Table 3.
Complications stratified by continence surgery alone vs. continence surgery with concomitant surgery and by treatment group at 24 month
| No. of events/No. Pts (% - complication rate)
|
||||||
|---|---|---|---|---|---|---|
| Continence Only | Continence + Concomitant | |||||
| Retropubic | Transob. | P-value* | Retropubic | Transob. | P-value* | |
| Total # of pts | 225 | 221 | 73 | 78 | ||
| SAEs | ||||||
| Bladder Perforation | 10/10 (4.4%) | 0/0 | 0.002 | 5/5 (6.8%) | 0/0 | 0.02 |
| Urethral Perforation | 1/1 (0.4%) | 0/0 | 1.00 | 0/0 | 0/0 | - |
| Pulmonary Embolus | 0/0 | 0/0 | - | 0/0 | 1/1 (1.3%) | 1.00 |
| Postoperative Bleeding | 0/0 | 0/0 | - | 1/1 (1.4%) | 0/0 | 0.48 |
| Mesh Complication: Erosion | 1/1 (0.4%) | 1/1 (0.5%) | 1.00 | 0/0 | 0/0 | - |
| Mesh Complication: Exposure | 10/9 (4.0%) | 5/5 (2.3%) | 0.42 | 0/0 | 1/1 (1.3%) | 1.00 |
| Surg Site Inf: Deep Incisional | 0/0 | 1/1 (0.5%) | 0.50 | 0/0 | 0/0 | - |
| Surg Site Inf: Organ/Space | 0/0 | 0/0 | - | 0/0 | 2/2 (2.6%) | 0.50 |
| Recurrent UTI | 2/2 (0.9%) | 0/0 | 0.50 | 1/1 (1.4%) | 0/0 | 0.48 |
| Neurologic Symptoms | 2/2 (0.9%) | 1/1 (0.5%) | 1.00 | 1/1 (1.4%) | 0/0 | 0.48 |
| Granulation Tissue | 0/0 | 0/0 | - | 0/0 | 1/1 (1.3%) | 1.00 |
| Vaginal Epithelium Perforation | 6/6 (2.7%) | 9/9 (4.1%) | 0.44 | 0/0 | 4/4 (5.1%) | 0.12 |
|
| ||||||
| Voiding dysfunction requiring surgery (and/or catheter use) | 6/6 (2.7%) | 0/0 | 0.03 | 3/3 (4.1%) | 0/0 | 0.11 |
|
| ||||||
| Other | 0/0 | 1/1 (0.5%) | 0.50 | 0/0 | 2/2 (2.6%) | 0.50 |
|
|
|
|||||
| Total SAEs | 38/36 (16.0%) | 18/17 (7.7%) | 0.008 | 11/10 (13.7%) | 11/9 (11.5%) | 0.81 |
| AEs | ||||||
| Intraoperative Bleeding | 10/10 (4.4%) | 6/6 (2.7%) | 0.45 | 4/4 (5.5%) | 1/1 (1.3%) | 0.20 |
| Postoperative Bleeding | 4/4 (1.8%) | 0/0 | 0.12 | 2/2 (2.7%) | 0/0 | 0.23 |
| Mesh Complication: Exposure | 3/3 (1.3%) | 1/1 (0.5%) | 0.62 | 1/1 (1.4%) | 1/1 (1.3%) | 1.00 |
| Surg Site Inf: Superficial Incisional | 2/2 (0.9%) | 0/0 | 0.50 | 0/0 | 0/0 | - |
| UTI Culture proven | 15/14 (6.2%) | 10/9 (4.1%) | 0.39 | 12/11 (15.1%) | 6/5 (6.4%) | 0.11 |
| Empiric | 11/11 (4.9%) | 7/7 (3.2%) | 0.47 | 5/4 (5.5%) | 2/2 (2.6%) | 0.43 |
| Recurrent | 13/12 (5.3%) | 7/7 (3.2%) | 0.35 | 5/4 (5.5%) | 3/3 (3.8%) | 0.71 |
| Neurologic Symptoms | 14/11 (4.9%) | 20/17 (7.7%) | 0.25 | 4/2 (2.7%) | 11/11 (14.1%) | 0.02 |
|
| ||||||
| Voiding dysfunction | 4/4 (1.8%) | 6/6 (2.7%) | 0.54 | 6/6 (8.2%) | 0/0 | 0.01 |
| Pain per patient self-report ≥6 weeks | 5/5 (2.2%) | 3/3 (1.4%) | 0.72 | 2/2 (2.7%) | 4/3 (3.8%) | 1.00 |
| De novo urge incontinence | 0/0 | 1/1 (0.5%) | 0.50 | 0/0 | 0/0 | - |
| Persistent urge incontinence | 34/34 (15.0%) | 33/33 (14.9%) | 1.00 | 8/8 (11.0%) | 5/5 (6.4%) | 0.39 |
|
| ||||||
| Other | 3/2 (0.9%) | 2/2 (0.9%) | 1.00 | 5/5 (6.8%) | 4/4 (5.1%) | 0.74 |
|
|
|
|||||
| Total AEs | 118/84 (37.3%) | 96/70 (31.7%) | 0.23 | 54/36 (49.3%) | 37/27 (34.6%) | 0.07 |