Objective To identify the factors contributing to tacker dislodgement and associated complications during sacrospinous ligament fixation (SSF) procedures. Design Retrospective study. Setting Tertiary medical center. Population Six hundred and seventy‐six patients with stage ≥ 3 pelvic organ prolapse (POP) who underwent SSF with anchor‐based devices (tackers) between April 2018 and November 2023. Methods Of these, 657 underwent SSF with transvaginal mesh (Surelift: 463; Calistar‐S: 194), and 19 underwent SSF with Anchorsure alone. Patients were grouped into secure ( n = 649) and dislodged tacker ( n = 27) groups. Standardised institutional protocols, included pre‐operative assessments, validated Chinese questionnaires at baseline and follow‐up at 6 and 12 months postoperatively. Main Outcome Measures Determine the occurrence of a tacker dislodge during application and the injury caused to the patient and the operator. Results Tacker dislodgement occurred in 2.2% of the cases. The dislodged group had a significantly higher BMI ( p < 0.001) and prevalence of hypertension ( p = 0.004). Complications in this group included two bladder injuries and four operator injuries, including glove tears and finger cuts ( p < 0.001). The secure group demonstrated significantly less blood loss than the non‐secure group ( p < 0.001). Objective and subjective cure rates were high and comparable between the groups: 95.5% and 94.4% for the secure group and 90% for the dislodged group. The quality of life and sexual function outcomes were similarly favourable. Conclusion SSF using a tacker‐based device was safe and effective. Recognising the risks associated with tacker dislodgement can enhance preparedness and minimise complications for both patients and operators.
{"title":"Operator and Patient Injuries From Tacker Dislodgement During Sacrospinous Ligament Fixation: A Retrospective Study","authors":"Tsia‐Shu Lo, Louiza Erika Rellora, Chien‐Chien Yu, Ai‐Leen Ro, Chia‐Hsuan Yang","doi":"10.1111/1471-0528.70089","DOIUrl":"https://doi.org/10.1111/1471-0528.70089","url":null,"abstract":"Objective To identify the factors contributing to tacker dislodgement and associated complications during sacrospinous ligament fixation (SSF) procedures. Design Retrospective study. Setting Tertiary medical center. Population Six hundred and seventy‐six patients with stage ≥ 3 pelvic organ prolapse (POP) who underwent SSF with anchor‐based devices (tackers) between April 2018 and November 2023. Methods Of these, 657 underwent SSF with transvaginal mesh (Surelift: 463; Calistar‐S: 194), and 19 underwent SSF with Anchorsure alone. Patients were grouped into secure ( <jats:italic>n</jats:italic> = 649) and dislodged tacker ( <jats:italic>n</jats:italic> = 27) groups. Standardised institutional protocols, included pre‐operative assessments, validated Chinese questionnaires at baseline and follow‐up at 6 and 12 months postoperatively. Main Outcome Measures Determine the occurrence of a tacker dislodge during application and the injury caused to the patient and the operator. Results Tacker dislodgement occurred in 2.2% of the cases. The dislodged group had a significantly higher BMI ( <jats:italic>p</jats:italic> < 0.001) and prevalence of hypertension ( <jats:italic>p</jats:italic> = 0.004). Complications in this group included two bladder injuries and four operator injuries, including glove tears and finger cuts ( <jats:italic>p</jats:italic> < 0.001). The secure group demonstrated significantly less blood loss than the non‐secure group ( <jats:italic>p</jats:italic> < 0.001). Objective and subjective cure rates were high and comparable between the groups: 95.5% and 94.4% for the secure group and 90% for the dislodged group. The quality of life and sexual function outcomes were similarly favourable. Conclusion SSF using a tacker‐based device was safe and effective. Recognising the risks associated with tacker dislodgement can enhance preparedness and minimise complications for both patients and operators.","PeriodicalId":8984,"journal":{"name":"BJOG: An International Journal of Obstetrics & Gynaecology","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145593463","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Prossy Namirembe, Alice Nassanga, Christopher Baleke, Beatrice Nanyonga, Ronald Kyasanku, Sophie Belfield, Denis Ssenyondwa, Esther Martha Haruri, Shamirah Nakalema, Katherine A. Thomas, Denis Ndekezi, Kate Andrews Nelson, Belen Torondel‐Lopez, Helen A. Weiss
Objective To describe menstrual pain and pain management, and the associations of pain relief with school absenteeism and educational performance, among Ugandan adolescents. Design Cross‐sectional mixed‐methods study, nested within a school‐based cluster randomised controlled trial. Setting and Population Adolescent girls in 60 secondary schools in Uganda. Methods Quantitative surveys, focus group discussions and in‐depth interviews were conducted. Data were analysed using thematic framework analysis for qualitative data, and random‐effects regression analysis for quantitative data. Main Outcome Measures Self‐reported pain during the last menstrual period (LMP), school absenteeism and educational performance. Results Among 2683 participants, the majority ( n = 2227; 83.0%) reported pain during their LMP and were more likely to miss school than those without pain (mean days missed per month 2.1 vs. 1.4; adjusted incidence rate ratio [aIRR] = 1.46, 95% CI 1.30–1.65). Participants reported that menstrual pain hindered their ability to engage at school, leading to reduced class attendance and participation. Pain management strategies (painkillers, warm water bottles, stretching, or exercise) were reported by 1587 (71.3%) participants with pain at LMP, and were less commonly reported among participants with mental health problems and poorer menstrual self‐efficacy. Participants who did not report pain relief missed more school days than those who did report pain relief (aIRR = 1.39, 95% CI 1.11–1.74). Conclusion Menstrual pain without effective relief was associated with increased school absenteeism. There is a need to improve the uptake of effective pain relief strategies in Ugandan schools and similar settings.
