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OnabotulinumtoxinA for Injection (Botox): For the Treatment of Overactive Bladder [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Jul.

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OnabotulinumtoxinA for Injection (Botox): For the Treatment of Overactive Bladder [Internet].

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APPENDIX 4DETAILED OUTCOME DATA

Bladder Activity: Micturition Episodes

Table 8Micturition Episodes

StudyTreatment
OutcomeOna A 100 UPlacebo
Mean daily frequency of micturition episodes
Study 191622-095abN = 280N = 277
Baseline, n280277
Baseline, mean (SD)11.98 (4.3)11.20 (3.1)
Week 12, n263258
Change from baseline at week 12, LS mean (95% CI)−2.01 (−2.39 to −1.64)−0.98 (−1.34 to −0.61)
LS mean difference (95% CI), P value versus placebo at week 12−1.04 (−1.48 to −0.59) P < 0.001ref
Study 191622-520abN = 277N = 271
Baseline, n277270
Baseline, mean (SD)12.01 (4.0)11.77 (3.6)
Week 12, n264260
Change from baseline at week 12, LS mean (95% CI)−2.35 (−2.74 to −1.96)−0.63 (−1.04 to −0.22)
LS mean difference (95% CI), P value versus placebo at week 12−1.72 (−2.19 to −1.26) P < 0.001ref
Study P030438N = 22N = 29
P values of MD at 90 days versus placeboP < 0.001ref
P values of MD at 180 days versus placeboNSref
Mean weekly frequency of micturition episodes
Study 191622-077aN = 54N = 44
Baseline, n5444
Baseline, mean (SD)80.3 (22.6)73.3 (23.0)
Week 12, n4839
Mean change from baseline at week 12 (SD)−21.7 (19.8)−8.3 (22.9)
MD (95% CI), P value versus placebo at week 12c−8.2 (−16.5 to 0.12) P = 0.053ref
Week 36, n4435
Mean change from baseline at week 36 (SD)−22.9 (17.5)−9.3 (26.5)
MD (95% CI), P value versus placebo at week 36c−8.2 (−16.4 to 0.0) P = 0.050ref

CI = confidence interval; LS = least squares; MD = mean difference; NS = not statistically significant; Ona A = onabotulinumtoxinA; ref = reference group; SD = standard deviation.

a

Intention-to-treat population; missing values were not imputed.

b

P values for between-treatment comparisons are from an analysis of covariance model with treatment group as factor, baseline value of micturition episodes, stratification factor and site as covariates.

c

P values are from pairwise contrasts from an analysis of covariance model with factors for treatment group and investigator, using baseline as a covariate.

Source: Study 191622-520 Clinical Study Report;20 Study 191622-095 Clinical Study Report;21 Study 191622-077 Clinical Study Report;22 Denys et al.19

Bladder Activity: Incontinence Episodes

Table 9Incontinence Episodes

StudyTreatment
OutcomeOna A 100 UPlacebo
Mean daily frequency of incontinence episodes
Study 191622-095aN = 280N = 277
Baseline, mean (SD)5.47 (3.6)5.09 (3.2)
Change from baseline at week 12, LS mean (95% CI)−2.52 (−2.91 to −2.12)−0.87 (−1.25 to −0.48)
LS mean difference (95% CI), P value versus placebo at week 12b−1.65 (−2.13 to −1.17) P < 0.001ref
Percentage of patients with ≥ 50% reduction in incontinence episodes at week 1257.5%28.9%
P value compared with placebocP < 0.001ref
Percentage of patients with ≥ 75% reduction in incontinence episodes at week 1244.6%15.2%
P value compared with placebocP < 0.001ref
Percentage of patients with 100% reduction in incontinence episodes at week 1222.9%6.5%
P value compared with placebocP < 0.001ref
Study 191622-520aN = 277N = 271
Baseline, mean (SD)5.52 (3.8)5.70 (3.9)
Change from baseline at week 12, LS mean (95% CI)−2.96 (−3.40 to −2.53)−1.05 (−1.50 to −0.60)
LS mean difference (95% CI), P value versus placebo at week 12b−1.91 (−2.43 to −1.39) P < 0.001ref
Percentage of patients with ≥ 50% reduction in incontinence episodes at week 1263.5%33.2%
P value compared with placebocP < 0.001ref
Percentage of patients with ≥ 75% reduction in incontinence episodes at week 1247.3%20.3%
P value compared with placebocP < 0.001ref
Percentage of patients with 100% reduction in incontinence episodes at week 1231.4%10.3%
P value compared with placebocP < 0.001ref
Study 191622-077NRNR
Study P030438NRNR

CI = confidence interval; LS = least squares; Ona A = onabotulinumtoxinA; ref = reference group; SD = standard deviation.

a

Intention-to-treat population; missing values were imputed using last observation carried forward method.

b

P values for between-treatment comparisons are from analysis of covariance model with treatment group as factor, baseline value of urinary-incontinence episodes, and site as covariates.

c

P values for between-treatment comparisons are based on Cochran–Mantel–Haenszel test with urinary urgency incontinence ≤ 9 or > 9 episodes at baseline as a stratification factor.

