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Manufacturer and User Facility Device Experience Reporting of Events Related to Transvaginal Mesh: Understanding the Data 制造商和用户设备设备经验报告与阴道网状物相关的事件:理解数据
IF 1.6 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2022-04-15 DOI: 10.1097/SPV.0000000000001177
K. Dallas, Colby P. Souders, A. Caron, K. Clark, Ndidiamaka Obi, Lynn Mcclelland, B. Chughtai, K. Eilber, J. Anger
Objective The aim of this study was to examine potential bias in reports to the Manufacturer and User Facility Device Experience (MAUDE) database involving vaginal mesh by identifying the party submitting the report, the nature of the complaints, and whether the reports were edited. Methods All reports submitted to the MAUDE database involving synthetic transvaginal mesh from January 2000 through December 2017 (40,266 safety reports) were identified. A random 2% sample (900) of these reports was reviewed in depth to determine the specific relevant details, including reporter type (patient, manufacturer, lawyer) and details of the complaint/injury. Results Of the 40,226 reports to MAUDE identified, 28,473 (70.7%) were sling reports, and 11,793 (29.3%) described mesh products augmenting pelvic organ prolapse repair. Of the 900 reports reviewed in depth, 46%, 41%, 10%, and 2% of entries were reported by the manufacturer, attorney, health care provider, and patients, respectively. In the 4 years after submission, 18.6% of reports were modified at least once. Conclusions The MAUDE database allows physicians, manufacturers, and patients to immediately report adverse events experienced due to medical devices. While this database is an important means to identify potential danger to patients, any individual can file a report and, thus, it should not be the sole source of evidence to consider when assessing device safety. Further, the MAUDE database provides no information into the total number of cases performed without complication.
目的本研究的目的是通过确定提交报告的一方、投诉的性质以及报告是否经过编辑,来检查制造商和用户设施设备体验(MAUDE)数据库中涉及阴道网片的报告中的潜在偏见。方法对2000年1月至2017年12月提交给MAUDE数据库的所有涉及合成阴道网片的报告(40266份安全报告)进行鉴定。对这些报告中随机2%的样本(900)进行了深入审查,以确定具体的相关细节,包括报告人类型(患者、制造商、律师)和投诉/伤害的细节。结果在40226份MAUDE报告中,28473份(70.7%)是吊带报告,11793份(29.3%)描述了网状物产品增强盆腔器官脱垂修复。在深入审查的900份报告中,制造商、律师、医疗保健提供者和患者分别报告了46%、41%、10%和2%的条目。在提交后的4年内,18.6%的报告至少修改过一次。结论MAUDE数据库允许医生、制造商和患者立即报告因医疗器械而发生的不良事件。虽然该数据库是识别患者潜在危险的重要手段,但任何个人都可以提交报告,因此,在评估设备安全性时,它不应是唯一需要考虑的证据来源。此外,MAUDE数据库没有提供无并发症病例总数的信息。
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引用次数: 0
Trends Among Female Pelvic Medicine and Reconstructive Surgery Fellowships and Graduates 女性盆腔医学和重建外科研究员和毕业生的趋势
IF 1.6 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2022-04-15 DOI: 10.1097/SPV.0000000000001186
K. Gerjevic, E. Brandes, E. Gormley, Samantha G Auty, K. Strohbehn
Importance Understanding differences in female pelvic medicine and reconstructive surgery (FPMRS) urology and gynecology-based fellowships is important because both are accredited by the American Board of Medical Subspecialties. Objective The aim of the study was to characterize urology-based and gynecology-based FPMRS fellowships. Material and Methods An institutional review board–approved 21-item survey was emailed to Accreditation Council for Graduate Medical Education-accredited FPMRS fellowship program directors from January 8 through March 9, 2021. The survey aimed to characterize fellowships through a series of common and specialty-specific questions. Responses were collected with Qualtrics and analyzed using STATA/MP Version 16.1. Results The response rate was 75% (52/69). Many programs accept both gynecology- and urology-trained applicants (urology-based fellowships, 45.4%; gynecology-based fellowships, 68.3%) since the Accreditation Council for Graduate Medical Education accreditation in 2012. Within the gynecology-based cohort, there have been 10 urology-trained graduates among 7 programs (n = 1–2). Barriers to accepting urology applicants were limited gynecologic knowledge/experience (n = 14) and length of training (n = 11). Thirty-seven (94.8%) reported their graduates log more than 30 hysterectomies and 8.3% (n = 3) log 3 or more urinary diversions. Within the urology-based cohort, there have been 16 gynecology-trained graduates among 4 programs (n = 2–7). Lack of urologic clinical knowledge (n = 4) and training length (n = 2) were cited as barriers to accepting gynecology-trained applicants. Three (27%) reported that their graduates log more than 30 hysterectomies, while 8 (72.7%) reported that graduates log 3 or more urinary diversions. Conclusions Despite many FPMRS programs stating that they accept gynecology or urology-trained applicants, few fellows graduate from outside specialty FPMRS training programs. Several barriers were identified that may prevent trainees acceptance outside of their residency specialty. Procedural training experience differs between urology- and gynecology-based fellowships.
重要性了解女性盆腔医学和重建外科(FPMRS)泌尿外科和妇科研究金的差异很重要,因为这两项研究金都得到了美国医学子专业委员会的认可。目的研究以泌尿外科和妇科为基础的FPMRS研究金的特点。材料和方法机构审查委员会批准的21项调查于2021年1月8日至3月9日通过电子邮件发送给研究生医学教育认证委员会认可的FPMRS研究金项目主任。该调查旨在通过一系列常见问题和特定专业问题来描述研究金的特点。使用Qualtrics收集响应,并使用STATA/MP版本16.1进行分析。结果有效率为75%(52/69)。自2012年研究生医学教育认证委员会认证以来,许多项目同时接受妇科和泌尿外科培训的申请人(泌尿外科奖学金,45.4%;妇科奖学金,68.3%)。在以妇科为基础的队列中,7个项目中有10名受过泌尿外科培训的毕业生(n=1-2)。接受泌尿外科申请者的障碍是妇科知识/经验有限(n=14)和培训时间(n=11)。37人(94.8%)报告他们的毕业生记录了30次以上的子宫切除术,8.3%(n=3)记录了3次或3次以上的尿路改道。在以泌尿外科为基础的队列中,4个项目中有16名受过妇科培训的毕业生(n=2-7)。缺乏泌尿外科临床知识(n=4)和培训时间(n=2)被认为是接受妇科培训申请人的障碍。三名(27%)的毕业生报告称,他们的毕业生进行了30多次子宫切除术,而八名(72.7%)的毕业生则报告说,他们进行了3次或3次以上的尿液改道。结论尽管许多FPMRS项目表示接受妇科或泌尿外科培训的申请人,但很少有研究员从专业外的FPMRS培训项目毕业。发现了一些障碍,这些障碍可能会阻碍学员在实习专业之外接受培训。泌尿外科和妇科奖学金的程序培训经验不同。
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引用次数: 0
Assessing the Content and Readability of Robotic and Laparoscopic Sacrocolpopexy Information Online 在线评估机器人和腹腔镜骶管切除术信息的内容和可读性
IF 1.6 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2022-04-14 DOI: 10.1097/SPV.0000000000001184
Remington Lim, Joanna C. Wang, Liz B. Wang, Linda Ng, S. Wason, David S. Wang
Importance Apical pelvic organ prolapse is a common condition that affects women. Currently, sacrocolpopexy is considered the criterion standard surgical treatment, with an increasing preference for minimally invasive techniques. Objective In this study, the content and readability of select internet pages describing robotic and laparoscopic sacrocolpopexy were evaluated. Study Design Using an online key word planner, the phrases “robotic sacrocolpopexy” and “laparoscopic sacrocolpopexy” were determined to be the most popular search terms. These terms were systematically browsed in incognito mode in 3 of the most popular web search engines: Google, Yahoo, and Bing. Links that were nontext primary, duplicate, irrelevant, and non-English were excluded. The Flesch-Kincaid Grade Level and Flesch-Kincaid Reading Ease indices were used to assess readability. Results The average readability of all sites was 12.9, requiring at least a 12th-grade reading level, which is significantly higher than the recommended American Medical Association/National Institutes of Health (AMA/NIH) level of sixth-grade or below. One hundred percent of all analyzed sites were above this recommended sixth-grade reading level. There was no significant difference between mean grade level or reading ease score from the type of web source (P = 0.32 and 0.34, respectively), approach of surgery (P = 0.91, 0.70), or specialty (P = 0.48, 0.36). Conclusions Almost all websites require at least a high school education to properly comprehend, regardless of source or specialty. It is important that health care providers be aware of available information, so they may direct patients to specific resources that are personally validated or provide in-office materials at an appropriate reading level.
重要意义顶端盆腔器官脱垂是影响女性的常见疾病。目前,骶管切除术被认为是标准的外科治疗方法,越来越倾向于微创技术。目的在本研究中,对描述机器人和腹腔镜骶管切除术的精选网页的内容和可读性进行评估。研究设计使用一个在线关键词规划器,短语“机器人骶管切除术”和“腹腔镜骶管切除手术”被确定为最受欢迎的搜索词。这些术语在谷歌、雅虎和必应这三个最受欢迎的网络搜索引擎中被系统地以匿名模式浏览。非文本的主要、重复、不相关和非英语的链接被排除在外。Flesch-Kincaid等级水平和Flesch-Kincaid阅读轻松指数用于评估可读性。结果所有网站的平均可读性为12.9,至少需要12年级的阅读水平,显著高于美国医学会/美国国立卫生研究院推荐的6年级或以下的阅读水平。所有被分析的网站中,百分之百的网站都超过了六年级推荐的阅读水平。网站来源类型(分别为0.32和0.34)、手术方法(P=0.91、0.70)或专业(P=0.48、0.36)的平均年级水平或阅读能力得分之间没有显著差异。结论几乎所有网站都需要至少受过高中教育才能正确理解,无论来源或专业如何。重要的是,医疗保健提供者要了解可用的信息,这样他们就可以指导患者使用经过个人验证的特定资源,或者以适当的阅读水平提供办公室内的材料。
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引用次数: 0
Effect of COVID-19 on Female Pelvic Medicine and Reconstructive Surgery Fellowship Education and Training 新型冠状病毒肺炎对女性骨盆内科及重建外科医师教育培训的影响
IF 1.6 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2022-04-02 DOI: 10.1097/SPV.0000000000001175
Brandy M. Butler, D. Biller
Importance The COVID-19 pandemic has caused a noticeable disruption in national medical and surgical care, including medical training. Objectives We designed a survey to examine the educational effect of the pandemic on female pelvic medicine and reconstructive surgery (FPMRS) training and secondarily to identify areas for innovation and opportunity in FPMRS fellowship training. Study Design We used an online survey, approved by the American Urogynecologic Society Scientific Committee and distributed it to FPMRS fellows with responses obtained and stored in REDCap. Demographic data, educational and surgical experiences, the implications of the changes, and data regarding working from home were collected. Results The survey was completed by 88 fellows, with 92% of respondents being obstetrics and gynecology- based. All 10 geographic regions had at least one response. Six regions had a 50% or greater redeployment rate. Only 16% of respondents were not redeployed or on-call to be redeployed. Eighty-five percent of the ob/gyn fellow redeployments were within their home department. There was no relationship between training region and redeployment. Only 31.7% of the respondents continued to perform any FPMRS surgery. Approximately 35% of the fellows desired the opportunity for surgical simulation training because surgical cases were reduced. No relationship was seen between either redeployment status and needs (P = 0.087–0.893) or difficulties (P = 0.092–0.864) nor training location and needs (P = 0.376–0.935) or difficulties (P = 0.110–0.921). Conclusions There was a high rate of redeployment among fellows; however, this was not associated with their reported needs and difficulties. The FPMRS-related surgical experience was affected during this time, and the fellows desired increased surgical simulation training.
重要性新冠肺炎大流行对包括医疗培训在内的国家医疗和外科护理造成了明显干扰。目的我们设计了一项调查,以检查疫情对女性骨盆医学和重建外科(FPMRS)培训的教育影响,其次确定FPMRS奖学金培训的创新和机会领域。研究设计我们使用了一项由美国泌尿妇科学会科学委员会批准的在线调查,并将其分发给FPMRS研究员,获得并存储在REDCap中。收集了人口统计数据、教育和手术经验、变化的影响以及在家工作的数据。结果本次调查共有88名研究人员参与,其中92%的调查对象为妇产科。所有10个地理区域都至少有一个答复。六个地区的重新部署率达到或超过50%。只有16%的受访者没有被重新部署或随时待命。85%的妇产科同事被重新部署在他们的家庭部门。训练区域和重新部署之间没有关系。只有31.7%的受访者继续进行任何FPMRS手术。大约35%的研究员希望有机会进行手术模拟培训,因为手术病例减少了。调动状态与需求(P=0.087–0.893)或困难(P=0.092–0.864)、培训地点与需求(0.376–0.935)或困难之间均无相关性(P=0.110–0.921);然而,这与他们报告的需求和困难无关。在这段时间里,FPMRS相关的手术经验受到了影响,研究人员希望增加手术模拟训练。
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引用次数: 3
Development of a Simplified Patient-Centered Pelvic Floor Surgery Complication Scale. 以患者为中心的盆底手术并发症简化量表的开发。
IF 1.6 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2022-04-01 DOI: 10.1097/SPV.0000000000001099
Jocelyn Fitzgerald, Holly E Richter, Vivian Sung, Gena Dunivan, Mihriye Mete, Robert E Gutman

