Pessaries

子宫托
  • DOI:
    文章类型: Journal Article
    背景:妊娠期盆腔器官脱垂很少见。随之而来的并发症包括宫颈感染,自然流产,和早产。通过子宫托进行保守管理已被描述为改善母体症状并最大程度地减少妊娠风险。交付方式存在争议。
    目的:描述妊娠期间诊断为盆腔器官脱垂的患者的临床过程,并介绍我们的多学科方法。
    方法:在本回顾性病例系列中,我们总结了在一所大学附属医院妊娠期间诊断为盆腔器官脱垂的女性的产科结局.
    结果:我们确定了8名妇女患有晚期子宫脱垂,平均年龄为30.3岁。7例诊断为晚期子宫脱垂(盆腔器官脱垂定量[POPQ]分期≥3)。所有人都通过子宫托放置治疗,这是可以容忍的,并提供症状缓解。根据脱垂阶段选择子宫托类型。在宫颈脱垂POPQ分期>2且宫颈水肿的女性中,支持子宫托的好处不大。然而,用充满空间的Gellhorn子宫托很好地控制了脱垂。低并发症发生率与阴道分娩相关。报告的少数并发症包括轻微的宫颈裂伤,产后出血,并保留胎盘。
    结论:妊娠期间盆腔器官脱垂的治疗必须个体化,需要泌尿科妇科医生的多学科方法,产科医生,营养师,盆底物理治疗师,和社会工作者。保守管理,包括在出现脱垂症状时插入阴道子宫托,为盆底提供足够的支撑,改善症状学,尽量减少妊娠并发症。阴道分娩对大多数妇女是可行的。
    BACKGROUND: Pelvic organ prolapse in pregnancy is rare. Consequent complications include cervical infection, spontaneous abortion, and premature birth. Conservative management by means of a pessary have been described as improving maternal symptomatology and minimizing gestational risk. The delivery mode is controversial.
    OBJECTIVE: To describe the clinical courses of patients diagnosed with pelvic organ prolapse during pregnancy, and to present our multidisciplinary approach.
    METHODS: In this retrospective case series, we summarized the obstetrical outcomes of women diagnosed with pelvic organ prolapse during pregnancy in a single university-affiliated hospital.
    RESULTS: We identified eight women with advanced uterine prolapse at a mean age of 30.3 years. Seven were diagnosed with advanced uterine prolapse (Pelvic Organ Prolapse Quantification [POPQ] stage ≥ 3). All were treated by pessary placement, which was tolerable and provided symptomatic relief. The pessary type was chosen according to the prolapse stage. In women with cervical prolapse POPQ stage > 2 and cervical edema, a support pessary was less beneficial. However, the prolapse was well-controlled with a space-filling Gellhorn pessary. Low complication rates were associated with vaginal deliveries. The few complications that were reported included minor cervical laceration, postpartum hemorrhage, and retained placenta.
    CONCLUSIONS: Treatment of pelvic organ prolapse during pregnancy must be individualized and requires a multidisciplinary approach of urogynecologists, obstetricians, dietitians, pelvic floor physiotherapists, and social workers. Conservative management, consisting of insertion of a vaginal pessary when prolapse symptoms appeared, provided adequate support for the pelvic floor, improved symptomatology, and minimized pregnancy complications. Vaginal delivery was feasible for most of the women.
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  • 文章类型: English Abstract
    研究并比较宫颈阴道栓和孕酮预防宫颈长度短(CL)的单胎孕妇早产的临床效果。
    本研究为前瞻性队列研究。CL≤25mm的孕妇共148例,根据怀孕28周前进行的超声检查确定,包括在研究中。所有受试者均入住华西第二医院,四川大学,2020年8月至2022年12月。根据他们的治疗计划,将孕妇分为宫颈阴道栓组(n=55)和孕酮组(n=93)。妊娠37周前的自发性早产被定义为主要结局指标。在怀孕37、34、32、30和28周之前的早产(流产)或自发性早产(流产),平均延长胎龄,新生儿发病率,新生儿死亡率是次要结局指标.比较两组患者的妊娠结局和新生儿结局,并进行统计学分析。
    早产的发生率无统计学差异(包括医源性早产,自发性早产,和流产)在宫颈栓剂组和孕酮组之间的37、34、32、30和28周之前。当医源性早产被排除在外时,宫颈栓组37周前自发性早产发生率(23.6%)低于孕酮组(41.9%),两组之间的差异具有统计学意义(P=0.024)。在34、32、30和28周之前,自发性早产(包括流产)的发生率没有统计学上的显着差异。新生儿发病率差异无统计学意义,出生后转入新生儿监护病房的比率,两组新生儿死亡率。多因素分析显示,与孕酮治疗相比,宫颈子宫托治疗是37周前自发性早产的保护因素。
    在妊娠中期宫颈长度较短的单胎孕妇中使用宫颈子宫托预防自发性早产,可以显着降低37周前自发性早产的发生率。
    UNASSIGNED: To study and compare the clinical effects of cervical pessary and progesterone for preventing preterm birth in singleton pregnant women with a short cervical length (CL).