Source: Study 191622-520 Clinical Study Report;20 Study 191622-095 Clinical Study Report.21

Table 10Subgroup Analysis of Incontinence Episodes by Age

StudyAge < 65 yearsAge ≥ 65 years
TreatmentTreatment
OutcomeOna A 100 UPlaceboOna A 100 UPlacebo
Mean daily frequency of incontinence episodes
Study 191622-095aN = 159N = 160N = 121N = 117
Baseline, mean (SD)5.06 (3.4)4.86 (3.2)6.0 (3.8)5.4 (3.2)
Change from baseline at week 12, LS mean (95% CI)−2.38 (−2.93 to −1.82)−0.97 (−1.50 to −0.44)−2.40 (−2.95 to −1.85)−0.96 (−1.51 to −0.41)
LS mean difference (95% CI), P value versus placebo at week 12b−1.40 (−2.09 to −0.72) P < 0.001ref−1.44 (−2.19 to −0.69) P < 0.001ref
Study 191622-520aN = 153N = 163N = 124N = 108
Baseline, mean (SD)4.9 (3.3)5.1 (3.6)6.3 (4.1)6.5 (4.1)
Change from baseline at week 12, LS mean (95% CI)−2.50 (−3.06 to −1.94)−0.83 (−1.37 to −0.29)−3.46 (−4.18 to −2.74)−1.37 (−2.19 to −0.55)
LS mean difference (95% CI), P value versus placebo at week 12b−1.67 (−2.34 to −1.00) P < 0.001ref−2.09 (−3.10 to −1.09) P < 0.001ref
Study 191622-077NRNRNRNR
Study P030438NRNRNRNR

CI = confidence interval; LS = least squares; NR = not reported; Ona A = onabotulinumtoxinA; ref = reference group; SD = standard deviation.

a

Intention-to-treat population; missing values were imputed using last observation carried forward method.

b

P values for between-treatment comparisons are from analysis of covariance model with treatment group as factor, baseline value of urinary-incontinence episodes and site as covariates.

Source: Study 191622-520 Clinical Study Report;20 Study 191622-095 Clinical Study Report.21

Bladder Activity: Urge-Incontinence Episodes

Table 11Urge-Incontinence Episodes

   StudyTreatment
   OutcomeOna A 100 UPlacebo
Mean daily frequency of urge-incontinence episodes
Study 191622-095aN = 280N = 277
Baseline, n280277
Baseline, mean (SD)4.8 (3.2)4.5 (3.1)
Week 12, n263258
Change from baseline at week 12, LS mean (95% CI)−2.35 (−2.8 to −2.0)−0.69 (−1.1 to −0.3)
LS mean difference (95% CI), P value versus placebo at week 12b−1.66 (−2.1 to −1.2) P < 0.001ref
Percentage of patients with ≥ 50% reduction in urge-incontinence episodes at week 1261.2%29.1%
P value compared with placebocP < 0.001ref
Percentage of patients with ≥ 75% reduction in urge-incontinence episodes at week 1248.3%15.5%
P value compared with placebocP < 0.001ref
Percentage of patients with 100% reduction in urge-incontinence episodes at week 1228.9%7.8%
P value compared with placebocP < 0.001ref
Study 191622-520aN = 277N = 271
Baseline, n277271
Baseline, mean (SD)5.1 (3.7)5.2 (3.7)
Week 12, n264260
Change from baseline at week 12, LS mean (95% CI)−2.82 (−3.4 to −2.4)−0.85 (−2.1 to −0.7)
LS mean difference (95% CI), P value versus placebo at week 12b−1.97 (−2.5 to −1.5) P < 0.001ref
Percentage of patients with ≥ 50% reduction in urge-incontinence episodes at week 1264.8%31.5%
P value compared with placebocP < 0.001ref
Percentage of patients with ≥ 75% reduction in urge-incontinence episodes at week 1248.1%20.8%
P value compared with placebocP < 0.001ref
Percentage of patients with 100% reduction in urge-incontinence episodes at week 1231.8%13.1%
P value compared with placebocP < 0.001ref
   Study P030438dN = 20N = 28
Percentage of patients with ≥ 50% improvement in urgency and urge-incontinence episodes at month 365%29%
P value compared with placebo0.09ref
Percentage of patients with ≥ 75% improvement in urgency and urge-incontinence episodes at month 340%18%
P value compared with placebo0.06ref
Mean weekly frequency of urinary urge-incontinence episodes
Study 191622-077eN = 54N = 44
Baseline, mean (SD)27.8 (22.7)32.5 (20.2)
Mean change from baseline at week 12 (SD)−18.4 (20.2)−17.4 (18.2)
MD at week 12f−4.8 (−10.4 to 0.8) P = 0.094ref
Mean change from baseline at week 36 (SD)−18.5 (18.2)−17.9 (17.7)
MD at week 36f−4.7 (−10.0 to 0.7) P = 0.085ref
Percentage of patients with ≥ 50% reduction in urge-incontinence episodes at week 1270.4%52.3%
P value compared with placebogP = 0.07ref
Percentage of patients with ≥ 50% reduction in urge-incontinence episodes at week 3666.7%45.5%
P value compared with placebogP = 0.04ref
Percentage of patients with ≥ 75% reduction in urge-incontinence episodes at week 1255.6%36.4%
P value compared with placebogP = 0.06ref
Percentage of patients with ≥ 75% reduction in urge-incontinence episodes at week 3650.0%27.3%
P value compared with placebogP = 0.02ref
Percentage of patients with 100% reduction in urge-incontinence episodes at week 1237.0%15.9%
P value compared with placebogP = 0.02ref
Percentage of patients with 100% reduction in urge-incontinence episodes at week 3633.3%11.4%
P value compared with placebogP = 0.01ref

