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

Terminated

Conditions: Urinary Incontinence
Prolapse

Registration Number: NCT00099372

Lead Sponsor: NICHD Pelvic Floor Disorders Network

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 215

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Symptomatic Failure	7 year	Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
Number of Participants With Anatomic Failure (Original Definition)	7 year	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
Number of Participants With Anatomic Failure (Updated Definition)	7 year	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
Number of Participants With Composite Failure	7 year	Anatomic failure (updated definition) or symptomatic failure
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index	7 year	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.
Number of Participants With Stress Urinary Incontinence (SUI) Prevention	7 year	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
Number of Participants With Stress Urinary Incontinence (SUI)	7 year	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (8): USCD Medical Center
🇺🇸
La Jolla, California, United States
University of Iowa
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Iowa City, Iowa, United States
The University of Alabama at Birmingham
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Birmingham, Alabama, United States
Kaiser Permanente
🇺🇸
San Diego, California, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
Johns Hopkins School of Medicine
🇺🇸
Baltimore, Maryland, United States
Magee-Womens Hospital
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Pittsburgh, Pennsylvania, United States
Duke University
🇺🇸
Durham, North Carolina, United States