Purpose/Objective: The primary objective of this FDA study is to evaluate the safety and efficacy of the ACT device (Adjustable Continence Therapy) in the treatment of female recurrent Stress Urinary Incontinence (SUI...Purpose/Objective: The primary objective of this FDA study is to evaluate the safety and efficacy of the ACT device (Adjustable Continence Therapy) in the treatment of female recurrent Stress Urinary Incontinence (SUI). The secondary objective is to evaluate the difficulty of placement and aspects of device adjustability. Materials and Methods: The Adjustable Continence Therapy (ACT) system (Uromedica, Inc., Plymouth, MN) consists of two silicone balloons providing urethral coaption and bladder neck support. Each balloon is attached to a titanium port buried in the labia allowing for post-operative adjustment of volume. Females with recurrent SUI with or without urethral hypermobility were evaluated at baseline and follow-up periods of 6 weeks, 3, 6, 9, 12 months and annually thereafter including urinalysis, a 3-day voiding diary, provocative pad weight test, direct visual stress test, Stamey score and validated questionnaires to assess severity of incontinence, voiding dysfunction, sexual function and quality of life. Results: During a 5 years period (2002-2007), 162 patients were implanted (mean age 67.6, range 31 - 94 years). Of these 162 patients 142, 90, 80, 56 and 31 patients completed the 1, 2, 3, 4 and 5 years follow-up respectively. One hundred and thirty five (83%) had failed at least one surgery for incontinence and 44% had failed 2 or more procedures prior to ACT implantation. Difficulty of ACT placement was rated mild in 62%, moderate in 30% and severe in 9%. Improvement in Stamey score of >1 grade was achieved in 75% (107/142) at 1 year, 76% (68/90) at 2 years, 86% (62/78) at 3 years, 93% (50/54) at 4 years and 83% (25/30) at 5 years. Dry rate (provocative pad weight 2 gms) was 51%, 62% , 76%, 76% and 76% at 1 through 5 years, and >50% improvement was achieved in 83%, 86%, 86%, 90% and 93%,respectively. IQoL improved from 37 at baseline to 71, 71, 75, 77 and 74 during the study, and optimal continence was achieved with a mean of 4 adjustments, and mean balloon volumes of 4.0 ml (1.0 - 11.5 ml). Complications including bladder perforation, erosion, migration, pain and urinary retention were reported in 25% (38/155) at 12 months, and 9% (10/109), 3% (3/91) , 6% (5/79) and 4% (3/69) respectively, and of these, the majority were mild to moderate. At 5 years, 33 patients had undergone permanent explants of both devices, 48 were lost to follow-up and 6 had died of unrelated causes. Conclusions: Five years data suggest that ACT is, a safe and effective, minimally invasive treatment for recurrent SUI, which is easy to place and adjust to optimize urinary control without impairing bladder emptying.展开更多
目的基于“三辨三期三调”探讨真实世界中针药联合对慢性心力衰竭患者运动耐力的影响。方法基于大型医院信息系统(hospital information system,HIS)集成数据库,提取2017年1月-2022年8月云南中医药大学第一附属医院/云南省中医医院所有...目的基于“三辨三期三调”探讨真实世界中针药联合对慢性心力衰竭患者运动耐力的影响。方法基于大型医院信息系统(hospital information system,HIS)集成数据库,提取2017年1月-2022年8月云南中医药大学第一附属医院/云南省中医医院所有出院诊断为慢性心力衰竭患者病例,共纳入1080例。将应用“三辨三期三调”针药联合疗法529例设为观察组,未应用“三辨三期三调”针药联合疗法551例设为对照组。通过χ2检验、倾向评分匹配法分析两组患者运动耐力疗效。结果倾向评分法处理前后均显示观察组总有效率明显优于对照组(P<0.001)。结论基于“三辨三期三调”针药联合治疗能够明显改善慢性心力衰竭患者的运动耐力。展开更多
目的探讨校正改良早期预警评分(modified early warning score,MEWS)联合流程优化护理对急性心力衰竭的急救效果。方法选择2021年1月至2022年6月云浮市中医院收治的90例急性心力衰竭患者作为本研究对象,采用随机数字表法分为两组,每组...目的探讨校正改良早期预警评分(modified early warning score,MEWS)联合流程优化护理对急性心力衰竭的急救效果。方法选择2021年1月至2022年6月云浮市中医院收治的90例急性心力衰竭患者作为本研究对象,采用随机数字表法分为两组,每组各45例,其中观察组45例,对照组45例。对照组行常规急救急诊干预,观察组基于对照组接受MEWS为指导的干预联合急诊流程优化护理,比较两组患者的急救效率、生命体征恢复时间、生活质量评分。结果观察组患者的分诊时间、检查时间、开通静脉通道时间、心电图时间、总抢救时间均低于对照组(P<0.05);观察组自主循环、自主呼吸、窦性心律等指标的恢复时间均低于对照组(P<0.05);干预后30d,两组患者的躯体健康、社会功能、心理功能、物质功能评分均较干预前明显提高,且观察组高于对照组(P<0.05)。结论急性心力衰竭患者急诊急救中予以MEWS为指导联合流程优化护理可促进急救效率的提升及生命体征的恢复,进而提高患者的预后及生活质量。展开更多
