Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse (E-CARE)

NICHD Pelvic Floor Disorders Network

Status: Terminated

Conditions: Prolapse; Urinary Incontinence

Study type: Observational

Funder types: Other; NETWORK; NIH

Identifiers

NCT00099372

U10HD041261 (U.S. NIH Grant/Contract)

U10HD041268 (U.S. NIH Grant/Contract)

U10HD041248 (U.S. NIH Grant/Contract)

U10HD041263 (U.S. NIH Grant/Contract)

U10HD041267 (U.S. NIH Grant/Contract)

PFD 001 U01HD41249;

U10HD041269 (U.S. NIH Grant/Contract)

U01HD041249

U10HD041250 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

215 participants in 2 patient groups

Abdominal Sacral Colpopexy with no Burch colposuspension

Description:

Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse

Abdominal Sacral Colpopexy with Burch Colposuspension

Description:

Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse