the efficacy and safety of pessaries for the treatment of SUI.

Study design: We searched for the terms "stress urinary incontinence" and "pessar/y/ies/ium" in PubMed, Embase, and Cinhal on June 10, 2020. Studies that characterized subjective and/or objective data were included. Studies performed in pediatric populations, pregnancy, and use of pessaries not for SUI were excluded. Two reviewers independently screened and assessed data quality and risk of bias according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Results: Ten studies, including 376 patients, were included. In terms of subjective outcomes, 76% of 72 patients reported feeling continent after pessary treatment compared with 0% of 86 patients surveyed before pessary use (P < 0.0001). Both Urinary Distress Inventory and Incontinence Impact Questionnaire scores decreased significantly by 46.7% (n = 155 baseline, n = 139 follow-up; P < 0.0001) and 67.8% (n = 139 baseline, n = 107 follow-up; P < 0.0001), respectively. Significant objective measures associated with pessary use included increased urethral closure pressure (n = 122; g = 0.56; 95% confidence interval [CI], -0.66 to 1.77; P < 0.049) and decreased pad weight (n = 129 baseline; n = 118 follow-up; g = -0.89; 95% CI, -1.986 to 0.19; P = 0.009). Adverse events significantly decreased at greater than 6 months follow-up compared with less than 6 months follow-up, including pain (31.5%, n = 29/92 vs 14.3%, n = 5/35; P = 0.0513) and discomfort (50%, n = 46/92 vs 29.3%, n = 12/41; P = 0.0268).

Conclusions: Based on both subjective and objective measures, pessaries are an effective conservative treatment option for SUI. This supports pessary use, though larger studies with longer-term follow-up are warranted.