目的描述乌干达青少年的月经疼痛和疼痛管理，以及疼痛缓解与旷课和学习成绩的关系。设计横断面混合方法研究，嵌套在以学校为基础的随机对照试验中。环境和人口：乌干达60所中学的少女。方法采用定量调查法、焦点小组讨论法和深度访谈法。定性数据采用专题框架分析，定量数据采用随机效应回归分析。主要观察指标：自我报告的末次月经疼痛（LMP）、缺勤率和学习成绩。结果在2683名参与者中，大多数（n = 2227; 83.0%）在LMP期间报告疼痛，并且比没有疼痛的人更有可能缺课（平均每月缺课天数2.1 vs. 1.4；调整后的发病率比[aIRR] = 1.46, 95% CI 1.30-1.65）。参与者报告说，月经疼痛阻碍了他们在学校的参与能力，导致上课出勤率和参与度下降。1587名（71.3%）LMP疼痛参与者报告了疼痛管理策略（止痛药、温水瓶、伸展或运动），而在有心理健康问题和月经自我效能较差的参与者中较少报告。未报告疼痛缓解的受试者比报告疼痛缓解的受试者缺课天数更多（aIRR = 1.39, 95% CI 1.11-1.74）。结论无有效缓解的经期疼痛与缺勤率增加有关。有必要在乌干达的学校和类似的环境中改进有效的止痛策略。
{"title":"Menstrual Pain Management, School Absenteeism and Educational Performance Among Adolescent Students: Cross‐Sectional Mixed‐Methods Analysis Nested Within a Cluster Randomised Trial","authors":"Prossy Namirembe, Alice Nassanga, Christopher Baleke, Beatrice Nanyonga, Ronald Kyasanku, Sophie Belfield, Denis Ssenyondwa, Esther Martha Haruri, Shamirah Nakalema, Katherine A. Thomas, Denis Ndekezi, Kate Andrews Nelson, Belen Torondel‐Lopez, Helen A. Weiss","doi":"10.1111/1471-0528.70094","DOIUrl":"https://doi.org/10.1111/1471-0528.70094","url":null,"abstract":"Objective To describe menstrual pain and pain management, and the associations of pain relief with school absenteeism and educational performance, among Ugandan adolescents. Design Cross‐sectional mixed‐methods study, nested within a school‐based cluster randomised controlled trial. Setting and Population Adolescent girls in 60 secondary schools in Uganda. Methods Quantitative surveys, focus group discussions and in‐depth interviews were conducted. Data were analysed using thematic framework analysis for qualitative data, and random‐effects regression analysis for quantitative data. Main Outcome Measures Self‐reported pain during the last menstrual period (LMP), school absenteeism and educational performance. Results Among 2683 participants, the majority ( <jats:italic>n</jats:italic> = 2227; 83.0%) reported pain during their LMP and were more likely to miss school than those without pain (mean days missed per month 2.1 vs. 1.4; adjusted incidence rate ratio [aIRR] = 1.46, 95% CI 1.30–1.65). Participants reported that menstrual pain hindered their ability to engage at school, leading to reduced class attendance and participation. Pain management strategies (painkillers, warm water bottles, stretching, or exercise) were reported by 1587 (71.3%) participants with pain at LMP, and were less commonly reported among participants with mental health problems and poorer menstrual self‐efficacy. Participants who did not report pain relief missed more school days than those who did report pain relief (aIRR = 1.39, 95% CI 1.11–1.74). Conclusion Menstrual pain without effective relief was associated with increased school absenteeism. There is a need to improve the uptake of effective pain relief strategies in Ugandan schools and similar settings.","PeriodicalId":8984,"journal":{"name":"BJOG: An International Journal of Obstetrics & Gynaecology","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145592867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Matteo Pavone, Chiara Innocenzi, Nicola Macellari, Chiara Cantarini, Massimo Criscione, Andrea Rosati, Lise Lecointre, Antonella Carcagnì, Barbara Costantini, Jacques Marescaux, Anna Fagotti, Francesco Fanfani, David Cibula, Denis Querleu, Nicolò Bizzarri
Objective Although large language models are increasingly used in clinical and research settings, the validity of the information they provide remains uncertain. This study aimed to evaluate the accuracy, consistency, and reliability of three large language models—ChatGPT 4.0, DeepSeek R1, and Gemini 2.0—in answering cervical cancer‐related questions based on the ESGO/ESTRO/ESP guidelines. Design Prospective, comparative in silico benchmarking study. Setting Fondazione Policlinico Universitario A. Gemelli, Rome, Italy. Population or Sample: Fifty questions derived from the ESGO/ESTRO/ESP (European Society of Gynaecologic Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology) Guidelines for Cervical Cancer. Methods Each question was submitted simultaneously to ChatGPT 4.0, DeepSeek R1, and Gemini 2.0, and re‐entered twice to assess response repeatability. Answers were evaluated for accuracy using a Global Quality Score (GQS) from 1 (poor) to 5 (completely accurate). Consistency (intra‐model response stability) and reliability (alignment with guidelines) were assessed using binary classification. Main Outcome Measures: Median GQS, percentage of GQS 5 responses, consistency between repeated answers, and reliability. Results ChatGPT 4.0 achieved the highest performance, with 42% of responses rated GQS 5, followed by Gemini 2.0 (30%) and DeepSeek R1 (28%). DeepSeek R1 and Gemini 2.0 scored lower in median GQS (3.50) compared to ChatGPT 4.0 (4.00). Response consistency varied significantly, with ChatGPT 4.0 and DeepSeek R1 showing differences from Gemini 2.0 ( p = 0.034 and p = 0.044, respectively). No significant difference was observed in reliability ( p = 0.602). Conclusion All models demonstrated suboptimal accuracy in aligning with clinical guidelines. ChatGPT 4.0 was the most accurate and consistent whereas DeepSeek R1 underperformed. Despite similar reliability across models, expert oversight remains essential to ensure safe clinical application and prevent misinformation.
