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

December 10, 2004
September 27, 2013
May 2004
June 2011   (final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT00099372 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse: The Extended Colpopexy and Urinary Reduction Efforts (E-CARE) Study

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Women who completed the CARE study

  • Prolapse
  • Urinary Incontinence
Not Provided
  • Abdominal Sacral Colpopexy with no Burch colposuspension
  • Abdominal Sacral Colpopexy with Burch Colposuspension
Nygaard I, Brubaker L, Zyczynski HM, Cundiff G, Richter H, Gantz M, Fine P, Menefee S, Ridgeway B, Visco A, Warren LK, Zhang M, Meikle S. Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. JAMA. 2013 May 15;309(19):2016-24. doi: 10.1001/jama.2013.4919.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
215
June 2011
June 2011   (final data collection date for primary outcome measure)

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).
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00099372
PFD 001; U01HD41249, U01HD041249, U10HD041268, U10HD041248, U10HD041250, U10HD041261, U10HD041263, U10HD041269, U10HD041267
Yes
dwallace, RTI International
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)
Study Chair: Ingrid Nygaard, MD University of Utah
NICHD Pelvic Floor Disorders Network
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP