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

Sponsor
NICHD Pelvic Floor Disorders Network (Other)
Overall Status
Terminated
CT.gov ID
NCT00099372
Collaborator
University of Iowa (Other), Baylor College of Medicine (Other), Loyola University (Other), University of North Carolina, Chapel Hill (Other), Johns Hopkins University (Other), University of Pittsburgh (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
215
8
85
26.9
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    215 participants
    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
    Study Start Date :
    May 1, 2004
    Actual Primary Completion Date :
    Jun 1, 2011
    Actual Study Completion Date :
    Jun 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Symptomatic Failure [24 months]

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

    2. Number of Participants With Symptomatic Failure [3 year]

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

    3. Number of Participants With Symptomatic Failure [4 year]

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

    4. Number of Participants With Symptomatic Failure [5 year]

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

    5. Number of Participants With Symptomatic Failure [6 year]

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

    6. Number of Participants With Symptomatic Failure [7 year]

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

    7. Number of Participants With Anatomic Failure (Original Definition) [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

    8. Number of Participants With Anatomic Failure (Original Definition) [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

    9. Number of Participants With Anatomic Failure (Original Definition) [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

    10. Number of Participants With Anatomic Failure (Original Definition) [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

    11. Number of Participants With Anatomic Failure (Original Definition) [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

    12. Number of Participants With Anatomic Failure (Original Definition) [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

    13. Number of Participants With Anatomic Failure (Updated Definition) [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

    14. Number of Participants With Anatomic Failure (Updated Definition) [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

    15. Number of Participants With Anatomic Failure (Updated Definition) [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

    16. Number of Participants With Anatomic Failure (Updated Definition) [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

    17. Number of Participants With Anatomic Failure (Updated Definition) [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

    18. Number of Participants With Anatomic Failure (Updated Definition) [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

    19. Number of Participants With Composite Failure [24 months]

      Anatomic failure (updated definition) or symptomatic failure

    20. Number of Participants With Composite Failure [3 year]

      Anatomic failure (updated definition) or symptomatic failure

    21. Number of Participants With Composite Failure [4 year]

      Anatomic failure (updated definition) or symptomatic failure

    22. Number of Participants With Composite Failure [5 year]

      Anatomic failure (updated definition) or symptomatic failure

    23. Number of Participants With Composite Failure [6 year]

      Anatomic failure (updated definition) or symptomatic failure

    24. Number of Participants With Composite Failure [7 year]

      Anatomic failure (updated definition) or symptomatic failure

    25. Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index [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.

    26. Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index [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.

    27. Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index [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.

    28. Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index [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.

    29. Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index [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.

    30. Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index [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.

    31. Number of Participants With Stress Urinary Incontinence (SUI) Prevention [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

    32. Number of Participants With Stress Urinary Incontinence (SUI) Prevention [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

    33. Number of Participants With Stress Urinary Incontinence (SUI) Prevention [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

    34. Number of Participants With Stress Urinary Incontinence (SUI) Prevention [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

    35. Number of Participants With Stress Urinary Incontinence (SUI) Prevention [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

    36. Number of Participants With Stress Urinary Incontinence (SUI) Prevention [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

    37. Number of Participants With Stress Urinary Incontinence (SUI) [24 months]

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

    38. Number of Participants With Stress Urinary Incontinence (SUI) [3 year]

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

    39. Number of Participants With Stress Urinary Incontinence (SUI) [4 year]

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

    40. Number of Participants With Stress Urinary Incontinence (SUI) [5 year]

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

    41. Number of Participants With Stress Urinary Incontinence (SUI) [6 year]

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

    42. Number of Participants With Stress Urinary Incontinence (SUI) [7 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 The University of Alabama at Birmingham Birmingham Alabama United States 35233-7333
    2 USCD Medical Center La Jolla California United States 92037
    3 Kaiser Permanente San Diego California United States 92120
    4 Loyola University Medical Center Maywood Illinois United States 60153
    5 University of Iowa Iowa City Iowa United States 52242
    6 Johns Hopkins School of Medicine Baltimore Maryland United States 21287
    7 Duke University Durham North Carolina United States 27710
    8 Magee-Womens Hospital Pittsburgh Pennsylvania United States 15213-3180

    Sponsors and Collaborators

    • NICHD Pelvic Floor Disorders Network
    • 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)

