Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
| Status: | Terminated |
|---|---|
| Conditions: | Overactive Bladder, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 5/4/2018 |
| Start Date: | May 2004 |
| End Date: | June 2011 |
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.
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.
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.
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).
We found this trial at
8
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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