    UNASSIGNED: This study was a prospective cohort study. A total of 148 pregnant women with CL≤25 mm, as determined by ultrasound examination performed before 28 weeks of pregnancy, were included in the study. All subjects were admitted to West China Second Hospital, Sichuan University between August 2020 and December 2022. According to their treatment plans, the pregnant women were divided into a cervical pessary group (n=55) and a progesterone group (n=93). Spontaneous preterm birth before 37 weeks of pregnancy was defined as the main outcome index. Preterm birth (abortion) or spontaneous preterm birth (abortion) before 37, 34, 32, 30, and 28 weeks of pregnancy, mean extended gestational age, neonatal morbidity, and neonatal mortality were the secondary outcome indicators. The pregnancy outcomes and the neonatal outcomes of the two groups were compared and statistically analyzed.
    UNASSIGNED: There was no statistically significant difference in the incidence of preterm birth (including iatrogenic preterm birth, spontaneous preterm birth, and abortion) before 37, 34, 32, 30, and 28 weeks between the cervical pessary group and the progesterone group. When iatrogenic preterm birth was excluded, the incidence of spontaneous preterm birth before 37 weeks was lower in the cervical pessary group (23.6%) than that in the progesterone group (41.9%), with the difference between the two groups being statistically significant (P=0.024). There was no statistically significant difference in the incidence of spontaneous preterm birth (including miscarriage) before 34, 32, 30, and 28 weeks. There was no statistically significant difference in the incidence of neonatal morbidity, the rate of transfer to the neonatal care unit after birth, and the neonatal mortality rate between the two groups. Multivariate logistic analysis showed that treatment with cervical pessary was a protective factor for spontaneous preterm birth before 37 weeks compared to progesterone therapy.
    UNASSIGNED: Using cervical pessary to prevent spontaneous preterm birth in singleton pregnant women with a short cervical length in the second trimester can significantly reduce the incidence of spontaneous preterm birth before 37 weeks.
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  • 文章类型: Journal Article
    子宫托是可移动的妇科假体装置,为骨盆底疾病的暂时或长期症状缓解提供机械支持,如盆腔器官脱垂和压力性尿失禁。迄今为止,已经对物理子宫托设计进行了有限的机械测试,以表征它们在负载下的行为;然而,定制子宫托制造是昂贵和耗时的。作为替代,有限元(FE)建模可以提供详细的数值洞察,以响应的阴道环设计在负载下,但迄今为止已经看到有限的应用,很少有数据可用于子宫托硅胶材料。这项研究旨在确定用于定制子宫托茧成型制造的两种有机硅材料的超弹性材料模型,以进行带支撑(RWS)子宫托的环的FE分析。假设可以识别超弹性材料模型,以捕获不同边界条件和有机硅材料(肖氏60A和40A)下多个RWS尺寸的力和变形响应。要了解子宫托硅胶的材料特性,进行了单轴拉伸和压缩测试,然后将实验数据与Mooney-Rivlin(MR)材料模型拟合。为了确保材料模型表征子宫托行为,将代表RWS子宫托折叠和改良的3点弯曲的机械试验数据与应用于子宫托的MR材料的相同试验的FE重建(FEBio)进行比较.FE模型结果表明,对于不同的子宫托尺寸和硅树脂刚度,折叠和3点弯曲模型的力-位移响应具有良好的一致性。这项工作证明了超弹性材料模型的功效,并将使未来的研究能够改善硅胶阴道栓设计的生物力学分析。
    Pessaries are removable gynecological prosthetic devices that provide mechanical support for temporary or long-term symptom relief of pelvic floor disorders, such as pelvic organ prolapse and stress urinary incontinence. To date, limited mechanical tests have been performed on physical pessary designs to characterize their behaviour under load; however, custom pessary manufacturing is expensive and time consuming. As an alternative, finite element (FE) modeling can provide detailed numerical insight into the response of a pessary design under load but to date has seen limited application, with little data available for pessary silicone materials. This study aimed to identify hyperelastic material models for two silicone materials used in custom pessary cocoon moulded manufacturing towards FE analysis of ring with support (RWS) pessaries. It was hypothesized that hyperelastic material models could be identified to capture the force and deformation response of multiple RWS sizes under different boundary conditions and silicone materials (Shore 60A and 40A). To understand the material characteristics of pessary silicone, uniaxial tension and compression tests were performed then the experimental data was fit with Mooney-Rivlin (MR) material models. To ensure the material models characterize the pessary behaviour, data from mechanical tests representing the RWS pessary folding and modified 3-point bending were compared to FE recreations (FEBio) of the same tests with the MR materials applied to the pessaries. The FE model results demonstrated good agreement in the force-displacement response for the fold and 3-point bending models for different pessary sizes and silicone stiffnesses. This work demonstrates the hyperelastic material models\' efficacy and will enable future studies to improve biomechanical analysis of silicone pessary designs.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    目的:系统回顾和综合已知的非药物保守干预措施对女性在体育锻炼过程中经历的尿失禁(UI)管理的有效性。
