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

Stopped early

Conditions studied: Prolapse, Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT00099372

Run by

NICHD Pelvic Floor Disorders Network

People needed

215

Starts

2004-05-01

Expected to finish

2011-06-01

Last updated by the study team

2021-03-22

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women enrolled in CARE

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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