Objectives: There does not currently exist a complication scale to evaluate pelvic reconstructive surgery (PRS) that takes in account patient-centered outcomes. The purpose of this study was to characterize and compare patient and surgeon responses to a simplified, patient-centered version of the previously described Pelvic Floor Complication Scale (PFCS).

Methods: This is a multicenter (4 female pelvic medicine and reconstructive surgery practices) cross-sectional study of patients and surgeons. Using focus groups and telephone surveys, the original PFCS questionnaire was simplified. One hundred and twenty-four patients were recruited 6-12 months after PRS. Fifty-seven surgeons were recruited via electronic questionnaires. Surgeons and patients were asked to rank the severity and bother of each complication on a scale of 0 to 5 (0, none; 1, mild; 3, moderate; 5, major).

Results: Patients rated bother higher than severity for 36 of 38 complications (all differences ≤0.5 points). For statistical analysis, the highest response to patient bother/severity was chosen to weigh in favor of the patient. Patient bother/severity scores were significantly different (±0.5 points) for 27 of 38 complications compared with surgeon responses. Surgeon scores were higher for 5 complications (0.5-1.9 point differences) related to major injury requiring repair and wound breakdown. Patient scores were higher for 22 complications with the highest differences related to dyspareunia, constipation, or new/persistent urinary incontinence.

Conclusions: This mixed methods investigation revealed key differences between how patients and surgeons value PRS complications. Surgeons scored major surgical injuries higher than patients, whereas patients rated issues that many surgeons consider quality-of-life outcomes higher due to potential long-term bother. These data will be used to create a simplified, patient-centered PFCS.

