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TerminatedNCT00099372E-CAREUpdated Mar 22, 2021Results posted

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

An observational study in Prolapse and Urinary Incontinence, sponsored by NICHD Pelvic Floor Disorders Network. Terminated at 8 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-03-22.

Sponsored by NICHD Pelvic Floor Disorders Network · Observational

Why this study was terminated
resource and prioritization change as Network transition to a new funding cycle
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
215
Ages
21 Years and older
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Prolapse
  • Urinary Incontinence

Keywords

  • sacrocolpopexy
  • abdominal sacrocolpopexy
  • surgical procedure, prolapse
  • pelvic organ prolapse
  • urinary incontinence
  • stress urinary incontinence
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 215 is above the median of 120 across 305 observational studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

NICHD Pelvic Floor Disorders Network is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women who completed the CARE study

Inclusion criteria

  • Women enrolled in CARE

Exclusion criteria

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
215 participants (actual)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Number of Participants With Symptomatic Failure

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

    Time frame: 24 months

  2. Number of Participants With Symptomatic Failure

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

    Time frame: 3 year

  3. Number of Participants With Symptomatic Failure

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

    Time frame: 4 year

  4. Number of Participants With Symptomatic Failure

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

    Time frame: 5 year

  5. Number of Participants With Symptomatic Failure

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

    Time frame: 6 year

  6. Number of Participants With Symptomatic Failure

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

    Time frame: 7 year

  7. 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

    Time frame: 24 months

  8. 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

    Time frame: 3 year

  9. 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

    Time frame: 4 year

  10. 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

    Time frame: 5 year

  11. 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

    Time frame: 6 year

  12. 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

    Time frame: 7 year

  13. 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

    Time frame: 24 months

  14. 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

    Time frame: 3 year

  15. 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

    Time frame: 4 year

  16. 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

    Time frame: 5 year

  17. 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

    Time frame: 6 year

  18. 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

    Time frame: 7 year

  19. Number of Participants With Composite Failure

    Anatomic failure (updated definition) or symptomatic failure

    Time frame: 24 months

  20. Number of Participants With Composite Failure

    Anatomic failure (updated definition) or symptomatic failure

    Time frame: 3 year

  21. Number of Participants With Composite Failure

    Anatomic failure (updated definition) or symptomatic failure

    Time frame: 4 year

  22. Number of Participants With Composite Failure

    Anatomic failure (updated definition) or symptomatic failure

    Time frame: 5 year

  23. Number of Participants With Composite Failure

    Anatomic failure (updated definition) or symptomatic failure

    Time frame: 6 year

  24. Number of Participants With Composite Failure

    Anatomic failure (updated definition) or symptomatic failure

    Time frame: 7 year

  25. 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.

    Time frame: 24 months

  26. 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.

    Time frame: 3 year

  27. 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.

    Time frame: 4 year

  28. 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.

    Time frame: 5 year

  29. 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.

    Time frame: 6 year

  30. 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.

    Time frame: 7 year

  31. 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

    Time frame: 24 months

  32. 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

    Time frame: 3 year

  33. 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

    Time frame: 4 year

  34. 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

    Time frame: 5 year

  35. 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

    Time frame: 6 year

  36. 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

    Time frame: 7 year

  37. Number of Participants With Stress Urinary Incontinence (SUI)

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

    Time frame: 24 months

  38. Number of Participants With Stress Urinary Incontinence (SUI)

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

    Time frame: 3 year

  39. Number of Participants With Stress Urinary Incontinence (SUI)

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

    Time frame: 4 year

  40. Number of Participants With Stress Urinary Incontinence (SUI)

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

    Time frame: 5 year

  41. Number of Participants With Stress Urinary Incontinence (SUI)

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

    Time frame: 6 year

  42. Number of Participants With Stress Urinary Incontinence (SUI)

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

    Time frame: 7 year

07

Results

Posted Mar 22, 2021

Participant flow

Enrolled in Extended CARE Trial
Participant flow — Enrolled in Extended CARE Trial
MilestoneAbdominal Sacral Colpopexy With Burch ColposuspensionAbdominal Sacral Colpopexy With No Burch Colposuspension
Started104111
Completed104111
Not completed00
Followed up 5 Years After Index Surgery
Participant flow — Followed up 5 Years After Index Surgery
MilestoneAbdominal Sacral Colpopexy With Burch ColposuspensionAbdominal Sacral Colpopexy With No Burch Colposuspension
Started104111
Completed8992
Not completed1519
Followed up 7 Years After Index Surgery
Participant flow — Followed up 7 Years After Index Surgery
MilestoneAbdominal Sacral Colpopexy With Burch ColposuspensionAbdominal Sacral Colpopexy With No Burch Colposuspension
Started8992
Completed6660
Not completed2332

Outcome measures

PrimaryNumber of Participants With Symptomatic Failure

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

Time frame:
24 months
Reported as:
Count of participants · Participants
Number of Participants With Symptomatic Failure
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1516
Non-failure8995
PrimaryNumber of Participants With Symptomatic Failure

