Table 4.
Adverse Events during the First Year after Surgery, According to Study Group in the Randomized-Trial Cohort.*
| Event | Sling (N = 165) |
Sham (N = 172) |
P Value |
|---|---|---|---|
| Serious adverse events — no. of patients (%) | 28 (17.0) | 20 (11.6) | 0.16 |
| Unexpected adverse events — no. of patients (%) | 14 (8.5) | 14 (8.1) | 1.0 |
| Ureteral injury | 6 (3.6) | 3 (1.7) | 0.33 |
| Other | 8 (4.8) | 11 (6.4) | 0.64 |
| Expected adverse events — no. of patients/total no. (%) | |||
| Bladder perforation during sling placement | 11/164 (6.7) | 0/172 | <0.01 |
| Mesh erosion or exposure | 0/160 (0) | 0/171 | NA |
| Urinary tract infection† | 49/158 (31.0) | 30/164 (18.3) | 0.008 |
| Major bleeding or vascular complication | 5/164 (3.0) | 0/172 | 0.03 |
| Incomplete bladder emptying‡ | |||
| At hospital discharge | 69/162 (42.6) | 51/170 (30.0) | 0.02 |
| At 2 wk | 9/163 (5.5) | 1/169 (0.6) | 0.01 |
| At 6 wk | 6/162 (3.7) | 0/170 | 0.01 |
| Urethrolysis for voiding dysfunction | 4/165 (2.4) | 0/172 | 0.06 |
A serious adverse event was defined as any untoward medical occurrence (whether or not it was plausibly related to the index surgery) that resulted in death, was life threatening, required inpatient hospitalization, resulted in persistent or serious disability or incapacity, resulted in a congenital anomaly or birth defect, or constituted a medically important condition. An unexpected adverse event was defined as any other untoward event that did not qualify as an expected adverse event. Expected adverse events were defined as common side effects attributable to the placement of a sling. Any expected or unexpected adverse event that qualified as a serious adverse event was counted as such. Details of serious and unexpected adverse events are reported in Tables 7 and 8 in the Supplementary Appendix, respectively. A patient may have had more than one adverse event.
A urinary tract infection was diagnosed either by a positive urinalysis in clinic, resulting in treatment with antibiotics, or because patients reported symptoms, resulting in treatment with antibiotics.
A urethral catheter was left in place until day 1 after surgery. A successful voiding trial was defined as a postvoiding residual volume of less than 150 ml. Women with poor bladder emptying received treatment according to the clinical care standards at that site until voiding was successful.