E-CARE: Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
Study Details
Study Description
Brief Summary
The Colpopexy and Urinary Reduction Effort (CARE) trial is a research study designed to evaluate whether the addition of a second surgical procedure in addition to a procedure for female pelvic organ prolapse (POP) affects the rates of urinary incontinence. This study will follow women in the CARE study for 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in CARE. Recruitment into CARE is closed.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
The primary aims of this prospective cohort study are:
-
To determine the long-term (up to 10 years) anatomic success rate of sacrocolpopexy (defined as Stage 0 apical prolapse AND <= Stage 2 anterior and posterior prolapse AND no re-operation or pessary treatment for POP), and whether anatomic success differs between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy;
-
To determine whether there is a difference in long-term stress continence (by symptoms) between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy;
-
To determine whether there is a long-term difference between overall pelvic floor symptoms and pelvic-floor specific quality of life between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Abdominal Sacral Colpopexy with no Burch colposuspension Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse |
|
Abdominal Sacral Colpopexy with Burch Colposuspension Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse |
Outcome Measures
Primary Outcome Measures
- 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 Symptomatic Failure [3 year]
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
- Number of Participants With Symptomatic Failure [4 year]
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
- Number of Participants With Symptomatic Failure [5 year]
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
- Number of Participants With Symptomatic Failure [6 year]
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
- Number of Participants With Symptomatic Failure [7 year]
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
- Number of Participants With Anatomic Failure (Original Definition) [24 months]
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen
- Number of Participants With Anatomic Failure (Original Definition) [3 year]
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen
- Number of Participants With Anatomic Failure (Original Definition) [4 year]
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen
- Number of Participants With Anatomic Failure (Original Definition) [5 year]
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen
- Number of Participants With Anatomic Failure (Original Definition) [6 year]
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen
- Number of Participants With Anatomic Failure (Original Definition) [7 year]
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen
- Number of Participants With Anatomic Failure (Updated Definition) [24 months]
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
- Number of Participants With Anatomic Failure (Updated Definition) [3 year]
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
- Number of Participants With Anatomic Failure (Updated Definition) [4 year]
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
- Number of Participants With Anatomic Failure (Updated Definition) [5 year]
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
- Number of Participants With Anatomic Failure (Updated Definition) [6 year]
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
- Number of Participants With Anatomic Failure (Updated Definition) [7 year]
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
- Number of Participants With Composite Failure [24 months]
Anatomic failure (updated definition) or symptomatic failure
- Number of Participants With Composite Failure [3 year]
Anatomic failure (updated definition) or symptomatic failure
- Number of Participants With Composite Failure [4 year]
Anatomic failure (updated definition) or symptomatic failure
- Number of Participants With Composite Failure [5 year]
Anatomic failure (updated definition) or symptomatic failure
- Number of Participants With Composite Failure [6 year]
Anatomic failure (updated definition) or symptomatic failure
- Number of Participants With Composite Failure [7 year]
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 Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index [3 year]
Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.
- Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index [4 year]
Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.
- Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index [5 year]
Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.
- Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index [6 year]
Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.
- Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index [7 year]
Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.
- 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) Prevention [3 year]
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI
- Number of Participants With Stress Urinary Incontinence (SUI) Prevention [4 year]
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI
- Number of Participants With Stress Urinary Incontinence (SUI) Prevention [5 year]
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI
- Number of Participants With Stress Urinary Incontinence (SUI) Prevention [6 year]
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI
- Number of Participants With Stress Urinary Incontinence (SUI) Prevention [7 year]
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI
- Number of Participants With Stress Urinary Incontinence (SUI) [24 months]
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
- Number of Participants With Stress Urinary Incontinence (SUI) [3 year]
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
- Number of Participants With Stress Urinary Incontinence (SUI) [4 year]
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
- Number of Participants With Stress Urinary Incontinence (SUI) [5 year]
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
- Number of Participants With Stress Urinary Incontinence (SUI) [6 year]
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
- Number of Participants With Stress Urinary Incontinence (SUI) [7 year]
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
Eligibility Criteria
Criteria
Inclusion Criteria:
- Women enrolled in CARE
Exclusion Criteria:
-
Inability to provide informed consent.
