Sacral neuromodulation (SNM) is a safe, effective, and minimally invasive FDA approved treatment for urinary and fecal incontinence, urinary frequency, urgency, and urinary retention. In this study we are assessing the effectiveness of sacral neuromodulation in women with suffering from chronic pelvic pain (CPP), through a single device implant procedure.

开始日期2024-12-01

申办/合作机构

Beaumont Hospital

NCT05062902 / Not yet recruiting早期临床1期

An Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management

The purpose of this study is to evaluate if it is possible to use intravaginal high-density surface electromyography to guide Botulinum neurotoxin (BoNT) injection to treat pelvic floor muscle overactivity that complicates Chronic Pelvic Pain (CPP).

开始日期2024-12-01

申办/合作机构

University of Houston

[+1]

NCT06168058 / Not yet recruitingN/AIIT

Randomized Controlled, Single-Blinded, Parallel-Group Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices (EMBOLIZE) Trial

The purpose of this study is to see if a randomized controlled trial of ovarian vein and pelvic vein embolization versus venography alone could determine outcomes for women with chronic pelvic pain and pelvic varicose veins.
The data gathered will assist in addressing changes in quality of life in patients who have ovarian/pelvic vein embolization versus no embolization.

开始日期2024-11-01

申办/合作机构

Weill Medical College of Cornell University

[+2]

100 项与慢性盆腔疼痛综合征相关的临床结果

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100 项与慢性盆腔疼痛综合征相关的转化医学

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0 项与慢性盆腔疼痛综合征相关的专利（医药）

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项与慢性盆腔疼痛综合征相关的文献（医药）

2024-12-01·Journal of Electromyography and Kinesiology

Pelvic floor muscle electrical coupling in chronic pelvic pain: Insights into pathophysiology and botulinum toxin treatment effects

Article

作者: De-Arriba, Maria ; Alberola-Rubio, Jose ; Garcia-Casado, Javier ; Tarazona-Motes, Marta ; Jose Nohales-Alfonso, Francisco ; Albaladejo-Belmonte, Monica

This study aimed to assess the electrical coupling between both pelvic floor muscle (PFM) sides (two-sided coupling) and within individual PFM sides (one-sided coupling) in chronic pelvic pain (CPP) before and after botulinum neurotoxin type A (BoNT/A) treatment. Surface electromyographic (sEMG) signals were recorded from the left and right PFM of 24 patients (P) with CPP before and after being treated with BoNT/A (Weeks 0,8,12,24). Recordings were also made in 24 healthy women (H). PFM two-sided and one-sided coupling was evaluated during contractions by the cross-correlation (CC) and the imaginary part of coherency (iCOH) of their sEMG signals. Significant differences between their values were assessed comparing P(0) vs. P(8,12,24) and H vs. P(0,8,12,24). This study showed that PFM two-sided coupling is similar across groups before treatment, while PFM one-sided coupling on the patients' most painful side is deranged before and also after BoNT/A treatment: amplitude coupling is lower (iCOH) than healthy women's. This could be justified by altered neuromotor control strategies developed as an adaptation to muscle pain, structural and electrical changes in PFM, and alterations in their innervation pattern, which may influence the onset, perpetuation, or recurrence of CPP after treatment.

2024-12-01·Techniques in Coloproctology

Evaluation and management of chronic anorectal and pelvic pain syndromes: Italian Society of Colorectal Surgery (SICCR) position statement

Review

作者: Martellucci, J ; Marino, F ; Losacco, L ; Navarra, L ; Bottini, C ; Gozzo, C ; Menconi, C ; La Greca, G ; Carlucci, D

Chronic pelvic pain is a hidden issue which needs to involve many different usually uncoordinated specialists. For this reason there is a risk that treatments, in the absence of well-defined pathways, common goals, and terminology, may be poorly effective. The aim of the present paper is to summarize the evidence on anorectal pelvic pain, offering useful evidence-based practice parameters for colorectal surgeons' daily activity. Analysis of chronic anorectal and pelvic pain syndromes, the diagnostic and clinical optimal needs for evaluation, and the innumerable low evidence treatments and therapeutic options currently available suggests that a multimodal individualized management of pain may be the most promising approach. The limited availability of dedicated centers still negatively affects the applicability of these principles.

