Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)
CompletedPhase 3Results postedLast updated 30 April 2019
What this trial tests
Phase 3 trial testing OnabotulinumtoxinA in Urinary Incontinence in 144 participants. Completed in 27 March 2015.
18 and older, any sex, with Urinary Incontinence or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Daily Average Frequency of Urinary Incontinence EpisodesPrimary· Baseline, Week 6
Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).
Baseline
Group
Value
95% CI
OnabotulinumtoxinA
4.18
± 3.167
Placebo (Normal Saline)
4.32
± 2.422
Change from Baseline at Week 6
Group
Value
95% CI
OnabotulinumtoxinA
-3.34
± 2.881
Placebo (Normal Saline)
-1.10
± 2.083
Change From Baseline in Maximum Cystometric Capacity (MCC)Secondary· Baseline, Week 6
MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in the maximum volume of urine the bladder holds and a negative number change from baseline represents a worsening (decrease) in the maximum volume of urine the bladder holds.
Baseline
Group
Value
95% CI
OnabotulinumtoxinA
246.4
± 138.49
Placebo (Normal Saline)
245.7
± 133.90
Change from Baseline at Week 6 (N=62,72)
Group
Value
95% CI
OnabotulinumtoxinA
127.2
± 139.25
Placebo (Normal Saline)
-1.8
± 93.23
Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)Secondary· Baseline, Week 6
Maximum detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. A negative number change from baseline indicates an improvement in pressure and a positive number change from baseline indicates a worsening in pressure.
Baseline
Group
Value
95% CI
OnabotulinumtoxinA
35.9
± 34.90
Placebo (Normal Saline)
36.1
± 37.21
Change from Baseline at Week 6 (N=25,51)
Group
Value
95% CI
OnabotulinumtoxinA
-19.6
± 37.61
Placebo (Normal Saline)
3.7
± 33.24
Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary ScoreSecondary· Baseline, Week 6
The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement and a negative change from baseline represents a worsening.
Baseline
Group
Value
95% CI
OnabotulinumtoxinA
32.43
± 16.337
Placebo (Normal Saline)
34.24
± 21.163
Change from Baseline at Week 6 (N=55,68)
Group
Value
95% CI
OnabotulinumtoxinA
40.39
± 26.499
Placebo (Normal Saline)
9.92
± 15.863
Duration of Treatment Effect Through Week 52Secondary· Up to 52 Weeks
The duration of treatment effect is the time to patient request for retreatment.
Group
Value
95% CI
OnabotulinumtoxinA
51.7
36.9 – NA
Placebo (Normal Saline)
12.6
12.3 – 13.0
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 30 April 2019
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