Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse (E-CARE)

Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse: The Extended Colpopexy and Urinary Reduction Efforts (E-CARE) Study

The Colpopexy and Urinary Reduction Effort (CARE) trial is a research study designed to evaluate whether the addition of a second surgical procedure in addition to a procedure for female pelvic organ prolapse (POP) affects the rates of urinary incontinence. This study will follow women in the CARE study for 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in CARE. Recruitment into CARE is closed.

Study Overview

• Status: Terminated
• Conditions: Urinary Incontinence; Prolapse

Detailed Description

The primary aims of this prospective cohort study are:

1. To determine the long-term (up to 10 years) anatomic success rate of sacrocolpopexy (defined as Stage 0 apical prolapse AND <= Stage 2 anterior and posterior prolapse AND no re-operation or pessary treatment for POP), and whether anatomic success differs between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy;
2. To determine whether there is a difference in long-term stress continence (by symptoms) between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy;
3. To determine whether there is a long-term difference between overall pelvic floor symptoms and pelvic-floor specific quality of life between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy.

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-7333
      • The University of Alabama at Birmingham
  • California
    • La Jolla, California, United States, 92037
      • USCD Medical Center
    • San Diego, California, United States, 92120
      • Kaiser Permanente
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins School of Medicine
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-3180
      • Magee-Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women who completed the CARE study

Description

Inclusion Criteria:

• Women enrolled in CARE

Exclusion Criteria:

• Inability to provide informed consent.
• Subjects who, at the time of enrollment into E-CARE, are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Abdominal Sacral Colpopexy with no Burch colposuspension; Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Abdominal Sacral Colpopexy with Burch Colposuspension; Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Symptomatic Failure	Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery	24 months
Number of Participants With Symptomatic Failure	Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery	3 year
Number of Participants With Symptomatic Failure	Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery	4 year
Number of Participants With Symptomatic Failure	Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery	5 year
Number of Participants With Symptomatic Failure	Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery	6 year
Number of Participants With Symptomatic Failure	Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery	7 year
Number of Participants With Anatomic Failure (Original Definition)	Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen	24 months
Number of Participants With Anatomic Failure (Original Definition)	Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen	3 year
Number of Participants With Anatomic Failure (Original Definition)	Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen	4 year
Number of Participants With Anatomic Failure (Original Definition)	Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen	5 year
Number of Participants With Anatomic Failure (Original Definition)	Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen	6 year
Number of Participants With Anatomic Failure (Original Definition)	Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen	7 year
Number of Participants With Anatomic Failure (Updated Definition)	Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen	24 months
Number of Participants With Anatomic Failure (Updated Definition)	Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen	3 year
Number of Participants With Anatomic Failure (Updated Definition)	Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen	4 year
Number of Participants With Anatomic Failure (Updated Definition)	Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen	5 year
Number of Participants With Anatomic Failure (Updated Definition)	Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen	6 year
Number of Participants With Anatomic Failure (Updated Definition)	Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen	7 year
Number of Participants With Composite Failure	Anatomic failure (updated definition) or symptomatic failure	24 months
Number of Participants With Composite Failure	Anatomic failure (updated definition) or symptomatic failure	3 year
Number of Participants With Composite Failure	Anatomic failure (updated definition) or symptomatic failure	4 year
Number of Participants With Composite Failure	Anatomic failure (updated definition) or symptomatic failure	5 year
Number of Participants With Composite Failure	Anatomic failure (updated definition) or symptomatic failure	6 year
Number of Participants With Composite Failure	Anatomic failure (updated definition) or symptomatic failure	7 year
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index	Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.	24 months
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index	Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.	3 year
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index	Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.	4 year
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index	Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.	5 year
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index	Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.	6 year
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index	Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.	7 year
Number of Participants With Stress Urinary Incontinence (SUI) Prevention	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI	24 months
Number of Participants With Stress Urinary Incontinence (SUI) Prevention	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI	3 year
Number of Participants With Stress Urinary Incontinence (SUI) Prevention	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI	4 year
Number of Participants With Stress Urinary Incontinence (SUI) Prevention	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI	5 year
Number of Participants With Stress Urinary Incontinence (SUI) Prevention	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI	6 year
Number of Participants With Stress Urinary Incontinence (SUI) Prevention	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI	7 year
Number of Participants With Stress Urinary Incontinence (SUI)	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory	24 months
Number of Participants With Stress Urinary Incontinence (SUI)	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory	3 year
Number of Participants With Stress Urinary Incontinence (SUI)	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory	4 year
Number of Participants With Stress Urinary Incontinence (SUI)	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory	5 year
Number of Participants With Stress Urinary Incontinence (SUI)	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory	6 year
Number of Participants With Stress Urinary Incontinence (SUI)	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory	7 year

Collaborators and Investigators

• Sponsor: NICHD Pelvic Floor Disorders Network
• Collaborators: Johns Hopkins University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Baylor College of Medicine; University of Pittsburgh; University of Iowa; University of North Carolina, Chapel Hill; Loyola University
• Investigators: Study Chair: Ingrid Nygaard, MD, University of Utah

Publications and helpful links

General Publications

• Nygaard I, Brubaker L, Zyczynski HM, Cundiff G, Richter H, Gantz M, Fine P, Menefee S, Ridgeway B, Visco A, Warren LK, Zhang M, Meikle S. Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. JAMA. 2013 May 15;309(19):2016-24. doi: 10.1001/jama.2013.4919. Erratum In: JAMA. 2013 Sep 11;310(10):1076.

Helpful Links

• Pelvic Floor Disorders Network

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: December 10, 2004
• First Submitted That Met QC Criteria: December 10, 2004
• First Posted (ESTIMATE): December 13, 2004

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: stress urinary incontinence; urinary incontinence; pelvic organ prolapse; sacrocolpopexy; abdominal sacrocolpopexy; surgical procedure, prolapse
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Elimination Disorders; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Enuresis
• Other Study ID Numbers: PFD 001; U01HD41249; 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)