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OnabotulinumtoxinA for Urinary Incontinence from Neurogenic Detrusor Overactivity

OnabotulinumtoxinA for Urinary Incontinence from Neurogenic Detrusor Overactivity. Study Design. 416 patients (227 MS; 189 spinal cord injury) with neurogenic detrusor overactivity and urinary incontinence (UI)

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OnabotulinumtoxinA for Urinary Incontinence from Neurogenic Detrusor Overactivity

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  1. OnabotulinumtoxinAfor Urinary Incontinence from Neurogenic Detrusor Overactivity

  2. Study Design • 416 patients (227 MS; 189 spinal cord injury) with neurogenic detrusor overactivity and urinary incontinence (UI) • Randomized 1:1:1 to placebo, 200 U onabotulinumtoxinA, or 300 U onabotulinumtoxinA • Primary endpoints (assessed at 6 weeks) • Change from baseline in the number of weekly episodes of UI • Decrease in weekly UI episodes from baseline, categorized as ≥50%, ≥75%, and 100%, or dry • Secondary endpoints (assessed at 6 weeks) • Maximum cystometric capacity • Maximum detrusor pressure during the first involuntary detrusor pressure • Incontinence quality of life total summary score Ginsberg D, et al. J Urol. 2012;187:2131-2139.

  3. Urinary IncontinenceChange from Baseline at Week 6* OnabotulinumtoxinA200 U(n = 135) OnabotulinumtoxinA300 U(n = 132) Placebo(n = 149) -30% 38% 10% -67% 75%† 36%† -74% 77%† 41%† Change from baseline in UI episodes Patients attaining ≥50% reduction in weekly UI Patients achieving dry status *MS and spinal cord injury patients combined; similar results seen in both subpopulations. †P <.001 vs placebo. Abbreviation: UI, urinary incontinence. Ginsberg D, et al. J Urol. 2012;187:2131-2139.

  4. Urologic and Quality of Life ParametersChange from Baseline at Week 6* OnabotulinumtoxinA200 U(n = 135) OnabotulinumtoxinA300 U(n = 132) Placebo(n = 149) Urinary incontinence(no. per wk.) Maximum cystometriccapacity (mL) Maximum detrusorpressure at firstIDC (H2O) Incontinence quality of life total summary score‡ -8.816-2.4 10.8 -21.0†151†-35.1† 26.9† -22.7†168†-33.3† 32.9† *MS and SCI patients combined; similar results seen in both subpopulations. †P<.05 vs placebo. ‡Higher scores indicate improvement. Abbreviation: IDC, involuntary detrusorcontraction. Ginsberg D, et al. J Urol. 2012;187:2131-2139.

  5. Urologic and Quality of Life Parameters in MS PatientsChange from Baseline at Week 6 OnabotulinumtoxinA200 U(n = 77) OnabotulinumtoxinA300 U(n = 69) Placebo(n = 81) Urinary incontinence(no. per wk.) Maximum cystometriccapacity (mL) Maximum detrusorpressure at firstIDC (cm H2O) Incontinence quality of life total summary score† -11.5 -7.5 12.1 12.4 -20.4 142* -28.4* 28.0* -23.8* 162* -29.0* 38.3* *P <.05 vs placebo. †Higher scores indicate improvement. Abbreviation: IDC, involuntary detrusorcontraction. Ginsberg D, et al. J Urol. 2012;187:2131-2139.

  6. Patients with Urinary Retention and Urinary Tract Infections OnabotulinumtoxinA200 U OnabotulinumtoxinA300 U Placebo Urinary retentionMS patientsSCI patients Urinary tract infection MS patients SCI patients 4 (5%)1 (2%) 22 (28%)27 (42%) 22 (29%)5 (9%) 38 (50%)28 (48%) 19 (28%)4 (5%) 34 (51%)30 (50%) Abbreviations: MS, multiple sclerosis; SCI, spinal cord injury. Ginsberg D, et al. J Urol. 2012;187:2131-2139.

  7. Postvoid Residual at Week 2* OnabotulinumtoxinA200 U(n = 60) OnabotulinumtoxinA300 U(n = 55) Placebo(n = 58) 7 ± 55 4 106 ± 165† 32 169 ± 300† 36 Mean change (mL) % patients withpostvoid residual≥200 mL *MS and spinal cord injury patients combined. †P =.004. Ginsberg D, et al. J Urol. 2012;187:2131-2139.

  8. Patients Initiating Intermittent Catheterization DuringTreatment Cycle 1* OnabotulinumtoxinA200 U(n = 60) OnabotulinumtoxinA300 U(n = 55) Placebo(n = 58) 13 (22%) 6 (10%) 28 (47%) 21 (35%) 27 (49%) 23 (42%) Any reason Urinaryretention *Patients with no intermittent catheterization at baseline; MS and spinal cord injury patients combined. Ginsberg D, et al. J Urol. 2012;187:2131-2139.

  9. Take-Home Messages • Neurogenic detrusor overactivity (NDO) and related incontinence symptoms seriously impact the quality of life of many MS patients, but may not always be recognized by clinicians; therefore, all patients should be screened for these issues • Anticholinergics are the initial treatment for NDO-related urinary incontinence, but if they fail, other very effective options are available, including onabotulinumtoxinA • Depending on the individual, treatment with onabotulinumtoxinAmay require intermittentself-catheterization

  10. Take-Home Messages • Results with onabotulinumtoxinA last 10 months, which compares very favorably with use in other indications. • Although onabotulinumtoxinA is indicated only for those who have failed or cannot tolerate anticholinergics, it is more effective than anticholinergics and is without the problematic side effects, such as dry mouth (and associated tooth decay), constipation, and cognitive effects, that can accompany anticholinergics

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