Table 2. Primary and Secondary Outcomes Through 12 Monthsa.
| Outcome Type | Baselineb | 3 Monthsb | 6 Monthsb | 12 Monthsb | ||||
|---|---|---|---|---|---|---|---|---|
| Combined Sling and Training (n = 235) | Sling Only (n = 229) | Combined Sling and Training (n = 194) | Sling Only (n = 198) | Combined Sling and Training (n = 182) | Sling Only (n = 176) | Combined Sling and Training (n = 181) | Sling Only (n = 174) | |
| UDI Total Score (Primary)c | ||||||||
| Score, unadjusted, mean (SD) | 178.0 (42.8) | 176.8 (40.5) | 35.4 (44.1) | 37.2 (44.4) | 30.4 (40.1) | 36.6 (49.6) | 30.7 (42.6) | 34.5 (44.7) |
| Difference from baseline, adjusted mean (95% CI) | −125.7 (−143.4 to −107.9) |
−119.9 (−137.6 to −102.3) |
−126.5 (−144.2 to −108.8) |
−118.2 (−135.8 to −100.7) |
−128.1 (−146.5 to −109.8) |
−114.7 (−133.3 to −96.2) |
||
| Difference-in-difference, adjusted mean (95% CI) | −5.7 (−15.8 to 4.4) | −8.3 (−18.0 to 1.5) | −13.4 (−25.9 to −1.0) | |||||
| P value | .27 | .10 | .04 | |||||
| UDI-Irritative Score (Secondary)d | ||||||||
| Score, unadjusted mean (SD) | 66.0 (19.6) | 67.6 (19.7) | 15.5 (20.5) | 16.9 (21.9) | 12.2 (17.7) | 16.4 (24.0) | 12.2 (18.7) | 15.1 (21.2) |
| Difference from baseline, adjusted mean (95% CI) | −42.7 (−50.7 to −34.6) |
−41.1 (−49.1 to −33.1) |
−43.4 (−51.5 to −35.4) |
−40.4 (−48.3 to −32.4) |
−45.0 (−53.4 to −36.6) |
−38.9 (−47.4 to −30.3) |
||
| Difference in difference, adjusted mean (95% CI) | −1.6 (−6.2 to 3.1) | −3.1 (−7.5 to 1.4) | −6.1 (−12.1 to −0.2) | |||||
| P value | .51 | .18 | .04 | |||||
| UDI-Stress Score (Secondary)d | ||||||||
| Score, unadjusted mean (SD) | 86.0 (17.6) | 84.9 (18.0) | 14.6 (22.7) | 14.6 (21.0) | 14.1 (21.5) | 15.3 (23.9) | 13.3 (22.0) | 15.3 (23.5) |
| Difference from baseline, adjusted mean (95% CI) | −66.4 (−75.2 to −57.7) |
−65.1 (−73.8 to −56.4) |
−66.6 (−75.3 to −58.0) |
−64.0 (−72.6 to −55.3) |
−67.1 (−76.1 to −58.1) |
−61.6 (−70.7 to −52.6) |
||
| Difference in difference, adjusted mean (95% CI) | −1.3 (−6.4 to 3.8) | −2.7 (−7.5 to 2.2) | −5.5 (−11.5 to 0.6) | |||||
| P value | .62 | .28 | .08 | |||||
Abbreviation: UDI, Urogenital Distress Inventory.
Difference from baseline, difference in difference, and P values are derived from longitudinal treatment models that accounted for multiple observations per participant and were adjusted for time since baseline and interaction between treatment and time, re-treatment and interactions with treatment and time, baseline incontinence severity, and clinical site, which accounted for multiple observations per participant.
Sample sizes present the number of participants with observed data at each time point excluding data after retreatment.
The UDI total score ranges from 0 to 300; the minimum clinically important difference (MCID) is 35 points, with higher scores indicating greater symptom severity.
The UDI subscales range from 0 to 100; the MCID is 15 points for irritative and 8 points for stress incontinence, with higher scores indicating greater symptom severity.