CI = confidence interval; LS = least squares; MD = mean difference; Ona A = onabotulinumtoxinA; ref = reference group; SD = standard deviation.

a

Intention-to-treat population; missing values were not imputed.

b

P values for between-treatment comparisons are from analysis of covariance model with treatment group as factor, baseline value of urinary urge-incontinence episodes and site as covariates.

C

P values for between-treatment comparisons are based on Cochran–Mantel–Haenszel test with urinary urge-incontinence ≤ 9 or > 9 episodes at baseline as a stratification factor.

d

Results include both urgency and urge urinary incontinence, calculated with the last observation carried forward.

e

Intention-to-treat population; missing values were imputed using last observation carried forward method.

f

P values are from pairwise contrasts from an analysis of covariance model with factors for treatment group and investigator, using baseline as a covariate.

g

Calculated by CADTH using Review Manager.

Source: Study 191622-520 Clinical Study Report;20 Study 191622-095 Clinical Study Report;21 Study 191622-077 Clinical Study Report;22 Denys et al.19

Bladder Activity: Nocturia Episodes

Table 12Nocturia Episodes

StudyTreatment
OutcomeOna A 100 UPlacebo
Mean daily frequency of nocturia episodes
Study 191622-095aN = 280N = 277
Baseline, n280277
Baseline, mean (SD)2.15 (1.5)2.01 (1.3)
Week 12, n263258
Change from baseline at week 12, LS mean (95% CI)−0.45 (−0.60 to −0.30)−0.25 (−0.40 to −0.10)
LS mean difference (95% CI), P value versus placebo at week 12b−0.20 (−0.38 to −0.02)
P = 0.029		ref
Study 191622-520aN = 277N = 271
Baseline, n277270
Baseline, mean (SD)2.19 (1.5)2.08 (1.5)
Week 12, n264260
Change from baseline at week 12, LS mean (95% CI)−0.46 (−0.69 to −0.31)−0.18 (−0.60 to 0.05)
LS mean difference (95% CI), P value versus placebo at week 12b−0.27 (−0.47 to −0.08)
P = 0.007		ref
Mean weekly frequency of nocturia episodes
Study 191622-077aN = 54N = 44
Baseline, n5444
Baseline, mean (SD)13.9 (6.9)12.3 (8.2)
Week 12, n4839
mean change from baseline at week 12 (SD)−4.1 (7.0)−0.3 (6.8)
MD (95% CI), P value versus placebo at week 12c−2.1 (−5.0 to 0.87)
P = 0.166		ref
Week 36, n4435
mean change from baseline at week 36 (SD)−4.1 (4.4)0.5 (9.2)
MD (95% CI), P value versus placebo at week 36c−2.3 (−5.6 to 1.0)
P = 0.172		ref
Study P030438NANA

CI = confidence interval; LS = least squares; MD = mean difference; NA = not applicable; Ona A = onabotulinumtoxinA; ref = reference group; SD = standard deviation.

a

Intention-to-treat population; missing values were not imputed.

b

P values for between-treatment comparisons are from analysis of covariance model with treatment group as factor, baseline value of nocturia episodes, and sites as covariates.

c

P values are from pairwise contrasts from an analysis of covariance model with factors for treatment group and investigator, using baseline as a covariate.

Source: Study 191622-520 Clinical Study Report;20 Study 191622-095 Clinical Study Report;21 Study 191622-077 Clinical Study Report.22

Bladder Activity: Urgency Episodes

Table 13Urgency Episodes

StudyTreatment
OutcomeOna A 100 UPlacebo
Mean daily frequency of urgency episodes
Study 191622-095aN = 280N = 277
Baseline, n280277
Baseline, mean (SD)8.54 (4.7)7.85 (3.7)
Week 12, n263258
Change from baseline at week 12, LS mean (95% CI)−2.76 (−3.30 to −2.23)−1.26 (−1.78 to −0.73)
LS mean difference (95% CI), P value versus placebo at week 12b−1.51 (−2.15 to −0.87)
P < 0.001		ref
Study 191622-520aN = 277N = 271
Baseline, n277270
Baseline, mean (SD)9.11 (4.6)8.78 (4.5)
Week 12, n264260
Change from baseline at week 12, LS mean (95% CI)−3.39 (−3.93 to −2.84)−0.95 (−1.52 to −0.37)
LS mean difference (95% CI), P value versus placebo at week 12b−2.44 (−3.09 to −1.79)
P < 0.001		ref
Study P030438N = 22N = 29
P values of MD at 90 days versus placeboNSref
P values of MD at 180 days versus placeboNSref
Mean weekly frequency of urgency episodes
Study 191622-077aN = 54N = 44
Baseline, n5444
Baseline, mean (SD)69.9 (28.2)62.0 (26.6)
Week 12, n4839
Mean change from baseline at week 12 (SD)−30.5 (27.6)−14.1 (30.2)
MD (95% CI), P value versus placebo at week 12c−11.7 (−23.0 to −0.4)
P = 0.043		ref
Week 36, n4435
Mean change from baseline at week 36 (SD)−30.1 (24.9)−15.1 (32.9)
MD (95% CI), P value versus placebo at week 36c−9.1 (−20.2 to 2.0)
P = 0.109		ref

