Lynn C. Sadler, John M. D. Thompson, Jane M. Alsweiler, Christopher J. D. McKinlay, Robin Cronin, Meghan G. Hill
{"title":"Authors' Reply","authors":"Lynn C. Sadler, John M. D. Thompson, Jane M. Alsweiler, Christopher J. D. McKinlay, Robin Cronin, Meghan G. Hill","doi":"10.1111/1471-0528.18014","DOIUrl":"10.1111/1471-0528.18014","url":null,"abstract":"","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 4","pages":"545-546"},"PeriodicalIF":4.7,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142678172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Emma J. Smith, Melissa Hill, Michelle Peter, Wing Han Wu, Corinne Mallinson, Steven Hardy, Lyn S. Chitty, Stephen Morris
Objective
Prenatal exome sequencing (pES) for diagnosing fetal structural anomalies commenced in the English National Health Service (NHS) in 2020. We evaluated cost-effectiveness to the healthcare system, and costs to families, of pES in addition to standard testing, compared to standard testing alone.
Design
A cost-effectiveness analysis combining costs, outcomes, parent and professional interview and professional survey data.
Setting
The English NHS Genomic Medicine Service.
Sample
413 families with fetal anomalies with a suspected genetic cause referred for pES from 01 October 2021 to 30 June 2022.
Methods
We costed the incremental resource required to deliver the pES clinical pathway. We calculated the diagnostic yield (proportion of cases with pathogenic variants). We divided the total incremental cost by the number of cases with a diagnosis to calculate cost-effectiveness. We estimated the annual NHS budget requirement based on case numbers. We determined parental costs from interviews.
Main Outcome Measures
Incremental costs of pES to the NHS and families, incremental cost per additional diagnosis and NHS budget impact.
Results
Of 413 referred cases, 241 were tested, at a cost of £2331 (95% credibility interval £1894–£2856) per referred case or £3592 (£2959–£4250) per case that proceeded with testing. The incremental cost per diagnosis (yield 35.3%) was £11 326 (£8582–£15 361). Based on referrals data 01 October 2022 to 30 September 2023, pES costs the NHS £1.8 m annually. Family costs could not be separated from other pregnancy-related appointments but were not considered burdensome; most appointments were concurrent or remote.
Conclusion
pES costs the English NHS £11 326 for each additional diagnosis. Incremental costs to families are negligible.
{"title":"Implementation of a National Prenatal Exome Sequencing Service in England: Cost-Effectiveness Analysis","authors":"Emma J. Smith, Melissa Hill, Michelle Peter, Wing Han Wu, Corinne Mallinson, Steven Hardy, Lyn S. Chitty, Stephen Morris","doi":"10.1111/1471-0528.18020","DOIUrl":"10.1111/1471-0528.18020","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Prenatal exome sequencing (pES) for diagnosing fetal structural anomalies commenced in the English National Health Service (NHS) in 2020. We evaluated cost-effectiveness to the healthcare system, and costs to families, of pES in addition to standard testing, compared to standard testing alone.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design</h3>\u0000 \u0000 <p>A cost-effectiveness analysis combining costs, outcomes, parent and professional interview and professional survey data.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Setting</h3>\u0000 \u0000 <p>The English NHS Genomic Medicine Service.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Sample</h3>\u0000 \u0000 <p>413 families with fetal anomalies with a suspected genetic cause referred for pES from 01 October 2021 to 30 June 2022.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We costed the incremental resource required to deliver the pES clinical pathway. We calculated the diagnostic yield (proportion of cases with pathogenic variants). We divided the total incremental cost by the number of cases with a diagnosis to calculate cost-effectiveness. We estimated the annual NHS budget requirement based on case numbers. We determined parental costs from interviews.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Outcome Measures</h3>\u0000 \u0000 <p>Incremental costs of pES to the NHS and families, incremental cost per additional diagnosis and NHS budget impact.