{"title":"Assessing the Accuracy of Large Language Models on European Guidelines for Cervical Cancer: An In Silico Benchmarking Study","authors":"Matteo Pavone, Chiara Innocenzi, Nicola Macellari, Chiara Cantarini, Massimo Criscione, Andrea Rosati, Lise Lecointre, Antonella Carcagnì, Barbara Costantini, Jacques Marescaux, Anna Fagotti, Francesco Fanfani, David Cibula, Denis Querleu, Nicolò Bizzarri","doi":"10.1111/1471-0528.70095","DOIUrl":"https://doi.org/10.1111/1471-0528.70095","url":null,"abstract":"Objective Although large language models are increasingly used in clinical and research settings, the validity of the information they provide remains uncertain. This study aimed to evaluate the accuracy, consistency, and reliability of three large language models—ChatGPT 4.0, DeepSeek R1, and Gemini 2.0—in answering cervical cancer‐related questions based on the ESGO/ESTRO/ESP guidelines. Design Prospective, comparative in silico benchmarking study. Setting Fondazione Policlinico Universitario A. Gemelli, Rome, Italy. Population or Sample: Fifty questions derived from the ESGO/ESTRO/ESP (European Society of Gynaecologic Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology) Guidelines for Cervical Cancer. Methods Each question was submitted simultaneously to ChatGPT 4.0, DeepSeek R1, and Gemini 2.0, and re‐entered twice to assess response repeatability. Answers were evaluated for accuracy using a Global Quality Score (GQS) from 1 (poor) to 5 (completely accurate). Consistency (intra‐model response stability) and reliability (alignment with guidelines) were assessed using binary classification. Main Outcome Measures: Median GQS, percentage of GQS 5 responses, consistency between repeated answers, and reliability. Results ChatGPT 4.0 achieved the highest performance, with 42% of responses rated GQS 5, followed by Gemini 2.0 (30%) and DeepSeek R1 (28%). DeepSeek R1 and Gemini 2.0 scored lower in median GQS (3.50) compared to ChatGPT 4.0 (4.00). Response consistency varied significantly, with ChatGPT 4.0 and DeepSeek R1 showing differences from Gemini 2.0 ( <jats:italic>p</jats:italic> = 0.034 and <jats:italic>p</jats:italic> = 0.044, respectively). No significant difference was observed in reliability ( <jats:italic>p</jats:italic> = 0.602). Conclusion All models demonstrated suboptimal accuracy in aligning with clinical guidelines. ChatGPT 4.0 was the most accurate and consistent whereas DeepSeek R1 underperformed. Despite similar reliability across models, expert oversight remains essential to ensure safe clinical application and prevent misinformation.","PeriodicalId":8984,"journal":{"name":"BJOG: An International Journal of Obstetrics & Gynaecology","volume":"139 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145592868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Rising Trends and Inequalities in Pre‐Existing Diabetes in Pregnancy: A Population‐Based Time‐Trend Analysis","authors":"Hasan Jamil, Roham Hadidchi, Stuart Gilmour","doi":"10.1111/1471-0528.70098","DOIUrl":"https://doi.org/10.1111/1471-0528.70098","url":null,"abstract":"","PeriodicalId":8984,"journal":{"name":"BJOG: An International Journal of Obstetrics & Gynaecology","volume":"70 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145594058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kristyn Dunlop, Sophie Callanan, Kaat Philippe, Catherine McNestry, Alexander Douglass, Ricardo Segurado, Rachel K. Crowley, Patrick J. Twomey, Catherine M. Phillips, Fionnuala M. McAuliffe
Objective To explore associations between pregnancy metabolic complications and maternal cardiometabolic health 10 years postpartum. Design Prospective Longitudinal Cohort Study following a randomised controlled trial. Setting Single‐centre. Population Pregnancy metabolic complication (pregnancy‐induced hypertension, impaired glucose tolerance, or gestational diabetes) versus an uncomplicated pregnancy in secundigravid women who previously delivered a macrosomic infant. Methods Health and lifestyle data were obtained from 422 women during pregnancy and again 10 years postpartum. Anthropometry, dual‐energy X‐ray absorptiometry scans, and non‐fasting blood samples were recorded 10 years postpartum. Unadjusted and adjusted linear regression explored associations between pregnancy metabolic complications and cardiometabolic markers with adjustment for potential confounders (study group allocation, age at follow‐up, maternal ethnicity, early pregnancy body mass index (BMI), use of cardiometabolic medications, maternal smoking at 10 years postpartum, and socio‐economic status). Main Outcome Measures Cardiometabolic risk profile 10 years postpartum. Results Of 422 women, 27.7% ( n = 117) experienced a metabolic complication in pregnancy. Pregnancy metabolic complications were associated with greater postpartum weight retention ( ß = 1.72, 95% CI 0.08, 3.36), higher BMI ( ß = 0.70, 95% CI 0.09, 1.31), greater visceral adipose tissue mass ( ß = 0.12, 95% CI 0.01, 0.23), greater total cholesterol ( ß = 0.36, 95% CI 0.15, 0.58), greater LDL‐cholesterol ( ß = 0.29, 95% CI 0.09, 0.50), greater triglycerides ( ß = 0.06, 95% CI 0.03, 0.32), and greater glucose ( ß = 0.22, 95% CI 0.03, 0.40) at 10 years postpartum. Conclusions Pregnancy metabolic complications were associated with an altered cardiometabolic risk profile 10 years postpartum.