    Investigators

    • Study Chair: Ingrid Nygaard, MD, University of Utah

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    NICHD Pelvic Floor Disorders Network
    ClinicalTrials.gov Identifier:
    NCT00099372
    Other Study ID Numbers:
    • PFD 001; U01HD41249
    • U01HD041249
    • U10HD041268
    • U10HD041248
    • U10HD041250
    • U10HD041261
    • U10HD041263
    • U10HD041269
    • U10HD041267
    First Posted:
    Dec 13, 2004
    Last Update Posted:
    Mar 22, 2021
    Last Verified:
    Dec 1, 2020

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Abdominal Sacral Colpopexy With Burch Colposuspension Abdominal Sacral Colpopexy With No Burch Colposuspension
    Arm/Group Description Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
    Period Title: Enrolled in Extended CARE Trial
    STARTED 104 111
    COMPLETED 104 111
    NOT COMPLETED 0 0
    Period Title: Enrolled in Extended CARE Trial
    STARTED 104 111
    COMPLETED 89 92
    NOT COMPLETED 15 19
    Period Title: Enrolled in Extended CARE Trial
    STARTED 89 92
    COMPLETED 66 60
    NOT COMPLETED 23 32

    Baseline Characteristics

    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY Total
    Arm/Group Description Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse Total of all reporting groups
    Overall Participants 104 111 215
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    62.9
    (9.4)
    60.9
    (10.5)
    61.9
    (10)
    Sex/Gender, Customized (Count of Participants)
    Female
    104
    100%
    111
    100%
    215
    100%
    Race/Ethnicity, Customized (Count of Participants)
    Black or African American
    4
    3.8%
    9
    8.1%
    13
    6%
    Other
    1
    1%
    3
    2.7%
    4
    1.9%
    White
    99
    95.2%
    99
    89.2%
    198
    92.1%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic
    1
    1%
    7
    6.3%
    8
    3.7%
    Not Hispanic
    103
    99%
    104
    93.7%
    207
    96.3%
    Married or living as married (Count of Participants)
    Missing
    1
    1%
    0
    0%
    1
    0.5%
    No
    23
    22.1%
    31
    27.9%
    54
    25.1%
    Yes
    80
    76.9%
    80
    72.1%
    160
    74.4%
    Education level (Count of Participants)
    College degree or higher
    53
    51%
    63
    56.8%
    116
    54%
    High school degree or equivalent
    36
    34.6%
    44
    39.6%
    80
    37.2%
    Less than High School
    15
    14.4%
    4
    3.6%
    19
    8.8%
    Number of vaginal deliveries (deliveries) [Median (Full Range) ]
    Median (Full Range) [deliveries]
    3
    3
    3
    Number of cesarean deliveries (deliveries) [Median (Full Range) ]
    Median (Full Range) [deliveries]
    0
    0
    0
    Number of previous births (births) [Median (Full Range) ]
    Median (Full Range) [births]
    3
    3
    3
    Hysterectomy (Count of Participants)
    Missing
    17
    16.3%
    15
    13.5%
    32
    14.9%
    No
    7
    6.7%
    17
    15.3%
    24
    11.2%
    Yes
    80
    76.9%
    79
    71.2%
    159
    74%
    Prior SUI Surgery (Count of Participants)
    No
    95
    91.3%
    104
    93.7%
    199
    92.6%
    Yes
    9
    8.7%
    7
    6.3%
    16
    7.4%
    Prior POP Surgery (Count of Participants)
    No
    56
    53.8%
    75
    67.6%
    131
    60.9%
    Yes
    48
    46.2%
    36
    32.4%
    84
    39.1%
    Pelvic Organ Prolapse-Q stage (Count of Participants)
    2
    9
    8.7%
    15
    13.5%
    24
    11.2%
    3
    75
    72.1%
    78
    70.3%
    153
    71.2%
    4
    20
    19.2%
    18
    16.2%
    38
    17.7%
    Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    26.6
    (4)
    26.8
    (4.8)
    26.7
    (4.4)
    BMI >= 30 (obesity) (Count of Participants)
    No
    85
    81.7%
    85
    76.6%
    170
    79.1%
    Yes
    19
    18.3%
    26
    23.4%
    45
    20.9%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Symptomatic Failure
    Description Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
    Measure Participants 104 111
    Failure
    15
    14.4%
    16
    14.4%
    Non-failure
    89
    85.6%
    95
    85.6%
    2. Primary Outcome
    Title Number of Participants With Symptomatic Failure
    Description Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
    Time Frame 3 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 101 108
    Failure
    16
    15.4%
    19
    17.1%
    Non-failure
    85
    81.7%
    89
    80.2%
    3. Primary Outcome
    Title Number of Participants With Symptomatic Failure
    Description Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
    Time Frame 4 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 94 103
    Failure
    19
    18.3%
    20
    18%
    Non-failure
    75
    72.1%
    83
    74.8%
    4. Primary Outcome
    Title Number of Participants With Symptomatic Failure
    Description Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
    Time Frame 5 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 91 96
    Failure
    25
    24%
    21
    18.9%
    Non-failure
    66
    63.5%
    75
    67.6%
    5. Primary Outcome
    Title Number of Participants With Symptomatic Failure
    Description Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
    Time Frame 6 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 86 90
    Failure
    27
    26%
    21
    18.9%
    Non-failure
    59
    56.7%
    69
    62.2%
    6. Primary Outcome
    Title Number of Participants With Symptomatic Failure
    Description Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
    Time Frame 7 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 73 71
    Failure
    27
    26%
    22
    19.8%
    Non-failure
    46
    44.2%
    49
    44.1%
    7. Primary Outcome
    Title Number of Participants With Anatomic Failure (Original Definition)
