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.
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
215
The University of Alabama at Birmingham
Birmingham, Alabama, United States
USCD Medical Center
La Jolla, California, United States
Kaiser Permanente
San Diego, California, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Duke University
Durham, North Carolina, United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Number of Participants With Symptomatic Failure
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7 year
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Time frame: 24 months
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Time frame: 3 year
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Time frame: 4 year
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Time frame: 5 year
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Time frame: 6 year
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7 year
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Time frame: 24 months
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Time frame: 3 year
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Time frame: 4 year
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Time frame: 5 year
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Time frame: 6 year
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Time frame: 7 year
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