Table 2. Primary and Secondary Outcomes.
| Variable | Electroacupuncture (n = 252) |
Sham Electroacupuncture (n = 252) |
Difference (95% CI) |
P Valuea |
|---|---|---|---|---|
| Primary Outcome | ||||
| Urine leakage at wk 6, mean (95% CI), gb,c | 8.2 (6.3 to 10.0) | 16.8 (13.5 to 20.1) | ||
| Change at wk 6, adjusted mean (95% CI)d | −9.9 (−12.5 to −7.3) | −2.6 (−5.2 to 0) | 7.4 (4.8 to 10.0) | <.001 |
| Secondary Outcomese | ||||
| Change in mean No. of 72-h incontinence episodes, adjusted mean (95% CI), wkf | ||||
| 1-6 | −2.9 (−3.6 to −2.2) | −2.0 (−2.7 to −1.2) | 1.0 (0.2 to 1.7) | .01 |
| 15-18 | −4.7 (−5.4 to −4.0) | −2.7 (−3.4 to −2.0) | 2.0 (1.3 to 2.7) | <.001 |
| 27-30 | −5.0 (−5.8 to −4.3) | −3.0 (−3.7 to −2.2) | 2.1 (1.3 to 2.8) | <.001 |
| Change at wk 2, urine leakage, adjusted mean (95% CI), gb | −5.8 (−8.3 to −3.2) | −2.0 (−4.6 to 0.5) | 3.7 (1.5 to 6.0) | <.001g |
| Reduction ≥50% at wk 6, urine leakage from baselineb | 159/246 (64.6) | 52/240 (21.7) | −43.0 (−50.9 to −35.0) | <.001h |
| Reduction ≥50% in mean 72-h incontinence episodes from baselineh | ||||
| Weeks 1-6 | 91/239 (38.1) | 56/243 (23.1) | −15.0 (−23.2 to −6.9) | <.001 |
| Weeks 15-18 | 152/237 (64.1) | 91/236 (38.6) | −25.6 (−34.3 to −16.9) | <.001 |
| Weeks 27-30 | 160/237 (67.5) | 99/236 (42.0) | −25.6 (−34.2 to −16.9) | <.001 |
| Change, ICIQ-SF score, adjusted mean (95% CI)i | ||||
| Week 6 | −2.4 (−3.1 to −1.8) | −0.9 (−1.6 to −0.2) | 1.5 (0.7 to 2.3) | <.001 |
| Week 18 | −3.6 (−4.3 to −2.9) | −1.3 (−2.0 to −0.6) | 2.3 (1.4 to 3.2) | <.001 |
| Week 30 | −4.1 (−4.8 to −3.4) | −1.6 (−2.4 to −0.9) | 2.5 (1.5 to 3.4) | <.001 |
| Volume of liquid intake at 24 h, median (range), mLj | ||||
| Weeks 1-6 | 1077.7 (755.6 to 1400.0) | 999.4 (766.7 to 1438.9) | NA | .74 |
| Weeks 15-18 | 1025.0 (799.2 to 1360.0) | 975.0 (745.8 to 1412.5) | NA | .74 |
| Weeks 27-30 | 975.0 (775.0 to 1316.7) | 937.5 (725.0 to 1370.8) | NA | .47 |
| Participants using urine padsh | ||||
| Weeks 1-6 | 115/245 (46.9) | 111/245 (45.3) | −1.6 (−10.5 to 7.2) | .72 |
| Weeks 7-18 | 72/242 (29.8) | 89/237 (37.6) | 7.8 (−0.6 to 16.2) | .07 |
| Weeks 19-30 | 75/242 (31.0) | 93/237 (39.2) | 8.3 (−0.3 to 16.8) | .06 |
| Weekly mean use of urine pads, median (IQR)k | ||||
| Weeks 1-6 | 3.0 (1.7 to 6.0) | 3.7 (1.7 to 7.0) | NA | .12 |
| Weeks 7-18 | 3.1 (1.5 to 5.9) | 3.3 (1.3 to 7.0) | NA | .75 |
| Weeks 19-30 | 3.0 (1.0 to 6.0) | 3.8 (2.0 to 7.0) | NA | .02 |
| Use of other treatment for stress urinary incontinence | ||||
| Weeks 1-6l | 1/245 (0.4) | 0 | NA | >.99 |
| Weeks 7-18l | 1/242 (0.4) | 0 | NA | >.99 |
| Weeks 19-30 | 0 | 0 | NA | NA |
Abbreviations: ICIQ-SF, International Consultation on Incontinence Questionnaire-Short Form; IQR, interquartile range; NA, not applicable.
All tests were 2-sided. P value of less than .05 was considered significant.
Measured using the 1-hour pad test.
Number of participants: 240, sham electroacupuncture group and 246, electroacupuncture group.
Number of participants with imputed data: 12 (4.8%), sham electroacupuncture group and 6 (2.4%), electroacupuncture group (from mixed-effects model–adjusted baseline values).
Missing data not imputed for secondary outcomes analyses.
Number of participants: 243, electroacupuncture group and 239, sham electroacupuncture group (from repeated-measures mixed-effects model–adjusted baseline values).
Calculated using a mixed-effects model with baseline adjustment.
Calculated using a generalized linear model.
Scoring was additive (0 [better]-21 [worse] outcomes). Minimally clinically important difference: 2.52. Repeated-measures mixed-effects model–adjusted baseline values were used (243, electroacupuncture group; 239, sham electroacupuncture group).
Calculated using the Wilcoxon rank-sum test (participants [electroacupuncture group: 246, wk 1-6; 243, wk 15-18; 243, wk 27-30 and for the sham electroacupuncture group: 246, wk 1-6; 239, wk 15-18; 238, wk 27-30]).
Weekly use assessed among participants who used urine pads by the Wilcoxon rank-sum test. Between-group differences were not provided.
One participant used pelvic floor muscle training. P value was calculated using the Fisher exact test.