The Colpopexy and Urinary Reduction Efforts (CARE) study was designed to assess whether the addition of standardized Burch colposuspension to abdominal sacrocolpopexy for the treatment of pelvic-organ prolapse decreases postoperative stress urinary incontinence (SUI) in women without preoperative symptoms of stress incontinence. Women who did not report symptoms of stress incontinence and who chose to undergo sacrocolpopexy to treat prolapse were randomly assigned to concomitant Burch colposuspension or to no Burch colposuspension (control) and were evaluated in a blinded fashion three months after the surgery.
The surgical team was masked to a standardized pre-operative multi-channel urodynamic assessment, including prolapse reduction. The primary outcome at 3 months after surgery was SUI, defined as positive stress test at 300 cc bladder volume OR affirmative answers to any of the Pelvic Floor Distress Inventory (PFDI) stress incontinence subscale questions OR treatment (or re-treatment) for SUI. Due to concern that other urinary symptoms may be worsened by addition of the Burch, a parallel urge endpoint was defined as a positive response to any PFDI urgency and obstructed voiding subscale questions OR treatment for urge incontinence. Evaluators and subjects were also masked to treatment assignment.
In this study of 322 women (157 Burch colposuspension and 165 controls), 3 months after surgery, 33.6 percent of the women in the Burch group and 57.4 percent of the controls met one or more of the criteria for stress incontinence.
STUDY RESULTS:
Brubaker L, Cundiff G, Fine P, Nygaard I, Richter H, Visco A, Zyczynski H, Brown MB, Weber A, Pelvic Floor Disorders Network. A randomized trial of colpopexy and urinary reduction efforts (CARE): design and methods. Controlled clinical trials. 2003 Oct; 24(5): 629-42.
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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. International urogynecology journal and pelvic floor dysfunction. 2008 May; 19(5): 607-14.
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Visco AG, Wei JT, McClure LA, Handa VL, Nygaard IE, Pelvic Floor Disorders Network. Effects of examination technique modifications on pelvic organ prolapse quantification (POP-Q) results. International urogynecology journal and pelvic floor dysfunction. 2003 Jun; 14(2): 136-40.
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Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H, Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstetrics and gynecology. 2004 Oct; 104(4): 805-23.
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Wren PA, Janz NK, Brubaker L, Fitzgerald MP, Weber AM, LaPorte FB, Wei JT, Pelvic Floor Disorders Network. Reliability of health-related quality-of-life measures 1 year after surgical procedures for pelvic floor disorders. American journal of obstetrics and gynecology. 2005 Mar; 192(3): 780-8.
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Hundley AF, Brown MB, Brubaker L, Cundiff GW, Kreder K, Lotze P, Richter HE, Zyczynski H, Weber AM, Visco AG. A multicentered comparison of measurements obtained with microtip and external water pressure transducers. International urogynecology journal and pelvic floor dysfunction. 2006 Jun; 17(4): 400-6.
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Nygaard I, Handa V, Brubaker L, Borello-France D, Wei J, Wells E, Weber AM, Pelvic Floor Disorders Network. Physical activity in women planning sacrocolpopexy. International urogynecology journal and pelvic floor dysfunction. 2007 Jan; 18(1): 33-7.
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Bradley CS, Brown MB, Cundiff GW, Goode PS, Kenton KS, Nygaard IE, Whitehead WE, Wren PA, Weber AM, Pelvic Floor Disorders Network. Bowel symptoms in women planning surgery for pelvic organ prolapse. American journal of obstetrics and gynecology. 2006 Dec; 195(6): 1814-9.
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Richter HE, Goode PS, Kenton K, Brown MB, Burgio KL, Kreder K, Moalli P, Wright EJ, Weber AM, Pelvic Floor Disorders Network. The effect of age on short-term outcomes after abdominal surgery for pelvic organ prolapse. Journal of the American Geriatrics Society. 2007 Jun; 55(6): 857-63.
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Fitzgerald MP, Janz NK, Wren PA, Wei JT, Weber AM, Ghetti C, Cundiff GW, Pelvic Floor Disorders Network. Prolapse severity, symptoms and impact on quality of life among women planning sacrocolpopexy. International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2007 Jul; 98(1): 24-8.
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Whitehead WE, Bradley CS, Brown MB, Brubaker L, Gutman RE, Varner RE, Visco AG, Weber AM, Zyczynski H, Pelvic Floor Network. Gastrointestinal complications following abdominal sacrocolpopexy for advanced pelvic organ prolapse. American journal of obstetrics and gynecology. 2007 Jul; 197(1): 78.e1-7.
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Richter HE, Nygaard I, Burgio KL, Handa VL, Fitzgerald MP, Wren P, Zyczynski H, Fine P, Brown MB, Weber AM, Pelvic Floor Disorders Network. Lower urinary tract symptoms, quality of life and pelvic organ prolapse: irritative bladder and obstructive voiding symptoms in women planning to undergo abdominal sacrocolpopexy for advanced pelvic organ prolapse. The Journal of urology. 2007 Sep; 178(3 Pt 1): 965-9; discussion 969.
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Handa VL, Zyczynski HM, Brubaker L, Nygaard I, Janz NK, Richter HE, Wren PA, Brown MB, Weber AM, Pelvic Floor Disorders Network. Sexual function before and after sacrocolpopexy for pelvic organ prolapse. American journal of obstetrics and gynecology. 2007 Dec; 197(6): 629.e1-6.
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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. American journal of obstetrics and gynecology. 2007 Dec; 197(6): 647.e1-6.
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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. American journal of obstetrics and gynecology. 2007 Dec; 197(6): 642.e1-8.
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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. American journal of obstetrics and gynecology. 2008 May; 198(5): 570.e1-5.
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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. Journal of the American College of Surgeons. 2008 Aug; 207(2): 240-5.
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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. Journal of the American College of Surgeons. 2008 Sep; 207(3): 303-11.
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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. Obstetrics and gynecology. 2008 07; 112(1): 49-55.
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Bradley CS, Kenton KS, Richter HE, Gao X, Zyczynski HM, Weber AM, Nygaard IE, Pelvic Floor Disorders Network. Obesity and outcomes after sacrocolpopexy. American journal of obstetrics and gynecology. 2008 Dec; 199(6): 690.e1-8.
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Brubaker L, Barber MD, Nygaard I, Nager CW, Varner E, Schaffer J, Visco A, Meikle S, Spino C, Pelvic Floor Disorders Network. Quantification of vaginal support: are continuous summary scores better than POPQ stage? American journal of obstetrics and gynecology. 2010 Nov; 203(5): 512.e1-6.
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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). Neurourology and urodynamics. 2011 Apr; 30(4): 541-6.
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Gutman RE, Nygaard IE, Ye W, Rahn DD, Barber MD, Zyczynski HM, Rickey L, Nager CW, Varner RE, Kenton K, Dandreo KJ, Richter HE, Pelvic Floor Disorders Network, Urinary Incontinence Treatment Network. The pelvic floor complication scale: a new instrument for reconstructive pelvic surgery. American journal of obstetrics and gynecology. 2013 Jan; 208(1): 81.e1-9.
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Young AE, Fine PM, McCrery R, Wren PA, Richter HE, Brubaker L, Brown MB, Weber AM, Pelvic Floor Disorders Network. Spanish language translation of pelvic floor disorders instruments. International urogynecology journal and pelvic floor dysfunction. 2007 Oct; 18(10): 1171-8.
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Barber MD, Brubaker L, Nygaard I, Wheeler TL, Schaffer J, Chen Z, Spino C, Pelvic Floor Disorders Network. Defining success after surgery for pelvic organ prolapse. Obstetrics and gynecology. 2009 Sep; 114(3): 600-9.
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Borello-France DF, Handa VL, Brown MB, Goode P, Kreder K, Scheufele LL, Weber AM, Pelvic Floor Disorders Network. Pelvic-floor muscle function in women with pelvic organ prolapse. Physical therapy. 2007 Apr; 87(4): 399-407.
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Fine P, Burgio K, Borello-France D, Richter H, Whitehead W, Weber A, Brown M, Pelvic Floor Disorders Network. Teaching and practicing of pelvic floor muscle exercises in primiparous women during pregnancy and the postpartum period. American journal of obstetrics and gynecology. 2007 Jul; 197(1): 107.e1-5.
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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. American journal of obstetrics and gynecology. 2008 Dec; 199(6): 688.e1-5.
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Jelovsek JE, Chagin K, Brubaker L, Rogers RG, Richter HE, Arya L, Barber MD, Shepherd JP, Nolen TL, Norton P, Sung V, Menefee S, Siddiqui N, Meikle SF, Kattan MW, Pelvic Floor Disorders Network. A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery. Obstetrics and gynecology. 2014 Feb; 123(2 Pt 1): 279-87.
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Brubaker L, Brown MB, Weber AM, NICHD Pelvic Floor Disorders Network Investigators. Corrections to Report of a Trial of Burch Colposuspension. The New England journal of medicine. 2016 Jun; 374(23): 2295.
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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. The New England journal of medicine. 2006 Apr; 354(15): 1557-66.
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Jelovsek JE, Chagin K, Lukacz ES, Nolen TL, Shepherd JP, Barber MD, Sung V, Brubaker L, Norton PA, Rahn DD, Smith AL, Ballard A, Jeppson P, Meikle SF, Kattan MW, NICHD Pelvic Floor Disorders Network. Models for Predicting Recurrence, Complications, and Health Status in Women After Pelvic Organ Prolapse Surgery. Obstetrics and gynecology. 2018 08; (): .
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Rogers RG, Nolen TL, Weidner AC, Richter HE, Jelovsek JE, Shepherd JP, Harvie HS, Brubaker L, Menefee SA, Myers D, Hsu Y, Schaffer JI, Wallace D, Meikle SF, NICHD Pelvic Floor Disorders Network. Open sacrocolpopexy and vaginal apical repair: retrospective comparison of success and serious complications. International urogynecology journal. 2018 08; 29(8): 1101-1110.
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Harvie HS, Honeycutt AA, Neuwahl SJ, Barber MD, Richter HE, Visco AG, Sung VW, Shepherd JP, Rogers RG, Jakus-Waldman S, Mazloomdoost D, NICHD Pelvic Floor Disorders Network. Responsiveness and Minimally Important Difference of SF-6D and EQ-5D Utility Scores for the Treatment of Pelvic Organ Prolapse. American journal of obstetrics and gynecology. 2019 Mar; (): .
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Read more about this study at clinicaltrials.gov.