CI = confidence interval; LS = least squares; MD = mean difference; NS = not statistically significant; Ona A = onabotulinumtoxinA; ref = reference group; SD = standard deviation.

a

Intention-to-treat population; missing values were not imputed.

b

P values for between-treatment comparisons are from analysis of covariance model with treatment group as factor, baseline value of urgency episodes, stratification factor, and site as covariates.

c

P values are from pairwise contrasts from an analysis of covariance model with factors for treatment group and investigator, using baseline as a covariate.

Source: Study 191622-520 Clinical Study Report;20 Study 191622-095 Clinical Study Report;21 Study 191622-077 Clinical Study Report;22 Denys et al.19

Bladder Activity: Time to Request and Qualify for Re-treatment

Table 14Time to Request and Qualify for Re-treatment and Proportion of Patients Who Requested Re-treatment

StudyTreatment
OutcomeOna A 100 UPlacebo
Study 191622-095N = 280N = 277
Patients who requested re-treatment, n (%)173 (61.8)223 (80.5)
Time to request for re-treatment
  Median (weeks)21.112.4
  95% CI for median (weeks)(18.3 to 24.0)(12.3 to 13.0)
  P value versus placeboaP < 0.001ref
Patients who received re-treatment, n (%)150 (53.6)222 (80.1)
Time to request for re-treatment
  Median (weeks)2412.6
  95% CI for median (weeks)(20.4 to 25.1)(12.3 to 13.1)
  P value versus placeboaP < 0.001ref
Study 191622-520N = 277N = 271
Patients who requested re-treatment, n (%)175 (63.2)229 (84.5)
Time to request for re-treatment
  Median (weeks)18.112.9
  95% CI for median (weeks)(17.4 to 22.9)(12.4 to 13.1)
  P value versus placeboaP < 0.001ref
Patients who received re-treatment, n (%)170 (61.4)227 (83.8)
Time to request for re-treatment
  Median (weeks)19.113.1
  95% CI for median (weeks)(18.1 to 24)(12.6 to 13.3)
  P value versus placeboaP < 0.001ref
Study 191622-077NANA
Study P030438NANA

CI = confidence interval; NA = not applicable; Ona A = onabotulinumtoxinA; ref = reference group.

a

P value is from stratified log-rank test with baseline urinary urge-incontinence episodes as stratification factor.

Source: Study 191622-520 Clinical Study Report;20 Study 191622-095 Clinical Study Report.21

Health-Related Quality of Life Data

Table 15Health-Related Quality of Life Outcomes (King’s Health Questionnaire)

