Prolapse, Urinary Incontinence
Conditions
Keywords
sacrocolpopexy, abdominal sacrocolpopexy, surgical procedure, prolapse, pelvic organ prolapse, urinary incontinence, stress urinary incontinence
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.
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.
Interventions
None listed
Sponsors
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)
NICHD Pelvic Floor Disorders Network
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Number of Participants With Composite Failure | 24 months | Anatomic failure (updated definition) or symptomatic failure |
| 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. |
| 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 |
| Number of Participants With Stress Urinary Incontinence (SUI) | 24 months | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BURCH URETHROPEXY Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse | 104 |
| NO URETHROPEXY Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse | 111 |
| Total | 215 |
Baseline characteristics
| Characteristic | NO URETHROPEXY | BURCH URETHROPEXY | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 10.5 | 62.9 years STANDARD_DEVIATION 9.4 | 61.9 years STANDARD_DEVIATION 10 |
| BMI >= 30 (obesity) No | 85 Participants | 85 Participants | 170 Participants |
| BMI >= 30 (obesity) Yes | 26 Participants | 19 Participants | 45 Participants |
| Body Mass Index | 26.8 kg/m^2 STANDARD_DEVIATION 4.8 | 26.6 kg/m^2 STANDARD_DEVIATION 4 | 26.7 kg/m^2 STANDARD_DEVIATION 4.4 |
| Education level College degree or higher | 63 Participants | 53 Participants | 116 Participants |
| Education level High school degree or equivalent | 44 Participants | 36 Participants | 80 Participants |
| Education level Less than High School | 4 Participants | 15 Participants | 19 Participants |
| Hysterectomy Missing | 15 Participants | 17 Participants | 32 Participants |
| Hysterectomy No | 17 Participants | 7 Participants | 24 Participants |
| Hysterectomy Yes | 79 Participants | 80 Participants | 159 Participants |
| Married or living as married Missing | 0 Participants | 1 Participants | 1 Participants |
| Married or living as married No | 31 Participants | 23 Participants | 54 Participants |
| Married or living as married Yes | 80 Participants | 80 Participants | 160 Participants |
| Number of cesarean deliveries | 0 deliveries | 0 deliveries | 0 deliveries |
| Number of previous births | 3 births | 3 births | 3 births |
| Number of vaginal deliveries | 3 deliveries | 3 deliveries | 3 deliveries |
| Pelvic Organ Prolapse-Q stage 2 | 15 Participants | 9 Participants | 24 Participants |
| Pelvic Organ Prolapse-Q stage 3 | 78 Participants | 75 Participants | 153 Participants |
| Pelvic Organ Prolapse-Q stage 4 | 18 Participants | 20 Participants | 38 Participants |
| Prior POP Surgery No | 75 Participants | 56 Participants | 131 Participants |
| Prior POP Surgery Yes | 36 Participants | 48 Participants | 84 Participants |
| Prior SUI Surgery No | 104 Participants | 95 Participants | 199 Participants |
| Prior SUI Surgery Yes | 7 Participants | 9 Participants | 16 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 4 Participants | 13 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Not Hispanic | 104 Participants | 103 Participants | 207 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 99 Participants | 99 Participants | 198 Participants |
| Sex/Gender, Customized Female | 111 Participants | 104 Participants | 215 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 104 | 0 / 111 |
| other Total, other adverse events | 12 / 104 | 15 / 111 |
| serious Total, serious adverse events | 0 / 104 | 0 / 111 |
Outcome results
Primary
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.
Time frame: 24 months
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Failure | 48 Participants |
| BURCH URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Non-failure | 56 Participants |
| NO URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Failure | 66 Participants |
| NO URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Non-failure | 45 Participants |
Primary
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.
Time frame: 7 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Failure | 62 Participants |
| BURCH URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Non-failure | 29 Participants |
| NO URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Failure | 73 Participants |
| NO URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Non-failure | 19 Participants |
Primary
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.
Time frame: 6 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Failure | 59 Participants |
| BURCH URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Non-failure | 38 Participants |
| NO URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Failure | 73 Participants |
| NO URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Non-failure | 29 Participants |
Primary
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.
Time frame: 5 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Failure | 58 Participants |
| BURCH URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Non-failure | 40 Participants |
| NO URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Failure | 72 Participants |
| NO URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Non-failure | 32 Participants |
Primary
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.
Time frame: 4 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Failure | 55 Participants |
| BURCH URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Non-failure | 44 Participants |
| NO URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Failure | 70 Participants |
| NO URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Non-failure | 35 Participants |
Primary
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.