目的探讨产后10年妊娠代谢并发症与产妇心脏代谢健康的关系。设计：随机对照试验后的前瞻性纵向队列研究。设置单一的中心。妊娠代谢并发症（妊娠引起的高血压、糖耐量受损或妊娠糖尿病）与先前生过巨大婴儿的二次妊娠妇女的无并发症妊娠比较方法对422名妇女进行孕期和产后10年的健康和生活方式调查。人体测量、双能X线吸收测量扫描和产后10年非空腹血液样本记录。未调整和调整的线性回归探讨了妊娠代谢并发症与心脏代谢标志物之间的关系，并调整了潜在的混杂因素（研究组分配、随访年龄、母亲种族、妊娠早期体重指数（BMI）、使用心脏代谢药物、产后10年母亲吸烟和社会经济地位）。主要观察指标产后10年心脏代谢风险概况。结果422例妇女中，27.7% （n = 117）发生妊娠期代谢并发症。怀孕的代谢并发症与更大的产后体重保留(ß= 1.72,95% CI 0.08, 3.36),高BMI(ß= 0.70,95% CI 0.09, 1.31),更大的内脏脂肪组织质量(ß= 0.12,95% CI 0.01, 0.23),更大的总胆固醇(ß= 0.36,95% CI 0.15, 0.58),更大的低密度脂蛋白胆固醇应承担(ß= 0.29,95% CI 0.09, 0.50),更大的甘油三酯(ß= 0.06,95% CI 0.03, 0.32),和更大的葡萄糖(ß= 0.22,95% CI 0.03, 0.40)在10年产后。结论妊娠代谢并发症与产后10年心脏代谢风险相关。
{"title":"The Impact of Metabolic Complications in Pregnancy on Later Life Maternal Cardiometabolic Health: Findings From the ROLO Longitudinal Cohort Study","authors":"Kristyn Dunlop, Sophie Callanan, Kaat Philippe, Catherine McNestry, Alexander Douglass, Ricardo Segurado, Rachel K. Crowley, Patrick J. Twomey, Catherine M. Phillips, Fionnuala M. McAuliffe","doi":"10.1111/1471-0528.70092","DOIUrl":"https://doi.org/10.1111/1471-0528.70092","url":null,"abstract":"Objective To explore associations between pregnancy metabolic complications and maternal cardiometabolic health 10 years postpartum. Design Prospective Longitudinal Cohort Study following a randomised controlled trial. Setting Single‐centre. Population Pregnancy metabolic complication (pregnancy‐induced hypertension, impaired glucose tolerance, or gestational diabetes) versus an uncomplicated pregnancy in secundigravid women who previously delivered a macrosomic infant. Methods Health and lifestyle data were obtained from 422 women during pregnancy and again 10 years postpartum. Anthropometry, dual‐energy X‐ray absorptiometry scans, and non‐fasting blood samples were recorded 10 years postpartum. Unadjusted and adjusted linear regression explored associations between pregnancy metabolic complications and cardiometabolic markers with adjustment for potential confounders (study group allocation, age at follow‐up, maternal ethnicity, early pregnancy body mass index (BMI), use of cardiometabolic medications, maternal smoking at 10 years postpartum, and socio‐economic status). Main Outcome Measures Cardiometabolic risk profile 10 years postpartum. Results Of 422 women, 27.7% ( <jats:italic>n</jats:italic> = 117) experienced a metabolic complication in pregnancy. Pregnancy metabolic complications were associated with greater postpartum weight retention ( <jats:italic>ß</jats:italic> = 1.72, 95% CI 0.08, 3.36), higher BMI ( <jats:italic>ß</jats:italic> = 0.70, 95% CI 0.09, 1.31), greater visceral adipose tissue mass ( <jats:italic>ß</jats:italic> = 0.12, 95% CI 0.01, 0.23), greater total cholesterol ( <jats:italic>ß</jats:italic> = 0.36, 95% CI 0.15, 0.58), greater LDL‐cholesterol ( <jats:italic>ß</jats:italic> = 0.29, 95% CI 0.09, 0.50), greater triglycerides ( <jats:italic>ß</jats:italic> = 0.06, 95% CI 0.03, 0.32), and greater glucose ( <jats:italic>ß</jats:italic> = 0.22, 95% CI 0.03, 0.40) at 10 years postpartum. Conclusions Pregnancy metabolic complications were associated with an altered cardiometabolic risk profile 10 years postpartum.","PeriodicalId":8984,"journal":{"name":"BJOG: An International Journal of Obstetrics & Gynaecology","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145592866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maureen Makama,Alicia Ferguson,Mairead Connolly,Sarah Boudova,Samia Aziz,Lorena Romero,Joshua P Vogel
BACKGROUNDThe role of uterine gauze packing in treating refractory postpartum haemorrhage (PPH) is uncertain given limited evidence of benefit and possible harms.OBJECTIVESTo evaluate the safety and effectiveness of uterine packing using plain gauze or gauze impregnated with haemostatic agent(s) for treating refractory PPH.SEARCH STRATEGYWe searched MEDLINE, Embase, Emcare, Web of Science, CINAHL and CENTRAL from inception through March 2025.SELECTION CRITERIARandomised controlled trials (RCTs) and non-randomised controlled studies of intervention (NRSIs) evaluating uterine packing using plain gauze or gauze impregnated with haemostatic agents, compared with usual care or other interventions, for women with refractory PPH.DATA COLLECTION AND ANALYSISWe included one RCT (204 women) and six NRSIs (814 women). We presented findings from the RCT in a forest plot and conducted random-effects meta-analyses for NRSIs.MAIN RESULTSThree comparisons had data: plain gauze versus balloon tamponade; gauze impregnated with haemostatic agents versus balloon tamponade; and plain gauze versus uterine artery ligation/embolisation. From the RCT, uterine packing with plain gauze may not reduce the need for additional surgical/radiological intervention (relative risk (RR) 1.29, 95% CI 0.50-3.32) or blood transfusion (RR 0.97, 95% CI 0.67-1.41; low certainty evidence). Moderate-certainty evidence indicates that for women with refractory PPH, uterine packing with plain gauze probably increases postpartum anaemia (< 11 g/dL) (RR 1.27, 95% CI 1.07-1.51) and maternal fever > 38°C (RR 2.40, 95% CI 1.21-4.76), compared to balloon tamponade. From NRSIs, evidence is very uncertain about the effects of uterine packing with plain gauze or gauze impregnated with haemostatic agents on all outcomes (very low certainty evidence).CONCLUSIONThere are no clear benefits of uterine packing with plain gauze or gauze impregnated with haemostatic agents for treating refractory PPH, and the risk of postpartum anaemia and maternal fever is probably increased compared to standard care. Prospective well-controlled trials are needed to evaluate the effects of uterine packing and its role in treating refractory PPH.