StudyTreatment
OutcomeOna A 100 UPlacebo
KHQ — General Health Perception
Study 191622-095aN = 280N = 277
Baseline, n278276
Baseline, mean (SD)22.8 (19.1)23.4 (17.4)
Week 12, n263254
Change from baseline at week 12, LS mean0.9 (−1.3 to 3.1)2.3 (0.2 to 4.5)
LS mean difference (95% CI), P value versus placebo at week 12b−1.5 (−4.1 to 1.1) P = 0.271ref
Study 191622-520aN = 277N = 271
Baseline, n275270
Baseline, mean (SD)39.8 (24.9)41.3 (26.2)
Week 12, n262255
Change from baseline at week 12, LS mean−5.4 (−8.2 to −2.7)−0.4 (−3.3 to 2.4)
LS mean difference (95% CI), P value versus placebo at week 12b−5.0 (−8.3 to −1.7) P = 0.003ref
KHQ — Incontinence Impact
Study 191622-095aN = 280N = 277
Baseline, n278276
Baseline, mean (SD)81.1 (25.5)81.3 (24.1)
Week 12, n263254
Change from baseline at week 12, LS mean−18.8 (−23.2 to −14.5)−3.4 (−7.6 to 0.9)
LS mean difference (95% CI), P value versus placebo at week 12b−15.5 (−20.6 to −10.4) P < 0.001ref
Study 191622-520aN = 277N = 271
Baseline, n275270
Baseline, mean (SD)85.6 (23.6)85.6 (21.9)
Week 12, n262255
Change from baseline at week 12, LS mean (95% CI)−23.4 (−27.6 to −19.2)−8.5 (−12.9 to −4.2)
LS mean difference (95% CI), P value versus placebo at week 12b−14.9 (−19.9 to −9.9) P < 0.001ref
KHQ — Role Limitations
Study 191622-095cN = 280N = 277
Baseline, n278276
Baseline, mean (SD)61.2 (30.4)56.2 (30.1)
Week 12, n264254
Change from baseline at week 12, LS mean (95% CI)−22.1 (−26.3 to −17.9)−1.4 (−5.5 to 2.7)
LS mean difference (95% CI), P value versus placebo at week 12b−20.64 (−25.56 to −15.73) P < 0.001ref
Study 191622-520cN = 277N = 271
Baseline, n275270
Baseline, mean (SD)69.6 (26.8)66.4 (26.8)
Week 12, n262256
Change from baseline at week 12, LS mean (95% CI)−26.4 (−30.6 to −22.1)−6.6 (−11.0 to −2.2)
LS mean difference (95% CI), P value versus placebo at week 12b−19.8 (−24.8 to −14.7) P < 0.001ref
KHQ — Social Limitations
Study 191622-095cN = 280N = 277
Baseline, n278276
Baseline, mean (SD)40.5 (30.7)39.4 (30.1)
Week 12, n264254
Change from baseline at week 12, LS mean (95% CI)−15.8 (−19.4 to −12.2)−1.9 (−5.4 to 1.6)
LS mean difference (95% CI), P value versus placebo at week 12b−13.89 (−18.07 to −9.71) P < 0.001ref
Study 191622-520cN = 277N = 271
Baseline, n275270
Baseline, mean (SD)49.1 (31.5)45.4 (30.8)
Week 12, n262256
Change from baseline at week 12, LS mean (95% CI)−16.2 (−20.0 to −12.3)−3.0 (−7.0 to 1.0)
LS mean difference (95% CI), P value versus placebo at week 12b−13.2 (−17.8 to −8.6) P < 0.001ref
KHQ — Physical Limitations
Study 191622-095cN = 280N = 277
Baseline, n278276
Baseline, mean (SD)63.5 (29.3)60.3 (31.8)
Week 12, n264254
Change from baseline at week 12, LS mean (95% CI)−20.0 (−24.4 to −15.6)−5.1 (−9.4 to −0.8)
LS mean difference (95% CI), P value versus placebo at week 12b−14.9 (−20.1 to −9.8) P < 0.001ref
Study 191622-520cN = 277N = 271
Baseline, n275270
Baseline, mean (SD)70.5 (27.2)69.5 (27.1)
Week 12, n262256
Change from baseline at week 12, LS mean (95% CI)−22.2 (−26.4 to −18.1)−6.3 (−10.6 to −2.0)
LS mean difference (95% CI), P value versus placebo at week 12b−15.9 (−20.9 to −10.9) P < 0.001ref
KHQ — Personal Relationship
Study 191622-095cN = 280N = 277
Baseline, n203215
Baseline, mean (SD)35.0 (34.9)33.7 (35.2)
Week 12, n165190
Change from baseline at week 12, LS mean (95% CI)−11.2 (−15.6 to −6.8)1.9 (−2.2 to 6.0)