    方法:2023年9月在以下数据库中进行了系统搜索:在线医学文献分析和检索系统(MEDLINE),护理和相关健康文献累积指数(CINAHL),摘录医学数据库(EMBASE),在线科学电子图书馆(SciELO)拉丁美洲和加勒比健康科学文献(LILACS),和物理治疗证据数据库(PEDro)。如果人群包括在参加体育锻炼时报告UI症状的女性,则研究被认为是合格的。干预措施涉及任何非药物保守治疗,以控制运动期间的症状。主要结果是UI体征和症状的严重程度。该方案已在国际前瞻性系统审查注册(PROSPERO标识符:CRD42022379138)中注册。
    结果:在筛选的3429篇摘要中,保留了19项研究。盆底肌肉训练(PFMT)和阴道内装置是最常用的研究方式。只有两项随机对照试验(RCT),在排球运动员中,将PFMT与没有PFM运动进行比较,仅在实验组干预后显示垫体重增加减少。在士兵中随机进行和不进行生物反馈的PFMT表明,两组的尿液渗漏发作频率均降低。虽然在不同运动项目的运动员中随机分配有监督和无监督的PFMT,但仅在有监督的组中显示垫体重增加减少。七项单臂研究表明,根据问卷调查,单独使用PFMT或与其他方式结合使用可能会降低活跃女性的UI严重程度。膀胱日记,和自我报告的症状。一项单臂交叉研究发现,根据问卷调查和垫体重增加,子宫托的使用有利于减少尿液泄漏,分别。当比较阴道栓时,卫生棉条,没有干预,两项重复测量研究发现,在CrossFit锻炼者和进行有氧运动的女性中,卫生棉条可能比子宫托减少渗漏更多。阴道海绵还可以减少有氧运动期间垫的体重增加。其他模式(即,尿道内装置,光生物调节,和联合疗法)使用病例系列或单一病例研究进行调查。虽然所有干预措施都显示出一些有效性的证据,由于方法学上的局限性和较高的偏倚风险,必须谨慎解释结果.特别是,尽管高度依赖垫测试作为主要结果,我们发现pad试验的管理和解释方式不一致.
    结论:仅通过随机对照试验评估了PFMT减少运动期间尿漏的有效性,有一些有效性的证据。我们明确需要更高质量的研究,通过更好地报告干预措施,以及对结果指标的更明智的使用和解释。
    OBJECTIVE: To systematically review and synthesise what is known about the effectiveness of non-pharmaceutical conservative interventions for the management of urinary incontinence (UI) experienced by women during physical exercise.
    METHODS: A systematic search was performed in the following databases in September 2023: the Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica dataBASE (EMBASE), Scientific Electronic Library Online (SciELO), Latin American and Caribbean Health Sciences Literature (LILACS), and Physiotherapy Evidence Database (PEDro). Studies were deemed eligible if population consisted of females who reported symptoms of UI while participating in physical exercise, and the interventions involved any non-pharmaceutical conservative treatment to manage symptoms during exercise. The primary outcome was severity of UI signs and symptoms. The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO identifier: CRD42022379138).
    RESULTS: Of the 3429 abstracts screened, 19 studies were retained. Pelvic floor muscle training (PFMT) and intravaginal devices were the most commonly investigated modalities. Only two randomised controlled trials (RCTs), both among volleyball players, compared PFMT with no PFM exercise, showing a reduction in pad weight gain after the intervention in the experimental groups only. PFMT with and without biofeedback randomised among soldiers demonstrated a reduction in the frequency of urine leakage episodes in both groups, while supervised and unsupervised PFMT randomised among athletes from different sports showed pad weight gain reduction in the supervised group only. Seven single-arm studies suggested that PFMT alone or combined with other modalities may reduce UI severity in active women based on questionnaires, bladder diaries, and self-reported symptoms. A single-arm and a crossover study found pessary use beneficial in reducing urine leakage based on questionnaires and pad weight gain, respectively. When comparing pessary, tampon, and no intervention, two repeated-measures studies found tampons may reduce leakage more than pessaries in CrossFit exercisers and women performing aerobic exercises. A vaginal sponge also reduced pad weight gain during aerobic exercises. Other modalities (i.e., an intraurethral device, photobiomodulation, and combined therapies) were investigated using case series or single case studies. While all interventions showed some evidence of effectiveness, the results must be interpreted with caution due to methodological limitations and high risk of bias. In particular, despite a high reliance on pad tests as a primary outcome, we identified inconsistencies in how pad tests were administered and interpreted.