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

Time frame:
3 year
Reported as:
Count of participants · Participants
Number of Participants With Symptomatic Failure
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1619
Non-failure8589
PrimaryNumber of Participants With Symptomatic Failure

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

Time frame:
4 year
Reported as:
Count of participants · Participants
Number of Participants With Symptomatic Failure
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1920
Non-failure7583
PrimaryNumber of Participants With Symptomatic Failure

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

Time frame:
5 year
Reported as:
Count of participants · Participants
Number of Participants With Symptomatic Failure
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure2521
Non-failure6675
PrimaryNumber of Participants With Symptomatic Failure

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

Time frame:
6 year
Reported as:
Count of participants · Participants
Number of Participants With Symptomatic Failure
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure2721
Non-failure5969
PrimaryNumber of Participants With Symptomatic Failure

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

Time frame:
7 year
Reported as:
Count of participants · Participants
Number of Participants With Symptomatic Failure
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure2722
Non-failure4649
PrimaryNumber 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

Time frame:
24 months
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Failure (Original Definition)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure69
Non-failure95101
PrimaryNumber 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

Time frame:
3 year
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Failure (Original Definition)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure910
Non-failure7580
PrimaryNumber 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

Time frame:
4 year
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Failure (Original Definition)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1012
Non-failure5465
PrimaryNumber 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

Time frame:
5 year
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Failure (Original Definition)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1213
Non-failure4656
PrimaryNumber 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

Time frame:
6 year
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Failure (Original Definition)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1514
Non-failure4042
PrimaryNumber 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

Time frame:
7 year
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Failure (Original Definition)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1514
Non-failure2932
PrimaryNumber 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

Time frame:
24 months
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Failure (Updated Definition)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure58
Non-failure96102
PrimaryNumber 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

Time frame:
3 year
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Failure (Updated Definition)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure810
Non-failure7681
PrimaryNumber 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

Time frame:
4 year
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Failure (Updated Definition)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1012
Non-failure5467
PrimaryNumber 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

Time frame:
5 year
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Failure (Updated Definition)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1412
Non-failure4259
PrimaryNumber 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

Time frame:
6 year
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Failure (Updated Definition)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1813
Non-failure3646
PrimaryNumber 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

Time frame:
7 year
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Failure (Updated Definition)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1813
Non-failure2736
PrimaryNumber of Participants With Composite Failure

Anatomic failure (updated definition) or symptomatic failure

Time frame:
24 months
Reported as:
Count of participants · Participants
Number of Participants With Composite Failure
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1415
Non-failure8895
PrimaryNumber of Participants With Composite Failure

Anatomic failure (updated definition) or symptomatic failure

Time frame:
3 year
Reported as:
Count of participants · Participants
Number of Participants With Composite Failure
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1618
Non-failure7374
PrimaryNumber of Participants With Composite Failure

Anatomic failure (updated definition) or symptomatic failure

Time frame:
4 year
Reported as:
Count of participants · Participants
Number of Participants With Composite Failure
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure1919
Non-failure5163
PrimaryNumber of Participants With Composite Failure

Anatomic failure (updated definition) or symptomatic failure

Time frame:
5 year
Reported as:
Count of participants · Participants
Number of Participants With Composite Failure
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure2720
Non-failure3655
PrimaryNumber of Participants With Composite Failure

Anatomic failure (updated definition) or symptomatic failure

Time frame:
6 year
Reported as:
Count of participants · Participants
Number of Participants With Composite Failure
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure3021
Non-failure3145
PrimaryNumber of Participants With Composite Failure

Anatomic failure (updated definition) or symptomatic failure

Time frame:
7 year
Reported as:
Count of participants · Participants
Number of Participants With Composite Failure
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure3021
Non-failure2440
PrimaryNumber 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.

Time frame:
24 months
Reported as:
Count of participants · Participants
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure4866
Non-failure5645
PrimaryNumber 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.

Time frame:
3 year
Reported as:
Count of participants · Participants
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure5270
Non-failure4939
PrimaryNumber 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.

Time frame:
4 year
Reported as:
Count of participants · Participants
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure5570
Non-failure4435
PrimaryNumber 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.

Time frame:
5 year
Reported as:
Count of participants · Participants
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure5872
Non-failure4032
PrimaryNumber 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.

Time frame:
6 year
Reported as:
Count of participants · Participants
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure5973
Non-failure3829
PrimaryNumber 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.