LS mean difference (95% CI), P value versus placebo at week 12b−13.1 (−18.4 to −7.7) P < 0.001ref
Study 191622-520cN = 277N = 271
Baseline, n214202
Baseline, mean (SD)40.7 (36.0)38.8 (36.5)
Week 12, n184171
Change from baseline at week 12, LS mean (95% CI)−10.2 (−14.8 to −5.5)−0.8 (−5.7 to 4.0)
LS mean difference (95% CI), P value versus placebo at week 12b−9.3 (−15.0 to −3.7) P = 0.001ref
KHQ — Emotions
Study 191622-095cN = 280N = 277
Baseline, n278276
Baseline, mean (SD)49.8 (31.5)49.9 (29.2)
Week 12, n264254
Change from baseline at week 12, LS mean (95% CI)−16.0 (−19.6 to −12.4)−3.4 (−6.9 to 0.1)
LS mean difference (95% CI), P value versus placebo at week 12b−12.6 (−16.8 to −8.4) P < 0.001ref
Study 191622-520cN = 277N = 271
Baseline, n275270
Baseline, mean (SD)62.4 (29.9)60.8 (28.4)
Week 12, n262256
Change from baseline at week 12, LS mean (95% CI)−19.4 (−23.1 to −15.6)−4.2 (−8.1 to −0.3)
LS mean difference (95% CI), P value versus placebo at week 12b−15.2 (−19.6 to −10.7) P < 0.001ref
KHQ — Sleep and Energy
Study 191622-095cN = 280N = 277
Baseline, n278276
Baseline, mean (SD)64.6 (26.1)65.6 (26.6)
Week 12, n264254
Change from baseline at week 12, LS mean (95% CI)−12.7 (−16.2 to −9.2)−2.2 (−5.6 to 1.2)
LS mean difference (95% CI), P value versus placebo at week 12b−10.5 (−14.5 to −6.4) P < 0.001ref
Study 191622-520cN = 277N = 271
Baseline, n275270
Baseline, mean (SD)64.8 (27.9)64.9 (26.6)
Week 12, n262256
Change from baseline at week 12, LS mean (95% CI)−19.1 (−22.3 to −15.8)−5.8 (−9.2 to −2.4)
LS mean difference (95% CI), P value versus placebo at week 12b−13.2 (−17.2 to −9.3) P < 0.001ref
KHQ — Severity Coping Measure
Study 191622-095cN = 280N = 277
Baseline, n278276
Baseline, mean (SD)64.9 (22.5)62.7 (23.0)
Week 12, n264254
Change from baseline at week 12, LS mean (95% CI)−18.5 (−21.7 to −15.3)−2.4 (−5.6 to 0.7)
LS mean difference (95% CI), P value versus placebo at week 12b−16.0 (−19.8 to −12.3) P < 0.001ref
Study 191622-520cN = 277N = 271
Baseline, n275270
Baseline, mean (SD)66.4 (23.2)66.5 (23.1)
Week 12, n262256
Change from baseline at week 12, LS mean (95% CI)−19.9 (−23.0 to −16.8)−3.9 (−7.1 to −0.7)
LS mean difference (95% CI), P value versus placebo at week 12b−16.0 (−19.7 to −12.3) P < 0.001ref
KHQ — Utility Score
Study 191622-095cN = 280N = 277
Baseline, n278276
Baseline, mean (SD)0.93 (0.024)0.93 (0.023)
Week 12, n264254
Change from baseline at week 12, LS mean (95% CI)0.02 (0.01 to 0.02)0.00 (−0.00 to 0.00)
LS mean difference (95% CI), P value versus placebo at week 12d0.0 (0.0 to 0.0) P < 0.001ref
Study 191622-520cN = 277N = 271
Baseline, n275270
Baseline, mean (SD)0.92 (0.023)0.93 (0.021)
Week 12, n262256
Change from baseline at week 12, LS mean (95% CI)0.02 (0.02 to 0.02)0.01 (0.00 to 0.01)
LS mean difference (95% CI), P value versus placebo at week 12d0.01 (0.01 to 0.02) P < 0.001ref
KHQ — Symptoms Component
Study 191622-077cN = 54N = 44
Baseline, n5443
Baseline, mean (SD)45.3 (14.1)42.1 (11.7)
Week 12, n4736
Mean change from baseline at week 12 (SD)−18.1 (18.0)−9.3 (17.7)
MD (95% CI), P value versus placebo at week 12e−9.0 (−15.8 to −2.3) P = 0.009ref
Week 36, n4436
Mean change from baseline at week 36 (SD)−11.0 (16.8)−8.7 (16.5)
MD (95% CI), P value versus placebo at week 36e−3.0 (−9.6 to 3.7) P = 0.379ref