-
Subjects who, at the time of enrollment into E-CARE, are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233-7333 |
2 | USCD Medical Center | La Jolla | California | United States | 92037 |
3 | Kaiser Permanente | San Diego | California | United States | 92120 |
4 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
5 | University of Iowa | Iowa City | Iowa | United States | 52242 |
6 | Johns Hopkins School of Medicine | Baltimore | Maryland | United States | 21287 |
7 | Duke University | Durham | North Carolina | United States | 27710 |
8 | Magee-Womens Hospital | Pittsburgh | Pennsylvania | United States | 15213-3180 |
Sponsors and Collaborators
- NICHD Pelvic Floor Disorders Network
- University of Iowa
- Baylor College of Medicine
- Loyola University
- University of North Carolina, Chapel Hill
- Johns Hopkins University
- University of Pittsburgh
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Study Chair: Ingrid Nygaard, MD, University of Utah
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- PFD 001; U01HD41249
- U01HD041249
- U10HD041268
- U10HD041248
- U10HD041250
- U10HD041261
- U10HD041263
- U10HD041269
- U10HD041267
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Abdominal Sacral Colpopexy With Burch Colposuspension | Abdominal Sacral Colpopexy With No Burch Colposuspension |
---|---|---|
Arm/Group Description | Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse | Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse |
Period Title: Enrolled in Extended CARE Trial | ||
STARTED | 104 | 111 |
COMPLETED | 104 | 111 |
NOT COMPLETED | 0 | 0 |
Period Title: Enrolled in Extended CARE Trial | ||
STARTED | 104 | 111 |
COMPLETED | 89 | 92 |
NOT COMPLETED | 15 | 19 |
Period Title: Enrolled in Extended CARE Trial | ||
STARTED | 89 | 92 |
COMPLETED | 66 | 60 |
NOT COMPLETED | 23 | 32 |
Baseline Characteristics
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY | Total |
---|---|---|---|
Arm/Group Description | Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse | Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse | Total of all reporting groups |
Overall Participants | 104 | 111 | 215 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
62.9
(9.4)
|
60.9
(10.5)
|
61.9
(10)
|
Sex/Gender, Customized (Count of Participants) | |||
Female |
104
100%
|
111
100%
|
215
100%
|
Race/Ethnicity, Customized (Count of Participants) | |||
Black or African American |
4
3.8%
|
9
8.1%
|
13
6%
|
Other |
1
1%
|
3
2.7%
|
4
1.9%
|
White |
99
95.2%
|
99
89.2%
|
198
92.1%
|
Race/Ethnicity, Customized (Count of Participants) | |||
Hispanic |
1
1%
|
7
6.3%
|
8
3.7%
|
Not Hispanic |
103
99%
|
104
93.7%
|
207
96.3%
|
Married or living as married (Count of Participants) | |||
Missing |
1
1%
|
0
0%
|
1
0.5%
|
No |
23
22.1%
|
31
27.9%
|
54
25.1%
|
Yes |
80
76.9%
|
80
72.1%
|
160
74.4%
|
Education level (Count of Participants) | |||
College degree or higher |
53
51%
|
63
56.8%
|
116
54%
|
High school degree or equivalent |
36
34.6%
|
44
39.6%
|
80
37.2%
|
Less than High School |
15
14.4%
|
4
3.6%
|
19
8.8%
|
Number of vaginal deliveries (deliveries) [Median (Full Range) ] | |||
Median (Full Range) [deliveries] |
3
|
3
|
3
|
Number of cesarean deliveries (deliveries) [Median (Full Range) ] | |||
Median (Full Range) [deliveries] |
0
|
0
|
0
|
Number of previous births (births) [Median (Full Range) ] | |||
Median (Full Range) [births] |
3
|
3
|
3
|
Hysterectomy (Count of Participants) | |||
Missing |
17
16.3%
|
15
13.5%
|
32
14.9%
|
No |
7
6.7%
|
17
15.3%
|
24
11.2%
|
Yes |
80
76.9%
|
79
71.2%
|
159
74%
|
Prior SUI Surgery (Count of Participants) | |||
No |
95
91.3%
|
104
93.7%
|
199
92.6%
|
Yes |
9
8.7%
|
7
6.3%
|
16
7.4%
|
Prior POP Surgery (Count of Participants) | |||
No |
56
53.8%
|
75
67.6%
|
131
60.9%
|
Yes |
48
46.2%
|
36
32.4%
|
84
39.1%
|
Pelvic Organ Prolapse-Q stage (Count of Participants) | |||
2 |
9
8.7%
|
15
13.5%
|
24
11.2%
|
3 |
75
72.1%
|
78
70.3%
|
153
71.2%
|
4 |
20
19.2%
|
18
16.2%
|
38
17.7%
|
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [kg/m^2] |
26.6
(4)
|
26.8
(4.8)
|
26.7
(4.4)
|
BMI >= 30 (obesity) (Count of Participants) | |||
No |
85
81.7%
|
85
76.6%
|
170
79.1%
|
Yes |
19
18.3%
|
26
23.4%
|
45
20.9%
|
Outcome Measures
Title | Number of Participants With Symptomatic Failure |
---|---|
Description | Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery |
Time Frame | 24 months |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse | Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse |
Measure Participants | 104 | 111 |
Failure |
15
14.4%
|
16
14.4%
|
Non-failure |
89
85.6%
|
95
85.6%
|
Title | Number of Participants With Symptomatic Failure |
---|---|