目的:目前还没有一个并发症量表来评估骨盆重建手术(PRS),考虑到以患者为中心的结果。本研究的目的是描述和比较患者和外科医生对先前描述的盆底并发症量表(PFCS)的简化,以患者为中心的版本的反应。方法:这是一项多中心(4名女性骨盆医学和重建外科实践)患者和外科医生的横断面研究。采用焦点小组和电话调查,简化了原来的PFCS问卷。124例患者在PRS后6-12个月被招募。57名外科医生通过电子问卷被招募。外科医生和患者被要求将每种并发症的严重程度和麻烦程度按0到5分进行排序(0,无;1、温和;3、中等;5、主要)。结果:38例并发症中,患者对36例的评分高于严重程度(差异均≤0.5分)。为了进行统计分析,选择对患者困扰/严重程度的最高反应来衡量对患者有利。与外科医生的反应相比,38个并发症中的27个患者的困扰/严重程度评分有显著差异(±0.5分)。与需要修复和伤口破裂相关的5种并发症(0.5-1.9分差异)的外科医生评分较高。患者在22种并发症中得分较高,其中与性交困难、便秘或新发/持续性尿失禁相关的差异最大。结论:这种混合方法的调查揭示了患者和外科医生如何评价PRS并发症的关键差异。外科医生对重大手术损伤的评分高于患者,而许多外科医生认为由于潜在的长期困扰,患者对生活质量结果的评分更高。这些数据将用于创建一个简化的、以患者为中心的PFCS。
{"title":"Development of a Simplified Patient-Centered Pelvic Floor Surgery Complication Scale.","authors":"Jocelyn Fitzgerald,&nbsp;Holly E Richter,&nbsp;Vivian Sung,&nbsp;Gena Dunivan,&nbsp;Mihriye Mete,&nbsp;Robert E Gutman","doi":"10.1097/SPV.0000000000001099","DOIUrl":"https://doi.org/10.1097/SPV.0000000000001099","url":null,"abstract":"<p><strong>Objectives: </strong>There does not currently exist a complication scale to evaluate pelvic reconstructive surgery (PRS) that takes in account patient-centered outcomes. The purpose of this study was to characterize and compare patient and surgeon responses to a simplified, patient-centered version of the previously described Pelvic Floor Complication Scale (PFCS).</p><p><strong>Methods: </strong>This is a multicenter (4 female pelvic medicine and reconstructive surgery practices) cross-sectional study of patients and surgeons. Using focus groups and telephone surveys, the original PFCS questionnaire was simplified. One hundred and twenty-four patients were recruited 6-12 months after PRS. Fifty-seven surgeons were recruited via electronic questionnaires. Surgeons and patients were asked to rank the severity and bother of each complication on a scale of 0 to 5 (0, none; 1, mild; 3, moderate; 5, major).</p><p><strong>Results: </strong>Patients rated bother higher than severity for 36 of 38 complications (all differences ≤0.5 points). For statistical analysis, the highest response to patient bother/severity was chosen to weigh in favor of the patient. Patient bother/severity scores were significantly different (±0.5 points) for 27 of 38 complications compared with surgeon responses. Surgeon scores were higher for 5 complications (0.5-1.9 point differences) related to major injury requiring repair and wound breakdown. Patient scores were higher for 22 complications with the highest differences related to dyspareunia, constipation, or new/persistent urinary incontinence.</p><p><strong>Conclusions: </strong>This mixed methods investigation revealed key differences between how patients and surgeons value PRS complications. Surgeons scored major surgical injuries higher than patients, whereas patients rated issues that many surgeons consider quality-of-life outcomes higher due to potential long-term bother. These data will be used to create a simplified, patient-centered PFCS.</p>","PeriodicalId":48831,"journal":{"name":"Female Pelvic Medicine and Reconstructive Surgery","volume":"28 4","pages":"233-239"},"PeriodicalIF":1.6,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9164991/pdf/nihms-1745906.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9232018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Long-Term Outcomes After Midurethral Mesh Sling Surgery for Stress Urinary Incontinence. 中尿道网吊带手术治疗压力性尿失禁的远期疗效。
IF 1.6 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2022-04-01 DOI: 10.1097/SPV.0000000000001094
Sara Z Dejene, Michele Jonsson Funk, Virginia Pate, Jennifer M Wu

Objectives: Although midurethral mesh slings are the criterion standard surgical treatment for stress urinary incontinence (SUI), limited data exist regarding long-term outcomes. Thus, our objectives were to evaluate the long-term risk of sling revision and the risk of repeat SUI surgery up to 15 years after the initial sling procedure and to identify predictors of these outcomes.

Methods: Using a population-based cohort of commercially insured individuals in the United States, we identified women aged 18 years or older who underwent a sling procedure between 2001 and 2018. For sling revision, we evaluated indications (mesh exposure or urinary retention). We estimated the cumulative risks of sling revision and repeat SUI surgery annually using Kaplan-Meier survival curves and evaluated predictors using Cox proportional hazards models.