CI = confidence interval; KHQ = King’s Health Questionnaire; LS = least squares; MD = mean difference; Ona A = onabotulinumtoxinA; ref = reference group; SD = standard deviation.

a

Intention-to-treat population; missing values were not imputed.

b

P values for between-treatment comparisons are from analysis of covariance model with treatment group as factor, baseline value of domain score, stratification factor, and site as covariates.

c

Intention-to-treat population; missing values were imputed if at least half of the items in the domain had non-missing responses.

d

P values for between-treatment comparisons are from analysis of covariance model with treatment group as factor, baseline value of utility score, stratification factor, and site as covariates.

e

P values are from pairwise contrasts from an analysis of covariance model with factors for treatment group and investigator, using baseline as a covariate.

Source: Study 191622-520 Clinical Study Report;20 Study 191622-095 Clinical Study Report;21 Study 191622-077 Clinical Study Report.22

Table 16Health-Related Quality of Life Outcomes (Incontinence Quality of Life Questionnaire)

StudyTreatment
OutcomeOna A 100 UPlacebo
I-QOL Total Summary Score
   Study 191622-095aN = 280N = 277
Baseline, n280277
Baseline, mean (SD)36.5 (20.6)37.3 (19.4)
Week 12, n266255
Change from baseline at week 12, LS mean (95% CI)19.8 (16.6 to 23.0)4.9 (1.7 to 8.1)
LS mean difference (95% CI), P value versus placebo at week 12b14.92 (11.13 to 18.71) P < 0.001ref
   Study 191622-520N = 277N = 271
Baseline, n274270
Baseline, mean (SD)31.7 (17.0)32.1 (17.2)
Week 12, n261254
Change from baseline at week 12, LS mean (95% CI)22.8 (19.8 to 25.9)5.9 (2.7 to 9.1)
LS mean difference (95% CI), P value versus placebo at week 12b16.9 (13.2 to 20.6) P < 0.001ref
   Study 191622-077aN = 54N = 44
Baseline, n5444
Baseline, mean (SD)34.3 (17.8)35.9 (19.8)
Week 12, n4638
Mean change from baseline at week 12 (SD)32.9 (25.7)17.9 (25.5)
MD (95% CI), P value versus placebo at week 12e14.8 (5.3 to 24.4) P = 0.002ref
Week 36, n4737
Mean change from baseline at week 36 (SD)27.7 (24.8)12.3 (25.3)
MD (95% CI), P value versus placebo at week 36e15.2 (4.6 to 25.7) P = 0.005ref
   Study P030438N = 22N = 29
P values of MD at 90 days versus placebo0.01 ≤ P < 0.05ref
P values of MD at 180 days versus placebo0.001 ≤ P < 0.05ref
I-QOL Avoidance and Limiting Behaviour
   Study 191622-095cN = 280N = 277
Baseline, n280277
Baseline, mean (SD)31.9 (18.22)31.9 (17.4)
Week 12, n266255
Change from baseline at week 12, LS mean (95% CI)22.2 (18.7 to 25.6)5.2 (1.9 to 8.6)
LS mean difference (95% CI), P value versus placebo at week 12d16.9 (12.9 to 21.0) P < 0.001ref
   Study 191622-520cN = 277N = 271
Baseline, n275271
Baseline, mean (SD)30.6 (15.9)31.4 (16.4)
Week 12, n262257
Change from baseline at week 12, LS mean (95% CI)23.1 (20.0 to 26.1)5.4 (2.2 to 8.5)
LS mean difference (95% CI), P value versus placebo at week 12d17.7 (14.0 to 21.4) P < 0.001ref
   Study 191622-077cN = 54N = 44
Baseline, n5444
Baseline, mean (SD)30.6 (15.1)32.0 (17.3)
Week 12, n4838
Mean change from baseline at week 12 (SD)34.7 (26.4)19.3 (26.7)
MD (95% CI), P value versus placebo at week 12e15.8 (5.8 to 25.9) P = 0.002ref
Week 36, n4737
Mean change from baseline at week 36 (SD)28.9 (26.7)13.0 (24.7)
MD (95% CI); P value versus placebo at week 36e17.2 (6.3 to 28.1) P = 0.002ref
   Study P030438N = 22N = 29
P values of MD at 90 days versus placebo0.01 ≤ P < 0.05ref
P values of MD at 180 days versus placebo0.01 ≤ P < 0.05ref
I-QOL Psychosocial Impact
   Study 191622-095cN = 280N = 277
Baseline, n280277
Baseline, mean (SD)46.6 (26.06)47.6 (24.18)
Week 12, n266255
Change from baseline at week 12, LS mean (95% CI)17.4 (14.2 to 20.6)4.1 (1.0 to 7.2)
LS mean difference (95% CI), P value versus placebo at week 12d13.3 (9.6 to 17.0) P < 0.001ref
   Study 191622-520cN = 277N = 271
Baseline, n275271
Baseline, mean (SD)37.9 (22.7)38.2 (22.4)
Week 12, n262257
Change from baseline at week 12, LS mean (95% CI)21.0 (17.8 to 24.2)5.8 (2.5 to 9.1)
LS mean difference (95% CI); P value versus placebo at week 12d15.2 (11.3 to 19.0) P < 0.001ref
   Study 191622-077cN = 54N = 44
Baseline, n5444
Baseline, mean (SD)42.3 (23.3)45.2 (26.2)
Week 12, n4838
Mean change from baseline at week 12 (SD)29.5 (23.9)14.5 (25.2)
MD (95% CI), P value versus placebo at week 12e14.6 (5.5 to 23.7) P = 0.002ref
Week 36, n4737
Mean change from baseline at week 36 (SD)25.3 (25.6)10.8 (28.4)
MD (95% CI), P value versus placebo at week 36e12.2 (1.5 to 22.9) P = 0.026ref
   Study P030438N = 22N = 29
P values of MD at 90 days versus placebo0.01 ≤ P < 0.05ref
P values of MD at 180 days versus placebo0.001 ≤ P < 0.05ref
I-QOL Social Embarrassment
   Study 191622-095cN = 280N = 277
Baseline, n280277
Baseline, mean (SD)25.7 (21.99)27.6 (21.87)
Week 12, n266255
Change from baseline at week 12, LS mean (95% CI)20.6 (16.9 to 24.3)5.7 (2.1 to 9.3)
LS mean difference (95% CI), P value versus placebo at week 12d14.9 (10.6 to 19.2) P < 0.001ref
   Study 191622-520cN = 277N = 271
Baseline, n275271
Baseline, mean (SD)23.0 (19.5)22.4 (19.9)
Week 12, n262257
Change from baseline at week 12, LS mean (95% CI)25.4 (21.9 to 28.8)6.2 (2.6 to 9.7)
LS mean difference (95% CI), P value versus placebo at week 12d19.2 (15.1 to 23.3) P < 0.001ref
   Study 191622-077cN = 54N = 44
Baseline, n5444
Baseline, mean (SD)25.7 (21.0)25.3 (23.0)
Week 12, n4838
Mean change from baseline at week 12 (SD)36.2 (31.3)21.8 (30.2)
MD (95% CI), P value versus placebo at week 12e15.4 (4.6 to 26.3) P = 0.005ref
Week 36, n4737
Mean change from baseline at week 36 (SD)30.0 (25.5)13.9 (26.7)
MD (95% CI), P value versus placebo at week 36e17.1 (5.6 to 28.6) P = 0.004ref
   Study P030438N = 22N = 29
P values of MD at 90 days versus placeboNSref
P values of MD at 180 days versus placebo0.001 ≤ P < 0.05ref

CI = confidence interval; I-QOL = Incontinence Quality of Life Questionnaire; LS = least squares; MD = mean difference; NS = not statistically significant; Ona A = onabotulinumtoxinA; ref = reference group; SD = standard deviation.

a

Intention-to-treat population; missing values were imputed if three or fewer items were missing.

b

P values for between-treatment comparisons are from analysis of covariance model with treatment group as factor, baseline value of I-QOL, stratification factor, and site as covariates.

c

Intention-to-treat population; missing values were not imputed.

d

P values for between-treatment comparisons are from analysis of covariance model with treatment group as factor, baseline value, stratification factor, and site as covariates.

e

P values are from pairwise contrasts from an analysis of covariance model with factors for treatment group and investigator, using baseline as a covariate.