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of 413 referred cases, 241 were tested, at a cost of £2331 (95% credibility interval £1894–£2856) per referred case or £3592 (£2959–£4250) per case that proceeded with testing. The incremental cost per diagnosis (yield 35.3%) was £11 326 (£8582–£15 361). Based on referrals data 01 October 2022 to 30 September 2023, pES costs the NHS £1.8 m annually. Family costs could not be separated from other pregnancy-related appointments but were not considered burdensome; most appointments were concurrent or remote.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>pES costs the English NHS £11 326 for each additional diagnosis. Incremental costs to families are negligible.</p>\u0000 </section>\u0000 </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 4","pages":"483-491"},"PeriodicalIF":4.7,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18020","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142684154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Enhanced Recovery After Gynaecological Surgery: Insights and Future Directions.","authors":"Jiayu Yan, Bilan Li","doi":"10.1111/1471-0528.18012","DOIUrl":"10.1111/1471-0528.18012","url":null,"abstract":"","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142669832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"BJOG Editors-in-Chief Since 1902","authors":"Philip J. Steer","doi":"10.1111/1471-0528.18011","DOIUrl":"10.1111/1471-0528.18011","url":null,"abstract":"","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 3","pages":"229-230"},"PeriodicalIF":4.7,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142672991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"'Necessity Is the Mother of Invention'-The Wider Significance of Novel Mid-Urethral Rectus Fascial Sling.","authors":"Peter Emanuel Petros","doi":"10.1111/1471-0528.18015","DOIUrl":"10.1111/1471-0528.18015","url":null,"abstract":"","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142669834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Allan J Kember, Jane Warland, Sebastian R Hobson, Kuan Liu, Jerry Coleman
{"title":"Position Modification Devices to Prevent Supine Sleep During Pregnancy.","authors":"Allan J Kember, Jane Warland, Sebastian R Hobson, Kuan Liu, Jerry Coleman","doi":"10.1111/1471-0528.18019","DOIUrl":"https://doi.org/10.1111/1471-0528.18019","url":null,"abstract":"","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142649652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hitomi Okubo, Shoji F. Nakayama, Asako Mito, Naoko Arata, Yukihiro Ohya, the Japan Environment and Children's Study Group
Objective
To quantify the association between a combination of modifiable prepregnancy lifestyle factors and the risk of adverse pregnancy outcomes (APOs).
Design
Prospective cohort study.
Setting
The Japan Environment and Children's Study.
Population
A total of 79 703 pregnant Japanese women without chronic disease.
Methods
Maternal lifestyle before pregnancy was assessed using a self-administered questionnaire. A healthy lifestyle score (HLS, 0–5 points) was calculated based on adherence to five prepregnancy healthy lifestyle factors: healthy weight, high-quality diet, regular physical activity, not smoking, and not drinking alcohol. Relative risks (RRs) and 95% credible intervals (CrIs) were estimated using a Bayesian log-binomial regression model.
Main Outcome Measures
Composite APOs, defined as the development of any APO, including gestational diabetes, hypertensive disorders of pregnancy, preterm birth, low birth weight, and small-for-gestational-age, transcribed from medical records.
Results
A total of 13 894 women (17.4%) experienced one or more APOs. HLS was inversely associated with the risk of APOs in a dose–response manner. Women with an HLS of 5 points had a 33% (RR 0.67; 95% CrI, 0.61–0.74) lower risk of APOs than those with the lowest HLS (0–1 points). The population attributable fraction of five healthy lifestyle factors was 10.3%. A 1-point increase of HLS could have reduced APO cases by 6.6%.
Conclusions
A higher HLS was associated with a lower risk of APOs, suggesting that adopting a healthy lifestyle before pregnancy may reduce the risk of APOs, which can increase the risk of future chronic diseases in both mother and child.
