Table 3.
Changes in Health Status and Lower Urinary Tract Symptoms from Baseline, According to Study Group in the Randomized-Trial Cohort.*
| Variable | Sling Group (N = 165) |
Sham Group (N = 172) |
Difference, Sling vs. Sham (95% Cl)† |
P Value |
|---|---|---|---|---|
| SF-36 mental component summary‡ | ||||
| At 3 mo | ||||
| No. of patients | 156 | 154 | ||
| Score change | 1.5 ± 9.25 | 0.6 ± 8.44 | 0.8 (−1.1 to 2.8) | 0.40 |
| At 12 mo | ||||
| No. of patients | 154 | 152 | ||
| Score change | 1.9 ± 8.40 | 2.0 ± 8.94 | −0.1 (−2.1 to 1.9) | 0.92 |
| SF-36 physical component summary‡ | ||||
| At 3 mo | ||||
| No. of patients | 156 | 154 | ||
| Score change | 2.1 ± 8.21 | 1.5 ± 7.52 | 0.6 (−1.2 to 2.4) | 0.50 |
| At 12 mo | ||||
| No. of patients | 154 | 152 | ||
| Score change | 3.1 ± 9.23 | 2.3 ± 7.51 | 0.8 (−1.1 to 2.7) | 0.42 |
| PFDI UDI§ | ||||
| At 3 mo | ||||
| No. of patients | 160 | 155 | ||
| Score change | −44.9 ± 48.24 | −34.3 ± 44.92 | −10.6 (−20.9 to −0.2) | 0.04 |
| At 12 mo | ||||
| No. of patients | 157 | 152 | ||
| Score change | −43.1 ± 44.25 | −39.3 ± 40.93 | −3.7 (−13.3 to 5.8) | 0.44 |
| UDI obstructive symptom subscale¶ | ||||
| At 3 mo | ||||
| No. of patients | 160 | 158 | ||
| Score change | −27.3 ± 22.69 | −28.0 ± 20.81 | 0.7 (−4.1 to 5.6) | 0.76 |
| At 12 mo | ||||
| No. of patients | 157 | 154 | ||
| Score change | −26.4 ± 22.69 | −27.1 ± 21.39 | 0.7 (−4.2 to 5.6) | 0.77 |
| UDI irritative symptom subscale¶ | ||||
| At 3 mo | ||||
| No. of patients | 160 | 158 | ||
| Score change | −12.5 ± 18.83 | −10.5 ± 17.06 | −2.0 (−6.0 to 2.0) | 0.33 |
| At 12 mo | ||||
| No. of patients | 157 | 154 | ||
| Score change | −10.9 ± 17.15 | −11.6 ± 15.87 | 0.6 (−3.0 to 4.3) | 0.73 |
| UDI stress subscale¶ | ||||
| At 3 mo | ||||
| No. of patients | 160 | 155 | ||
| Score change | −5.1 ± 16.29 | 4.2 ± 20.42 | −9.4 (−13.5 to −5.3) | <0.001 |
| At 12 mo | ||||
| No. of patients | 157 | 152 | ||
| Score change | −5.7 ± 14.62 | −0.5 ± 16.89 | −5.3 (−8.8 to −1.7) | 0.004 |
| Incontinence Severity Index‖ | ||||
| At 3 mo | ||||
| No. of patients | 157 | 156 | ||
| Score change | −0.9 ± 3.01 | 0.6 ± 3.26 | −1.5 (−2.2 to −0.8) | <0.001 |
| At 12 mo | ||||
| No. of patients | 154 | 152 | ||
| Score change | −0.9 ± 2.70 | 0.1 ± 2.70 | −1.0 (−1.6 to −0.4) | <0.001 |
Plus–minus values are means ±SD.
Percentage-point differences may vary slightly from percents reported, because of rounding.
Scores on the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) have normalized values with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status.
Scores on the Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) subscale range from 0 to 300, with higher scores indicating more symptoms.
Scores on the UDI subscales range from 0 to 100, with higher scores indicating more symptoms.
Scores on the Incontinence Severity Index range from 1 to 12, with higher scores indicating greater severity.