Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- Score on the irritative subscale of the Urinary Distress Inventory (UDI) on the Pelvic Floor Distress Inventory (PFDI)
- Score on the obstructive/discomfort subscale of UDI on PFDI
- 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:
- 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;
- 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;
- 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 |
Women who completed the CARE study
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| 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 | |
| Study Chair: | Ingrid Nygaard, MD | University of Utah |
More Information
Additional Information:
No publications provided
| Responsible Party: | Susan Meikle, MD MSPH, Project Scientist, National Institute of Child Health and Human Development |
| 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: | January 7, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
sacrocolpopexy abdominal sacrocolpopexy surgical procedure, prolapse |
pelvic organ prolapse urinary incontinence stress urinary incontinence |
Additional relevant MeSH terms:
|
Prolapse Urinary Incontinence Pelvic Organ Prolapse Pathological Conditions, Anatomical |
Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013