摘要量化可改变的孕前生活方式因素组合与不良妊娠结局（APOs）风险之间的关联：前瞻性队列研究：环境：日本环境与儿童研究：方法：通过对孕前生活方式进行评估，确定孕前生活方式与不良妊娠结局（APOs）之间的关系：方法：采用自填式问卷对孕产妇怀孕前的生活方式进行评估。根据孕前五项健康生活方式因素（健康体重、优质饮食、规律运动、不吸烟、不饮酒）的坚持情况计算出健康生活方式得分（HLS，0-5 分）。采用贝叶斯对数二叉回归模型估算相对风险（RRs）和 95% 可信区间（CrIs）：主要结果测量指标：根据医疗记录转录的复合 APOs，定义为任何 APO 的发生，包括妊娠糖尿病、妊娠高血压疾病、早产、低出生体重和小于胎龄：共有 13 894 名妇女（17.4%）经历过一次或多次妊娠高血压。HLS与发生APO的风险呈剂量反应式的反比关系。健康生活方式指数为 5 分的妇女比健康生活方式指数最低（0-1 分）的妇女发生 APO 的风险低 33% (RR 0.67; 95% CrI, 0.61-0.74)。五项健康生活方式因素的人群可归因比例为 10.3%。结论：健康生活方式指数每增加1分，APO病例就会减少6.6%：结论：较高的健康生活方式指数与较低的 APO 风险相关，这表明在怀孕前采取健康的生活方式可降低 APO 风险，而 APO 可增加母婴未来罹患慢性疾病的风险。
{"title":"Adherence to Healthy Prepregnancy Lifestyle and Risk of Adverse Pregnancy Outcomes: A Prospective Cohort Study","authors":"Hitomi Okubo, Shoji F. Nakayama, Asako Mito, Naoko Arata, Yukihiro Ohya, the Japan Environment and Children's Study Group","doi":"10.1111/1471-0528.17994","DOIUrl":"10.1111/1471-0528.17994","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To quantify the association between a combination of modifiable prepregnancy lifestyle factors and the risk of adverse pregnancy outcomes (APOs).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design</h3>\u0000 \u0000 <p>Prospective cohort study.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Setting</h3>\u0000 \u0000 <p>The Japan Environment and Children's Study.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Population</h3>\u0000 \u0000 <p>A total of 79 703 pregnant Japanese women without chronic disease.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Maternal lifestyle before pregnancy was assessed using a self-administered questionnaire. A healthy lifestyle score (HLS, 0–5 points) was calculated based on adherence to five prepregnancy healthy lifestyle factors: healthy weight, high-quality diet, regular physical activity, not smoking, and not drinking alcohol. Relative risks (RRs) and 95% credible intervals (CrIs) were estimated using a Bayesian log-binomial regression model.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Outcome Measures</h3>\u0000 \u0000 <p>Composite APOs, defined as the development of any APO, including gestational diabetes, hypertensive disorders of pregnancy, preterm birth, low birth weight, and small-for-gestational-age, transcribed from medical records.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 13 894 women (17.4%) experienced one or more APOs. HLS was inversely associated with the risk of APOs in a dose–response manner. Women with an HLS of 5 points had a 33% (RR 0.67; 95% CrI, 0.61–0.74) lower risk of APOs than those with the lowest HLS (0–1 points). The population attributable fraction of five healthy lifestyle factors was 10.3%. A 1-point increase of HLS could have reduced APO cases by 6.6%.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>A higher HLS was associated with a lower risk of APOs, suggesting that adopting a healthy lifestyle before pregnancy may reduce the risk of APOs, which can increase the risk of future chronic diseases in both mother and child.</p>\u0000 </section>\u0000 </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 3","pages":"375-386"},"PeriodicalIF":4.7,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11704023/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142649644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andrea Stuart, Johanna Wagenius, Levon Badiglian-Filho, Jens Schnabel, Alvaro Montealegre, Sophia Ehrström, Michael Hartmann, Jona Vercammen, Daniela Huber, Anna Lingström, Jan Baekelandt
<div> <section> <h3> Objective</h3> <p>To present the rates of intra- and postoperative complications and conversions in a large cohort of unselected vNOTES hysterectomies, performed by surgeons with different levels of expertise.</p> </section> <section> <h3> Design</h3> <p>International register-based cohort study.</p> </section> <section> <h3> Setting</h3> <p>Hysterectomies in the iNOTESs registry, 2015 to January 2024, performed by 201 surgeons from multiple countries.</p> </section> <section> <h3> Population</h3> <p>4565 patients undergoing vNOTES hysterectomy.</p> </section> <section> <h3> Methods</h3> <p>Descriptive data are presented in frequencies (<i>n</i>) and percent (%).</p> </section> <section> <h3> Main Outcome Measure</h3> <p>Intra- and postoperative complications. Conversions.