    CONCLUSIONS: Only the effectiveness of PFMT to reduce urine leakage during exercise has been evaluated through RCTs, with some evidence of effectiveness. We identified a clear need for higher quality studies, with better reporting on the interventions, and more judicious use and interpretation of outcome measures.
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  • 文章类型: Journal Article
    背景:宫颈环扎术,宫颈子宫托,和阴道孕酮都被证明可以减少高危妇女的早产(PTB),但就我们所知,尚未对3种干预措施进行随机比较.TheSuPPoRT\"Stitch,Pessary,或孕酮随机试验旨在比较妊娠中子宫颈短的女性中每次干预之间的PTB<37周的发生率。
    结果:SuppoRT是一个多中心,2015年7月1日至2021年7月1日,在英国19个产科单元进行了旨在证明等效性(等效性幅度20%)的开放标签三臂随机对照试验.无症状的单胎妊娠妇女,经阴道超声检查宫颈长度<25mm,妊娠14+0至23+6周,符合随机分组(1:1:1)接受阴道宫颈环扎术(n=128),宫颈子宫托(n=126),或阴道孕酮(n=132)。最小化变量是招募时的妊娠,体重指数(BMI),和PTB的危险因素。主要结果是PTB<37周妊娠。次要结果包括PTB<34周,<30周\',和不良的围产期结局。分析是有意治疗。共有386名妊娠14+0至23+6周宫颈长度<25mm的孕妇被随机分配到3种干预措施之一。大约67%是白人,18%的黑人种族,和7.5%的亚洲种族。平均BMI为25.6。约85%的女性先前有PTB的危险因素;39.1%的女性经历过自发性PTB或中期妊娠(>14周妊娠);45.8%的女性曾进行过宫颈手术。来自381名女性的数据可用于结果分析。使用二元回归,发现随机疗法(环扎与子宫托与阴道孕酮)对PTB<37周的主要结局具有相似的影响(39/127对38/122对32/132,p=0.4,环扎与子宫托风险差异(RD)-0.7%[-12.1至10.7],环扎与孕酮RD6.2%[-5.0至17.0],孕酮与子宫托RD-6.9%[-17.9至4.1])。同样,PTB<34周和30周没有差异,也没有不良的围产期结局。干预措施(阴道分泌物和出血)与随机接受黄体酮治疗的妇女报告的腹痛更严重之间的轻度副作用有一些差异。一小部分妇女没有按照协议接受干预;然而,符合方案和处理后的分析显示出相似的结果.主要的研究局限性是该试验对新生儿结局的影响不足,并且由于COVID-19大流行而提前停止。
    结论:在这项研究中,我们发现对于子宫颈短的女性,环扎术,子宫托,和阴道孕酮在预防PTB方面同样有效,以20%的等效余量判断。开始任何治疗将是合理的临床管理。这些结果可用作临床医生在管理宫颈短的妇女时的咨询工具。
    背景:欧盟临床试验注册。EudraCT编号:2015-000456-15,临床试验注册。欧盟。,ISRCTN注册表:ISRCTN13364447,isrctn.com.
    BACKGROUND: Cervical cerclage, cervical pessary, and vaginal progesterone have each been shown to reduce preterm birth (PTB) in high-risk women, but to our knowledge, there has been no randomised comparison of the 3 interventions. The SuPPoRT \"Stitch, Pessary, or Progesterone Randomised Trial\" was designed to compare the rate of PTB <37 weeks between each intervention in women who develop a short cervix in pregnancy.