背景子宫纱布填塞在治疗难治性产后出血（PPH）中的作用尚不确定，因为有关其益处和可能危害的证据有限。目的评价平纱布或浸渍止血剂纱布子宫填塞治疗难治性PPH的安全性和有效性。检索策略：我们检索了MEDLINE， Embase, Emcare, Web of Science， CINAHL和CENTRAL从成立到2025年3月。选择标准：随机对照试验（rct）和非随机对照干预研究（NRSIs）对难治性PPH妇女使用平纱布或浸渍止血剂纱布进行子宫填塞，与常规护理或其他干预措施进行比较。数据收集和分析我们纳入了1项RCT（204名女性）和6项NRSIs（814名女性）。我们介绍了在森林样地进行的随机对照试验的结果，并对nrsi进行了随机效应荟萃分析。主要结果有平纱布与球囊填塞3项比较资料；纱布浸渍止血剂与球囊填塞的比较平纱布与子宫动脉结扎/栓塞的对比。从随机对照试验来看，用平纱布填塞子宫可能不会减少额外手术/放射干预的需要（相对风险（RR） 1.29, 95% CI 0.50-3.32）或输血（RR 0.97, 95% CI 0.67-1.41；低确定性证据）。中等确定性证据表明，对于难治性PPH妇女，与球囊填塞相比，平纱布子宫填塞可能增加产后贫血(38°C （RR 2.40, 95% CI 1.21-4.76）。从NRSIs来看，用普通纱布或浸渍止血剂的纱布填充子宫对所有结果的影响的证据非常不确定（非常低确定性的证据）。结论平纱布或纱布浸渍止血剂子宫填塞治疗难治性PPH疗效不明显，产后贫血及产妇发热风险较标准治疗可能增加。需要前瞻性的对照试验来评估子宫填充物及其在治疗难治性PPH中的作用。
{"title":"Safety and Effectiveness of Uterine Gauze Packing for Refractory Postpartum Haemorrhage: A Systematic Review and Meta-Analysis.","authors":"Maureen Makama,Alicia Ferguson,Mairead Connolly,Sarah Boudova,Samia Aziz,Lorena Romero,Joshua P Vogel","doi":"10.1111/1471-0528.70091","DOIUrl":"https://doi.org/10.1111/1471-0528.70091","url":null,"abstract":"BACKGROUNDThe role of uterine gauze packing in treating refractory postpartum haemorrhage (PPH) is uncertain given limited evidence of benefit and possible harms.OBJECTIVESTo evaluate the safety and effectiveness of uterine packing using plain gauze or gauze impregnated with haemostatic agent(s) for treating refractory PPH.SEARCH STRATEGYWe searched MEDLINE, Embase, Emcare, Web of Science, CINAHL and CENTRAL from inception through March 2025.SELECTION CRITERIARandomised controlled trials (RCTs) and non-randomised controlled studies of intervention (NRSIs) evaluating uterine packing using plain gauze or gauze impregnated with haemostatic agents, compared with usual care or other interventions, for women with refractory PPH.DATA COLLECTION AND ANALYSISWe included one RCT (204 women) and six NRSIs (814 women). We presented findings from the RCT in a forest plot and conducted random-effects meta-analyses for NRSIs.MAIN RESULTSThree comparisons had data: plain gauze versus balloon tamponade; gauze impregnated with haemostatic agents versus balloon tamponade; and plain gauze versus uterine artery ligation/embolisation. From the RCT, uterine packing with plain gauze may not reduce the need for additional surgical/radiological intervention (relative risk (RR) 1.29, 95% CI 0.50-3.32) or blood transfusion (RR 0.97, 95% CI 0.67-1.41; low certainty evidence). Moderate-certainty evidence indicates that for women with refractory PPH, uterine packing with plain gauze probably increases postpartum anaemia (< 11 g/dL) (RR 1.27, 95% CI 1.07-1.51) and maternal fever > 38°C (RR 2.40, 95% CI 1.21-4.76), compared to balloon tamponade. From NRSIs, evidence is very uncertain about the effects of uterine packing with plain gauze or gauze impregnated with haemostatic agents on all outcomes (very low certainty evidence).CONCLUSIONThere are no clear benefits of uterine packing with plain gauze or gauze impregnated with haemostatic agents for treating refractory PPH, and the risk of postpartum anaemia and maternal fever is probably increased compared to standard care. Prospective well-controlled trials are needed to evaluate the effects of uterine packing and its role in treating refractory PPH.","PeriodicalId":8984,"journal":{"name":"BJOG: An International Journal of Obstetrics & Gynaecology","volume":"240 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145559168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lucy Pembrey, Gillian Santorelli, Sergio Souza da Cunha, Sam Oddie, Emily S. Petherick, Neil Pearce, Amy Hough, John Wright
Objective To investigate whether the risk of asthma, eczema and allergic rhinitis at 5 years in children born by caesarean section (CS) differs by the timing of antibiotic administration to the mother (pre‐incision vs. post‐cord clamping). Design Natural experiment using birth cohort data. Setting UK single centre population‐based birth cohort. Participants 3013 liveborn children delivered by CS, from the Born in Bradford (BiB) cohort born 2007–2011 and BiB's Better Start (BiBBS) cohort born 2016–2019. Only the first‐born of multiple births was included. Main Outcome Measures Risk of asthma, atopic eczema and allergic rhinitis at age 5 years. Results Among 3013 children, 579 (19.2%) were exposed to pre‐incision antibiotics. At 5 years, 272 (9.0%) children had asthma, 672 (22.3%) had eczema and 180 (6.0%) had allergic rhinitis. There was no evidence of an increased risk of asthma (adjusted risk ratio [aRR] 1.01, 95% CI 0.56, 1.83; adjusted risk difference [aRD] 0.08 per 100, 95% CI −5.28, 5.44), eczema (aRR 0.96, 95% CI 0.68, 1.35; aRD −1.01 per 100, 95% CI −8.65, 6.63) or allergic rhinitis (aRR 1.16, 95% CI 0.59, 2.28; aRD 0.88 per 100, 95% CI −3.17, 4.92) at 5 years in children exposed to pre‐incision antibiotics versus post‐cord clamping. Conclusions This study found no evidence of an association between pre‐incision antibiotics for CS and increased risk of asthma, eczema or allergic rhinitis by age 5. These findings contribute to the evidence base informing the optimum timing of maternal antibiotic prophylaxis for CS, balancing risks and benefits to the mother and her child.
