Colpopexy and Urinary Reduction Efforts (CARE) Protocol (CARE)
2011年1月9日 更新者：Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts
Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina.
Pelvic organ prolapse can be corrected with surgery.
However, women who have this surgery may develop urinary incontinence.
This study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence.
研究概览
详细说明
Many women have surgery for pelvic organ prolapse (cystocele, uterine prolapse, rectocele). Women with advanced pelvic organ prolapse may experience stress urinary incontinence following surgery to repair the prolapse. Development of incontinence is unpredictable. This study will determine which, if any, clinical tests are useful for predicting post-operative urinary incontinence. The study will also determine if a Burch urethropexy should be performed routinely or selectively at the time of sacrocolpopexy in continent women.
Women with pelvic organ prolapse who are scheduled for prolapse repair will be randomized to a Burch urethropexy group or to a control group. Women in the Burch group will undergo urethropexy at the time of prolapse repair. Assessments will include a quality of life telephone interview, urodynamic testing, and physical examination. Follow-up evaluations occur at 6 weeks, 3 months, and 1 and 2 years following surgery. Post-operative phone interviews will occur at 3 months, 6 months, and 1 and 2 years.
研究类型
介入性
注册 (实际的)
322
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35233-7333
- The University of Alabama at Birmingham
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Illinois
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Maywood、Illinois、美国、60153
- Loyola University Medical Center
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Iowa
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Iowa City、Iowa、美国、52242
- University of Iowa College of Medicine
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins School of Medicine
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North Carolina
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Chapel Hill、North Carolina、美国、27599-7590
- University of North Carolina at Chapel Hill
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213-3180
- Magee-Womens Hospital
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Texas
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Houston、Texas、美国、77030
- Baylor College of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria
- Eligibility for primary procedure (sacrocolpopexy)
- Eligibility for secondary procedure (Burch colposuspension)
- Stage II-IV anterior vaginal prolapse, defined as POP-Q Point Aa at -1, 0, +1, +2, or +3 cm.
- Negative stress incontinence screen
- Negative stress incontinence screen (MESA questionnaire)
Exclusion Criteria
Contraindication for sacrocolpopexy or Burch colposuspension.
- Anatomic contraindication for Burch colposuspension (i.e., Point Aa fixed at -2 or -3 cm).
- Surgeon judgment that a contraindication to Burch colposuspension exists.
- Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening).
- Inability to provide informed consent or to complete testing or data collection.
- Currently pregnant.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Abdominal Sacral Colpopexy with no Burch colposuspension
Abdominal sacral colpopexy is performed through a laparotomy approach.
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实验性的：Abdominal Sacral Colpopexy with Burch Colposuspension
The Burch colposuspension procedure entails the retropubic placement of at least two stitches in the vaginal tissue lateral to each side of the urethra, and suspension of these stitches from Cooper's ligament (the iliopectineal line at the superior aspect of the posterior pubic bone).
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The Burch colposuspension procedure entails the retropubic placement of at least two stitches in the vaginal tissue lateral to each side of the urethra, and suspension of these stitches from Cooper's ligament (the iliopectineal line at the superior aspect of the posterior pubic bone).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Stress urinary continence
大体时间：3 months
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Patients will be categorized as stress continent or stress incontinent on the basis of symptom assessment and stress testing.
The symptoms will be assessed by the stress incontinence subscale of the Pelvic Floor Distress Inventory (PFDI).
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Complications at surgery
大体时间：2 years
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Complications at surgery
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2 years
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Occurrence of other lower urinary tract symptoms
大体时间：3 mo, 2 years
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measured by the urgency and obstructed voiding subscales of the PFDI
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3 mo, 2 years
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Other pelvic symptoms and health-related quality of life
大体时间：3 mo, 2 years
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includes bowel function and sexual function
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3 mo, 2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Linda Brubaker, MD、Loyola University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22.
- Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992.
- Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208. Erratum In: N Engl J Med. 2016 Jun 9;374(23):2297-8.
- Burgio KL, Nygaard IE, Richter HE, Brubaker L, Gutman RE, Leng W, Wei J, Weber AM; Pelvic Floor Disorders Network. Bladder symptoms 1 year after abdominal sacrocolpopexy with and without Burch colposuspension in women without preoperative stress incontinence symptoms. Am J Obstet Gynecol. 2007 Dec;197(6):647.e1-6. doi: 10.1016/j.ajog.2007.08.048.
- Bradley CS, Nygaard IE, Brown MB, Gutman RE, Kenton KS, Whitehead WE, Goode PS, Wren PA, Ghetti C, Weber AM; Pelvic Floor Disorders Network. Bowel symptoms in women 1 year after sacrocolpopexy. Am J Obstet Gynecol. 2007 Dec;197(6):642.e1-8. doi: 10.1016/j.ajog.2007.08.023.
- Visco AG, Brubaker L, Nygaard I, Richter HE, Cundiff G, Fine P, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Reduction Efforts (CARE) randomized surgical trial. Int Urogynecol J Pelvic Floor Dysfunct. 2008 May;19(5):607-14. doi: 10.1007/s00192-007-0498-2. Epub 2008 Jan 9.
- Nygaard I, Handa VL, Brubaker L, Borello-France D, Wei J, Wells E, Goode P; Pelvic Floor Disorders Network. Changes in physical activity after abdominal sacrocolpopexy for advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):570.e1-5. doi: 10.1016/j.ajog.2008.01.044.
- Wren PA, Janz NK, FitzGerald MP, Barber MD, Burgio KL, Cundiff GW, Nygaard IE, Zyczynski HM, Gao X; Pelvic Floor Disorders Network. Optimism in women undergoing abdominal sacrocolpopexy for pelvic organ prolapse. J Am Coll Surg. 2008 Aug;207(2):240-5. doi: 10.1016/j.jamcollsurg.2008.02.019. Epub 2008 May 12.
- Goode PS, Fitzgerald MP, Richter HE, Whitehead WE, Nygaard I, Wren PA, Zyczynski HM, Cundiff G, Menefee S, Senka JM, Gao X, Weber AM; Pelvic Floor Disorders Network. Enhancing participation of older women in surgical trials. J Am Coll Surg. 2008 Sep;207(3):303-11. doi: 10.1016/j.jamcollsurg.2008.03.012. Epub 2008 May 19.
- Brubaker L, Nygaard I, Richter HE, Visco A, Weber AM, Cundiff GW, Fine P, Ghetti C, Brown MB. Two-year outcomes after sacrocolpopexy with and without burch to prevent stress urinary incontinence. Obstet Gynecol. 2008 Jul;112(1):49-55. doi: 10.1097/AOG.0b013e3181778d2a. Erratum In: Obstet Gynecol. 2016 May;127(5):968-969.
- Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW, Norton PA, Schaffer J, Brown MB, Brubaker L; Pelvic Floor Disorders Network. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. 2008 Dec;199(6):688.e1-5. doi: 10.1016/j.ajog.2008.07.029. Epub 2008 Oct 31.
- Bradley CS, Kenton KS, Richter HE, Gao X, Zyczynski HM, Weber AM, Nygaard IE; Pelvic Floor Disorders Network. Obesity and outcomes after sacrocolpopexy. Am J Obstet Gynecol. 2008 Dec;199(6):690.e1-8. doi: 10.1016/j.ajog.2008.07.030. Epub 2008 Oct 9.
- Barber MD, Brubaker L, Nygaard I, Wheeler TL 2nd, Schaffer J, Chen Z, Spino C; Pelvic Floor Disorders Network. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol. 2009 Sep;114(3):600-609. doi: 10.1097/AOG.0b013e3181b2b1ae.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2002年4月1日
初级完成 (实际的)
2007年3月1日
研究完成 (实际的)
2007年4月1日
研究注册日期
首次提交
2003年8月1日
首先提交符合 QC 标准的
2003年8月4日
首次发布 (估计)
2003年8月5日
研究记录更新
最后更新发布 (估计)
2011年1月11日
上次提交的符合 QC 标准的更新
2011年1月9日
最后验证
2010年10月1日
更多信息
与本研究相关的术语
其他研究编号
- U01HD041249 (美国 NIH 拨款/合同)
- U10HD041268 (美国 NIH 拨款/合同)
- U10HD041248 (美国 NIH 拨款/合同)
- U10HD041250 (美国 NIH 拨款/合同)
- U10HD041261 (美国 NIH 拨款/合同)
- U10HD041263 (美国 NIH 拨款/合同)
- U10HD041267 (美国 NIH 拨款/合同)
- U10HD041269 (美国 NIH 拨款/合同)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.