Results: We identified 334,601 mesh sling surgical procedures. For sling revision, the 10-year and 15-year risks were 6.9% (95% confidence interval [CI], 6.7-7.0) and 7.9% (95% CI, 7.5-8.3), with 48.7% of sling revisions associated with mesh exposure. The 10-year and 15-year risks of repeat SUI surgery were 14.5% (95% CI, 14.2-14.8) and 17.9% (95% CI, 17.3-18.6). Women aged 18-29 years had an elevated risk for both sling revision (hazard ratio, 1.20; 95% CI, 1.15-1.25) and repeat SUI surgery (hazard ratio, 1.30; 95% CI, 1.25-1.37) compared with women 70 years and older.

Conclusions: In our study population, the 15-year risk of sling revision was 7.9%, with nearly half of revisions due to mesh exposure. These findings provide critical long-term data to support informed decisions for women and health care providers considering midurethral mesh slings.

目的:尽管尿道中网吊带是压力性尿失禁(SUI)的标准外科治疗方法,但关于长期结果的数据有限。因此,我们的目的是评估吊带翻修的长期风险和首次吊带手术后15年内重复SUI手术的风险,并确定这些结果的预测因素。方法:使用基于人群的美国商业保险个体队列,我们确定了2001年至2018年期间接受过吊带手术的18岁及以上女性。对于吊带修复,我们评估了适应症(网状物暴露或尿潴留)。我们使用Kaplan-Meier生存曲线估计每年吊带翻修和重复SUI手术的累积风险,并使用Cox比例风险模型评估预测因子。结果:我们确定了334,601目吊带手术。对于吊带修复,10年和15年的风险分别为6.9%(95%置信区间[CI], 6.7-7.0)和7.9% (95% CI, 7.5-8.3),其中48.7%的吊带修复与补片暴露相关。10年和15年重复SUI手术的风险分别为14.5% (95% CI, 14.2-14.8)和17.9% (95% CI, 17.3-18.6)。18-29岁的女性进行吊带翻修的风险较高(风险比,1.20;95% CI, 1.15-1.25)和重复SUI手术(风险比,1.30;95% CI, 1.25-1.37),与70岁及以上的女性相比。结论:在我们的研究人群中,15年吊带翻修的风险为7.9%,近一半的翻修是由于补片暴露。这些发现提供了重要的长期数据,以支持妇女和卫生保健提供者在考虑尿道中网吊带时做出明智的决定。
{"title":"Long-Term Outcomes After Midurethral Mesh Sling Surgery for Stress Urinary Incontinence.","authors":"Sara Z Dejene,&nbsp;Michele Jonsson Funk,&nbsp;Virginia Pate,&nbsp;Jennifer M Wu","doi":"10.1097/SPV.0000000000001094","DOIUrl":"https://doi.org/10.1097/SPV.0000000000001094","url":null,"abstract":"<p><strong>Objectives: </strong>Although midurethral mesh slings are the criterion standard surgical treatment for stress urinary incontinence (SUI), limited data exist regarding long-term outcomes. Thus, our objectives were to evaluate the long-term risk of sling revision and the risk of repeat SUI surgery up to 15 years after the initial sling procedure and to identify predictors of these outcomes.</p><p><strong>Methods: </strong>Using a population-based cohort of commercially insured individuals in the United States, we identified women aged 18 years or older who underwent a sling procedure between 2001 and 2018. For sling revision, we evaluated indications (mesh exposure or urinary retention). We estimated the cumulative risks of sling revision and repeat SUI surgery annually using Kaplan-Meier survival curves and evaluated predictors using Cox proportional hazards models.</p><p><strong>Results: </strong>We identified 334,601 mesh sling surgical procedures. For sling revision, the 10-year and 15-year risks were 6.9% (95% confidence interval [CI], 6.7-7.0) and 7.9% (95% CI, 7.5-8.3), with 48.7% of sling revisions associated with mesh exposure. The 10-year and 15-year risks of repeat SUI surgery were 14.5% (95% CI, 14.2-14.8) and 17.9% (95% CI, 17.3-18.6). Women aged 18-29 years had an elevated risk for both sling revision (hazard ratio, 1.20; 95% CI, 1.15-1.25) and repeat SUI surgery (hazard ratio, 1.30; 95% CI, 1.25-1.37) compared with women 70 years and older.</p><p><strong>Conclusions: </strong>In our study population, the 15-year risk of sling revision was 7.9%, with nearly half of revisions due to mesh exposure. These findings provide critical long-term data to support informed decisions for women and health care providers considering midurethral mesh slings.</p>","PeriodicalId":48831,"journal":{"name":"Female Pelvic Medicine and Reconstructive Surgery","volume":"28 4","pages":"188-193"},"PeriodicalIF":1.6,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9169553/pdf/nihms-1745901.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9232019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Success of Concomitant Versus Interval Slings for Prevention and Treatment of Bothersome de Novo Stress Urinary Incontinence. 与间隔吊带相比,联合吊带成功预防和治疗令人烦恼的新生压力性尿失禁。
IF 1.6 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2022-04-01 DOI: 10.1097/SPV.0000000000001092
Jocelyn J Fitzgerald, Alex Soriano, Joseph Panza, Tanya P Hoke, Shweta P Desai, Amanda M Artsen, Sarah E Andiman, Danielle D Antosh, Robert E Gutman

Background: Despite large trials designed to guide management on whether to perform a prophylactic continence procedure at the time of pelvic organ prolapse (POP) repair, it remains unclear if a staged or interval approach confers advantages in treatment of bothersome stress urinary incontinence (SUI) in women without bothersome SUI before their POP repair.