目的探讨剖宫产（CS）患儿5岁时发生哮喘、湿疹和变应性鼻炎的风险是否因给药时间（切口前与脐带夹紧后）的不同而不同。设计使用出生队列数据的自然实验。设置英国单中心人口出生队列。参与者3013名CS分娩的活产儿，来自2007-2011年出生的出生在布拉德福德（BiB）队列和2016-2019年出生的BiBBS更好的开始（BiBBS）队列。仅包括多胞胎中的头胎。5岁时哮喘、特应性湿疹和变应性鼻炎的风险。结果3013例患儿中，579例（19.2%）暴露于切口前抗生素。5岁时，272（9.0%）名儿童患有哮喘，672（22.3%）名儿童患有湿疹，180（6.0%）名儿童患有变应性鼻炎。没有证据表明，与脊髓夹夹后相比，5岁时暴露于切口前抗生素的儿童哮喘（校正风险比[aRR] 1.01, 95% CI 0.56, 1.83；校正风险差[aRD] 0.08 / 100, 95% CI - 5.28, 5.44）、湿疹（aRR 0.96, 95% CI 0.68, 1.35; aRR - 1.01, 95% CI - 8.65, 6.63）或过敏性鼻炎（aRR 1.16, 95% CI 0.59, 2.28; aRR 0.88 / 100, 95% CI - 3.17, 4.92）的风险增加。本研究未发现CS手术前使用抗生素与5岁前哮喘、湿疹或过敏性鼻炎风险增加之间存在关联的证据。这些发现有助于为CS产妇抗生素预防的最佳时机提供证据基础，平衡母亲和孩子的风险和利益。
{"title":"Timing of Intrapartum Antibiotics at Caesarean Section and Risk of Asthma, Eczema and Allergic Rhinitis: Results From a Natural Experiment","authors":"Lucy Pembrey, Gillian Santorelli, Sergio Souza da Cunha, Sam Oddie, Emily S. Petherick, Neil Pearce, Amy Hough, John Wright","doi":"10.1111/1471-0528.70083","DOIUrl":"https://doi.org/10.1111/1471-0528.70083","url":null,"abstract":"Objective To investigate whether the risk of asthma, eczema and allergic rhinitis at 5 years in children born by caesarean section (CS) differs by the timing of antibiotic administration to the mother (pre‐incision vs. post‐cord clamping). Design Natural experiment using birth cohort data. Setting UK single centre population‐based birth cohort. Participants 3013 liveborn children delivered by CS, from the Born in Bradford (BiB) cohort born 2007–2011 and BiB's Better Start (BiBBS) cohort born 2016–2019. Only the first‐born of multiple births was included. Main Outcome Measures Risk of asthma, atopic eczema and allergic rhinitis at age 5 years. Results Among 3013 children, 579 (19.2%) were exposed to pre‐incision antibiotics. At 5 years, 272 (9.0%) children had asthma, 672 (22.3%) had eczema and 180 (6.0%) had allergic rhinitis. There was no evidence of an increased risk of asthma (adjusted risk ratio [aRR] 1.01, 95% CI 0.56, 1.83; adjusted risk difference [aRD] 0.08 per 100, 95% CI −5.28, 5.44), eczema (aRR 0.96, 95% CI 0.68, 1.35; aRD −1.01 per 100, 95% CI −8.65, 6.63) or allergic rhinitis (aRR 1.16, 95% CI 0.59, 2.28; aRD 0.88 per 100, 95% CI −3.17, 4.92) at 5 years in children exposed to pre‐incision antibiotics versus post‐cord clamping. Conclusions This study found no evidence of an association between pre‐incision antibiotics for CS and increased risk of asthma, eczema or allergic rhinitis by age 5. These findings contribute to the evidence base informing the optimum timing of maternal antibiotic prophylaxis for CS, balancing risks and benefits to the mother and her child.","PeriodicalId":8984,"journal":{"name":"BJOG: An International Journal of Obstetrics & Gynaecology","volume":"35 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145509366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Eun‐Saem Choi, Sang‐Hyuk Jung, Young Mi Jung, Chan‐Wook Park, Joong Shin Park, Jong Kwan Jun, Jaeyoung Kim, Beomsu Kim, Chamlee Cho, Injeong Shim, Dokyoon Kim, Hong‐Hee Won, Seung Mi Lee
Objective To investigate whether genetic predisposition to pre‐eclampsia (PE), measured by a polygenic risk score (PRS), is associated with incident hypertension and cardiovascular disease (CVD) after delivery in Asian women. Design Prospective population‐based cohort study. Setting Data were utilised from the Korean Genome and Epidemiology Study and additional multicentre cohorts. Population 35 872 parous Korean women aged 40–80 years at last surveillance, with genotype data, no history of hypertension or CVD before delivery, and complete clinical information. For external validation, 559 parous Korean women were included. Methods The PE‐PRS was calculated for Asian women, and the study population was divided into the high PE‐PRS and low PE‐PRS groups. The long‐term risks of incident hypertension and CVD (ischaemic heart disease or stroke) after delivery were compared between the groups. Main Outcome Measures Incident hypertension and CVD after delivery. Results Women in the high PE‐PRS group had an increased risk of developing hypertension (adjusted hazard ratio [aHR] 1.25, 95% CI 1.17–1.34) and ischaemic heart disease (aHR 1.28, 95% CI 1.07–1.54) compared to the low PE‐PRS group. The risk of hypertension was highest among women with both a history of PE and a high PE‐PRS. Conclusions Genetic predisposition to PE, as measured by the PE‐PRS, is associated with an elevated risk of incident hypertension and ischaemic heart disease in Asian women. These findings suggest the potential utility of the PE‐PRS as a complementary tool in assessing individualised hypertension risk in parous women.