</p> </section> <section> <h3> Results</h3> <p>Intraoperative and postoperative complication rates were 3.2% (<i>n</i> = 144) and 2.5% (<i>n</i> = 115), respectively. Conversions occurred in 1.6% (<i>n</i> = 72), of which 10 (0.2%) to laparotomy, and 82% of the conversions occurred within the first 50 cases of the surgeon's learning curve. The most common intraoperative complication was cystotomy, occurring in 1.3%, and almost half were performed by inexperienced surgeons. Other intraoperative organ injuries occurred in 20 cases (0.44%). Postoperatively, the most common complications were haemorrhage (<i>n</i> = 28), vault complications (<i>n</i> = 26) including 11 infected vault hematomas, cystitis (<i>n</i> = 18) and non-specific infections (<i>n</i> = 14). The vNOTES hysterectomies were performed by 201 surgeons, of which 9.5% had performed more than 50 vNOTES cases, representing 70% of the registered cases in the registry. The remaining 30% of the hysterectomies mainly represent learning curve data from 90% of the included surgeons. The complication rate decreased with increasing surgical experience.</p> </section> <section> <h3> Conclusions</h3> <p>The largest study population of vNOTES hysterectomies is presented, including both learning curve data and data from experienced surgeons, with acceptable rates of intra- and postoperative complications. No imp
{"title":"Intra- and Postoperative Complications in 4565 vNOTES Hysterectomies: International Registry Cohort Study","authors":"Andrea Stuart, Johanna Wagenius, Levon Badiglian-Filho, Jens Schnabel, Alvaro Montealegre, Sophia Ehrström, Michael Hartmann, Jona Vercammen, Daniela Huber, Anna Lingström, Jan Baekelandt","doi":"10.1111/1471-0528.18000","DOIUrl":"10.1111/1471-0528.18000","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To present the rates of intra- and postoperative complications and conversions in a large cohort of unselected vNOTES hysterectomies, performed by surgeons with different levels of expertise.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design</h3>\u0000 \u0000 <p>International register-based cohort study.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Setting</h3>\u0000 \u0000 <p>Hysterectomies in the iNOTESs registry, 2015 to January 2024, performed by 201 surgeons from multiple countries.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Population</h3>\u0000 \u0000 <p>4565 patients undergoing vNOTES hysterectomy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Descriptive data are presented in frequencies (<i>n</i>) and percent (%).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Outcome Measure</h3>\u0000 \u0000 <p>Intra- and postoperative complications. Conversions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Intraoperative and postoperative complication rates were 3.2% (<i>n</i> = 144) and 2.5% (<i>n</i> = 115), respectively. Conversions occurred in 1.6% (<i>n</i> = 72), of which 10 (0.2%) to laparotomy, and 82% of the conversions occurred within the first 50 cases of the surgeon's learning curve. The most common intraoperative complication was cystotomy, occurring in 1.3%, and almost half were performed by inexperienced surgeons. Other intraoperative organ injuries occurred in 20 cases (0.44%). Postoperatively, the most common complications were haemorrhage (<i>n</i> = 28), vault complications (<i>n</i> = 26) including 11 infected vault hematomas, cystitis (<i>n</i> = 18) and non-specific infections (<i>n</i> = 14). The vNOTES hysterectomies were performed by 201 surgeons, of which 9.5% had performed more than 50 vNOTES cases, representing 70% of the registered cases in the registry. The remaining 30% of the hysterectomies mainly represent learning curve data from 90% of the included surgeons. The complication rate decreased with increasing surgical experience.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The largest study population of vNOTES hysterectomies is presented, including both learning curve data and data from experienced surgeons, with acceptable rates of intra- and postoperative complications. No imp","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 4","pages":"464-472"},"PeriodicalIF":4.7,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18000","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142649649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Melle A. Spruijt, Wenche M. Klerkx, Kim Notten, Hugo van Eijndhoven, Leonie Speksnijder, Manon H. Kerkhof, Kirsten B. Kluivers
Objective
To evaluate and compare the efficacy and safety of Botulinum Toxin A (BTA) injections versus placebo injections, combined with pelvic floor muscle therapy (PFMT), in women with chronic pelvic pain (CPP).
This multicentre study was conducted at four hospitals in the Netherlands.