Objective: The objective of this study was to compare success of concomitant versus interval slings for the prevention/treatment of de novo bothersome SUI after POP repair.

Study design: This multicenter retrospective cohort with prospective follow-up enrolled women with minimal or no SUI symptoms who underwent minimally invasive apical surgery for stage 2 or higher POP between 2011 and 2018 and had a concomitant sling placed at the time of POP surgery or an interval sling placed. Prospectively, all patients were administered the Urogenital Distress Inventory Short-Form 6, the Patient Global Impression of Improvement, and questions on reoperation/retreatment and complications.

Results: A total of 120 patients had concomitant slings, and 60 had interval slings. There were no differences in the proportion of patients who had intrinsic sphincter deficiency (22% vs 20%), although the concomitant sling group was more likely to have a positive cough stress test result (30% vs 8%, P = 0.006). The interval sling group was more likely to report "yes" to SUI symptoms on Urogenital Distress Inventory Short-Form 6 (3% vs 30%, P = 0.0006) and during their postoperative visit (0% vs 24%, P < 0.0001). There were no differences in surgical complications.

Conclusions: Among women with minimal or no SUI symptoms undergoing prolapse repair, concomitant slings resulted in lower rates of bothersome SUI compared with similar women undergoing interval sling placement.

背景:尽管大型试验旨在指导管理人员在盆腔器官脱垂(POP)修复时是否进行预防性尿失禁手术,但目前尚不清楚分阶段或间隔方法对在盆腔器官脱垂(POP)修复前没有烦人的压力性尿失禁(SUI)的女性是否具有治疗优势。目的:本研究的目的是比较联合吊索和间隔吊索在预防/治疗POP修复后新发SUI方面的成功。研究设计:该多中心回顾性队列研究采用前瞻性随访,纳入了2011年至2018年期间因2期或更高期POP接受微创根尖手术并在POP手术时同时放置吊带或间隔放置吊带的无SUI症状或轻微SUI症状的女性。前瞻性研究中,所有患者均接受泌尿生殖窘迫量表短表6、患者总体改善印象、再手术/再治疗和并发症问题的调查。结果:共120例伴发吊带,60例间隔吊带。虽然同时使用吊带的组更有可能出现咳嗽压力测试阳性结果(30%对8%,P = 0.006),但患有内在括约肌缺陷的患者比例没有差异(22%对20%)。在泌尿生殖窘迫量表短表6(3%对30%,P = 0.0006)和术后随访期间,间隔吊带组更有可能报告SUI症状(0%对24%,P < 0.0001)。手术并发症无差异。结论:与间隔放置吊带的女性相比,在接受脱垂修复的女性中,轻微或没有SUI症状的女性,伴随吊带导致的SUI发生率较低。
{"title":"Success of Concomitant Versus Interval Slings for Prevention and Treatment of Bothersome de Novo Stress Urinary Incontinence.","authors":"Jocelyn J Fitzgerald,&nbsp;Alex Soriano,&nbsp;Joseph Panza,&nbsp;Tanya P Hoke,&nbsp;Shweta P Desai,&nbsp;Amanda M Artsen,&nbsp;Sarah E Andiman,&nbsp;Danielle D Antosh,&nbsp;Robert E Gutman","doi":"10.1097/SPV.0000000000001092","DOIUrl":"https://doi.org/10.1097/SPV.0000000000001092","url":null,"abstract":"<p><strong>Background: </strong>Despite large trials designed to guide management on whether to perform a prophylactic continence procedure at the time of pelvic organ prolapse (POP) repair, it remains unclear if a staged or interval approach confers advantages in treatment of bothersome stress urinary incontinence (SUI) in women without bothersome SUI before their POP repair.</p><p><strong>Objective: </strong>The objective of this study was to compare success of concomitant versus interval slings for the prevention/treatment of de novo bothersome SUI after POP repair.</p><p><strong>Study design: </strong>This multicenter retrospective cohort with prospective follow-up enrolled women with minimal or no SUI symptoms who underwent minimally invasive apical surgery for stage 2 or higher POP between 2011 and 2018 and had a concomitant sling placed at the time of POP surgery or an interval sling placed. Prospectively, all patients were administered the Urogenital Distress Inventory Short-Form 6, the Patient Global Impression of Improvement, and questions on reoperation/retreatment and complications.</p><p><strong>Results: </strong>A total of 120 patients had concomitant slings, and 60 had interval slings. There were no differences in the proportion of patients who had intrinsic sphincter deficiency (22% vs 20%), although the concomitant sling group was more likely to have a positive cough stress test result (30% vs 8%, P = 0.006). The interval sling group was more likely to report \"yes\" to SUI symptoms on Urogenital Distress Inventory Short-Form 6 (3% vs 30%, P = 0.0006) and during their postoperative visit (0% vs 24%, P < 0.0001). There were no differences in surgical complications.</p><p><strong>Conclusions: </strong>Among women with minimal or no SUI symptoms undergoing prolapse repair, concomitant slings resulted in lower rates of bothersome SUI compared with similar women undergoing interval sling placement.</p>","PeriodicalId":48831,"journal":{"name":"Female Pelvic Medicine and Reconstructive Surgery","volume":"28 4","pages":"194-200"},"PeriodicalIF":1.6,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9021539/pdf/nihms-1751097.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9281647","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
European Urogynaecological Association 2021 Annual Meeting | Hybrid Edition. 欧洲泌尿妇科协会2021年会|混合版。
IF 1.6 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2022-04-01 DOI: 10.1097/SPV.0000000000001172
{"title":"European Urogynaecological Association 2021 Annual Meeting | Hybrid Edition.","authors":"","doi":"10.1097/SPV.0000000000001172","DOIUrl":"https://doi.org/10.1097/SPV.0000000000001172","url":null,"abstract":"","PeriodicalId":48831,"journal":{"name":"Female Pelvic Medicine and Reconstructive Surgery","volume":"28 4 1","pages":"244-271"},"PeriodicalIF":1.6,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48272676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Characteristics Associated With Repeated Evaluations for Urinary Tract Infections in Older Women: A Case-Control Study. 老年妇女尿路感染重复评估的相关特征:病例对照研究
IF 1.4 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2022-04-01 DOI: 10.1097/SPV.0000000000001129
Megan S Bradley, Michael Stanger, Cassie Ford, Jerry Lowder, Victoria L Handa