    RESULTS: SuPPoRT was a multicentre, open label 3-arm randomised controlled trial designed to demonstrate equivalence (equivalence margin 20%) conducted from 1 July 2015 to 1 July 2021 in 19 obstetric units in the United Kingdom. Asymptomatic women with singleton pregnancies with transvaginal ultrasound cervical lengths measuring <25 mm between 14+0 and 23+6 weeks\' gestation were eligible for randomisation (1:1:1) to receive either vaginal cervical cerclage (n = 128), cervical pessary (n = 126), or vaginal progesterone (n = 132). Minimisation variables were gestation at recruitment, body mass index (BMI), and risk factor for PTB. The primary outcome was PTB <37 weeks\' gestation. Secondary outcomes included PTB <34 weeks\', <30 weeks\', and adverse perinatal outcome. Analysis was by intention to treat. A total of 386 pregnant women between 14+0 and 23+6 weeks\' gestation with a cervical length <25 mm were randomised to one of the 3 interventions. Of these women, 67% were of white ethnicity, 18% black ethnicity, and 7.5% Asian ethnicity. Mean BMI was 25.6. Over 85% of women had prior risk factors for PTB; 39.1% had experienced a spontaneous PTB or midtrimester loss (>14 weeks gestation); and 45.8% had prior cervical surgery. Data from 381 women were available for outcome analysis. Using binary regression, randomised therapies (cerclage versus pessary versus vaginal progesterone) were found to have similar effects on the primary outcome PTB <37 weeks (39/127 versus 38/122 versus 32/132, p = 0.4, cerclage versus pessary risk difference (RD) -0.7% [-12.1 to 10.7], cerclage versus progesterone RD 6.2% [-5.0 to 17.0], and progesterone versus pessary RD -6.9% [-17.9 to 4.1]). Similarly, no difference was seen for PTB <34 and 30 weeks, nor adverse perinatal outcome. There were some differences in the mild side effect profile between interventions (vaginal discharge and bleeding) and women randomised to progesterone reported more severe abdominal pain. A small proportion of women did not receive the intervention as per protocol; however, per-protocol and as-treated analyses showed similar results. The main study limitation was that the trial was underpowered for neonatal outcomes and was stopped early due to the COVID-19 pandemic.
    CONCLUSIONS: In this study, we found that for women who develop a short cervix, cerclage, pessary, and vaginal progesterone were equally efficacious at preventing PTB, as judged with a 20% equivalence margin. Commencing with any of the therapies would be reasonable clinical management. These results can be used as a counselling tool for clinicians when managing women with a short cervix.
    BACKGROUND: EU Clinical Trials register. EudraCT Number: 2015-000456-15, clinicaltrialsregister.eu., ISRCTN Registry: ISRCTN13364447, isrctn.com.
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  • 文章类型: Journal Article
    Pelvic floor dysfunction (PFD) is a common clinical problem that can lead to bladder and bowel dysfunction such as urinary incontinence, urinary retention, fecal incontinence, pelvic organ prolapse, and sexual dysfunction. Pelvic floor rehabilitation aids are essential tools in the treatment of PFD. However, there is limited understanding of the efficacy and mechanisms of these aids, and there is a lack of standardized guidelines for selecting appropriate aids for different types of PFD. To assist patients in choosing suitable pelvic floor rehabilitation aids to their needs, it is necessary to summarize the existing types, mechanisms, and applications of these aids. Based on their mechanisms and target functions, pelvic floor rehabilitation aids can be mainly categorized into 3 main types. The first type includes aids that improve pelvic floor function, such as vaginal dumbbells, vaginal tampons, and vaginal dilators, which aim to strengthen pelvic floor muscles and enhance the contractility of the urethral, vaginal, and anal sphincters, thereby improving incontinence symptoms. The second type consists of aids that mechanically block the outlet, such as pessaries, urethral plugs, incontinence pads, incontinence pants, anal plugs, and vaginal bowel control systems, which directly or indirectly prevent incontinence leakage. The third type includes aids that assist in outlet drainage, such as catheters and anal excreta collection devices, which help patients effectively expel urine, feces, and other waste materials, preventing incontinence leakage. By summarizing the existing pelvic floor rehabilitation aids, personalized guidance can be provided to patients with PFD, helping them select the appropriate aids for their rehabilitation needs.
    盆底功能障碍是一种常见的临床问题,可引起膀胱和肠道功能障碍(如尿失禁、尿潴留、粪失禁等)、盆腔器官脱垂、性功能障碍等症状。盆底康复辅助器具是盆底功能障碍治疗中的重要工具。然而,目前对于盆底功能障碍辅助器具疗效和作用机制的了解尚有限,且针对不同类型的盆底功能障碍如何选用合适的辅助器具缺乏规范性。为帮助盆底功能障碍患者个性化地选择适合的盆底康复辅助器具,有必要对现有辅助器具的种类、作用机制和应用情况进行总结。根据盆底康复辅助器具的作用机制和目标功能,可以将其主要分为3类:第1类是改善盆底功能的辅助器具,如阴道哑铃、阴道卫生棉条和阴道扩张器,旨在增强盆底肌肉力量,改善尿道括约肌、阴道括约肌和肛门括约肌的收缩能力,从而改善失禁症状;第2类是阻塞机械出口的辅助器具,如子宫托、尿道栓、失禁垫、失禁裤、肛门塞和阴道肠道控制系统,直接或间接防止失禁渗漏;第3类是出口引流的辅助器具,如导尿管和肛门排泄物收集装置,协助患者有效导出尿液、粪便等废物,预防失禁渗漏。通过对现有盆底康复辅助器具的总结,可以为盆底功能障碍患者提供个性化的指导,并帮助其选择适合的盆底康复辅助器具。.