    Description 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
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 101 110
    Failure
    6
    5.8%
    9
    8.1%
    Non-failure
    95
    91.3%
    101
    91%
    8. Primary Outcome
    Title Number of Participants With Anatomic Failure (Original Definition)
    Description 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
    Time Frame 3 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 84 90
    Failure
    9
    8.7%
    10
    9%
    Non-failure
    75
    72.1%
    80
    72.1%
    9. Primary Outcome
    Title Number of Participants With Anatomic Failure (Original Definition)
    Description 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
    Time Frame 4 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 64 77
    Failure
    10
    9.6%
    12
    10.8%
    Non-failure
    54
    51.9%
    65
    58.6%
    10. Primary Outcome
    Title Number of Participants With Anatomic Failure (Original Definition)
    Description 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
    Time Frame 5 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 58 69
    Failure
    12
    11.5%
    13
    11.7%
    Non-failure
    46
    44.2%
    56
    50.5%
    11. Primary Outcome
    Title Number of Participants With Anatomic Failure (Original Definition)
    Description 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
    Time Frame 6 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 55 56
    Failure
    15
    14.4%
    14
    12.6%
    Non-failure
    40
    38.5%
    42
    37.8%
    12. Primary Outcome
    Title Number of Participants With Anatomic Failure (Original Definition)
    Description 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
    Time Frame 7 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 44 46
    Failure
    15
    14.4%
    14
    12.6%
    Non-failure
    29
    27.9%
    32
    28.8%
    13. Primary Outcome
    Title Number of Participants With Anatomic Failure (Updated Definition)
    Description 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
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 101 110
    Failure
    5
    4.8%
    8
    7.2%
    Non-failure
    96
    92.3%
    102
    91.9%
    14. Primary Outcome
    Title Number of Participants With Anatomic Failure (Updated Definition)
    Description 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
    Time Frame 3 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 84 91
    Failure
    8
    7.7%
    10
    9%
    Non-failure
    76
    73.1%
    81
    73%
    15. Primary Outcome
    Title Number of Participants With Anatomic Failure (Updated Definition)
    Description 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
    Time Frame 4 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 64 79
    Failure
    10
    9.6%
    12
    10.8%
    Non-failure
    54
    51.9%
    67
    60.4%
    16. Primary Outcome
    Title Number of Participants With Anatomic Failure (Updated Definition)
    Description 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
    Time Frame 5 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 56 71
    Failure
    14
    13.5%
    12
    10.8%
    Non-failure
    42
    40.4%
    59
    53.2%
    17. Primary Outcome
    Title Number of Participants With Anatomic Failure (Updated Definition)
    Description 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
    Time Frame 6 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 54 59
    Failure
    18
    17.3%
    13
    11.7%
    Non-failure
    36
    34.6%
    46
    41.4%
    18. Primary Outcome
    Title Number of Participants With Anatomic Failure (Updated Definition)
    Description 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
    Time Frame 7 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 45 49
    Failure
    18
    17.3%
    13
    11.7%
    Non-failure
    27
    26%
    36
    32.4%
    19. Primary Outcome
    Title Number of Participants With Composite Failure
    Description Anatomic failure (updated definition) or symptomatic failure
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 102 110
    Failure
    14
    13.5%
    15
    13.5%
    Non-failure
    88
    84.6%
    95
    85.6%
    20. Primary Outcome
    Title Number of Participants With Composite Failure
    Description Anatomic failure (updated definition) or symptomatic failure
    Time Frame 3 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 89 92
    Failure
    16
    15.4%
    18
    16.2%
    Non-failure
    73
    70.2%
    74
    66.7%
    21. Primary Outcome
    Title Number of Participants With Composite Failure
    Description Anatomic failure (updated definition) or symptomatic failure
    Time Frame 4 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 70 82
    Failure
    19
    18.3%
    19
    17.1%
    Non-failure
    51
    49%
    63
    56.8%
    22. Primary Outcome
    Title Number of Participants With Composite Failure
    Description Anatomic failure (updated definition) or symptomatic failure
    Time Frame 5 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 63 75
    Failure
    27
    26%
    20
    18%
    Non-failure
    36
    34.6%
    55
    49.5%
    23. Primary Outcome
    Title Number of Participants With Composite Failure
    Description Anatomic failure (updated definition) or symptomatic failure
    Time Frame 6 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 61 66
    Failure
    30
    28.8%
    21
    18.9%
    Non-failure
    31
    29.8%
    45
    40.5%
    24. Primary Outcome
    Title Number of Participants With Composite Failure
    Description Anatomic failure (updated definition) or symptomatic failure
    Time Frame 7 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 54 61
    Failure
    30
    28.8%
    21
    18.9%
    Non-failure
    24
    23.1%
    40
