Table 2.
Quality of life outcomes of the clinical responder population
| Table 2A – Quantitative quality of life outcomes over 6–24 mo | ||||
|---|---|---|---|---|
| Outcome | BTX (n = 159) | SNM (n = 139) | Treatment difference (95% CI) | p value |
| Overactive Bladder Short Form Questionnaire change from baseline, adjusted mean (Std Err) | ||||
| OABq SFa | ||||
| Symptom bother | ||||
| 6 mo | −51.9(1.9) | −44.5(2.1) | 7.4(2.3–12.6) | 0.005 |
| 12 mo | −39.1(2.1) | −39.5(2.2) | −0.4(−6.1–5.3) | 0.9 |
| 24 mo | −33.9(2.1) | −36.2(2.2) | −2.3(−8.0–3.4) | 0.4 |
| Overall | −41.6(1.9) | −40.1(2.1) | 1.6(−3.5–6.7) | 0.5 |
| Quality of life | ||||
| 6 mo | 46.4(1.9) | 44.8(2.1) | −1.6(−6.8–3.6) | 0.5 |
| 12 mo | 36.9(2.0) | 41.5(2.2) | 4.6(−0.9–10.1) | 0.1 |
| 24 mo | 34.3(2.0) | 38.9(2.2) | 4.6(−0.9–10.2) | 0.1 |
| Overall | 39.2(1.9) | 41.7(2.1) | 2.5(−2.6–7.7) | 0.3 |
| Overactive Bladder Satisfaction Short Form Questionnaireb, adjusted mean (Std Err) | ||||
| Treatment satisfaction | ||||
| 6 mo | 73.5(2.3) | 64.9(2.5) | −8.7(−15.0– −2.4) | 0.007 |
| 12 mo | 67.8(2.2) | 58.3(2.5) | −9.6(−15.7– −3.4) | 0.002 |
| 24 mo | 62.8(2.2) | 53.6(2.4) | −9.2(−15.4– −3.0) | 0.004 |
| Overall | 68.1(1.9) | 58.9(2.1) | −9.1(−14.4– −3.9) | <0.001 |
| Side effects | ||||
| 6 mo | 89.5(2.0) | 85.0(2.1) | −4.5(−10.0–1.0) | 0.1 |
| 12 mo | 85.8(1.9) | 84.2(2.1) | −1.6(−7.0–3.7) | 0.5 |
| 24 mo | 85.9(1.9) | 80.9(2.1) | −5.0(−10.3–0.3) | 0.07 |
| Overall | 87.1(1.5) | 83.4(1.7) | −3.7(−7.8–0.4) | 0.08 |
| Endorsement | ||||
| 6 mo | 84.1(2.4) | 74.0(2.6) | −10.2(−16.8– −3.6) | 0.003 |
| 12 mo | 79.0(2.3) | 64.0(2.6) | −15.1(−21.5– −8.6) | <0.001 |
| 24 mo | 71.8(2.3) | 60.6(2.6) | −11.3(−17.7– −4.8) | <0.001 |
| Overall | 78.3(2.0) | 66.2(2.2) | −12.2(−17.7– −6.6) | <0.001 |
| Convenience | ||||
| 6 mo | 70.4(2.2) | 72.5(2.4) | 2.1(−4.0–8.2) | 0.5 |
| 12 mo | 68.0(2.1) | 65.2(2.3) | −2.8(−8.6–3.1) | 0.4 |
| 24 mo | 65.5(2.1) | 66.8(2.3) | 1.3(−4.5–7.2) | 0.7 |
| Overall | 68.0(1.6) | 68.2(1.8) | 0.2(−4.2–4.6) | 0.9 |
| Urinary Distress Inventory and Incontinence Impact Questionnaires change from baseline, adjusted mean (Std Err) | ||||
| UDI SFc total score | ||||
| 6 mo | −26.3(2.1) | −23.6(2.3) | 2.7(−3.2–8.5) | 0.4 |
| 12 mo | −20.1(2.1) | −22.8(2.3) | −2.6(−8.4–3.1) | 0.4 |
| 24 mo | −18.9(2.1) | −20.0(2.3) | −1.1(−6.9–4.6) | 0.7 |
| Overall | −21.8(1.8) | −22.1(2.0) | −0.4(−5.2–4.5) | 0.9 |
| IIQ SFd Total Score | ||||
| 6 mo | −31.2(2.3) | −29.6(2.6) | 1.6(−4.8–8.1) | 0.6 |
| 12 mo | −28.4(2.3) | −33.1(2.5) | −4.7(−11.0–1.6) | 0.1 |
| 24 mo | −26.3(2.3) | −28.8(2.5) | −2.5(−8.8–3.8) | 0.4 |
| Overall | −28.6(2.1) | −30.5(2.3) | −1.9(7.5–3.7) | 0.5 |
| Table 2B – Categorical quality of life outcomes over 6–24 mo | ||||
| Patient Global Impression of Improvement and Treatment Preferencee at each time point, n (%) | ||||
| PGI-I | ||||