2024-11-01·Annals of Vascular Surgery

Effects of Venoactive Drug Therapy and Ovarian Vein Interventions on Vasoactive Neuropeptide and Cytokine Levels in Patients with Pelvic Venous Disorders

Article

作者: Alenichev, Alexander V ; Moskalenko, Yekaterina P ; Karalkin, Anatoly V ; Gavrilov, Sergey G

BACKGROUNDTo study and compare the effects of venoactive drug (VAD) therapy and ovarian vein embolization or resection (OVE or OVR, accordingly) on the levels of vasoactive peptides and cytokines in patients with pelvic venous disorders (PeVDs).METHODSThe study included 70 consecutive female patients with PeVD symptoms, such as chronic pelvic pain (CPP), dyspareunia, dysuria, and vulvar varicosities. Based on the results of clinical examination and duplex ultrasound of the pelvic veins, the patients were allocated to the VAD therapy (n = 38) or OVE/OVR (n = 32). Additionally, the enzyme-linked immunosorbent assay tests were performed to determine levels of calcitonin gene-related peptide (CGRP), substance P (SP), interleukins 6 and 8 (IL-6, IL-8) and monocyte chemotactic protein-1 (MCP-1) after a 2-month course of VAD therapy and at 3 months after OVE/OVR.RESULTSThe VAD therapy was associated with a significant decrease in CPP in 84% of patients with PeVD and isolated lesions of the parametrial veins (PVs) and uterine veins (UVs). VAD had no significant effect on the pelvic venous reflux. No changes in the CGRP, SP, IL-6, IL-8, and MCP-1 levels were detected after treatment. At 3 months after OVE or OVR, all patients with PeVD and combined lesions of the ovarian veins (OVs), PVs and UVs reported almost complete relief of CPP. Along with elimination of reflux in ovarian veins, the disappearance of reflux in PVs and UVs was noted. A decrease in the CGRP and SP levels was observed (0.7 ± 0.1 ng/mL and 0.12 ± 0.02 ng/mL before treatment; 0.5 ± 0.12 ng/mL and 0.09 ± 0.06 ng/mL after treatment, respectively; all P < 0.05). No changes in cytokine levels were revealed.CONCLUSIONSTreatment with VAD is associated with the CPP relief, but has no significant effect on the CGRP, SP, IL-6, IL-8, and MCP-1 levels. OVE/OVR results in the CPP relief, elimination of the pelvic venous reflux and a significant decrease in the CGRP and SP levels, but does not change cytokine levels.