Time frame:
7 year
Reported as:
Count of participants · Participants
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure6273
Non-failure2919
PrimaryNumber 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

Time frame:
24 months
Reported as:
Count of participants · Participants
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure3963
Non-failure6547
PrimaryNumber 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

Time frame:
3 year
Reported as:
Count of participants · Participants
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure4769
Non-failure5540
PrimaryNumber 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

Time frame:
4 year
Reported as:
Count of participants · Participants
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure4976
Non-failure5031
PrimaryNumber 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

Time frame:
5 year
Reported as:
Count of participants · Participants
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure5377
Non-failure4528
PrimaryNumber 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

Time frame:
6 year
Reported as:
Count of participants · Participants
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure5578
Non-failure4027
PrimaryNumber 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

Time frame:
7 year
Reported as:
Count of participants · Participants
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure5779
Non-failure3217
PrimaryNumber of Participants With Stress Urinary Incontinence (SUI)

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

Time frame:
24 months
Reported as:
Count of participants · Participants
Number of Participants With Stress Urinary Incontinence (SUI)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure3963
Non-failure6547
PrimaryNumber of Participants With Stress Urinary Incontinence (SUI)

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

Time frame:
3 year
Reported as:
Count of participants · Participants
Number of Participants With Stress Urinary Incontinence (SUI)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure4768
Non-failure5541
PrimaryNumber of Participants With Stress Urinary Incontinence (SUI)

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

Time frame:
4 year
Reported as:
Count of participants · Participants
Number of Participants With Stress Urinary Incontinence (SUI)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure4975
Non-failure5032
PrimaryNumber of Participants With Stress Urinary Incontinence (SUI)

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

Time frame:
5 year
Reported as:
Count of participants · Participants
Number of Participants With Stress Urinary Incontinence (SUI)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure5376
Non-failure4529
PrimaryNumber of Participants With Stress Urinary Incontinence (SUI)

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

Time frame:
6 year
Reported as:
Count of participants · Participants
Number of Participants With Stress Urinary Incontinence (SUI)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure5578
Non-failure4027
PrimaryNumber of Participants With Stress Urinary Incontinence (SUI)

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

Time frame:
7 year
Reported as:
Count of participants · Participants
Number of Participants With Stress Urinary Incontinence (SUI)
ParticipantsBURCH URETHROPEXYNO URETHROPEXY
Failure5779
Non-failure3217

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Abdominal Sacral Colpopexy With Burch Colposuspension0/104 (0%)0/104 (0%)12/104 (11.5%)
Abdominal Sacral Colpopexy With No Burch Colposuspension0/111 (0%)0/111 (0%)15/111 (13.5%)
Most frequent other events
Most frequent other events
EventAbdominal Sacral Colpopexy With Burch ColposuspensionAbdominal Sacral Colpopexy With No Burch Colposuspension
Medical device site reactionSurgical and medical procedures11/10412/111
Medical device site reactionSurgical and medical procedures1/1043/111

Baseline characteristics

Age, Continuous
Age, Continuous(years)BURCH URETHROPEXYNO URETHROPEXYTotal
Mean62.9 ± 9.460.9 ± 10.561.9 ± 10
Sex/Gender, Customized
Sex/Gender, Customized(Participants)BURCH URETHROPEXYNO URETHROPEXYTotal
Female104111215
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)BURCH URETHROPEXYNO URETHROPEXYTotal
Black or African American4913
Other134
White9999198
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)BURCH URETHROPEXYNO URETHROPEXYTotal
Hispanic178
Not Hispanic103104207
Married or living as married
Married or living as married(Participants)BURCH URETHROPEXYNO URETHROPEXYTotal
Missing101
No233154
Yes8080160
Education level
Education level(Participants)BURCH URETHROPEXYNO URETHROPEXYTotal
College degree or higher5363116
High school degree or equivalent364480
Less than High School15419
Number of vaginal deliveries
Number of vaginal deliveries(deliveries)BURCH URETHROPEXYNO URETHROPEXYTotal
Median3 (0 to 8)3 (1 to 8)3 (0 to 8)
Number of cesarean deliveries
Number of cesarean deliveries(deliveries)BURCH URETHROPEXYNO URETHROPEXYTotal
Median0 (0 to 5)0 (0 to 2)0 (0 to 5)

7 further baseline measures are reported on the registry.

08

Study locations

8 sites
  • The University of Alabama at Birmingham
    Birmingham, Alabama 35233-7333, United States
  • USCD Medical Center
    La Jolla, California 92037, United States
  • Kaiser Permanente
    San Diego, California 92120, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • University of Iowa
    Iowa City, Iowa 52242, United States
  • Johns Hopkins School of Medicine
    Baltimore, Maryland 21287, United States
  • Duke University
    Durham, North Carolina 27710, United States
  • Magee-Womens Hospital
    Pittsburgh, Pennsylvania 15213-3180, United States
09

References and documents

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. Erratum In: JAMA. 2013 Sep 11;310(10):1076. PubMed 23677313 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00099372
Lead sponsor
NICHD Pelvic Floor Disorders 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
First posted
Dec 13, 2004
Start date
May 2004
Primary completion
Jun 2011
Completion
Jun 2011
Results posted
Mar 22, 2021
Last update
Mar 22, 2021

Study contacts

Ingrid Nygaard, MD
study chair · University of Utah

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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