Description | Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery |
Time Frame | 3 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 101 | 108 |
Failure |
16
15.4%
|
19
17.1%
|
Non-failure |
85
81.7%
|
89
80.2%
|
Title | Number of Participants With Symptomatic Failure |
---|---|
Description | Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery |
Time Frame | 4 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 94 | 103 |
Failure |
19
18.3%
|
20
18%
|
Non-failure |
75
72.1%
|
83
74.8%
|
Title | Number of Participants With Symptomatic Failure |
---|---|
Description | Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery |
Time Frame | 5 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 91 | 96 |
Failure |
25
24%
|
21
18.9%
|
Non-failure |
66
63.5%
|
75
67.6%
|
Title | Number of Participants With Symptomatic Failure |
---|---|
Description | Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery |
Time Frame | 6 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 86 | 90 |
Failure |
27
26%
|
21
18.9%
|
Non-failure |
59
56.7%
|
69
62.2%
|
Title | Number of Participants With Symptomatic Failure |
---|---|
Description | Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery |
Time Frame | 7 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 73 | 71 |
Failure |
27
26%
|
22
19.8%
|
Non-failure |
46
44.2%
|
49
44.1%
|
Title | Number of Participants With Anatomic Failure (Original Definition) |
---|---|
Description | Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen |
Time Frame | 24 months |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 101 | 110 |
Failure |
6
5.8%
|
9
8.1%
|
Non-failure |
95
91.3%
|
101
91%
|
Title | Number of Participants With Anatomic Failure (Original Definition) |
---|---|
Description | Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen |
Time Frame | 3 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 84 | 90 |
Failure |
9
8.7%
|
10
9%
|
Non-failure |
75
72.1%
|
80
72.1%
|
Title | Number of Participants With Anatomic Failure (Original Definition) |
---|---|
Description | Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen |
Time Frame | 4 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 64 | 77 |
Failure |
10
9.6%
|
12
10.8%
|
Non-failure |
54
51.9%
|
65
58.6%
|
Title | Number of Participants With Anatomic Failure (Original Definition) |
---|---|
Description | Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen |
Time Frame | 5 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 58 | 69 |
Failure |
12
11.5%
|
13
11.7%
|
Non-failure |
46
44.2%
|
56
50.5%
|
Title | Number of Participants With Anatomic Failure (Original Definition) |
---|---|
Description | Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen |
Time Frame | 6 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 55 | 56 |
Failure |
15
14.4%
|
14
12.6%
|
Non-failure |
40
38.5%
|
42
37.8%
|
Title | Number of Participants With Anatomic Failure (Original Definition) |
---|---|
Description | Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends >= 2 cm, or the anterior or posterior vaginal wall decends >1 cm beyond the hymen |
Time Frame | 7 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 44 | 46 |
Failure |
15
14.4%
|
14
12.6%
|
Non-failure |
29
27.9%
|
32
28.8%
|
Title | Number of Participants With Anatomic Failure (Updated Definition) |
---|---|
Description | Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen |
Time Frame | 24 months |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 101 | 110 |
Failure |
5
4.8%
|
8
7.2%
|
Non-failure |
96
92.3%
|
102
91.9%
|
Title | Number of Participants With Anatomic Failure (Updated Definition) |
---|---|
Description | Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen |
Time Frame | 3 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 84 | 91 |
Failure |
8
7.7%
|
10
9%
|
Non-failure |
76
73.1%
|
81
73%
|
Title | Number of Participants With Anatomic Failure (Updated Definition) |
---|---|
Description | Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen |
Time Frame | 4 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 64 | 79 |
Failure |
10
9.6%
|
12
10.8%
|
Non-failure |
54
51.9%
|
67
60.4%
|
Title | Number of Participants With Anatomic Failure (Updated Definition) |
---|---|
Description | Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen |
Time Frame | 5 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 56 | 71 |
Failure |
14
13.5%
|
12
10.8%
|
Non-failure |
42
40.4%
|
59
53.2%
|
Title | Number of Participants With Anatomic Failure (Updated Definition) |
---|---|
Description | Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen |
Time Frame | 6 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 54 | 59 |
