ProlapseE-CARENCT00099372
Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
An observational study of Prolapse and Urinary Incontinence, run by NICHD Pelvic Floor Disorders Network at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Prolapse, Urinary Incontinence
- How many people
- 215 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2004to Jun 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who completed the CARE study
Who may be able to join
- Women enrolled in CARE
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
The University of Alabama at Birmingham
Birmingham, Alabama, 35233-7333
Duke University
Durham, North Carolina, 27710
University of Iowa
Iowa City, Iowa, 52242
USCD Medical Center
La Jolla, California, 92037
Loyola University Medical Center
Maywood, Illinois, 60153
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213-3180
Kaiser Permanente
San Diego, California, 92120
About this study
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
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.
Read the 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.
- Conditions
- Prolapse, Urinary Incontinence
- Keywords
- sacrocolpopexy, abdominal sacrocolpopexy, surgical procedure, prolapse, pelvic organ prolapse, urinary incontinence, stress urinary incontinence
- Medical subject headings
- Prolapse, Urinary Incontinence, Pelvic Organ Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Symptomatic Failure
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 year
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Measured: 24 months
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Measured: 3 year
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Measured: 4 year
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Measured: 5 year
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Measured: 6 year
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 year
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Measured: 24 months
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Measured: 3 year
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Measured: 4 year
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Measured: 5 year
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Measured: 6 year
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Measured: 7 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2004 (estimated)
- Study startMay 2004
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: resource and prioritization change as Network transition to a new funding cycle
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Sponsor type
- Research network
- Collaborators
- University of Iowa, Baylor College of Medicine, Loyola University, University of North Carolina, Chapel Hill, Johns Hopkins University, University of Pittsburgh, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Ingrid Nygaard, MD, Study chair, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099372
- Sponsor's protocol ID
- PFD 001; U01HD41249
- Other IDs
- U01HD041249, U10HD041268, U10HD041248, U10HD041250, U10HD041261, U10HD041263, U10HD041269, U10HD041267
- Acronym
- E-CARE
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2004
- Last updated
- 22 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23677313
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00099372
- Acronym / sponsor ID
- E-CARE / PFD 001; U01HD41249
- Conditions
- Prolapse, Urinary Incontinence
- Keywords
- sacrocolpopexy, abdominal sacrocolpopexy, surgical procedure, prolapse, pelvic organ prolapse, urinary incontinence, stress urinary incontinence
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: resource and prioritization change as Network transition to a new funding cycle
- Enrolment
- 215 participants (actual)
- Lead sponsor
- NICHD Pelvic Floor Disorders NetworkResearch network
- Collaborators
- University of Iowa, Baylor College of Medicine, Loyola University, University of North Carolina, Chapel Hill, Johns Hopkins University, University of Pittsburgh, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2004
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Dec 2004 (estimated)
- Results
- Posted 22 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who completed the CARE study
Key inclusion criteria (1 listed)
- Women enrolled in CARE
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Symptomatic Failure
Time frame: 24 months
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
Number of Participants With Symptomatic Failure
Time frame: 3 year
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
Number of Participants With Symptomatic Failure
Time frame: 4 year
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
Number of Participants With Symptomatic Failure
Time frame: 5 year
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
Number of Participants With Symptomatic Failure
Time frame: 6 year
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
Number of Participants With Symptomatic Failure
Time frame: 7 year
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
Number of Participants With Anatomic Failure (Original Definition)
Time frame: 24 months
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
Number of Participants With Anatomic Failure (Original Definition)
Time frame: 3 year
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
Number of Participants With Anatomic Failure (Original Definition)
Time frame: 4 year
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
Number of Participants With Anatomic Failure (Original Definition)
Time frame: 5 year
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
Number of Participants With Anatomic Failure (Original Definition)
Time frame: 6 year
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
Number of Participants With Anatomic Failure (Original Definition)
Time frame: 7 year
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
Number of Participants With Anatomic Failure (Updated Definition)
Time frame: 24 months
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
Number of Participants With Anatomic Failure (Updated Definition)
Time frame: 3 year
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
Number of Participants With Anatomic Failure (Updated Definition)
Time frame: 4 year
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
Number of Participants With Anatomic Failure (Updated Definition)
Time frame: 5 year
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
Number of Participants With Anatomic Failure (Updated Definition)
Time frame: 6 year
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
Number of Participants With Anatomic Failure (Updated Definition)
Time frame: 7 year
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
Number of Participants With Composite Failure
Time frame: 24 months
Anatomic failure (updated definition) or symptomatic failure
Number of Participants With Composite Failure
Time frame: 3 year
Anatomic failure (updated definition) or symptomatic failure
Number of Participants With Composite Failure
Time frame: 4 year
Anatomic failure (updated definition) or symptomatic failure
Number of Participants With Composite Failure
Time frame: 5 year
Anatomic failure (updated definition) or symptomatic failure
Number of Participants With Composite Failure
Time frame: 6 year
Anatomic failure (updated definition) or symptomatic failure
Number of Participants With Composite Failure
Time frame: 7 year
Anatomic failure (updated definition) or symptomatic failure
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
Time frame: 24 months
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.
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
Time frame: 3 year
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.
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
Time frame: 4 year
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.
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
Time frame: 5 year
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.
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
Time frame: 6 year
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.
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
Time frame: 7 year
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.
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
Time frame: 24 months
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
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
Time frame: 3 year
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
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
Time frame: 4 year
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
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
Time frame: 5 year
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
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
Time frame: 6 year
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
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
Time frame: 7 year
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
Number of Participants With Stress Urinary Incontinence (SUI)
Time frame: 24 months
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Number of Participants With Stress Urinary Incontinence (SUI)
Time frame: 3 year
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Number of Participants With Stress Urinary Incontinence (SUI)
Time frame: 4 year
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Number of Participants With Stress Urinary Incontinence (SUI)
Time frame: 5 year
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Number of Participants With Stress Urinary Incontinence (SUI)
Time frame: 6 year
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Number of Participants With Stress Urinary Incontinence (SUI)
Time frame: 7 year
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23677313Nygaard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Nygaard, MD study chair
University of Utah
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolapse and Urinary Incontinence, run by NICHD Pelvic Floor Disorders Network at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Symptomatic Failure (time frame: 24 months). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00099372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.