文摘Purpose/Objective: The primary objective of this FDA study is to evaluate the safety and efficacy of the ACT device (Adjustable Continence Therapy) in the treatment of female recurrent Stress Urinary Incontinence (SUI). The secondary objective is to evaluate the difficulty of placement and aspects of device adjustability. Materials and Methods: The Adjustable Continence Therapy (ACT) system (Uromedica, Inc., Plymouth, MN) consists of two silicone balloons providing urethral coaption and bladder neck support. Each balloon is attached to a titanium port buried in the labia allowing for post-operative adjustment of volume. Females with recurrent SUI with or without urethral hypermobility were evaluated at baseline and follow-up periods of 6 weeks, 3, 6, 9, 12 months and annually thereafter including urinalysis, a 3-day voiding diary, provocative pad weight test, direct visual stress test, Stamey score and validated questionnaires to assess severity of incontinence, voiding dysfunction, sexual function and quality of life. Results: During a 5 years period (2002-2007), 162 patients were implanted (mean age 67.6, range 31 - 94 years). Of these 162 patients 142, 90, 80, 56 and 31 patients completed the 1, 2, 3, 4 and 5 years follow-up respectively. One hundred and thirty five (83%) had failed at least one surgery for incontinence and 44% had failed 2 or more procedures prior to ACT implantation. Difficulty of ACT placement was rated mild in 62%, moderate in 30% and severe in 9%. Improvement in Stamey score of >1 grade was achieved in 75% (107/142) at 1 year, 76% (68/90) at 2 years, 86% (62/78) at 3 years, 93% (50/54) at 4 years and 83% (25/30) at 5 years. Dry rate (provocative pad weight 2 gms) was 51%, 62% , 76%, 76% and 76% at 1 through 5 years, and >50% improvement was achieved in 83%, 86%, 86%, 90% and 93%,respectively. IQoL improved from 37 at baseline to 71, 71, 75, 77 and 74 during the study, and optimal continence was achieved with a mean of 4 adjustments, and mean balloon volumes of 4.0 ml (1.0 - 11.5 ml). Complications including bladder perforation, erosion, migration, pain and urinary retention were reported in 25% (38/155) at 12 months, and 9% (10/109), 3% (3/91) , 6% (5/79) and 4% (3/69) respectively, and of these, the majority were mild to moderate. At 5 years, 33 patients had undergone permanent explants of both devices, 48 were lost to follow-up and 6 had died of unrelated causes. Conclusions: Five years data suggest that ACT is, a safe and effective, minimally invasive treatment for recurrent SUI, which is easy to place and adjust to optimize urinary control without impairing bladder emptying.
文摘目的基于“三辨三期三调”探讨真实世界中针药联合对慢性心力衰竭患者运动耐力的影响。方法基于大型医院信息系统(hospital information system,HIS)集成数据库,提取2017年1月-2022年8月云南中医药大学第一附属医院/云南省中医医院所有出院诊断为慢性心力衰竭患者病例,共纳入1080例。将应用“三辨三期三调”针药联合疗法529例设为观察组,未应用“三辨三期三调”针药联合疗法551例设为对照组。通过χ2检验、倾向评分匹配法分析两组患者运动耐力疗效。结果倾向评分法处理前后均显示观察组总有效率明显优于对照组(P<0.001)。结论基于“三辨三期三调”针药联合治疗能够明显改善慢性心力衰竭患者的运动耐力。
文摘目的探讨校正改良早期预警评分(modified early warning score,MEWS)联合流程优化护理对急性心力衰竭的急救效果。方法选择2021年1月至2022年6月云浮市中医院收治的90例急性心力衰竭患者作为本研究对象,采用随机数字表法分为两组,每组各45例,其中观察组45例,对照组45例。对照组行常规急救急诊干预,观察组基于对照组接受MEWS为指导的干预联合急诊流程优化护理,比较两组患者的急救效率、生命体征恢复时间、生活质量评分。结果观察组患者的分诊时间、检查时间、开通静脉通道时间、心电图时间、总抢救时间均低于对照组(P<0.05);观察组自主循环、自主呼吸、窦性心律等指标的恢复时间均低于对照组(P<0.05);干预后30d,两组患者的躯体健康、社会功能、心理功能、物质功能评分均较干预前明显提高,且观察组高于对照组(P<0.05)。结论急性心力衰竭患者急诊急救中予以MEWS为指导联合流程优化护理可促进急救效率的提升及生命体征的恢复,进而提高患者的预后及生活质量。