项与慢性盆腔疼痛综合征相关的新闻（医药）

2024-10-23

·和其瑞 Hope Medicine

和其瑞医药单克隆抗体HMI-115获得CDE突破性疗法认定

近日，Hope Medicine Inc.（和其瑞医药）（以下或简称“和其瑞”）宣布，其拥有全球权益的单克隆抗体一类新药HMI-115已被中国国家药品监督管理局（NMPA）药品评审中心（CDE）纳入突破性治疗药物品种名单（BTD），拟定用于治疗子宫内膜异位症相关的中重度疼痛。本次CDE对于HMI-115纳入突破性治疗药物品种的认定，是基于一项正在全球进行的临床II期研究（CDE临床试验登记号：CXSL2200442）的中期分析结果。这是一项国际多中心，评估HMI-115的有效性和安全性的随机、双盲、安慰剂对照的剂量探索临床研究，这项研究包括美国、波兰和中国的142名女性子宫内膜异位症患者，该项试验在中国的组长单位是北京协和医院。在中期分析包括的前102名患者中，HMI-115显示对于子宫内膜异位症相关疼痛有统计学意义的改善，HMI-115显示了良好的安全性，大多数患者报告月经正常，未报告典型的围绝经期症状，骨密度和重要性激素水平没有显著变化。（图片来源：国家药品监督管理局药品审评中心官网）对于这一重要进展，和其瑞首席执行官陈曦先生表示： “子宫内膜异位症是一种常见且严重的女性疾病，几十年来，患者和医生一直在寻求一种能缓解疼痛且不影响性激素的治疗方法，HMI-115有希望填补这一未被满足的医疗需求，因为HMI-115具有全球首创的治疗机制，这项临床二期研究也将首次证明阻断催乳素受体可以治疗子宫内膜异位症。” 和其瑞医药创始人，肖瑞平教授表示： “自创立以来，和其瑞医药始终关注和致力于改善全球妇女的健康，我们正在计划迅速推进HMI-115的全球III期临床试验，以便能够早日惠及患者。” 关于突破性治疗药物品种药物临床试验期间，用于防治严重危及生命或者严重影响生存质量的疾病且尚无有效防治手段或者与现有治疗手段相比有足够证据表明具有明显临床优势的创新药或者改良型新药等，申请方可以在临床试验开展前申请适用突破性治疗药物程序。药审中心会对纳入突破性治疗药物品种的研发过程保持密切关注和沟通指导，并给予优先审评审批机会。关于子宫内膜异位症（Endometriosis）子宫内膜异位症是一种以内膜细胞种植在子宫内膜以外位置为特征的一种的常见妇科疾病，通常表现为慢性炎症反应。子宫内膜是子宫腔内的一层粘膜组织，在月经周期中发生激素依赖性变化。子宫内膜异位症常见于育龄妇女，常见症状包括下腹及盆腔痛、痛经、性交痛及不孕。据综合文献报道，全球约10%的生育年龄妇女患有内异症，即全球约有1.9亿妇女为内异症患者；20%~50%的不孕症妇女合并内异症，71%~87%的慢性盆腔疼痛妇女患有内异症。内异症是导致痛经、不孕症和慢性盆腔痛的主要原因之一。子宫内膜异位症通常引起生活质量的下降，影响患者的性生活、心理及其社会行为。关于HMI-115与和其瑞医药和其瑞医药是一家科学驱动的临床阶段创新生物制药公司，在中国北京、上海和南京设有研发基地及办公室。公司的创立是基于北京大学未来技术学院院长肖瑞平教授及其团队在转化医学研究领域的深入理解及数十年的研究成果。和其瑞以卓越科学研究为基础，以改善生命质量为目标，针对威胁人类健康的常见病和重大疾病，致力于研究、开发和商业化首创新药。和其瑞依照与拜耳公司（Bayer AG）就开发与产业化靶向泌乳素受体（PRLR）的单克隆抗体 -- HMI-115，签署的一项全球独家许可协议，在全球开展多个适应症的开发和产业化。目前，HMI-115正在进行针对子宫内膜异位症和雄激素脱发两个适应症的全球临床二期试验，进展顺利。前瞻性声明本新闻稿包含前瞻性声明，主要基于公司管理层的当前展望、期望、估计和预测。在使用“希望”、“预期”、“相信”、 “可能”、“设计”、“效果”、“评估”、“期望”、“预测”、“目标”、 “计划”、 “目的”、“将”、“拟”、“会”及其他类似词语和类似表述，凡与本公司有关的，目的均是要指明其属于前瞻性表述。前瞻性表述会受到风险和不确定性的影响，其中许多是难以预测且通常是公司无法控制的，这可能会导致不同于前瞻性表述的实际结果。对任何前瞻性表述的更新或修订，本公司不承担公开宣布的义务。联系我们运营团队办公室上海市浦东新区亮秀路112号Y1座项目及媒体联系pr@hopemedinc.com 人才招聘hopemed.hr@hopemedinc.com 年轻的和其瑞期待您的加入！共同成就源头创新，走向全球！有志者，请与我们联系！

