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

This study is currently recruiting patients.

Sponsors and Collaborators: National Institute of Child Health and Human Development (NICHD)
University of Iowa
Baylor College of Medicine
Loyola University
University of North Carolina
Johns Hopkins University
University of Pittsburgh
Information provided by: National Institute of Child Health and Human Development (NICHD)

Purpose

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.

Condition
Prolapse
Urinary Incontinence

MedlinePlus related topics:  Urinary Incontinence

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Official Title: Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse: The Extended Colpopexy and Urinary Reduction Efforts (E-CARE) Study

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Female

Criteria

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).

Location and Contact Information

Ingrid Nygaard, MD, MS      319-356-2306    ingrid-nygaard@uiowa.edu

Iowa
      University of Iowa, Iowa City,  Iowa,  52242,  United States; Recruiting
Ingrid Nygaard, MD, MS  319-356-2306    ingrid-nygaard@uiowa.edu 
Debra Brandt, RN, BS  319-356-2306    debra-brandt@uiowa.edu 
Ingrid Nygaard, MD, MS,  Principal Investigator

Study chairs or principal investigators

Morton Brown, PhD,  Principal Investigator,  University of Michigan   

More Information

Study ID Numbers:  PFD 001; U01HD41249; U01 HD41249,; U10 HD41268,; U10 HD41248,; U10 HD41250,; U10 HD41261,; U10 HD41263,; U10 HD41269,; U10 HD41267
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005