Objectives: The aims of this study were to estimate the incidence of repeated evaluations for urinary tract infection (UTI) after a single occurrence and to identify characteristics associated with repeated evaluations in a female Medicare population.

Methods: This was a case-control study of women aged 65 years or older undergoing incident outpatient evaluation for UTI between the years of 2011 and 2018. We defined UTI evaluation as an outpatient encounter with diagnostic codes for UTI and an order for urine culture. We excluded women with diagnostic codes suggestive of a complicated UTI. Among all women with an incident UTI evaluation, cases were defined as those with repeated evaluations, defined as either a total of ≥2 UTI evaluations in 6 months and/or ≥3 in 1 year. The characteristics of cases versus controls were compared with both an unadjusted and adjusted logistic regression model.

Results: Our overall cohort consisted of 169,958, of which 13,779 (8.1%) had repeated evaluations for UTI. In unadjusted analyses, cases were more likely to be older than 75 years, of White race, and to have cardiovascular conditions, diabetes, dementia, renal disease, and chronic obstructive pulmonary disease (all P's < 0.01) as compared with controls. In adjusted analysis, ages 75 years to 84 years (P < 0.01) and ages older than 84 years (P < 0.01) along with multiple medical comorbidities were significant risk factors for repeated evaluations for UTI. Black women had lower odds of repeated evaluations for UTI (P < 0.01).

Conclusions: Among women with a single UTI evaluation, repeated evaluations for UTI were associated with older age, White race, and medical comorbidities. Future studies should investigate racial disparities seen in care-delivery behavior and/or care-seeking behavior.