突破性疗法临床2期临床3期优先审批申请上市

2024-10-15

·PRNewswire

FzioMed, Inc. to Highlight its Adhesion Barrier Product Solutions at the European Society for Gynecological Endoscopy (ESGE) Congress

SAN LUIS OBISPO, Calif., Oct. 15, 2024 /PRNewswire/ -- FzioMed, Inc. ("FzioMed" or the "Company"), a recognized global leader in post-surgical adhesion prevention, today announced it will attend the European Society of Gynecological Endoscopy (ESGE) 33rd annual congress October 27-30 in Marseille, France. The Company will showcase its innovative Oxiplex/IU® and Oxiplex/AP® adhesion barrier gels designed to reduce the formation of adhesions following intrauterine and abdominal/pelvic related surgical procedures. Since its foundation, ESGE has aimed to encourage the exchange of clinical experience, scientific thought and investigation among gynecological practitioners in minimally invasive techniques. FzioMed's synthetic adhesion barrier products, based on the Company's patented dual-polymer technology and more than 20 years of clinical use, provide a temporary physical barrier between tissues helping prevent the formation of adhesions, reducing the incidence of postoperative pain and other complications. For intrauterine and abdominal/pelvic related surgical procedures, Oxiplex/IU and Oxiplex/AP gels and their unique applicators offer ease of use combined with proven safety and clinical efficacy. Patrick Bellelis, MD, PhD, endometriosis specialist and minimally invasive gynecologic surgeon at the University of Sao Paolo, Brazil, will be presenting two video lectures on Tuesday, October 29 starting at 15:00 CET (UTC+01:00) titled: "Challenging Case of Deep Endometriosis with Significant Involvement of the Rectovaginal Septum" and "Postoperative Endometriosis Second Look after Application of Anti-Adhesion Viscoelastic Gel." Prof. Bellelis will also be available at FzioMed's exhibitor booth (Booth #A4) periodically throughout the congress to speak about his clinical experience with the Oxiplex family of adhesion barrier gels. "Even with the best surgical technique, postoperative adhesions can form following abdominal, pelvic, and gynecological procedures – from hernia and bariatric procedures to hysterectomy, endometriosis, and other tubal and ovarian surgeries," stated Stephanie Cortese, Senior Vice President of Science and Technology. "These adhesions can cause a variety of complications including chronic pelvic pain, small bowel obstructions, infertility, and scarring that can complicate future surgery." FzioMed's Adhesion Barrier Gels are provided sterile and ready to use with specialized applicators for hysteroscopic or laparoscopic use that allow for ease of application while the clear gel formula maintains local visibility. No special storage, refrigeration, mixing, or handling is required. Oxiplex/IU and Oxiplex/AP gels do not migrate after application as their unique viscosity is flowable yet remains where applied. FzioMed's portfolio of adhesion barrier products have been available since 2002 and have been used in nearly 1 million procedures worldwide. About FzioMed, Inc. Pioneering biomaterials since 1996, FzioMed is a vertically integrated medical device company focused exclusively on preserving surgical excellence in spine, orthopedic, abdominal/pelvic and gynecological procedures. FzioMed develops, manufactures, and commercializes surgical biomaterials used by clinicians as adhesion barriers to improve surgical outcomes and is a recognized global leader in post-surgical adhesion prevention. FzioMed's synthetic, absorbable gel formulations are based on the Company's patented dual-polymer technology platform that provide a temporary, mechanical separation of tissues during the body's natural healing process – reducing adhesion formation. FzioMed's portfolio of adhesion barrier products are marketed in more than 70 countries under various brand names and have been used clinically since 2002 in nearly 1 million procedures worldwide. Visit fziomed.com to learn more about FzioMed and our industry-leading products. SOURCE FzioMed WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-08-01