| Urinary leakage | ||||
| 6 mo | 93 (77) | 81 (75) | −1.0(−12.6–10.5) | 0.9 |
| 12 mo | 96 (70) | 76 (69) | 0.5(−11.0–12.0) | 0.9 |
| 24 mo | 83 (62) | 70 (61) | −4.7(−16.9–7.4) | 0.4 |
| Bladder function | ||||
| 6 mo | 93 (76) | 83 (78) | 2.9(−8.5–14.3) | 0.6 |
| 12 mo | 94 (68) | 76 (68) | 0.4(−11.2–12.0) | 0.9 |
| 24 mo | 88 (67) | 68 (59) | −10.5(−22.5–1.4) | 0.08 |
| OAB SATq SF | ||||
| Treatment preference | ||||
| 6 mo | 103 (95) | 80 (93) | −2.7(−10.1–4.6) | 0.5 |
| 12 mo | 109 (94) | 81 (93) | −2.0(−9.2–5.2) | 0.6 |
| 24 mo | 93 (95) | 77 (87) | −9.9(−18.5– −1.2) | 0.02 |
| Patient Global Symptom Controlf value of 3 or greater of five-point agreement scale, n (%) | ||||
| Adequate leakage control | ||||
| 6 mo | 113 (72) | 106 (78) | 0.2 | |
| 12 mo | 101 (66) | 98 (73) | 0.2 | |
| 24 mo | 89 (62) | 88 (67) | 0.2 | |
| Sandvik four-level severity index at each time point, n (%) | ||||
| 6 mo | 0.5 | |||
| Slight | 29 (28) | 21 (21) | ||
| Moderate | 30 (29) | 31 (31) | ||
| Severe | 20 (19) | 17 (17) | ||
| Very severe | 26 (25) | 30 (30) | ||
| 12 mo | 0.1 | |||
| Slight | 25 (19) | 17 (16) | ||
| Moderate | 52 (39) | 38 (35) | ||
| Severe | 23 (17) | 22 (20) | ||
| Very severe | 32 (24) | 32 (29) | ||
| 24 mo | 0.2 | |||
| Slight | 25 (20) | 18 (16) | ||
| Moderate | 45 (35) | 32 (29) | ||
| Severe | 21 (17) | 24 (21) | ||
| Very severe | 36 (28) | 38 (34) | ||
BTX = onabotulinumtoxinA; CI = confidence interval; IIQ-SF = Incontinence Impact Questionnaire short form; OAB-SATq = Overactive Bladder Satisfaction questionnaire; OAB-SF = Overactive Bladder Questionnaire Short Form; PGI-I = Patient Global Impression of Improvement; PGSC = Patient Global Symptom Control; SNM = sacral neuromodulation; UDI-SF = Urinary Distress Inventory short form.
Values for the Overactive Bladder Questionnaire Short Form (OAB-SF) range from 0 to 100, with higher scores on the symptom severity scale indicating greater severity of symptoms and higher scores on the quality-of-life scale indicating better quality of life.
Values for the Overactive Bladder Satisfaction questionnaire (OAB-SATq) range from 0 to 100 and includes five subscales; treatment satisfaction, side effects, treatment endorsement, convenience, and preference, with higher scores reflecting better satisfaction.
The Urinary Distress Inventory short form (UDI-SF) scale has a range of 0 to 100, with higher scores representing a worse outcome.
The Incontinence Impact Questionnaire short form (IIQ-SF) scale has a range of 0 to 100, with higher scores representing a worse outcome.
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 Patient Global Symptom Control (PGSC) is a patient reported measure of perceived symptom control with treatment on a scale of 1 (disagree strongly) and 5 (agree strongly). Included here are participants who had adequate symptom control, defined as a rating of 3,4,5