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

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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

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.

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
Baltimore, Maryland 21287
345
mi
from 43215
Baltimore, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
493
mi
from 43215
Birmingham, AL
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
352
mi
from 43215
Durham, NC
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
461
mi
from 43215
Iowa City, IA
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9300 Campus Point Drive
La Jolla, California 92037
1950
mi
from 43215
La Jolla, CA
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
283
mi
from 43215
Maywood, IL
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Pittsburgh, Pennsylvania 15213
165
mi
from 43215
Pittsburgh, PA
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San Diego, California 92120
1944
mi
from 43215
San Diego, CA
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