目的研究多基因风险评分（PRS）测量的先兆子痫（PE）遗传易感性是否与亚洲妇女分娩后高血压和心血管疾病（CVD）的发生有关。设计前瞻性人群队列研究。数据来自韩国基因组和流行病学研究以及其他多中心队列。人口：35 872名40-80岁的韩国产妇，有基因型数据，分娩前无高血压或心血管疾病史，临床资料完整。为了进行外部验证，纳入了559名韩国产妇。方法计算亚洲女性的PE - PRS，并将研究人群分为高PE - PRS组和低PE - PRS组。比较两组分娩后发生高血压和CVD（缺血性心脏病或中风）的长期风险。主要观察指标：产后高血压和心血管疾病发生率。结果与低PE‐PRS组相比，高PE‐PRS组的女性患高血压（校正危险比[aHR] 1.25, 95% CI 1.17-1.34）和缺血性心脏病（aHR 1.28, 95% CI 1.07-1.54）的风险增加。有PE病史和高PE - PRS的女性患高血压的风险最高。结论：PE‐PRS测量的PE遗传易感性与亚洲女性高血压和缺血性心脏病发生风险升高有关。这些发现提示PE - PRS作为评估产妇个体化高血压风险的补充工具的潜在效用。
{"title":"Polygenic Risk for Pre‐Eclampsia and the Long‐Term Risk of Incident Hypertension and Cardiovascular Disease: A Population‐Based Cohort Study","authors":"Eun‐Saem Choi, Sang‐Hyuk Jung, Young Mi Jung, Chan‐Wook Park, Joong Shin Park, Jong Kwan Jun, Jaeyoung Kim, Beomsu Kim, Chamlee Cho, Injeong Shim, Dokyoon Kim, Hong‐Hee Won, Seung Mi Lee","doi":"10.1111/1471-0528.70072","DOIUrl":"https://doi.org/10.1111/1471-0528.70072","url":null,"abstract":"Objective To investigate whether genetic predisposition to pre‐eclampsia (PE), measured by a polygenic risk score (PRS), is associated with incident hypertension and cardiovascular disease (CVD) after delivery in Asian women. Design Prospective population‐based cohort study. Setting Data were utilised from the Korean Genome and Epidemiology Study and additional multicentre cohorts. Population 35 872 parous Korean women aged 40–80 years at last surveillance, with genotype data, no history of hypertension or CVD before delivery, and complete clinical information. For external validation, 559 parous Korean women were included. Methods The PE‐PRS was calculated for Asian women, and the study population was divided into the high PE‐PRS and low PE‐PRS groups. The long‐term risks of incident hypertension and CVD (ischaemic heart disease or stroke) after delivery were compared between the groups. Main Outcome Measures Incident hypertension and CVD after delivery. Results Women in the high PE‐PRS group had an increased risk of developing hypertension (adjusted hazard ratio [aHR] 1.25, 95% CI 1.17–1.34) and ischaemic heart disease (aHR 1.28, 95% CI 1.07–1.54) compared to the low PE‐PRS group. The risk of hypertension was highest among women with both a history of PE and a high PE‐PRS. Conclusions Genetic predisposition to PE, as measured by the PE‐PRS, is associated with an elevated risk of incident hypertension and ischaemic heart disease in Asian women. These findings suggest the potential utility of the PE‐PRS as a complementary tool in assessing individualised hypertension risk in parous women.","PeriodicalId":8984,"journal":{"name":"BJOG: An International Journal of Obstetrics & Gynaecology","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145509361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mathies Rondagh,Lotte C M Zwinkels,Jeanine M M van Klink,Linda S de Vries,Sylke J Steggerda,Femke Slaghekke,E J T Joanne Verweij,Monique C Haak,Sophie G Groene,Enrico Lopriore
BACKGROUNDMonochorionic (MC) twins are at risk of acute exsanguination after single fetal demise (sFD) due to their shared placental circulation, which may result in sequelae for survivors.OBJECTIVESTo evaluate the prevalence of ante- and postnatal brain injury and long-term neurodevelopmental impairment (NDI) in co-twins after sFD. Secondary outcomes were the prevalence of termination of pregnancy (TOP), neonatal death (NND) and potential risk factors for brain injury.SEARCH STRATEGYPubMed, Embase, Scopus and Web of Science were searched to identify relevant studies in October 2024.SELECTION CRITERIAStudies reporting MC twin pregnancies with spontaneous sFD. Studies with selective feticide, twin reversed arterial perfusion sequence, twin anaemia-polycythaemia sequence, congenital anomalies, higher-order multiple pregnancies, fetoscopic laser surgery and double fetal demise were excluded.DATA COLLECTION AND ANALYSISSystematic review and meta-analysis were performed following the PRISMA and MOOSE guidelines.MAIN RESULTSThirteen studies involving 311 survivors after sFD were included. The prevalence of TOP, NND, brain injury and NDI was 3% (95% CI: 0%-7%), 6% (95% CI: 0%-16%), 27% (95% CI: 18%-37%), 6% (95% CI: 3%-11%), respectively. The median GA at birth in survivors with brain injury was 29 weeks (IQR 27.7-34.1) compared to 36 weeks (IQR: 32.3-37.0) in the overall group of survivors.CONCLUSIONSBrain injury occurs in one in four survivors and is associated with lower GA at birth, suggesting a double-hit injury due to a combination of exsanguination and (severe) prematurity. NDI occurs in one in 20 survivors, compared to two-thirds of those with brain injury.TRIAL REGISTRATIONPROSPERO number: CRD42024608912.