·米内网

这家中药龙头发威了！凝胶剂大涨108%，39款1类新药霸屏，9款中药新药上市可期

精彩内容近日，中药龙头企业康缘药业公布2024上半年业绩，报告期内实现营收22.6亿元，归母净利润2.65亿元。康缘药业坚持创新驱动，2024上半年研发费用约3.4亿元，占营收比重突破15%，目前公司有32款中药新药在研，其中9款已提交NDA或处于III期临床，上市可期；化药及生物药方面，12款1类新药来袭，9个仿制药瞄准超60亿市场。 48个独家中成药亮眼！新药研发进展不断康缘药业是一家大型中药企业，目前拥有药品生产批件207个，其中48个为中药独家品种（2个中药保护品种）。其主要产品线聚焦呼吸与感染疾病、妇科疾病、心脑血管疾病、骨伤科疾病等中医优势领域，覆盖口服液、注射液、胶囊剂、片剂/丸剂、颗粒剂/冲剂、贴剂、凝胶剂等剂型，代表品种包括金振口服液、七味通痹口服液、热毒宁注射液、复方南星止痛膏、杏贝止咳颗粒、桂枝茯苓胶囊、腰痹通胶囊、天舒胶囊、筋骨止痛凝胶等。 7月27日，康缘药业公布2024上半年业绩，报告期内实现营业收入22.6亿元，归母净利润2.65亿元，营收、净利润均出现下滑。康缘药业表示，公司坚持创新发展战略，强化公司内部治理，深化营销学术引领及合规建设。在全面合规建设推进和提升的过程中，公司面临内外部多重复杂环境和挑战，对公司短期经营业绩增速产生了一定的影响。从分产品收入看，2024上半年康缘药业多个板块产品收入出现下滑，口服液、凝胶剂表现亮眼，营业收入分别较上年同期增长28.6%、107.87%，主要系金振口服液、筋骨止痛凝胶销售同比增长所致。虽然改革阵痛让康缘药业业绩承受阶段性压力，但公司始终坚持创新驱动，以中医药发展为主体，并积极布局化学药、生物药等领域，研发管线有望进入集中兑现期。近年来公司持续加大研发力度，研发费用占营业收入比重逐年加大，2024年研发费用约3.4亿元，占营收比重突破15%。康缘药业自2020年以来保持每年皆有中药新药获批上市的态势，累计拿下筋骨止痛凝胶、银翘清热片、散寒化湿颗粒、苓桂术甘颗粒、济川煎颗粒5款中药新药；化药方面，注射用兰索拉唑、吸入用乙酰半胱氨酸溶液、米诺地尔搽剂、吸入用异丙托溴铵溶液、吡仑帕奈片、泊沙康唑肠溶片6款仿制药获批，除了注射用兰索拉唑，其余均视同过评。 2024上半年，康缘药业持续推动新药研发，3款中药新药提交NDA，包括2款中药1.1类新药龙七胶囊（肺癌之痰瘀阻肺证）、参蒲盆安颗粒（盆腔炎性疾病后遗症）及中药3.1类新药玉女煎颗粒（胃热阴虚证）；双鱼颗粒、苏辛通窍颗粒2款中药新药完成III期临床研究，均为呼吸系统中成药；2款中药1.1类新药羌芩颗粒、七味脂肝颗粒提交IND，且均已获批临床，分别用于治疗流行性感冒（风热证）、非酒精性脂肪性肝炎（湿热痰瘀互结证）。化药创新药方面，新一代乙酰胆酯酶抑制剂氟诺哌齐片(DC20)完成II期临床病例入组，全人源抗CD38单抗KYS202002A注射液开展系统性红斑狼疮适应症的I期临床研究；KYS202003A注射液、注射用AAPB提交IND，其中注射用AAPB已获批临床，用于治疗急性缺血性脑卒中。化药仿制药方面，获得3个药品注册证书，分别为吡仑帕奈片（2mg、4mg）、泊沙康唑肠溶片。此外，呋塞米口服溶液、盐酸左沙丁胺醇雾化吸入溶液、骨化三醇软胶囊3个品种以新注册分类报产。