    36%
    25. Primary Outcome
    Title Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
    Description 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.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 104 111
    Failure
    48
    46.2%
    66
    59.5%
    Non-failure
    56
    53.8%
    45
    40.5%
    26. Primary Outcome
    Title Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
    Description 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.
    Time Frame 3 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 101 109
    Failure
    52
    50%
    70
    63.1%
    Non-failure
    49
    47.1%
    39
    35.1%
    27. Primary Outcome
    Title Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
    Description 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.
    Time Frame 4 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 99 105
    Failure
    55
    52.9%
    70
    63.1%
    Non-failure
    44
    42.3%
    35
    31.5%
    28. Primary Outcome
    Title Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
    Description 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.
    Time Frame 5 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 98 104
    Failure
    58
    55.8%
    72
    64.9%
    Non-failure
    40
    38.5%
    32
    28.8%
    29. Primary Outcome
    Title Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
    Description 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.
    Time Frame 6 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 97 102
    Failure
    59
    56.7%
    73
    65.8%
    Non-failure
    38
    36.5%
    29
    26.1%
    30. Primary Outcome
    Title Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
    Description 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.
    Time Frame 7 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 91 92
    Failure
    62
    59.6%
    73
    65.8%
    Non-failure
    29
    27.9%
    19
    17.1%
    31. Primary Outcome
    Title Number of Participants With Stress Urinary Incontinence (SUI) Prevention
    Description 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
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 104 110
    Failure
    39
    37.5%
    63
    56.8%
    Non-failure
    65
    62.5%
    47
    42.3%
    32. Primary Outcome
    Title Number of Participants With Stress Urinary Incontinence (SUI) Prevention
    Description 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
    Time Frame 3 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 102 109
    Failure
    47
    45.2%
    69
    62.2%
    Non-failure
    55
    52.9%
    40
    36%
    33. Primary Outcome
    Title Number of Participants With Stress Urinary Incontinence (SUI) Prevention
    Description 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
    Time Frame 4 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 99 107
    Failure
    49
    47.1%
    76
    68.5%
    Non-failure
    50
    48.1%
    31
    27.9%
    34. Primary Outcome
    Title Number of Participants With Stress Urinary Incontinence (SUI) Prevention
    Description 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
    Time Frame 5 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 98 105
    Failure
    53
    51%
    77
    69.4%
    Non-failure
    45
    43.3%
    28
    25.2%
    35. Primary Outcome
    Title Number of Participants With Stress Urinary Incontinence (SUI) Prevention
    Description 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
    Time Frame 6 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 95 105
    Failure
    55
    52.9%
    78
    70.3%
    Non-failure
    40
    38.5%
    27
    24.3%
    36. Primary Outcome
    Title Number of Participants With Stress Urinary Incontinence (SUI) Prevention
    Description 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
    Time Frame 7 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 89 96
    Failure
    57
    54.8%
    79
    71.2%
    Non-failure
    32
    30.8%
    17
    15.3%
    37. Primary Outcome
    Title Number of Participants With Stress Urinary Incontinence (SUI)
    Description One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 104 110
    Failure
    39
    37.5%
    63
    56.8%
    Non-failure
    65
    62.5%
    47
    42.3%
    38. Primary Outcome
    Title Number of Participants With Stress Urinary Incontinence (SUI)
    Description One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
    Time Frame 3 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 102 109
    Failure
    47
    45.2%
    68
    61.3%
    Non-failure
    55
    52.9%
    41
    36.9%
    39. Primary Outcome
    Title Number of Participants With Stress Urinary Incontinence (SUI)
    Description One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
    Time Frame 4 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 99 107
    Failure
    49
    47.1%
    75
    67.6%
    Non-failure
    50
    48.1%
    32
    28.8%
    40. Primary Outcome
    Title Number of Participants With Stress Urinary Incontinence (SUI)
    Description One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
    Time Frame 5 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 98 105
    Failure
    53
    51%
    76
    68.5%
    Non-failure
    45
    43.3%
    29
    26.1%
    41. Primary Outcome
    Title Number of Participants With Stress Urinary Incontinence (SUI)
    Description One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
    Time Frame 6 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 95 105
    Failure
    55
    52.9%
    78
    70.3%
    Non-failure
    40
    38.5%
    27
    24.3%
    42. Primary Outcome
    Title Number of Participants With Stress Urinary Incontinence (SUI)
    Description One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
    Time Frame 7 year

