Table 1.
Demographic and Clinical Characteristics of Participants (n=527)
| Variables | Transobturator MUS N=263 |
Retropubic MUS N=264 |
|---|---|---|
| Age in years: mean (sd), yrs | 53.8 (11.3) | 53.4 (10.2) |
| Race /Ethnicity :n (%) | ||
| Hispanic | 32 (12%) | 29 (11%) |
| Non-hispanic White | 208 (79%) | 216 (82%) |
| Non-hispanic Black | 8 (3%) | 6 (2%) |
| Non-hispanic Other | 15 (6%) | 13 (5%) |
| Occupational Class: mean (sd) | 59.8 (22.8) | 59.8 (22.9) |
| Baseline BMI: mean (sd) | 29.9 (6.3) | 30.4(6.8) |
| Prior UI Treatment or surgery: n (%) | 149 (57%) | 153 (58%) |
| Baseline Anal incontinence: n (%) | 155 (59%) | 155 (59%) |
| Baseline Smoking status: n (%) | ||
| Never | 145 (55%) | 146 (55%) |
| Former | 89 (34%) | 83 (31%) |
| Current | 29 (11%) | 35 (13%) |
| UI type and Severity | ||
| Stress UI index (MESA) at baseline: mean (sd) | 72.5 (17.2) | 71.1 (17.2) |
| Stress UI index (MESA) at 12 months: mean (sd) | 8.8 (16.6) | 8.0 (16.4) |
| Urge UI index (MESA) at baseline: mean (sd) | 37.3(21.6) | 33.1 (21.9) |
| Urge UI index (MESA) at 12 months: mean (sd) | 9.9 (14.1) | 10.2 (14.8) |
| Baseline UI Severity (PGI-S): n (%) | ||
| Normal or Mild | 50 (19%) | 58 (22%) |
| Moderate | 123 (47%) | 142 (54%) |
| Severe | 89 (34%) | 63 (24%) |
| Symptom bother (UDI) : mean (sd) | ||
| Baseline | 136.3 (41.6) | 131.1 (453.8) |
| 12 months | 26.0 (39.0) | 24.4 (34.3) |
| Sexual Activity at 12 months | ||
| Sexually active: n (%) | 171 (65%) | 176 (67%) |
| Sexual Function(PISQ-12): mean (sd) | 38.0 (6.1) | 37.3 (5.6) |
| Surgical and Post-operative Course Experienced any adverse events: n (%) | ||
| No AE or SAE | 200 (76%) | 177 (67%) |
| Any AE, no SAE | 47 (18%) | 57 (22%) |
| Any SAE w/ or w/o AE | 16 (6%) | 30 (11%) |
| Any intraoperative AE: n (%) | 11 (4%) | 19 (7%) |
| Reoperation for UI in 12 months: n (%) | 52 (20%) | 49 (19%) |
| Post-operative voiding dysfunction*n (%) | ||
| Normal | 257 (98%) | 251 (95%) |
| Catheter use | 0 (0%) | 7 (3%) |
| Surgical intervention | 3 (1%) | 5 (2%) |
| All other voiding dysfunction | 1 (<1%) | 1 (<1%) |
| Post-operative pain**n (%) | 5 (2%) | 5 (2%) |
Voiding dysfunction is defined as a complication if one of the following criteria are met: 1) uses a catheter to facilitate bladder emptying at or beyond the 6 week visit or 2) has undergone medical therapy to facilitate bladder emptying at or beyond the 6 week visit or 3) has undergone surgical therapy to facilitate bladder emptying at anytime after TOMUS surgery.
Pain is defined as a complication if the following criteria are met at or beyond the 6 week visit: 1) patient answers “yes” to the introductory stem question “Have you had any pain within the last 24 hours as a result of your incontinence operation?” and 2) patient answers any of the first three McCarthy pain questions at a level 75mm or greater on the visual analog scale and 3) patient answers the bother question on the McCarthy visual analog scale at a level 75mm or greater.