Time frame: 3 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Failure | 52 Participants |
| BURCH URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Non-failure | 49 Participants |
| NO URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Failure | 70 Participants |
| NO URETHROPEXY | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index | Non-failure | 39 Participants |
Primary
Number of Participants With Anatomic Failure (Original Definition)
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen
Time frame: 24 months
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Failure | 6 Participants |
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Non-failure | 95 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Failure | 9 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Non-failure | 101 Participants |
Primary
Number of Participants With Anatomic Failure (Original Definition)
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen
Time frame: 3 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Failure | 9 Participants |
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Non-failure | 75 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Failure | 10 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Non-failure | 80 Participants |
Primary
Number of Participants With Anatomic Failure (Original Definition)
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen
Time frame: 4 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Failure | 10 Participants |
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Non-failure | 54 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Failure | 12 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Non-failure | 65 Participants |
Primary
Number of Participants With Anatomic Failure (Original Definition)
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen
Time frame: 5 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Failure | 12 Participants |
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Non-failure | 46 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Failure | 13 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Non-failure | 56 Participants |
Primary
Number of Participants With Anatomic Failure (Original Definition)
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen
Time frame: 6 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Failure | 15 Participants |
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Non-failure | 40 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Failure | 14 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Non-failure | 42 Participants |
Primary
Number of Participants With Anatomic Failure (Original Definition)
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen
Time frame: 7 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Failure | 15 Participants |
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Non-failure | 29 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Failure | 14 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Original Definition) | Non-failure | 32 Participants |
Primary
Number of Participants With Anatomic Failure (Updated Definition)
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
Time frame: 24 months
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Failure | 5 Participants |
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Non-failure | 96 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Failure | 8 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Non-failure | 102 Participants |
Primary
Number of Participants With Anatomic Failure (Updated Definition)
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
Time frame: 3 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Failure | 8 Participants |
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Non-failure | 76 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Failure | 10 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Non-failure | 81 Participants |
Primary
Number of Participants With Anatomic Failure (Updated Definition)
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
Time frame: 4 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Non-failure | 54 Participants |
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Failure | 10 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Non-failure | 67 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Failure | 12 Participants |
Primary
Number of Participants With Anatomic Failure (Updated Definition)
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
Time frame: 5 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Failure | 14 Participants |
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Non-failure | 42 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Failure | 12 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Non-failure | 59 Participants |
Primary
Number of Participants With Anatomic Failure (Updated Definition)
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
Time frame: 6 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Failure | 18 Participants |
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Non-failure | 36 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Failure | 13 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Non-failure | 46 Participants |
Primary
Number of Participants With Anatomic Failure (Updated Definition)
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
Time frame: 7 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Failure | 18 Participants |
| BURCH URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Non-failure | 27 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Failure | 13 Participants |
| NO URETHROPEXY | Number of Participants With Anatomic Failure (Updated Definition) | Non-failure | 36 Participants |
Primary
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Time frame: 24 months
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Composite Failure | Failure | 14 Participants |
| BURCH URETHROPEXY | Number of Participants With Composite Failure | Non-failure | 88 Participants |
| NO URETHROPEXY | Number of Participants With Composite Failure | Failure | 15 Participants |
| NO URETHROPEXY | Number of Participants With Composite Failure | Non-failure | 95 Participants |
Primary
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Time frame: 3 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Composite Failure | Failure | 16 Participants |
| BURCH URETHROPEXY | Number of Participants With Composite Failure | Non-failure | 73 Participants |
| NO URETHROPEXY | Number of Participants With Composite Failure | Failure | 18 Participants |
| NO URETHROPEXY | Number of Participants With Composite Failure | Non-failure | 74 Participants |
Primary
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Time frame: 4 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Composite Failure | Failure | 19 Participants |
| BURCH URETHROPEXY | Number of Participants With Composite Failure | Non-failure | 51 Participants |
| NO URETHROPEXY | Number of Participants With Composite Failure | Failure | 19 Participants |
| NO URETHROPEXY | Number of Participants With Composite Failure | Non-failure | 63 Participants |
Primary
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Time frame: 5 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Composite Failure | Failure | 27 Participants |
| BURCH URETHROPEXY | Number of Participants With Composite Failure | Non-failure | 36 Participants |
| NO URETHROPEXY | Number of Participants With Composite Failure | Failure | 20 Participants |
| NO URETHROPEXY | Number of Participants With Composite Failure | Non-failure | 55 Participants |
Primary
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Time frame: 6 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Composite Failure | Failure | 30 Participants |
| BURCH URETHROPEXY | Number of Participants With Composite Failure | Non-failure | 31 Participants |
