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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Stress; Uterine Prolapse; Vaginal Prolapse
• Intervention / Treatment: Procedure: Burch urethropexy at time of sacrocolpopexy

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 Type: Interventional
• Enrollment (Actual): 322
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-7333
      • The University of Alabama at Birmingham
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa College of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins School of Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7590
      • University of North Carolina at Chapel Hill
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-3180
      • Magee-Womens Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress urinary continence	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).	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Linda Brubaker, MD, Loyola University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Pelvic Floor Disorders Network website

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: August 1, 2003
• First Submitted That Met QC Criteria: August 4, 2003
• First Posted (Estimate): August 5, 2003

Study Record Updates

• Last Update Posted (Estimate): January 11, 2011
• Last Update Submitted That Met QC Criteria: January 9, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Urinary incontinence; Sacrocolpopexy; Stress incontinence; Pelvic organ prolapse; Burch urethropexy; Surgical Trials
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Uterine Diseases; Urination Disorders; Pathological Conditions, Anatomical; Elimination Disorders; Pelvic Organ Prolapse; Urinary Incontinence; Prolapse; Enuresis; Urinary Incontinence, Stress; Uterine Prolapse
• 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); U10HD041267 (U.S. NIH Grant/Contract); U10HD041269 (U.S. NIH Grant/Contract)