Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse

Urinary Incontinence Clinical Trial

— E-CARE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00099372
• Other study ID #: PFD 001; U01HD41249
• Secondary ID: U01HD041249U10HD
• Status: Terminated
• Start date: May 2004
• Est. completion date: June 2011

Study information

• Verified date: December 2020
• Source: NICHD Pelvic Floor Disorders Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 215
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Enuresis
• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Duke University	Durham	North Carolina
United States	University of Iowa	Iowa City	Iowa
United States	USCD Medical Center	La Jolla	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	Kaiser Permanente	San Diego	California

Sponsors (8)

Lead Sponsor	Collaborator
NICHD Pelvic Floor Disorders Network	Baylor College of Medicine, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Johns Hopkins University, Loyola University, University of Iowa, University of North Carolina, Chapel Hill, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of Participants With Composite Failure	Anatomic failure (updated definition) or symptomatic failure	24 months
Primary	Number of Participants With Composite Failure	Anatomic failure (updated definition) or symptomatic failure	3 year
Primary	Number of Participants With Composite Failure	Anatomic failure (updated definition) or symptomatic failure	4 year
Primary	Number of Participants With Composite Failure	Anatomic failure (updated definition) or symptomatic failure	5 year
Primary	Number of Participants With Composite Failure	Anatomic failure (updated definition) or symptomatic failure	6 year
Primary	Number of Participants With Composite Failure	Anatomic failure (updated definition) or symptomatic failure	7 year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of Participants With Stress Urinary Incontinence (SUI)	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory	24 months
Primary	Number of Participants With Stress Urinary Incontinence (SUI)	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory	3 year
Primary	Number of Participants With Stress Urinary Incontinence (SUI)	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory	4 year
Primary	Number of Participants With Stress Urinary Incontinence (SUI)	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory	5 year
Primary	Number of Participants With Stress Urinary Incontinence (SUI)	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory	6 year
Primary	Number of Participants With Stress Urinary Incontinence (SUI)	One or more SUI symptoms reported on the Pelvic Floor Distress Inventory	7 year

External Links

•   Pelvic Floor Disorders Network