| NO URETHROPEXY | Number of Participants With Composite Failure | Failure | 21 Participants |
| NO URETHROPEXY | Number of Participants With Composite Failure | Non-failure | 45 Participants |
Primary
Number of Participants With Composite Failure
Anatomic failure (updated definition) or symptomatic failure
Time frame: 7 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Composite Failure | Non-failure | 24 Participants |
| BURCH URETHROPEXY | Number of Participants With Composite Failure | Failure | 30 Participants |
| NO URETHROPEXY | Number of Participants With Composite Failure | Failure | 21 Participants |
| NO URETHROPEXY | Number of Participants With Composite Failure | Non-failure | 40 Participants |
Primary
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Time frame: 7 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Failure | 57 Participants |
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Non-failure | 32 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Failure | 79 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Non-failure | 17 Participants |
Primary
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Time frame: 24 months
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Failure | 39 Participants |
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Non-failure | 65 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Failure | 63 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Non-failure | 47 Participants |
Primary
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Time frame: 3 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Failure | 47 Participants |
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Non-failure | 55 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Failure | 68 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Non-failure | 41 Participants |
Primary
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Time frame: 4 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Failure | 49 Participants |
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Non-failure | 50 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Failure | 75 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Non-failure | 32 Participants |
Primary
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Time frame: 5 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Failure | 53 Participants |
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Non-failure | 45 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Failure | 76 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Non-failure | 29 Participants |
Primary
Number of Participants With Stress Urinary Incontinence (SUI)
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Time frame: 6 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Non-failure | 40 Participants |
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Failure | 55 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Failure | 78 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) | Non-failure | 27 Participants |
Primary
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI
Time frame: 24 months
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Failure | 39 Participants |
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Non-failure | 65 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Failure | 63 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Non-failure | 47 Participants |
Primary
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI
Time frame: 3 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Failure | 47 Participants |
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Non-failure | 55 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Failure | 69 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Non-failure | 40 Participants |
Primary
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI
Time frame: 4 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Failure | 49 Participants |
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Non-failure | 50 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Failure | 76 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Non-failure | 31 Participants |
Primary
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI
Time frame: 5 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Failure | 53 Participants |
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Non-failure | 45 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Failure | 77 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Non-failure | 28 Participants |
Primary
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI
Time frame: 6 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Failure | 55 Participants |
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Non-failure | 40 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Failure | 78 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Non-failure | 27 Participants |
Primary
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI
Time frame: 7 year
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Failure | 57 Participants |
| BURCH URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Non-failure | 32 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Failure | 79 Participants |
| NO URETHROPEXY | Number of Participants With Stress Urinary Incontinence (SUI) Prevention | Non-failure | 17 Participants |
Primary
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Symptomatic Failure | Failure | 15 Participants |
| BURCH URETHROPEXY | Number of Participants With Symptomatic Failure | Non-failure | 89 Participants |
| NO URETHROPEXY | Number of Participants With Symptomatic Failure | Failure | 16 Participants |
| NO URETHROPEXY | Number of Participants With Symptomatic Failure | Non-failure | 95 Participants |
Primary
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Symptomatic Failure | Failure | 27 Participants |
| BURCH URETHROPEXY | Number of Participants With Symptomatic Failure | Non-failure | 46 Participants |
| NO URETHROPEXY | Number of Participants With Symptomatic Failure | Failure | 22 Participants |
| NO URETHROPEXY | Number of Participants With Symptomatic Failure | Non-failure | 49 Participants |
Primary
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Symptomatic Failure | Failure | 27 Participants |
| BURCH URETHROPEXY | Number of Participants With Symptomatic Failure | Non-failure | 59 Participants |
| NO URETHROPEXY | Number of Participants With Symptomatic Failure | Failure | 21 Participants |
| NO URETHROPEXY | Number of Participants With Symptomatic Failure | Non-failure | 69 Participants |
Primary
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Symptomatic Failure | Failure | 25 Participants |
| BURCH URETHROPEXY | Number of Participants With Symptomatic Failure | Non-failure | 66 Participants |
| NO URETHROPEXY | Number of Participants With Symptomatic Failure | Failure | 21 Participants |
| NO URETHROPEXY | Number of Participants With Symptomatic Failure | Non-failure | 75 Participants |
Primary
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Symptomatic Failure | Failure | 19 Participants |
| BURCH URETHROPEXY | Number of Participants With Symptomatic Failure | Non-failure | 75 Participants |
| NO URETHROPEXY | Number of Participants With Symptomatic Failure | Failure | 20 Participants |
| NO URETHROPEXY | Number of Participants With Symptomatic Failure | Non-failure | 83 Participants |
Primary
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BURCH URETHROPEXY | Number of Participants With Symptomatic Failure | Failure | 16 Participants |
| BURCH URETHROPEXY | Number of Participants With Symptomatic Failure | Non-failure | 85 Participants |
| NO URETHROPEXY | Number of Participants With Symptomatic Failure | Failure | 19 Participants |
| NO URETHROPEXY | Number of Participants With Symptomatic Failure | Non-failure | 89 Participants |