Failure |
18
17.3%
|
13
11.7%
|
Non-failure |
36
34.6%
|
46
41.4%
|
Title | Number of Participants With Anatomic Failure (Updated Definition) |
---|---|
Description | Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen |
Time Frame | 7 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 45 | 49 |
Failure |
18
17.3%
|
13
11.7%
|
Non-failure |
27
26%
|
36
32.4%
|
Title | Number of Participants With Composite Failure |
---|---|
Description | Anatomic failure (updated definition) or symptomatic failure |
Time Frame | 24 months |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 102 | 110 |
Failure |
14
13.5%
|
15
13.5%
|
Non-failure |
88
84.6%
|
95
85.6%
|
Title | Number of Participants With Composite Failure |
---|---|
Description | Anatomic failure (updated definition) or symptomatic failure |
Time Frame | 3 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 89 | 92 |
Failure |
16
15.4%
|
18
16.2%
|
Non-failure |
73
70.2%
|
74
66.7%
|
Title | Number of Participants With Composite Failure |
---|---|
Description | Anatomic failure (updated definition) or symptomatic failure |
Time Frame | 4 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 70 | 82 |
Failure |
19
18.3%
|
19
17.1%
|
Non-failure |
51
49%
|
63
56.8%
|
Title | Number of Participants With Composite Failure |
---|---|
Description | Anatomic failure (updated definition) or symptomatic failure |
Time Frame | 5 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 63 | 75 |
Failure |
27
26%
|
20
18%
|
Non-failure |
36
34.6%
|
55
49.5%
|
Title | Number of Participants With Composite Failure |
---|---|
Description | Anatomic failure (updated definition) or symptomatic failure |
Time Frame | 6 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 61 | 66 |
Failure |
30
28.8%
|
21
18.9%
|
Non-failure |
31
29.8%
|
45
40.5%
|
Title | Number of Participants With Composite Failure |
---|---|
Description | Anatomic failure (updated definition) or symptomatic failure |
Time Frame | 7 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 54 | 61 |
Failure |
30
28.8%
|
21
18.9%
|
Non-failure |
24
23.1%
|
40
36%
|
Title | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index |
---|---|
Description | Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe. |
Time Frame | 24 months |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 104 | 111 |
Failure |
48
46.2%
|
66
59.5%
|
Non-failure |
56
53.8%
|
45
40.5%
|
Title | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index |
---|---|
Description | Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe. |
Time Frame | 3 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 101 | 109 |
Failure |
52
50%
|
70
63.1%
|
Non-failure |
49
47.1%
|
39
35.1%
|
Title | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index |
---|---|
Description | Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe. |
Time Frame | 4 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 99 | 105 |
Failure |
55
52.9%
|
70
63.1%
|
Non-failure |
44
42.3%
|
35
31.5%
|
Title | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index |
---|---|
Description | Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe. |
Time Frame | 5 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 98 | 104 |
Failure |
58
55.8%
|
72
64.9%
|
Non-failure |
40
38.5%
|
32
28.8%
|
Title | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index |
---|---|
Description | Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe. |
Time Frame | 6 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 97 | 102 |
Failure |
59
56.7%
|
73
65.8%
|
Non-failure |
38
36.5%
|
29
26.1%
|
Title | Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index |
---|---|
Description | Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe. |
Time Frame | 7 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 91 | 92 |
Failure |
62
59.6%
|
73
65.8%
|
Non-failure |
29
27.9%
|
19
17.1%
|
Title | Number of Participants With Stress Urinary Incontinence (SUI) Prevention |
---|---|
Description | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI |
Time Frame | 24 months |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 104 | 110 |
Failure |
39
37.5%
|
63
56.8%
|
Non-failure |
65
62.5%
|
47
42.3%
|
Title | Number of Participants With Stress Urinary Incontinence (SUI) Prevention |
---|---|
Description | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI |
Time Frame | 3 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 102 | 109 |
Failure |
47
45.2%
|
69
62.2%
|
Non-failure |
55
52.9%
|
40
36%
|
Title | Number of Participants With Stress Urinary Incontinence (SUI) Prevention |
---|---|
Description | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI |
Time Frame | 4 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 99 | 107 |
Failure |
49
47.1%
|
76
68.5%
|
Non-failure |
50
48.1%
|
31
27.9%
|
Title | Number of Participants With Stress Urinary Incontinence (SUI) Prevention |
---|---|
Description | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI |
Time Frame | 5 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 98 | 105 |
Failure |
53
51%
|
77
69.4%
|
Non-failure |
45
43.3%
|
28
25.2%
|
Title | Number of Participants With Stress Urinary Incontinence (SUI) Prevention |
---|---|
Description | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI |
Time Frame | 6 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 95 | 105 |
Failure |
55
52.9%
|
78
70.3%
|
Non-failure |
40
38.5%
|
27
24.3%
|
Title | Number of Participants With Stress Urinary Incontinence (SUI) Prevention |
---|---|
Description | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI |
Time Frame | 7 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 89 | 96 |
Failure |
57
54.8%
|
79
71.2%
|
Non-failure |
32
30.8%
|
17
15.3%
|
Title | Number of Participants With Stress Urinary Incontinence (SUI) |
---|---|
Description | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory |
Time Frame | 24 months |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 104 | 110 |
Failure |
39
37.5%
|
63
56.8%
|
Non-failure |
65
62.5%
|
47
42.3%
|
Title | Number of Participants With Stress Urinary Incontinence (SUI) |
---|---|
Description | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory |
Time Frame | 3 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 102 | 109 |
Failure |
47
45.2%
|
68
61.3%
|
Non-failure |
55
52.9%
|
41
36.9%
|
Title | Number of Participants With Stress Urinary Incontinence (SUI) |
---|---|
Description | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory |
Time Frame | 4 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 99 | 107 |
Failure |
49
47.1%
|
75
67.6%
|
Non-failure |
50
48.1%
|
32
28.8%
|
Title | Number of Participants With Stress Urinary Incontinence (SUI) |
---|---|
Description | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory |
Time Frame | 5 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 98 | 105 |
Failure |
53
51%
|
76
68.5%
|
Non-failure |
45
43.3%
|
29
26.1%
|
Title | Number of Participants With Stress Urinary Incontinence (SUI) |
---|---|
Description | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory |
Time Frame | 6 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 95 | 105 |
Failure |
55
52.9%
|
78
70.3%
|
Non-failure |
40
38.5%
|
27
24.3%
|
Title | Number of Participants With Stress Urinary Incontinence (SUI) |
---|---|
Description | One or more SUI symptoms reported on the Pelvic Floor Distress Inventory |
Time Frame | 7 year |
Outcome Measure Data
Analysis Population Description |
---|
This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. |
Arm/Group Title | BURCH URETHROPEXY | NO URETHROPEXY |
---|---|---|
Arm/Group Description | Abdominal Sacral Colpopexy with Burch Colposuspension | Abdominal Sacral Colpopexy with No Burch Colposuspension |
Measure Participants | 89 | 96 |
Failure |
57
54.8%
|
79
71.2%
|
Non-failure |
32
30.8%
|
17
15.3%
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Abdominal Sacral Colpopexy With Burch Colposuspension | Abdominal Sacral Colpopexy With No Burch Colposuspension | ||
Arm/Group Description | Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse | Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse | ||
All Cause Mortality |
||||
Abdominal Sacral Colpopexy With Burch Colposuspension | Abdominal Sacral Colpopexy With No Burch Colposuspension | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/104 (0%) | 0/111 (0%) | ||
Serious Adverse Events |
||||
Abdominal Sacral Colpopexy With Burch Colposuspension | Abdominal Sacral Colpopexy With No Burch Colposuspension | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/104 (0%) | 0/111 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Abdominal Sacral Colpopexy With Burch Colposuspension | Abdominal Sacral Colpopexy With No Burch Colposuspension | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 12/104 (11.5%) | 15/111 (13.5%) | ||
Surgical and medical procedures | ||||
Medical device site reaction | 11/104 (10.6%) | 11 | 12/111 (10.8%) | 12 |
Medical device site reaction | 1/104 (1%) | 1 | 3/111 (2.7%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Marie Gantz |
---|---|
Organization | RTI International |
Phone | 919-597-5110 |
mgantz@rti.org |
- PFD 001; U01HD41249
- U01HD041249
- U10HD041268
- U10HD041248
- U10HD041250
- U10HD041261
- U10HD041263
- U10HD041269
- U10HD041267