NCT00099372

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2004

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
9.8 years until next milestone

Results Posted

Study results publicly available

March 22, 2021

Completed
Last Updated

March 22, 2021

Status Verified

December 1, 2020

Enrollment Period

7.1 years

First QC Date

December 10, 2004

Results QC Date

December 10, 2020

Last Update Submit

February 24, 2021

Conditions

ProlapseUrinary Incontinence

Keywords

sacrocolpopexyabdominal sacrocolpopexysurgical procedure, prolapsepelvic organ prolapseurinary incontinencestress urinary incontinence

Outcome Measures

Primary Outcomes (42)

  • Number of Participants With Symptomatic Failure

    Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

    24 months

  • Number of Participants With Symptomatic Failure

    Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

    3 year

  • Number of Participants With Symptomatic Failure

    Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

    4 year

  • Number of Participants With Symptomatic Failure

    Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

    5 year

  • Number of Participants With Symptomatic Failure

    Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

    6 year

  • Number of Participants With Symptomatic Failure

    Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

    7 year

  • Number of Participants With Anatomic Failure (Original Definition)

    Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen

    24 months

  • Number of Participants With Anatomic Failure (Original Definition)

    Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen

    3 year

  • Number of Participants With Anatomic Failure (Original Definition)

    Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen

    4 year

  • Number of Participants With Anatomic Failure (Original Definition)

    Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen

    5 year

  • Number of Participants With Anatomic Failure (Original Definition)

    Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen

    6 year

  • Number of Participants With Anatomic Failure (Original Definition)

    Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen

    7 year

  • Number of Participants With Anatomic Failure (Updated Definition)

    Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen

    24 months

  • Number of Participants With Anatomic Failure (Updated Definition)

    Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen

    3 year

  • Number of Participants With Anatomic Failure (Updated Definition)

    Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen

    4 year

  • Number of Participants With Anatomic Failure (Updated Definition)

    Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen

    5 year

  • Number of Participants With Anatomic Failure (Updated Definition)

    Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen

    6 year

  • Number of Participants With Anatomic Failure (Updated Definition)

    Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen

    7 year

  • Number of Participants With Composite Failure

    Anatomic failure (updated definition) or symptomatic failure

    24 months

  • Number of Participants With Composite Failure

    Anatomic failure (updated definition) or symptomatic failure

    3 year

  • Number of Participants With Composite Failure

    Anatomic failure (updated definition) or symptomatic failure

    4 year

  • Number of Participants With Composite Failure

    Anatomic failure (updated definition) or symptomatic failure

    5 year

  • Number of Participants With Composite Failure

    Anatomic failure (updated definition) or symptomatic failure

    6 year

  • Number of Participants With Composite Failure

    Anatomic failure (updated definition) or symptomatic failure

    7 year

  • Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index

    Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.

    24 months

  • Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index

    Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.

    3 year

  • Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index

    Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.

    4 year

  • Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index

    Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.

    5 year

  • Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index

    Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.

    6 year

  • Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index

    Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.

    7 year

  • Number of Participants With Stress Urinary Incontinence (SUI) Prevention

    One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI

    24 months

  • Number of Participants With Stress Urinary Incontinence (SUI) Prevention

    One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI

    3 year

  • Number of Participants With Stress Urinary Incontinence (SUI) Prevention

    One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI

    4 year

  • Number of Participants With Stress Urinary Incontinence (SUI) Prevention

    One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI

    5 year

  • Number of Participants With Stress Urinary Incontinence (SUI) Prevention

    One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI

    6 year

  • Number of Participants With Stress Urinary Incontinence (SUI) Prevention

    One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI

    7 year

  • Number of Participants With Stress Urinary Incontinence (SUI)

    One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

    24 months

  • Number of Participants With Stress Urinary Incontinence (SUI)

    One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

    3 year

  • Number of Participants With Stress Urinary Incontinence (SUI)

    One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

    4 year

  • Number of Participants With Stress Urinary Incontinence (SUI)

    One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

    5 year

  • Number of Participants With Stress Urinary Incontinence (SUI)

    One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

    6 year

  • Number of Participants With Stress Urinary Incontinence (SUI)

    One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

    7 year

Study Arms (2)

Abdominal Sacral Colpopexy with no Burch colposuspension

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

Abdominal Sacral Colpopexy with Burch Colposuspension

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

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who completed the CARE study

You may qualify if:

  • Women enrolled in CARE

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233-7333, United States

Location

USCD Medical Center

La Jolla, California, 92037, United States

Location

Kaiser Permanente

San Diego, California, 92120, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213-3180, United States

Location

Related Publications (1)

  • 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.

    PMID: 23677313DERIVED

MeSH Terms

Conditions

ProlapseUrinary IncontinencePelvic Organ ProlapseUrinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and Symptoms

Results Point of Contact

Title
Dr. Marie Gantz
Organization
RTI International
mgantz@rti.org
919-597-5110

Study Officials

  • Ingrid Nygaard, MD

    University of Utah

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2004

First Posted

December 13, 2004

Study Start

May 1, 2004

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 22, 2021

Results First Posted

March 22, 2021

Record last verified: 2020-12

Locations

US(8)