Colpopexy and Urinary Reduction Efforts (CARE) Protocol (CARE)

• ClinicalTrials.gov Identifier: NCT00065845
• Recruitment Status: Completed
• First Posted: August 5, 2003
• Last Update Posted: January 11, 2011
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Urinary Incontinence, Stress; Uterine Prolapse; Vaginal Prolapse	Procedure: Burch urethropexy at time of sacrocolpopexy	Phase 3

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 322 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts
• Study Start Date: April 2002
• Actual Primary Completion Date: March 2007
• Actual Study Completion Date: April 2007

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Abdominal Sacral Colpopexy with no Burch colposuspension; Abdominal sacral colpopexy is performed through a laparotomy approach.
Experimental: 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).	Procedure: Burch urethropexy at time of sacrocolpopexy; 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).

Outcome Measures

Primary Outcome Measures :

1. Stress urinary continence [ Time Frame: 3 months ]
   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).

Secondary Outcome Measures :

1. Complications at surgery [ Time Frame: 2 years ]
   Complications at surgery
2. Occurrence of other lower urinary tract symptoms [ Time Frame: 3 mo, 2 years ]
   measured by the urgency and obstructed voiding subscales of the PFDI
3. Other pelvic symptoms and health-related quality of life [ Time Frame: 3 mo, 2 years ]
   includes bowel function and sexual function

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria

1. Eligibility for primary procedure (sacrocolpopexy)
2. Eligibility for secondary procedure (Burch colposuspension)
3. Stage II-IV anterior vaginal prolapse, defined as POP-Q Point Aa at -1, 0, +1, +2, or +3 cm.
4. Negative stress incontinence screen
5. Negative stress incontinence screen (MESA questionnaire)

Exclusion Criteria

1. 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.
2. Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening).
3. Inability to provide informed consent or to complete testing or data collection.
4. Currently pregnant.

Contacts and Locations

Locations

United States, Alabama

The University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233-7333

United States, Illinois

Loyola University Medical Center

Maywood, Illinois, United States, 60153

United States, Iowa

University of Iowa College of Medicine

Iowa City, Iowa, United States, 52242

United States, Maryland

Johns Hopkins School of Medicine

Baltimore, Maryland, United States, 21287

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599-7590

United States, Pennsylvania

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States, 15213-3180

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Linda Brubaker, MD; Loyola University

More Information

Additional Information:

Pelvic Floor Disorders Network website 

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Susan Meikle, MD, NICHD
• ClinicalTrials.gov Identifier: NCT00065845
• Other Study ID Numbers: U01HD041249 ( U.S. NIH Grant/Contract ); U10HD041268 ( U.S. NIH Grant/Contract ); U10HD041248 ( U.S. NIH Grant/Contract ); U10HD041250 ( U.S. NIH Grant/Contract ); U10HD041261 ( U.S. NIH Grant/Contract ); U10HD041263 ( U.S. NIH Grant/Contract ); U10HD041269 ( U.S. NIH Grant/Contract ); U10HD041267 ( U.S. NIH Grant/Contract )
• First Posted: August 5, 2003
• Last Update Posted: January 11, 2011
• Last Verified: October 2010

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Urinary incontinence; Pelvic organ prolapse; Stress incontinence; Sacrocolpopexy; Burch urethropexy; Surgical Trials

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Uterine Prolapse; Prolapse; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders; Pathological Conditions, Anatomical; Uterine Diseases; Pelvic Organ Prolapse