Source: Study 191622-520 Clinical Study Report;20 Study 191622-095 Clinical Study Report;21 Study 191622-077 Clinical Study Report;22 Denys et al.19

Table 17Health-Related Quality of Life Outcomes (12-Item Short-Form Health Survey)

StudyTreatment
OutcomeOna A 100 UPlacebo
SF-12 Physical Component Summary score
   Study 191622-095aN = 280N = 277
Baseline, n280274
Baseline, mean (SD)44.0 (10.4)43.7 (9.8)
week 12, n265251
Change from baseline at week 12, LS mean (95% CI)1.2 (0.0 to 2.4)0.0 (−1.2 to 1.2)
LS mean difference (95% CI), P value versus placebo at week 12b1.2 (−0.2 to 2.6) P = 0.091ref
   Study 191622-520aN = 277N = 271
Baseline, n274268
Baseline, mean (SD)42.8 (9.9)42.3 (9.9)
week 12, n259254
Change from baseline at week 12, LS mean (95% CI)1.7 (0.6 to 2.9)0.5 (−0.7 to 1.7)
LS mean difference (95% CI), P value versus placebo at week 12b1.2 (−0.1 to 2.6) P = 0.077ref
SF-12 Mental Component Summary Score
   Study 191622-095aN = 280N = 277
Baseline, n280274
Baseline, mean (SD)45.3 (11.7)46.5 (11.0)
week 12, n265251
Change from baseline at week 12, LS mean (95% CI)1.0 (−0.4 to 2.5)−1.6 (−3.0 to −0.2)
LS mean difference (95% CI), P value versus placebo at week 12b2.6 (0.9 to 4.3) P = 0.002ref
   Study 191622-520aN = 277N = 271
Baseline, n274268
Baseline, mean (SD)39.5 (11.9)41.4 (12.0)
week 12, n259254
Change from baseline at week 12, LS mean (95% CI)4.5 (3.1 to 5.8)0.9 (−0.5 to 2.3)
LS mean difference (95% CI), P value versus placebo at week 12b3.6 (2.0 to 5.1) P < 0.001ref
SF-12 Utility Score
   Study 191622-095aN = 280N = 277
Baseline, n280274
Baseline, mean (SD)0.68 (0.130)0.69 (0.122)
week 12, n265251
Change from baseline at week 12, LS mean (95% CI)0.01 (−0.00 to 0.03)−0.01 (−0.02 to 0.01)
LS mean difference (95% CI), P value versus placebo at week 12b0.0 (0.0 to 0.0) P = 0.024ref
   Study 191622-520aN = 277N = 271
Baseline, n274268
Baseline, mean (SD)0.63 (0.124)0.64 (0.124)
week 12, n260254
Change from baseline at week 12, LS mean (95% CI)0.05 (0.03 to 0.06)0.01 (−0.00 to 0.03)
LS mean difference (95% CI), P value versus placebo at week 12b0.04 (0.02 to 0.05) P < 0.001ref
   Study 191622-077NANA
   Study P030438NANA

CI = confidence interval; LS = least squares; MD = mean difference; NA = not applicable; Ona A = onabotulinumtoxinA; ref = reference group; SD = standard deviation; SF-12 = 12-Item Short-Form Health Survey.

a

Intention-to-treat population; missing values were not imputed.

b

P values for between-treatment comparisons are from analysis of covariance model with treatment group as factor, baseline value, stratification factor, and site as covariates.

Source: Study 191622-520 Clinical Study Report;20 Study 191622-095 Clinical Study Report.21

Table 18Health-Related Quality of Life Outcomes (EQ-VAS)

   StudyTreatment
   OutcomeOna A 100 UPlacebo
   Study 191622-077aN = 54N = 44
Baseline, n5343
Baseline, mean (SD)71.4 (22.6)74.3 (19.9)
Week 36, n4741
Mean change from baseline at week 36 (SD)−1.7 (16.6)−1.3 (17.1)
MD (95% CI), P value versus placebo at week 36b2.7 (−3.6, 8.9) P = 0.406ref
   Study P030438N = 22N = 29
P values of MD at 90 days versus placebo0.01 ≤ P < 0.05ref
P values of MD at 180 days versus placeboNSref

CI = confidence interval; EQ-VAS = European Quality of Life Scale Visual Analogue Scale; MD = mean difference; NS = not statistically significant; Ona A = onabotulinumtoxinA; ref = reference group; SD = standard deviation.

a

Intention-to-treat population; missing values were not imputed.

b

P values are from pairwise contrasts from an analysis of covariance model with factors for treatment group and investigator, using baseline as a covariate.

Source: Study 191622-077 Clinical Study Report;22 Denys et al.19

Copyright © CADTH 2015.

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