Population and Sample
Ninety-four women with CPP and increased pelvic floor muscle tone despite previous PFMT, were enrolled.
Methods
Participants received either BTA injections (100 units) or placebo injections into the pelvic floor muscle, followed by four PFMT sessions.
Main Outcomes and Measures
Primary outcomes included the number of women with at least a 33% reduction in pain and those reporting (very) much improvement of their pain. Secondary outcomes covered quality of life and pelvic floor function. Follow-up visits were scheduled at 4, 8, 12, and 26 weeks post-treatment. Mixed models for repeated measurements were used for analysis.
Results
A 33% reduction or more in average pain score was reported by 15 participants (33%) after BTA treatment and 9 participants (20%) after placebo treatment (odd ratio placebo/BTA 1.88; 95% CI 0.72–4.90, p = 0.19). In both groups, 8 women (17%) reported their improvement as (very) much better (odd ratio placebo/BTA 0.947; 95% CI 0.32–2.80, p = 0.92). Pelvic floor resting activity decreased significantly after BTA treatment compared to placebo (p = 0.001).
Conclusion
The results from this study do not support the use of BTA injections in the management of CPP in women.
目的：评估和比较肉毒杆菌毒素 A (BTA) 注射与安慰剂注射以及盆底肌肉疗法 (PFMT) 在慢性盆腔痛 (CPP) 女性患者中的疗效和安全性。
{"title":"The Efficacy of Botulinum Toxin A Injection in Pelvic Floor Muscles in Chronic Pelvic Pain Patients: A Double-Blinded Randomised Controlled Trial","authors":"Melle A. Spruijt, Wenche M. Klerkx, Kim Notten, Hugo van Eijndhoven, Leonie Speksnijder, Manon H. Kerkhof, Kirsten B. Kluivers","doi":"10.1111/1471-0528.17991","DOIUrl":"10.1111/1471-0528.17991","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To evaluate and compare the efficacy and safety of Botulinum Toxin A (BTA) injections versus placebo injections, combined with pelvic floor muscle therapy (PFMT), in women with chronic pelvic pain (CPP).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design</h3>\u0000 \u0000 <p>Randomised, double-blinded clinical trial (January 2020–April 2023).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Setting</h3>\u0000 \u0000 <p>This multicentre study was conducted at four hospitals in the Netherlands.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Population and Sample</h3>\u0000 \u0000 <p>Ninety-four women with CPP and increased pelvic floor muscle tone despite previous PFMT, were enrolled.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Participants received either BTA injections (100 units) or placebo injections into the pelvic floor muscle, followed by four PFMT sessions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Outcomes and Measures</h3>\u0000 \u0000 <p>Primary outcomes included the number of women with at least a 33% reduction in pain and those reporting (very) much improvement of their pain. Secondary outcomes covered quality of life and pelvic floor function. Follow-up visits were scheduled at 4, 8, 12, and 26 weeks post-treatment. Mixed models for repeated measurements were used for analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A 33% reduction or more in average pain score was reported by 15 participants (33%) after BTA treatment and 9 participants (20%) after placebo treatment (odd ratio placebo/BTA 1.88; 95% CI 0.72–4.90, <i>p</i> = 0.19). In both groups, 8 women (17%) reported their improvement as (very) much better (odd ratio placebo/BTA 0.947; 95% CI 0.32–2.80, <i>p</i> = 0.92). Pelvic floor resting activity decreased significantly after BTA treatment compared to placebo (<i>p</i> = 0.001).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The results from this study do not support the use of BTA injections in the management of CPP in women.</p>\u0000 </section>\u0000 </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 3","pages":"297-305"},"PeriodicalIF":4.7,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.17991","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142610060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andrew Grey, Alison Avenell, Mark J. Bolland, Jim G. Thornton
{"title":"The Fetal Pillow Deflates—Lessons for All","authors":"Andrew Grey, Alison Avenell, Mark J. Bolland, Jim G. Thornton","doi":"10.1111/1471-0528.18004","DOIUrl":"10.1111/1471-0528.18004","url":null,"abstract":"","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 4","pages":"429-432"},"PeriodicalIF":4.7,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142610061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
扫码关注我们
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号