2024H1康缘药业部分获批临床/生产的品种来源：米内网中国申报进度（MED）数据库 32款中药新药来袭，这9款上市可期作为国内中药创新龙头企业，康缘药业在中药新药研发方面已逐渐形成“上市一批、临床一批、开发一批”的良性循环，进一步夯实行业龙头地位。米内网数据显示，2023年中国三大终端六大市场（统计范围见文末）中成药合计销售额超过4100亿元，同比增长6.5%。在中成药TOP20集团中，康缘药业榜上有名。目前康缘药业有32款中药新药处于申请临床及以上阶段，覆盖呼吸系统、妇科、消化及代谢系统、儿科、心脑血管疾病等中医优势领域。其中，中药1类新药有27个，中药2类改良型新药有2个，中药3类新药有3个。康缘药业国内在研的中药新药来源：公司公告、米内网综合数据库呼吸系统是康缘药业重点布局的领域之一，在研中药新药涵盖感冒、鼻炎、支气管哮喘、慢阻肺等细分病种。其中，中药3.2类新药扶正解毒颗粒已经提交NDA，用于流行性感冒的热毒宁颗粒、双鱼颗粒，以及用于变应性鼻炎的紫辛鼻鼽颗粒均处于/完成III期临床，用于支气管哮喘的麻杏止哮颗粒、九味疏风平喘颗粒均处于II期临床。米内网数据显示，2023年中国三大终端六大市场呼吸系统中成药销售额超过860亿元。中成药在妇儿治疗领域具有优势，近年来中国三大终端六大市场妇儿中成药销售额逐年上涨，2023年超过370亿元。在该治疗领域，康缘药业的参蒲盆安颗粒已提交NDA，用于盆腔炎性疾病后遗症-慢性盆腔痛（湿热瘀阻证）；此外，用于小儿肺热咳喘证的泻白颗粒处于Pre-NDA阶段，用于更年期综合征（肾阴虚证）的六味地黄苷糖片处于III期临床，七味癸宝颗粒（早发性卵巢功能不全）、正宫胶囊（子宫内膜异位症）、小儿佛芍和中颗粒（儿童功能性腹痛）处于II期临床。除了开发中药新药，康缘药业也在拓展公司已上市品种的新适应症，其中大株红景天胶囊用于预防急性高原反应的新适应症已处于III期临床，金振口服液用于儿童病毒性肺炎的新适应症已步入II期临床，苁蓉总苷胶囊用于阿尔茨海默病(AD)轻中度痴呆属髓海不足患者的症状改善治疗的新适应症、杏贝止咳颗粒用于感染后咳嗽风热犯肺证的新适应症已获批临床。 12款化药/生物药1类新药、9个新品在路上在化药/生物药研发方面，康缘药业立足“创新为主，仿制为辅”的理念，在创新药及仿制药上均有布局。目前康缘药业有13款化药/生物药新药（12款为1类新药）处于申报临床及以上阶段，涵盖抗肿瘤及免疫调节、心脑血管系统、儿科等治疗领域。康缘药业国内在研的化药及生物药新药来源：公司公告、米内网综合数据库从研发进度上看，WXSH0493片（痛风）、氟诺哌齐片（阿尔茨海默氏病）、KY0467颗粒（儿童手足口病）、喹诺利辛片（前列腺增生）等已处于II期临床阶段。仿制药方面，目前公司有9个品种以新分类报产在审，若以通用名计，则9个药品2023年在中国三大终端六大市场的销售额合计超过60亿元，不乏骨化三醇、仑伐替尼等畅销品种。康缘药业新分类报产且在审的品种来源：米内网中国申报进度（MED）数据库 9个品种中，有2个暂无首仿（含剂型首仿）获批上市，包括琥珀酸舒马普坦萘普生钠片、色甘酸钠吸入溶液，康缘药业均首家/独家报产，有望拿下国内首仿。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至7月30日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

财报临床3期医药出海