研究目的本研究的目的是估算女性医保人群在一次尿路感染(UTI)发生后重复评估的发生率,并确定与重复评估相关的特征:这是一项病例对照研究,研究对象是 2011 年至 2018 年间因尿路感染接受门诊评估的 65 岁及以上女性。我们将UTI评估定义为具有UTI诊断代码和尿培养指令的门诊就诊。我们排除了诊断代码提示为复杂性UTI的女性。在所有进行过UTI评估的女性中,病例被定义为重复评估的女性,即在6个月内进行过≥2次UTI评估和/或在1年内进行过≥3次UTI评估。通过未调整和调整后的逻辑回归模型比较了病例与对照组的特征:我们的总体队列由 169 958 人组成,其中 13 779 人(8.1%)因UTI 而重复接受评估。在未经调整的分析中,与对照组相比,病例更有可能年龄超过 75 岁、属于白种人、患有心血管疾病、糖尿病、痴呆症、肾病和慢性阻塞性肺病(所有 P 均小于 0.01)。在调整后的分析中,75 岁至 84 岁(P < 0.01)和 84 岁以上(P < 0.01)以及多种并发症是UTI 重复评估的重要风险因素。黑人妇女重复评估UTI的几率较低(P < 0.01):结论:在接受过一次UTI评估的女性中,UTI重复评估与年龄偏大、白种人和合并症有关。未来的研究应调查在护理提供行为和/或护理寻求行为中出现的种族差异。
{"title":"Characteristics Associated With Repeated Evaluations for Urinary Tract Infections in Older Women: A Case-Control Study.","authors":"Megan S Bradley, Michael Stanger, Cassie Ford, Jerry Lowder, Victoria L Handa","doi":"10.1097/SPV.0000000000001129","DOIUrl":"10.1097/SPV.0000000000001129","url":null,"abstract":"<p><strong>Objectives: </strong>The aims of this study were to estimate the incidence of repeated evaluations for urinary tract infection (UTI) after a single occurrence and to identify characteristics associated with repeated evaluations in a female Medicare population.</p><p><strong>Methods: </strong>This was a case-control study of women aged 65 years or older undergoing incident outpatient evaluation for UTI between the years of 2011 and 2018. We defined UTI evaluation as an outpatient encounter with diagnostic codes for UTI and an order for urine culture. We excluded women with diagnostic codes suggestive of a complicated UTI. Among all women with an incident UTI evaluation, cases were defined as those with repeated evaluations, defined as either a total of ≥2 UTI evaluations in 6 months and/or ≥3 in 1 year. The characteristics of cases versus controls were compared with both an unadjusted and adjusted logistic regression model.</p><p><strong>Results: </strong>Our overall cohort consisted of 169,958, of which 13,779 (8.1%) had repeated evaluations for UTI. In unadjusted analyses, cases were more likely to be older than 75 years, of White race, and to have cardiovascular conditions, diabetes, dementia, renal disease, and chronic obstructive pulmonary disease (all P's < 0.01) as compared with controls. In adjusted analysis, ages 75 years to 84 years (P < 0.01) and ages older than 84 years (P < 0.01) along with multiple medical comorbidities were significant risk factors for repeated evaluations for UTI. Black women had lower odds of repeated evaluations for UTI (P < 0.01).</p><p><strong>Conclusions: </strong>Among women with a single UTI evaluation, repeated evaluations for UTI were associated with older age, White race, and medical comorbidities. Future studies should investigate racial disparities seen in care-delivery behavior and/or care-seeking behavior.</p>","PeriodicalId":48831,"journal":{"name":"Female Pelvic Medicine and Reconstructive Surgery","volume":"28 4","pages":"e133-e136"},"PeriodicalIF":1.4,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9035018/pdf/nihms-1756314.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9580338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Health Care Disparities in Surgical Management of Pelvic Organ Prolapse: A Contemporary Nationwide Analysis 盆腔器官脱垂手术治疗的医疗保健差异:当代全国分析
IF 1.6 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2022-04-01 DOI: 10.1097/SPV.0000000000001173
G. Yadav, E. C. Rutledge, T. Nisar, Jiaqiong Xu, S. Rozycki, T. Muir, D. Antosh
Objectives Our objective was to compare the rate of native tissue repair (NTR) versus sacrocolpopexy (SCP) and reconstructive (RECON) versus obliterative repair (OBR) for the treatment of pelvic organ prolapse (POP), evaluating for health care disparities based on race, socioeconomic, and geographic factors. Methods The National Inpatient Sample database was queried for patients older than 18 years undergoing POP surgery from 2008 to 2018. Baseline demographics, comorbidity index, socioeconomic, and hospital variables were extracted. The weighted t test, Wilcoxon test, and χ2 test were used to compare the rate of (1) NTR versus SCP and (2) RECON vs OBR. Multivariate weighted logistic regression was used to compare while controlling for confounders. Reference groups were White race, Medicare patients, northeast region, small hospital size, and rural location. Results Of 71,262 patients, 67,382 (94.6%) underwent RECON. Patients undergoing OBR were older and had a higher comorbidity score. Multivariate analysis showed the following: (1) Black, Hispanic, and other races; (2) Medicaid patients; (3) patients at urban teaching hospitals are less likely to receive RECON. Patients in the midwest were more likely to receive RECON. Among 68,401 patients, 23,808 (34.8%), and 44,593 (65.19%) underwent SCP and NTR, respectively. Hysterectomy was more common in the NTR group. Multivariate analysis showed the following:(1) Black, Hispanic, and “other” races; (2) uninsured and Medicaid patients; (3) patients in the midwest, south, and west were at higher odds of receiving NTR. Patients in large and urban hospitals were less likely to undergo NTR. Conclusions Racial, socioeconomic, and geographic disparities exist in surgical management for POP warranting further study to seek to eliminate these disparities.
目的我们的目的是比较自然组织修复术(NTR)与骶管切除术(SCP)以及重建术(RECON)与闭塞性修复术(OBR)治疗盆腔器官脱垂(POP)的比率,评估基于种族、社会经济和地理因素的医疗保健差异。方法查询2008年至2018年接受POP手术的18岁以上患者的全国住院患者样本数据库。提取基线人口统计学、共病指数、社会经济和医院变量。加权t检验、Wilcoxon检验和χ2检验用于比较(1)NTR与SCP的比率和(2)RECON与OBR的比率。在控制混杂因素的同时,使用多变量加权逻辑回归进行比较。参考组包括白人、医疗保险患者、东北地区、小型医院和农村地区。结果71262例患者中,67382例(94.6%)接受了RECON。接受OBR的患者年龄较大,合并症评分较高。多因素分析显示:(1)黑人、西班牙裔和其他种族;(2) 医疗补助患者;(3) 城市教学医院的患者接受RECON的可能性较小。中西部的患者更有可能接受RECON。68401名患者中,分别有23808名(34.8%)和44593名(65.19%)接受了SCP和NTR。子宫切除术在NTR组中更常见。多因素分析显示:(1)黑人、西班牙裔和“其他”种族;(2) 未参保和医疗补助患者;(3) 中西部、南部和西部的患者接受NTR的几率更高。大型和城市医院的患者不太可能接受NTR。结论POP手术管理中存在种族、社会经济和地理差异,需要进一步研究以消除这些差异。
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引用次数: 3
期刊
Female Pelvic Medicine and Reconstructive Surgery
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