| Primary | Number of Participants With Symptomatic Failure | Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery | 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. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse | | OG001 | NO URETHROPEXY | Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| Failure | | | Non-failure | |
|
| |
| Primary | Number of Participants With Symptomatic Failure | Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery | 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. | Posted | | Count of Participants | | Participants | | 3 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Symptomatic Failure | Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery | 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. | Posted | | Count of Participants | | Participants | | 4 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Symptomatic Failure | Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery | 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. | Posted | | Count of Participants | | Participants | | 5 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Symptomatic Failure | Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery | 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. | Posted | | Count of Participants | | Participants | | 6 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Symptomatic Failure | Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery | 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. | Posted | | Count of Participants | | Participants | | 7 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 3 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 4 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 5 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 6 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 7 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 3 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 4 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 5 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 6 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 7 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Composite Failure | Anatomic failure (updated definition) or symptomatic failure | 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. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Composite Failure | Anatomic failure (updated definition) or symptomatic failure | 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. | Posted | | Count of Participants | | Participants | | 3 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Composite Failure | Anatomic failure (updated definition) or symptomatic failure | 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. | Posted | | Count of Participants | | Participants | | 4 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Composite Failure | Anatomic failure (updated definition) or symptomatic failure | 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. | Posted | | Count of Participants | | Participants | | 5 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Composite Failure | Anatomic failure (updated definition) or symptomatic failure | 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. | Posted | | Count of Participants | | Participants | | 6 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Composite Failure | Anatomic failure (updated definition) or symptomatic failure | 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. | Posted | | Count of Participants | | Participants | | 7 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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. | 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. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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. | 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. | Posted | | Count of Participants | | Participants | | 3 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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. | 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. | Posted | | Count of Participants | | Participants | | 4 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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. | 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. | Posted | | Count of Participants | | Participants | | 5 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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. | 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. | Posted | | Count of Participants | | Participants | | 6 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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. | 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. | Posted | | Count of Participants | | Participants | | 7 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 3 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 4 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 5 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 6 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| 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 | 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. | Posted | | Count of Participants | | Participants | | 7 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Stress Urinary Incontinence (SUI) | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory | 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. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Stress Urinary Incontinence (SUI) | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory | 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. | Posted | | Count of Participants | | Participants | | 3 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Stress Urinary Incontinence (SUI) | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory | 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. | Posted | | Count of Participants | | Participants | | 4 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Stress Urinary Incontinence (SUI) | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory | 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. | Posted | | Count of Participants | | Participants | | 5 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Stress Urinary Incontinence (SUI) | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory | 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. | Posted | | Count of Participants | | Participants | | 6 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |
| Primary | Number of Participants With Stress Urinary Incontinence (SUI) | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory | 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. | Posted | | Count of Participants | | Participants | | 7 year | | | | ID | Title | Description |
|---|
| OG000 | BURCH URETHROPEXY | Abdominal Sacral Colpopexy with Burch Colposuspension | | OG001 | NO URETHROPEXY | Abdominal Sacral Colpopexy with No Burch Colposuspension |
| |