Table 3.
Adverse Events Related to the Surgical Outcome
| Variable | Treatment Group | Adjusted OR* (95% CI) | P value* | |
|---|---|---|---|---|
| Uterosacral Ligament Suspension N=188 |
Sacrospinous Ligament Fixation N=186 |
|||
| Participants with any Adverse Event (AE), n (%) | 140 (74.5%) | 142 (76.3%) | 0.9 (0.6, 1.4) | 0.65 |
| Serious AE, n (%) | 31 (16.5%) | 31 (16.7%) | 0.9 (0.5, 1.6) | 0.83 |
| Expected AE, n (%) | 130 (69.1%) | 130 (69.9%) | 0.9 (0.6, 1.5) | 0.80 |
| Perioperative Adverse Events (Surgery through 4–6 week postoperatively) – n (%) | ||||
| Participants with: | ||||
| Bladder injury | 22 (11.7%) | 18 (9.7%) | 1.2 (0.6, 2.4) | 0.60 |
| During mid-urethral sling | 18 (9.6%) | 18 (9.7%) | 1.0 (0.5, 2.0) | 1.00 |
| Other | 4 (2.1%) | 0 (0.0%) | N/A - LR | |
| Intraoperative ureteral obstruction | 6 (3.2%) | 0 (0.0%) | N/A - LR | |
| Treatment: | ||||
| Suture removed intra-operatively | 5 (2.7%) | 0 (0.0%) | N/A - LR | |
| Stent placement | 1 (0.5%) | 0 (0.0%) | N/A - LR | |
| Additional Procedure | 0 (0.0%) | 0 (0.0%) | N/A - LR | |
| Ureteral injury – delayed recognition* | 1 (0.5%) | 0 (0.0%) | N/A - LR | |
| Urethral injury | 0 (0.0%) | 0 (0.0%) | N/A - LR | |
| Rectal injury | 0 (0.0%) | 1 (0.5%) | N/A - LR | |
| Major vascular injury | 0 (0.0%) | 0 (0.0%) | N/A - LR | |
| Blood transfusion | 7 (3.7%) | 4 (2.2%) | 1.9 (0.5, 7.8) | 0.38 |
| Neurologic pain requiring treatment** | 13 (6.9%) | 23 (12.4%) | 0.5 (0.2, 1.0) | 0.049 |
| Treatment: | ||||
| Narcotic pain medication | 10 (5.3%) | 18 (9.7%) | ||
| Nerve block | 0 (0.0%) | 2 (1.1%) | ||
| Physical therapy | 2 (1.1%) | 3 (1.6%) | ||
| Other medication | 8 (4.3%) | 13 (7.0%) | ||
| Surgical (return to operating for suture removal) | 0 (0.0%) | 3 (1.6%) | ||
| Long-term complications n (%) | ||||
| Participants with: | ||||
| Vaginal granulation tissue at 6 to 24 months*** | 36 (19.1%) | 26 (14.0%) | 1.5 (0.8, 2.6) | 0.18 |
| Mesh erosion/exposure at 4 weeks to 24 months*** | 3 (1.6%) | 1 (0.5%) | N/A - LR | |
| Suture exposure at 6 to 24 months*** | 29 (15.4%) | 32 (17.2%) | 0.9 (0.5, 1.5) | 0.60 |
| Severity (Dindo Scores) for Expected Adverse Events n (%) | ||||
| Participants with Expected AE severity (most severe per participant), n (%) | ||||
| No such events | 30 (16.0%) | 22 (11.8%) | N/A | 0.58 |
| I | 29 (15.4%) | 38 (20.4%) | ||
| II | 74 (39.4%) | 74 (39.8%) | ||
| III | 33 (17.6%) | 24 (12.9%) | ||
| IV | 1 (0.5%) | 0 (0.0%) | ||
| V | 0 (0.0%) | 0 (0.0%) | ||
| Summary of Serious Adverse Events | ||||
| Participants with any SAE | 31 (16.5%) | 31 (16.7%) | 0.9 (0.5, 1.6) | 0.83 |
| Number of SAEs | 40 | 44 | ||
| Dindo Classification: | N/A | 0.75 | ||
| No such events | 157 (83.5%) | 155 (83.3%) | ||
| I | 3 (1.6%) | 2 (1.1%) | ||
| II | 11 (5.9%) | 11 (5.9%) | ||
| III | 15 (8.0%) | 17 (9.1%) | ||
| IV | 1 (0.5%) | 1 (0.5%) | ||
| V | 1 (0.5%)# | 0 (0.0%) | ||
| Participants with SAE by relationship to study | ||||
| No such events | 157 (83.5%) | 155 (83.3%) | N/A | 0.74 |
| Not assessable | 2 (1.1%) | 0 (0.0%) | ||
| Unlikely | 24 (12.8%) | 22 (11.8%) | ||
| Likely | 5 (2.7%) | 9 (4.8%) | ||
N/A = Not applicable; OR = Odds Ratio; CI = Confidence Interval.
N/A – LR = The Adjusted OR and P value isn’t shown due to reliability of test.
*
Not identified during surgical procedure.
**
Defined a priori as acute-onset pain involving the buttock, groin and/or lower extremity, usually unilateral, occurring on the side or sides where vault suspension stitches have been placed and within one week of the index surgery requiring an alteration of routine postoperative care (e.g., nerve block, physical therapy, return to OR for suture removal, addition of medications used to treat neuropathic pain such as anticonvulsants or tricyclic anti-depressants, or the increase or persistence of narcotic pain medication use beyond 14 days after surgery).
***
Not mutually exclusive. Location and need for or type of treatment not collected. Mesh erosion excludes from the denominator patients who did not receive TVT at surgery.
#
Patient death not attributable to study surgery.
Severity grade determined by a modified version of the Dindo classification system,24 which is based on the level of therapy required to treat an event.
| Grade | Definition | |
|---|---|---|
| I | Any deviation from the normal intraoperative or postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions | |
| Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside | ||
| II | Requiring pharmacological treatment with drugs other than such allowed for grade I complications. | |
| IIa | Oral administration of drugs other than such allowed for grade I, including antibiotics for wound or bladder infections | |
| IIb | IV administration of drugs other than such allowed for grade I, including antibiotics; blood transfusions and total parenteral nutrition are also included | |
| III | Requiring surgical, endoscopic or radiological intervention | |
| IIIo | Additional surgical measures required during OPTIMAL procedure | |
| IIIa | Intervention not under general anesthesia | |
| IIIb | Intervention under general anesthesia | |
| IV | Life-threatening complication (including CNS complications)* requiring IC/ICU management | |
| IVa | Single organ dysfunction (including dialysis) | |
| IVb | Multiorgan dysfunction | |
| V | Death of a patient | |
| Suffix “d” | If the patient suffers from a complication at the time of discharge, the suffix “d” (for “disability”) is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication. |
*
Brain hemorrhage, ischemic stroke, subarachnoidal bleeding, but excluding transient ischemic attacks.
CNS, central nervous system; IC, intermediate care; ICU, intensive care unit.