{"title":"Brain Injury and Neurodevelopmental Outcome in Survivors After Spontaneous Single Fetal Demise in Monochorionic Twins: A Systematic Review and Meta-Analysis.","authors":"Mathies Rondagh,Lotte C M Zwinkels,Jeanine M M van Klink,Linda S de Vries,Sylke J Steggerda,Femke Slaghekke,E J T Joanne Verweij,Monique C Haak,Sophie G Groene,Enrico Lopriore","doi":"10.1111/1471-0528.70084","DOIUrl":"https://doi.org/10.1111/1471-0528.70084","url":null,"abstract":"BACKGROUNDMonochorionic (MC) twins are at risk of acute exsanguination after single fetal demise (sFD) due to their shared placental circulation, which may result in sequelae for survivors.OBJECTIVESTo evaluate the prevalence of ante- and postnatal brain injury and long-term neurodevelopmental impairment (NDI) in co-twins after sFD. Secondary outcomes were the prevalence of termination of pregnancy (TOP), neonatal death (NND) and potential risk factors for brain injury.SEARCH STRATEGYPubMed, Embase, Scopus and Web of Science were searched to identify relevant studies in October 2024.SELECTION CRITERIAStudies reporting MC twin pregnancies with spontaneous sFD. Studies with selective feticide, twin reversed arterial perfusion sequence, twin anaemia-polycythaemia sequence, congenital anomalies, higher-order multiple pregnancies, fetoscopic laser surgery and double fetal demise were excluded.DATA COLLECTION AND ANALYSISSystematic review and meta-analysis were performed following the PRISMA and MOOSE guidelines.MAIN RESULTSThirteen studies involving 311 survivors after sFD were included. The prevalence of TOP, NND, brain injury and NDI was 3% (95% CI: 0%-7%), 6% (95% CI: 0%-16%), 27% (95% CI: 18%-37%), 6% (95% CI: 3%-11%), respectively. The median GA at birth in survivors with brain injury was 29 weeks (IQR 27.7-34.1) compared to 36 weeks (IQR: 32.3-37.0) in the overall group of survivors.CONCLUSIONSBrain injury occurs in one in four survivors and is associated with lower GA at birth, suggesting a double-hit injury due to a combination of exsanguination and (severe) prematurity. NDI occurs in one in 20 survivors, compared to two-thirds of those with brain injury.TRIAL REGISTRATIONPROSPERO number: CRD42024608912.","PeriodicalId":8984,"journal":{"name":"BJOG: An International Journal of Obstetrics & Gynaecology","volume":"15 6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145491477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Christian Phillips,Geetika Shah,Marianne Gamper,Andrzej Kuszka,Kandiah Chandrakumaran,Volker Viereck
OBJECTIVETo assess whether Er:YAG laser is superior to sham in treating women with mild/moderate stress urinary incontinence (SUI).DESIGNA single blinded, multi-centre RCT comparing Er:YAG laser to sham in women with mild/moderate SUI with patients blinded to allocated treatment.SETTINGThree urogynaecology departments in United Kingdom, Switzerland and Germany.POPULATION OR SAMPLE79 participants were recruited with mild/moderate SUI.METHODSParticipants were randomised (2 active: 1 sham) receiving 3 treatment sessions. Participants were assessed at baseline and 6 months post final treatment.MAIN OUTCOME MEASURESPrimary outcome measure: cure defined as at least 50% reduction in 1 h pad weigh test (PWT) at 6 months compared to baseline (as per FDA guidelines).SECONDARY OUTCOMESChange in PWT, (ICIQ-UI SF), (PISQ-12), cough test standing and supine and visual analogue score for pain.RESULTS32/51 patients (62.7%) of patients were defined as cured (per FDA guidelines) in the laser group compared with 4/23 (18.2%) cure in the sham group, p < 0.001, (OR 7.6, 2.2-25.8 95% CI). There was a statistically and clinically significant improvement in patients treated with laser in PWT, ICIQ-UI SF and PISQ-12 at 6 months (3 g, p = 0.002, 5 points, p < 0.001 and 6 points, p < 0.001, respectively). There was no evidence of statistically significant differences in the sham group.CONCLUSIONSThis RCT demonstrates a beneficial effect of Er:YAG laser in women with mild/moderate SUI compared with sham.TRIAL REGISTRATIONwww.CLINICALTRIALSgov (NCT03996070).
{"title":"Vaginal Erbium Laser for the Treatment of Mild-to-Moderate Stress Urinary Incontinence: A Multicentre Randomised Sham-Controlled Trial.","authors":"Christian Phillips,Geetika Shah,Marianne Gamper,Andrzej Kuszka,Kandiah Chandrakumaran,Volker Viereck","doi":"10.1111/1471-0528.70080","DOIUrl":"https://doi.org/10.1111/1471-0528.70080","url":null,"abstract":"OBJECTIVETo assess whether Er:YAG laser is superior to sham in treating women with mild/moderate stress urinary incontinence (SUI).DESIGNA single blinded, multi-centre RCT comparing Er:YAG laser to sham in women with mild/moderate SUI with patients blinded to allocated treatment.SETTINGThree urogynaecology departments in United Kingdom, Switzerland and Germany.POPULATION OR SAMPLE79 participants were recruited with mild/moderate SUI.METHODSParticipants were randomised (2 active: 1 sham) receiving 3 treatment sessions. Participants were assessed at baseline and 6 months post final treatment.MAIN OUTCOME MEASURESPrimary outcome measure: cure defined as at least 50% reduction in 1 h pad weigh test (PWT) at 6 months compared to baseline (as per FDA guidelines).SECONDARY OUTCOMESChange in PWT, (ICIQ-UI SF), (PISQ-12), cough test standing and supine and visual analogue score for pain.RESULTS32/51 patients (62.7%) of patients were defined as cured (per FDA guidelines) in the laser group compared with 4/23 (18.2%) cure in the sham group, p < 0.001, (OR 7.6, 2.2-25.8 95% CI). There was a statistically and clinically significant improvement in patients treated with laser in PWT, ICIQ-UI SF and PISQ-12 at 6 months (3 g, p = 0.002, 5 points, p < 0.001 and 6 points, p < 0.001, respectively). There was no evidence of statistically significant differences in the sham group.CONCLUSIONSThis RCT demonstrates a beneficial effect of Er:YAG laser in women with mild/moderate SUI compared with sham.TRIAL REGISTRATIONwww.CLINICALTRIALSgov (NCT03996070).","PeriodicalId":8984,"journal":{"name":"BJOG: An International Journal of Obstetrics & Gynaecology","volume":"07 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145491476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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