We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(resource and prioritization change as Network transition to a new funding cycle)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099372
First Posted: December 13, 2004
Last Update Posted: September 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Iowa
Baylor College of Medicine
Loyola University
University of North Carolina, Chapel Hill
Johns Hopkins University
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
dwallace, RTI International
  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. Recruitment into this study is open only to women that already participated in CARE. Recruitment into CARE is closed.

Condition
Prolapse Urinary Incontinence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by dwallace, RTI International:

Primary Outcome Measures:
  • Anatomic resolution of POP [ Time Frame: up to 10 years ]
    A successful anatomic outcome is defined by (1) Stage 0 apical prolapse (apex is supported within two cm of vaginal length) AND (2) <= Stage 2 anterior and posterior prolapse AND (3) no re-operation or pessary treatment for POP

  • Stress continence status (by symptoms) [ Time Frame: up to 10 years ]

    Stress continent: must answer "no" to all of the following questions of the stress incontinence subscale of the Pelvic Floor Distress Inventory (PFDI):

    i. Do you usually experience urine leakage related to coughing, sneezing, or laughing? ii. Do you usually experience urine leakage related to physical exercise such as walking, running, aerobics, or tennis? iii. Do you usually experience urine leakage related to lifting or bending over?


  • Obstructive/irritative urinary symptoms [ Time Frame: up to 10 years ]
    1. Score on the irritative subscale of the Urinary Distress Inventory (UDI) on the Pelvic Floor Distress Inventory (PFDI)
    2. Score on the obstructive/discomfort subscale of UDI on PFDI


Secondary Outcome Measures:
  • Pelvic floor symptoms [ Time Frame: up to 10 years ]
    Subscales of the Pelvic Floor Distress Inventory (PFDI) questionnaire

  • Prolapse status [ Time Frame: up to 10 years ]
    POP-Q value for each compartment (anterior, posterior, apical)

  • Long-term negative outcomes of the surgical procedure [ Time Frame: up to 10 years ]
    mesh erosion, incisional hernias, bowel obstruction, or sacral osteomyelitis

  • health-related quality of life [ Time Frame: up to 10 years ]
    SF-36, PFIQ, PISQ


Enrollment: 215
Study Start Date: May 2004
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Abdominal Sacral Colpopexy with no Burch colposuspension
Abdominal Sacral Colpopexy with Burch Colposuspension

Detailed Description:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who completed the CARE study
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099372


Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233-7333
United States, California
USCD Medical Center
La Jolla, California, United States, 92037
Kaiser Permanente
San Diego, California, United States, 92120
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213-3180
Sponsors and Collaborators
NICHD Pelvic Floor Disorders Network
University of Iowa
Baylor College of Medicine
Loyola University
University of North Carolina, Chapel Hill
Johns Hopkins University
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Chair: Ingrid Nygaard, MD University of Utah
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: dwallace, Project Director, RTI International
ClinicalTrials.gov Identifier: NCT00099372     History of Changes
Other Study ID Numbers: PFD 001; U01HD41249
U01HD041249 ( U.S. NIH Grant/Contract )
U10HD041268 ( U.S. NIH Grant/Contract )
U10HD041248 ( U.S. NIH Grant/Contract )
U10HD041250 ( U.S. NIH Grant/Contract )
U10HD041261 ( U.S. NIH Grant/Contract )
U10HD041263 ( U.S. NIH Grant/Contract )
U10HD041269 ( U.S. NIH Grant/Contract )
U10HD041267 ( U.S. NIH Grant/Contract )
First Submitted: December 10, 2004
First Posted: December 13, 2004
Last Update Posted: September 30, 2013
Last Verified: September 2013

Keywords provided by dwallace, RTI International:
sacrocolpopexy
abdominal sacrocolpopexy
surgical procedure, prolapse
pelvic organ prolapse
urinary incontinence
stress urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Prolapse
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical