Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse

Study Overview
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Brief Summary
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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.

Detailed Description
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The primary aims of this prospective cohort study are: 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; 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; 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.

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

Conditions
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Prolapse, Urinary Incontinence

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Abdominal Sacral Colpopexy with no Burch colposuspension<br>Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse | |
| Abdominal Sacral Colpopexy with Burch Colposuspension<br>Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sacrocolpopexy, abdominal sacrocolpopexy, surgical procedure, prolapse, pelvic organ prolapse, urinary incontinence, stress urinary incontinence