Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse - Article
Clinical Trial: Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
This study is currently recruiting patients.
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.
MedlinePlus related topics: Urinary Incontinence
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Expected Total Enrollment: 300
Study start: May 2004; Expected completion: May 2015
Last follow-up: May 2014; Data entry closure: May 2015
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.
Ages Eligible for Study: 21 Years and above, Genders Eligible for Study: Female
- Women enrolled in CARE
- 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).
Location and Contact Information
University of Iowa, Iowa City, Iowa, 52242, United States; Recruiting
Debra Brandt, RN, BS 319-356-2306 email@example.com
Ingrid Nygaard, MD, MS, Principal Investigator
Morton Brown, PhD, Principal Investigator, University of Michigan
Record last reviewed: December 2004
Last Updated: December 16, 2004
Record first received: December 10, 2004
ClinicalTrials.gov Identifier: NCT00099372
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005