Table 2.
Efficacy and Quality of Life Outcomes of Intention-to-Treat Population at 6 Months
| Outcomes | OnabotulinumtoxinA (n = 190) | Sacral Neuromodulation (n = 174) | Treatment Group Difference (95% CI) | P Value |
|---|---|---|---|---|
| Change in mean daily urgency urinary incontinence episodes, adjusted mean (95% CI)a | −3.89 (−4.26 to −3.52) | −3.25 (−3.64 to −2.87) | 0.63 (0.13 to 1.14) | .01 |
| Resolution of Urinary Incontinence, No./Total (%)b | ||||
| ≥4 mo of diaries completed | ||||
| Complete resolution | 35/178 (20) | 6/166 (4) | −16 (−26 to −5) | <.001 |
| ≥75% reduction | 81/178 (46) | 43/166 (26) | −20 (−30 to −9) | <.001 |
| ≥50% reduction | 109/178 (61) | 84/166 (51) | −11 (−21 to 0) | .06 |
| All 6 mo of diaries completedb | ||||
| Complete resolution | 26/127 (20) | 2/99 (2) | −18 (−31 to −5) | <.001 |
| ≥75% reduction | 63/127 (50) | 27/99 (27) | −22 (−35 to −9) | .004 |
| ≥50% reduction | 85/127 (67) | 51/99 (52) | −15 (−28 to −2) | .05 |
| Change From Baseline in Urinary Incontinence, Adjusted Mean (95% CI)a | ||||
| Any | −4.02 (−4.44 to −3.61) | −3.50 (−3.94 to −3.06) | 0.52 (−0.04 to 1.09) | .07 |
| Nocturia | −0.40 (−0.56 to −0.24) | −0.26 (−0.43 to −0.10) | 0.13 (−0.08 to 0.35) | .22 |
| Voids | −1.12 (−1.53 to −0.70) | −0.84 (−1.28 to −0.41) | 0.28 (−0.29 to 0.84) | .34 |
| Pads/d | −2.02 (−2.31 to −1.73) | −1.64 (−1.94 to −1.34) | 0.38 (−0.01 to 0.77) | .06 |
| Overactive Bladder Questionnaire Change From Baseline, Adjusted Mean (95% CI) | ||||
| Questionnaire SF | ||||
| Symptom bother | −46.7 (−50.5 to −43.0) | −38.6 (−42.5 to −34.6) | 8.1 (3.0 to 13.3) | .002 |
| Quality of life | 41.6 (37.9 to 45.4) | 38.1 (34.1 to 42.0) | −3.6 (−8.7 to 1.5) | .17 |
| Satisfaction Questionnairec | ||||
| Treatment satisfaction | 67.7 (63.2 to 72.1) | 59.8 (55.0 to 64.7) | 7.8 (1.6 to 14.1) | .01 |
| Adverse effects | 88.4 (84.7 to 92.2) | 85.1 (81.1 to 89.2) | 3.3 (−1.9 to 8.5) | .22 |
| Endorsement | 78.1 (73.7 to 82.4) | 67.6 (62.9 to 72.3) | 10.4 (4.3 to 16.5) | <.001 |
| Convenience | 67.6 (63.7 to 71.6) | 70.2 (65.8 to 74.5) | −2.5 (−8.1 to 3.0) | .36 |
| Treatment preference, No. (%)d | 113 (92) | 89 (89) | −3 (−16 to 10) | .49 |
| Score at 6 Months, No. (%) | ||||
| PGI-Ie | ||||
| Urinary leakage | 101 (71) | 91 (68) | −2 (−14 to 10) | .82 |
| Bladder function | 100 (68) | 92 (70) | 2 (−10 to 13) | .54 |
| Sandvikf | .14 | |||
| Slight | 29 (23) | 23 (19) | ||
| Moderate | 33 (26) | 33 (27) | ||
| Severe | 28 (22) | 24 (19) | ||
| Very severe | 36 (29) | 44 (35) | ||
| Change From Baseline, Adjusted Mean (95% CI) | ||||
| Urinary Distress Inventory SFg | −10.0 (−12.2 to −7.8) | −8.6 (−10.9 to −6.3) | −1.4 (−4.4 to 1.6) | .36 |
| Incontinence Impact SFh | −12.4 (−14.9 to −9.9) | −10.4 (−13.0 to −7.8) | −2.0 (−5.4 to 1.4) | .25 |
| Health Utility Index 3i | −0.011 (−0.028 to 0.007) | −0.006 (−0.025 to 0.013) | −0.005 (−0.029 to 0.020) | .72 |
Abbreviations: PGI-I, Patient Global Impression of Improvement; SF, Short Form.
Values for any urinary incontinence, urgency urinary incontinence, nocturia, voids are based on mean number of episodes per day on a 3-day diary captured monthly and are generated from model-based estimates. The adjusted models controlled for the stratification variables of age and clinical site.
Represents individuals who had this degree of improvement on all their diaries.
Values for the Overactive Bladder Satisfaction questionnaire range from 0–100 and includes 5 subscales; treatment satisfaction, side effects, treatment endorsement, convenience, and patient preference, with higher scores reflecting better satisfaction.
Treatment preference is a binary outcome that is classified as yes if a participant answers either “Slight preference for the treatment I am receiving now” or “Definitely prefer the treatment I am receiving now” to the question: “Do you prefer the treatment that you received since entering this study to the treatment you received before the study?” from the Overactive Bladder Questionnaire SF.
The Patient Global Impression of Improvement (PGI-I) is a patient reported measure of perceived improvement with treatment on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had adequate improvement, defined as a rating of 1, 2 or 3 (better).
The Sandvik scale has a range of 1–12, with higher scores representing worse outcomes.
The Urinary Distress Inventory short form (UDI-SF) scale has a range of 0–100, with higher scores indicating greater distress.
The Incontinence Impact Questionnaire short form (IIQ-SF) scale has a range of 0–100, with higher scores representing a worse quality of life.
The Health Utility Index, Version 3 (HUI 3) scale has a range of 0–1, with higher scores representing better health.