Table 2.
Demographic and baseline characteristics by study and overall
| CARE Trial | Colpocleisis Cohort | ATLAS Trial | ABBI Cohort | Total | |
|---|---|---|---|---|---|
|
| |||||
| N | 316 | 140 | 435 | 115 | 1006 |
|
| |||||
| Primary condition studied | Pelvic organ prolapse | Pelvic organ prolapse | Stress urinary incontinence | Fecal Incontinence | - |
|
| |||||
| Age (Mean ± SD) | 61.4 ± 10.3 | 79.2 ± 5.3 | 49.7 ± 11.9 | 57.8 ± 13.9 | 58.4 ± 14.7 |
|
| |||||
| Race (%) | |||||
| White/Caucasian | 294 (93.0%) | 129 (92.1%) | 369 (85.0%) | 99 (86.1%) | 891 (88.7%) |
| Black/African American | 16 (5.1%) | 11 (7.9%) | 45 (10.4%) | 13 (11.3%) | 85 (8.5%) |
| Other | 6 (1.9) | 0 (0.0%) | 20 (4.6%) | 3 (2.6%) | 29 (2.9%) |
|
| |||||
| Hispanic Ethnicity (%) | 9 (2.9%) | 1 (0.7%) | 32 (7.4%) | 9 (7.8%) | 51 (5.1%) |
|
| |||||
| Educational Level (%) | |||||
| Less than high school | 26 (8.2%) | 32 (22.9%) | 18 (4.1%) | 9 (7.9%) | 85 (8.5%) |
| Completed high school or equivalent | 121 (38.3%) | 63 (45.0%) | 81 (18.6%) | 31 (27.2%) | 296 (29.4%) |
| Some college or higher | 169 (53.5%) | 45 (32.1%) | 336 (77.2%) | 74 (64.9%) | 624 (62.1%) |
|
| |||||
| Body Mass Index (kg/m2) (Mean ± SD) | 27.0 ± 4.5 | 27.8 ± 5.4 | 29.5 ± 6.8 | 29.0 ± 7.0 | 28.4 ± 6.1 |
|
| |||||
| Parity (Median, Range) | 3 (1, 11) | NA | 2 (0, 11) | 3 (0, 9) | 2 (0, 11) |
|
| |||||
| Stress Urinary Incontinence* (%) | 60 (19.1%) | 105 (75.0%) | 430 (99.3%) | 77 (67.0%) | 672 (67.1%) |
|
| |||||
| Urge Urinary Incontinence# (%) | 87 (27.5%) | 91 (65.0%) | 183 (42.5%) | 69 (60.0%) | 430 (42.9%) |
|
| |||||
| Pelvic Organ Prolapse Stage ** (%) | NA | ||||
| Stage 0/1 | 0 (0.0%) | 0 (0.0%) | 249 (57.9%) | 249 (28.3%) | |
| Stage 2 | 44 (13.9%) | 0 (0.0%) | 181 (42.1%) | 225 (25.5%) | |
| Stage 3/4 | 272 (86.1%) | 135 (100.0%) | 0 (0.0%) | 407 (46.2%) | |
|
| |||||
| Fecal Incontinence## (%) | 64 (20.3%) | 44 (31.4%) | 104 (24.0%) | 104 (90.4%) | 316 (31.4%) |
NA, data not available
*
Defined as any affirmative response to one of the three items in the stress subscale of the Pelvic Floor Distress Inventory (PFDI)
#
Defined as an affirmative response to item 19 “Do you usually experience urine leakage associated with a feeling of urgency, that is, a strong sensation of needing to go to the bathroom?” or item 28 “Do you usually experience bed-wetting?” of the PFDI
**
Pelvic organ prolapse quantitation (POPQ) stage.[26]
##
Defined as an affirmative response to item 38 “Do you usually lose stool beyond your control if your stool is well formed?” or item 39 “Do you lose stool beyond your control if your stool is loose or liquid?” of the PFDI