Clinical trial NCT00099372: Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prolapse
Urinary Incontinence
Keywords: sacrocolpopexy
abdominal sacrocolpopexy
surgical procedure, prolapse
pelvic organ prolapse
urinary incontinence
stress urinary incontinence
Lead sponsor: NICHD Pelvic Floor Disorders Network
Sponsor class: NETWORK
Collaborators: name: University of Iowa
name: Baylor College of Medicine
name: Loyola University
name: University of North Carolina, Chapel Hill
name: Johns Hopkins University
name: University of Pittsburgh
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2004-12-13
Enrollment: 215
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who completed the CARE study

Brief summary: 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.

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 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).

Primary outcomes:
measure: Number of Participants With Symptomatic Failure
timeFrame: 24 months
measure: Number of Participants With Symptomatic Failure
timeFrame: 3 year
measure: Number of Participants With Symptomatic Failure
timeFrame: 4 year
measure: Number of Participants With Symptomatic Failure
timeFrame: 5 year
measure: Number of Participants With Symptomatic Failure
timeFrame: 6 year
measure: Number of Participants With Symptomatic Failure
timeFrame: 7 year
measure: Number of Participants With Anatomic Failure (Original Definition)
timeFrame: 24 months
measure: Number of Participants With Anatomic Failure (Original Definition)
timeFrame: 3 year
measure: Number of Participants With Anatomic Failure (Original Definition)
timeFrame: 4 year
measure: Number of Participants With Anatomic Failure (Original Definition)
timeFrame: 5 year
measure: Number of Participants With Anatomic Failure (Original Definition)
timeFrame: 6 year
measure: Number of Participants With Anatomic Failure (Original Definition)
timeFrame: 7 year
measure: Number of Participants With Anatomic Failure (Updated Definition)
timeFrame: 24 months
measure: Number of Participants With Anatomic Failure (Updated Definition)
timeFrame: 3 year
measure: Number of Participants With Anatomic Failure (Updated Definition)
timeFrame: 4 year
measure: Number of Participants With Anatomic Failure (Updated Definition)
timeFrame: 5 year
measure: Number of Participants With Anatomic Failure (Updated Definition)
timeFrame: 6 year
measure: Number of Participants With Anatomic Failure (Updated Definition)
timeFrame: 7 year
measure: Number of Participants With Composite Failure
timeFrame: 24 months
measure: Number of Participants With Composite Failure
timeFrame: 3 year
measure: Number of Participants With Composite Failure
timeFrame: 4 year
measure: Number of Participants With Composite Failure
timeFrame: 5 year
measure: Number of Participants With Composite Failure
timeFrame: 6 year
measure: Number of Participants With Composite Failure
timeFrame: 7 year
measure: Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
timeFrame: 24 months
measure: Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
timeFrame: 3 year
measure: Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
timeFrame: 4 year
measure: Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
timeFrame: 5 year
measure: Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
timeFrame: 6 year
measure: Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
timeFrame: 7 year
measure: Number of Participants With Stress Urinary Incontinence (SUI) Prevention
timeFrame: 24 months
measure: Number of Participants With Stress Urinary Incontinence (SUI) Prevention
timeFrame: 3 year
measure: Number of Participants With Stress Urinary Incontinence (SUI) Prevention
timeFrame: 4 year
measure: Number of Participants With Stress Urinary Incontinence (SUI) Prevention
timeFrame: 5 year
measure: Number of Participants With Stress Urinary Incontinence (SUI) Prevention
timeFrame: 6 year
measure: Number of Participants With Stress Urinary Incontinence (SUI) Prevention
timeFrame: 7 year
measure: Number of Participants With Stress Urinary Incontinence (SUI)
timeFrame: 24 months
measure: Number of Participants With Stress Urinary Incontinence (SUI)
timeFrame: 3 year
measure: Number of Participants With Stress Urinary Incontinence (SUI)
timeFrame: 4 year
measure: Number of Participants With Stress Urinary Incontinence (SUI)
timeFrame: 5 year
measure: Number of Participants With Stress Urinary Incontinence (SUI)
timeFrame: 6 year
measure: Number of Participants With Stress Urinary Incontinence (SUI)
timeFrame: 7 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: La Jolla
country: United States
facility: USCD Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Utah
name: Ingrid Nygaard, MD
role: STUDY_CHAIR
References:
citation: 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.