    Outcome Measure Data

    Analysis Population Description
    This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.
    Arm/Group Title BURCH URETHROPEXY NO URETHROPEXY
    Arm/Group Description Abdominal Sacral Colpopexy with Burch Colposuspension Abdominal Sacral Colpopexy with No Burch Colposuspension
    Measure Participants 89 96
    Failure
    57
    54.8%
    79
    71.2%
    Non-failure
    32
    30.8%
    17
    15.3%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Abdominal Sacral Colpopexy With Burch Colposuspension Abdominal Sacral Colpopexy With No Burch Colposuspension
    Arm/Group Description Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
    All Cause Mortality
    Abdominal Sacral Colpopexy With Burch Colposuspension Abdominal Sacral Colpopexy With No Burch Colposuspension
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/104 (0%) 0/111 (0%)
    Serious Adverse Events
    Abdominal Sacral Colpopexy With Burch Colposuspension Abdominal Sacral Colpopexy With No Burch Colposuspension
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/104 (0%) 0/111 (0%)
    Other (Not Including Serious) Adverse Events
    Abdominal Sacral Colpopexy With Burch Colposuspension Abdominal Sacral Colpopexy With No Burch Colposuspension
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 12/104 (11.5%) 15/111 (13.5%)
    Surgical and medical procedures
    Medical device site reaction 11/104 (10.6%) 11 12/111 (10.8%) 12
    Medical device site reaction 1/104 (1%) 1 3/111 (2.7%) 3

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Marie Gantz
    Organization RTI International
    Phone 919-597-5110
    Email mgantz@rti.org
    Responsible Party:
    NICHD Pelvic Floor Disorders Network
    ClinicalTrials.gov Identifier:
    NCT00099372
    Other Study ID Numbers:
    • PFD 001; U01HD41249
    • U01HD041249
    • U10HD041268
    • U10HD041248
    • U10HD041250
    • U10HD041261
    • U10HD041263
    • U10HD041269
    • U10HD041267
    First Posted:
    Dec 13, 2004
    Last Update Posted:
    Mar 22, 2021
    Last Verified:
    Dec 1, 2020