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:
Collaborators:
University of Iowa
Baylor College of Medicine
Loyola University
University of North Carolina, Chapel Hill
Johns Hopkins University
University of Pittsburgh
Information provided by (Responsible Party):
dwallace, RTI International
ClinicalTrials.gov Identifier:
NCT00099372
First received: December 10, 2004
Last updated: September 27, 2013
Last verified: September 2013
  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 NICHD Pelvic Floor Disorders Network:

Primary Outcome Measures:
  • Anatomic resolution of POP [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Subscales of the Pelvic Floor Distress Inventory (PFDI) questionnaire

  • Prolapse status [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    POP-Q value for each compartment (anterior, posterior, apical)

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

  • health-related quality of life [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Ingrid Nygaard, MD University of Utah
  More Information

Additional Information:
No publications provided by NICHD Pelvic Floor Disorders Network

Additional 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, U10HD041268, U10HD041248, U10HD041250, U10HD041261, U10HD041263, U10HD041269, U10HD041267
Study First Received: December 10, 2004
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by NICHD Pelvic Floor Disorders Network:
sacrocolpopexy
abdominal sacrocolpopexy
surgical procedure, prolapse
pelvic organ prolapse
urinary incontinence
stress urinary incontinence

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

ClinicalTrials.gov processed this record on September 15, 2014