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  • 文章类型: Journal Article
    目的:子宫托自我管理为女性带来益处,而不会增加并发症的风险。然而,许多人不愿意自我管理,更喜欢临床医生主导的护理。这项研究旨在探索与自我管理子宫托意愿相关的因素。
    方法:在英国一家医院参加子宫托诊所的妇女被要求填写一份问卷,提供有关子宫托使用的答复。合并症,女性生殖器自我形象,自我管理经验和愿意(或不愿意)学习自我管理。根据统计建议,我们的目标是招募90名女性。使用非参数Kruskal-Wallis检验和卡方检验分析数据。对自由文本数据进行了主题分析。
    结果:共有89名妇女完成了问卷。33名女性(38%)以前曾接受过子宫托自我管理的教育。剩下的女人中,12人(21%)愿意学习,28人(50%)不愿意,16人(29%)不确定。女性生殖器自我形象与自我管理子宫托的意愿之间没有相关性。年轻女性更愿意学习自我管理(p=<0.001)。愿意的妇女受到后续访问减少的激励。自我管理的妇女报告的好处包括增加自主权,清洁和给他们的身体“休息”。阻止女性进行自我管理的原因是缺乏自信;感觉身体无法;想要临床医生主导的护理;害怕子宫托的问题或以前的问题。
    结论:大多数女性要么不确定子宫托自我管理,要么不愿自我管理。年龄是我们发现与自我管理子宫托的意愿有重要关系的唯一因素。通过强大的自我管理教学,支持和后续行动,妇女报告的许多障碍很可能可以克服。
    OBJECTIVE: Pessary self-management offers benefits to women with no increased risk of complications. However, many are unwilling to self-manage, preferring clinician-led care. This study is aimed at exploring factors associated with willingness to self-manage a pessary.
    METHODS: Women attending pessary clinic at a UK hospital were asked to complete a questionnaire providing responses on pessary use, comorbidities, female genital self-image, self-management experience and willingness (or not) to learn self-management. Based upon statistical advice we aimed to recruit 90 women. Data were analysed using the non-parametric Kruskal-Wallis test and Chi-squared test. Free text data were analysed thematically.
    RESULTS: A total of 89 women completed the questionnaire. Thirty-three women (38%) had previously been taught pessary self-management. Of the remaining women, 12 (21%) were willing to learn, 28 (50%) were not willing and 16 (29%) were unsure. There was no correlation between female genital self-image and willingness to self-manage a pessary. Younger women were more willing to learn self-management (p =  < 0.001). Willing women were motivated by reduced follow-up visits. Self-managing women reported benefits including increased autonomy, cleanliness and giving their body \"a break\". Reasons discouraging women from self-managing were a lack of confidence; feeling physically unable; wanting clinician-led care; fear of problems or previous problems with their pessary.
    CONCLUSIONS: Most women were either unsure about pessary self-management or unwilling to self-manage. Age was the only factor we found that had a significant relationship with willingness to self-manage a pessary. With robust self-management teaching, support and follow-up, it is likely that many of the barriers women report can be overcome.
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  • 文章类型: Journal Article
    盆腔成像中遇到了各种各样的妇科设备,这可能不是成像的重点或主要原因。这种装置包括子宫托,月经产品,放射治疗设备,输卵管闭塞装置,和避孕装置,包括宫内节育器和阴道内环。本手稿提供了对盆腔成像中遇到的妇科设备的多模态成像外观的全面回顾,并讨论了设备适应症,定位,和并发症。
    There are a wide variety of gynecologic devices encountered on pelvic imaging which may not be the focus or primary reason for imaging. Such devices include pessaries, menstrual products, radiation therapy devices, tubal occlusion devices, and contraceptive devices, including intrauterine devices and intravaginal rings. This manuscript offers a comprehensive review of multimodality imaging appearances of gynecologic devices encountered on pelvic imaging and discusses device indications, positioning, and complications.
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  • 文章类型: Journal Article
    盆腔器官脱垂很常见,会引起不愉快的症状,并对女性的生活质量产生负面影响。在英国,大多数盆腔器官脱垂的女性都会去诊所接受子宫托护理。
    为了确定与临床护理相比,阴道子宫托自我管理对脱垂女性脱垂特定生活质量的临床效果和成本效益;并评估干预可接受性和对有效性的情境影响,坚持和忠诚。
    多中心,平行组,采用混合方法过程评估的优势随机对照试验。
    参加英国NHS门诊子宫托服务的妇女,年龄≥18岁,使用任何类型/材料的子宫托(架子除外,Gellhorn或Cube)至少2周。排除:手动灵活性有限的女性,认知缺陷(禁止同意或自我管理),怀孕或不讲英语。
    自我管理干预涉及30分钟的教学预约,一份信息传单,2周随访电话和当地诊所电话求助热线号码。基于诊所的护理涉及由中心的常规实践确定的常规预约。
    基于Web的远程应用程序;最小化是按年龄计算的,阴道栓型用户类型和中心。
    参与者,实施干预措施的人员和研究人员对小组分配没有盲化.
    患者报告的主要结局(使用盆底影响问卷-7进行测量)是脱垂特异性生活质量,成本-效果结局是随机化后18个月时每质量调整生命年的增量成本(使用专门制定的健康资源使用问卷).次要结果指标包括自我效能感和并发症。过程评估数据通过访谈收集,录音和检查表。分析是有意治疗。
    将三百四十名妇女随机分组(自我管理,n=169;诊所护理,n=171)。随机化后18个月,有291份具有有效主要结果数据的问卷(自我管理,n=139;诊所护理,n=152)。基线经济分析基于264名参与者(自我管理,n=125;诊所护理,n=139),具有有效的生活质量和资源使用数据。自我管理是一种可接受的干预措施。在18个月时,脱垂特异性生活质量没有组差异(校正平均差-0.03,95%置信区间-9.32至9.25)。干预交付是忠诚的。自我管理具有成本效益,每获得质量调整后的生命年的支付意愿门槛为20,000英镑,估计增量净收益为564.32英镑,成本效益概率为80.81%。18个月时,在以临床为基础的护理组中报告了更多的子宫托并发症(校正平均差3.83,95%置信区间0.81~6.86).一般自我效能感没有组间差异,但是自我管理的女性对子宫托自我管理活动更有信心。在这两组中,环境因素对依从性和有效性的影响。没有报告严重的意外严重不良反应。有32起严重不良事件(自我管理,n=17;诊所护理,n=14),都与干预无关。骨盆底影响问卷-7的基线数据出现偏差,全球COVID-19大流行的影响,在招募的样本中,交叉的潜在影响和缺乏种族多样性是可能的局限性.
    自我管理是可以接受且具有成本效益的,与临床治疗相比,脱垂女性的并发症较少,且未改善或恶化其生活质量.未来的研究需要开发一种对女性治疗欲望变化敏感的生活质量衡量标准。
    本研究注册为ISRCTN62510577。
    该奖项由美国国家卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖参考:16/82/01)资助,并在《卫生技术评估》中全文发布。28号23.有关更多奖项信息,请参阅NIHR资助和奖励网站。
    盆腔器官脱垂是大量女性所经历的一种常见且令人痛苦的疾病。脱垂是指通常在骨盆中的器官落入阴道。女人会有一种进入阴道的感觉,随着肠,膀胱和性问题。一种可能的治疗方法是阴道子宫托。子宫托是一种插入阴道并将盆腔器官保持在通常位置的装置。使用阴道子宫托的女性通常每6个月回到诊所,取出并更换子宫托;这被称为基于诊所的护理。然而,女人可以自己照顾子宫托;这叫做自我管理。本研究比较了自我管理和临床护理。240名脱垂妇女参加了会议;171人接受了诊所护理,169人进行了自我管理。每个女人在任何一组中都有平等的机会。自我管理小组中的妇女接受了30分钟的教学任命,一份信息传单,为期2周的后续电话和当地中心的电话号码。根据治疗医疗保健专业人员的建议,诊所护理组中的妇女返回诊所。自我管理被认为是可以接受的。妇女以适合自己生活方式的方式自我管理子宫托。18个月后,两组妇女的生活质量没有差异。与接受诊所护理的女性相比,自我管理组的女性经历的子宫托并发症较少。自我管理的成本低于诊所护理。总之,自我管理没有比诊所护理更能改善妇女的生活质量,但这确实导致女性经历更少的并发症,并且在NHS中交付的成本更低。研究结果支持将自我管理作为使用子宫托治疗脱垂的女性的治疗途径。
    UNASSIGNED: Pelvic organ prolapse is common, causes unpleasant symptoms and negatively affects women\'s quality of life. In the UK, most women with pelvic organ prolapse attend clinics for pessary care.
