Table 2. Urinary Incontinence-Specific Secondary Outcomes at 12-Week and 1-Year Follow-up.
| Variable | Total participants (individual/group), No. | Median (IQR) | Median difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Individual PFMT | Group PFMT | ||||
| Leakage episodes/d | |||||
| Baseline | 360 (183/177) | 1.57 (0.86 to 2.71) | 1.43 (0.86 to 2.14) | NA | |
| After 12-wk treatment | 336 (171/165) | 0.43 (0.14 to 1.00) | 0.43 (0.14 to 1.00) | 0 (−0.14 to 0.14) | .20 |
| At 1-y follow-up | 318 (165/153) | 0.43 (0.10 to 1.00) | 0.43 (0.14 to 1.00) | 0 (−0.29 to 0.14) | .67 |
| At 1-y follow-up (ITT) | 360 (183/177) | 0.43 (0.14 to 1.14) | 0.43 (0.14 to 1.14) | 0 (−0.29 to 0.14) | .57 |
| Urine loss on pad test, g per 24 h | |||||
| Baseline | 351 (180/171) | 6.67 (2.42 to 16.05) | 5.71 (2.52 to 17.66) | NA | |
| After 12-wk treatment | 319 (166/153) | 2.4 (1.16 to 5.82) | 2.52 (1.51 to 5.15) | −0.12 (−0.81 to 0.81) | .49 |
| At 1-y follow-up | 273 (142/131) | 2.75 (1.19 to 6.26) | 2.11 (1.10 to 4.86) | 0.64 (−0.14 to 1.42) | .92 |
| At 1-y follow-up (ITT) | 358 (183/175) | 2.97 (1.29 to 7.07) | 2.43 (1.24 to 5.59) | 0.54 (−0.22 to 1.38) | .85 |
| ICIQ-UI SFa | |||||
| Baseline | 361 (184/177) | 12.50 (10.00 to 14.00) | 12.00 (10.00 to 15.00) | NA | |
| After 12-wk treatment | 335 (171/164) | 6.00 (4.00 to 8.00) | 7.00 (4.75 to 10.00) | −1 (−2 to 0) | .02 |
| At 1-y follow-up | 314 (162/152) | 7.00 (5.00 to 10.00) | 6.00 (4.00 to 10.00) | 1 (−1 to 2) | .87 |
| At 1-y follow-up (ITT) | 362 (184/178) | 7.00 (5.00 to 11.00) | 7.00 (4.00 to 11.00) | 0 (−0.5 to 2) | .85 |
| ICIQ-LUTS QoLb | |||||
| Baseline | 358 (182/176) | 32.00 (28.00 to 38.00) | 32.00 (27.00 to 41.00) | NA | |
| After 12-wk treatment | 336 (171/165) | 24.00 (21.00 to 26.50) | 24.00 (21.00 to 27.00) | 0 (−2 to 1) | .39 |
| At 1-y follow-up | 314 (163/151) | 23.00 (21.00 to 27.00) | 23.00 (21.00 to 27.50) | 0 (−1 to 1) | .51 |
| At 1-y follow-up (ITT) | 361 (184/177) | 24.00 (21.00 to 27.00) | 23.00 (21.00 to 29.00) | 1 (−1 to 1.5) | .52 |
| Perceived benefit on PGI-I, No. (%)c | |||||
| After 12-wk treatment | 337 (171/166) | 164 (96) | 160 (96) | 0 (−4 to 4) | >.99 |
| At 1-y follow-up | 316 (163/153) | 138 (85) | 132 (86) | −1 (−9 to 7) | .88 |
| At 1-y follow-up (ITT) | 337 (171/166) | 146 (85) | 144 (87) | −2 (−9 to 5) | .91 |
| Satisfaction, No. (%)d | |||||
| After 12-wk treatment | 336 (171/165) | 160 (94) | 150 (91) | 3 (−3 to 9) | .48 |
| At 1-y follow-up | 317 (164/153) | 148 (90) | 139 (91) | −1 (−7 to 5) | >.99 |
| At 1-y follow-up (ITT) | 336 (171/165) | 154 (90) | 150 (91) | −1 (−7 to 5) | .94 |
Abbreviations: ICIQ-UI SF, International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form; ICIQ-LUTS QoL, International Consultation on Incontinence Modular Questionnaire-Lower Urinary Tract Symptoms Quality of Life; IQR, interquartile range; ITT, intention-to-treat; NA, not applicable; PFMT, pelvic floor muscle training; PGI-I, Patient Global Impression of Improvement.
Score range, 0 to 21; greater values indicate increased severity (minimal clinically important difference, 2.52 points).27
Score range, 19 to 76; greater values indicate a higher effect on quality of life (minimal clinically important difference, 3.71 points).27
Number of participants stating they are very much better or much better.
Number of participants stating they were satisfied (do not need another treatment) as opposed to unsatisfied (would like another treatment).