    UNASSIGNED: To determine the clinical effectiveness and cost-effectiveness of vaginal pessary self-management on prolapse-specific quality of life for women with prolapse compared with clinic-based care; and to assess intervention acceptability and contextual influences on effectiveness, adherence and fidelity.
    UNASSIGNED: A multicentre, parallel-group, superiority randomised controlled trial with a mixed-methods process evaluation.
    UNASSIGNED: Women attending UK NHS outpatient pessary services, aged ≥ 18 years, using a pessary of any type/material (except shelf, Gellhorn or Cube) for at least 2 weeks. Exclusions: women with limited manual dexterity, with cognitive deficit (prohibiting consent or self-management), pregnant or non-English-speaking.
    UNASSIGNED: The self-management intervention involved a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a local clinic telephone helpline number. Clinic-based care involved routine appointments determined by centres\' usual practice.
    UNASSIGNED: Remote web-based application; minimisation was by age, pessary user type and centre.
    UNASSIGNED: Participants, those delivering the intervention and researchers were not blinded to group allocation.
    UNASSIGNED: The patient-reported primary outcome (measured using the Pelvic Floor Impact Questionnaire-7) was prolapse-specific quality of life, and the cost-effectiveness outcome was incremental cost per quality-adjusted life-year (a specifically developed health Resource Use Questionnaire was used) at 18 months post randomisation. Secondary outcome measures included self-efficacy and complications. Process evaluation data were collected by interview, audio-recording and checklist. Analysis was by intention to treat.
    UNASSIGNED: Three hundred and forty women were randomised (self-management, n = 169; clinic-based care, n = 171). At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available (self-management, n = 139; clinic-based care, n = 152). Baseline economic analysis was based on 264 participants (self-management, n = 125; clinic-based care, n = 139) with valid quality of life and resource use data. Self-management was an acceptable intervention. There was no group difference in prolapse-specific quality of life at 18 months (adjusted mean difference -0.03, 95% confidence interval -9.32 to 9.25). There was fidelity to intervention delivery. Self-management was cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, with an estimated incremental net benefit of £564.32 and an 80.81% probability of cost-effectiveness. At 18 months, more pessary complications were reported in the clinic-based care group (adjusted mean difference 3.83, 95% confidence interval 0.81 to 6.86). There was no group difference in general self-efficacy, but self-managing women were more confident in pessary self-management activities. In both groups, contextual factors impacted on adherence and effectiveness. There were no reported serious unexpected serious adverse reactions. There were 32 serious adverse events (self-management, n = 17; clinic-based care, n = 14), all unrelated to the intervention. Skew in the baseline data for the Pelvic Floor Impact Questionnaire-7, the influence of the global COVID-19 pandemic, the potential effects of crossover and the lack of ethnic diversity in the recruited sample were possible limitations.
    UNASSIGNED: Self-management was acceptable and cost-effective, led to fewer complications and did not improve or worsen quality of life for women with prolapse compared with clinic-based care. Future research is needed to develop a quality-of-life measure that is sensitive to the changes women desire from treatment.
    UNASSIGNED: This study is registered as ISRCTN62510577.
    UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/82/01) and is published in full in Health Technology Assessment; Vol. 28, No. 23. See the NIHR Funding and Awards website for further award information.
    Pelvic organ prolapse is a common and distressing condition experienced by large numbers of women. Prolapse is when the organs that are usually in the pelvis drop down into the vagina. Women experience a feeling of something coming down into the vagina, along with bowel, bladder and sexual problems. One possible treatment is a vaginal pessary. The pessary is a device that is inserted into the vagina and holds the pelvic organs back in their usual place. Women who use a vaginal pessary usually come back to clinic every 6 months to have their pessary removed and replaced; this is called clinic-based care. However, it is possible for a woman to look after the pessary herself; this is called self-management. This study compared self-management with clinic-based care. Three hundred and forty women with prolapse took part; 171 received clinic-based care and 169 undertook self-management. Each woman had an equal chance of being in either group. Women in the self-management group received a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a telephone number for their local centre. Women in the clinic-based care group returned to clinic as advised by the treating healthcare professional. Self-management was found to be acceptable. Women self-managed their pessary in ways that suited their lifestyle. After 18 months, there was no difference between the groups in women’s quality of life. Women in the self-management group experienced fewer pessary complications than women who received clinic-based care. Self-management costs less to deliver than clinic-based care. In summary, self-management did not improve women’s quality of life more than clinic-based care, but it did lead to women experiencing fewer complications and cost less to deliver in the NHS. The findings support self-management as a treatment pathway for women using a pessary for prolapse.
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