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)

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600716
• Other study ID #: 191622-117
• Status: Completed
• Phase: Phase 3
• Start date: June 13, 2012
• Est. completion date: March 27, 2015

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 27, 2015
• Est. primary completion date: April 4, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 3 episodes of urinary incontinence over a 3-day period

• History of Multiple Sclerosis (MS)

• Urinary incontinence not adequately controlled by anticholinergic medication

Exclusion Criteria:

• Current use of intermittent catheter or indwelling catheter to manage urinary incontinence

• Previous or current botulinum toxin therapy of any serotype for any urological condition

• Previous or current botulinum toxin therapy of any serotype for any non-urological condition within the last 12 weeks

• Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis

Related Conditions & MeSH terms

• Enuresis
• Multiple Sclerosis
• Neurogenic Bladder
• Sclerosis
• Urinary Bladder, Neurogenic
• Urinary Incontinence

Intervention

Biological:
• OnabotulinumtoxinA
OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm. After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection.

Drug:
• Placebo (Normal Saline)
Placebo (normal saline) is administered into the detrusor at Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  France,  Poland,  Portugal,  Russian Federation, 

References & Publications (1)

Tullman M, Chartier-Kastler E, Kohan A, Keppenne V, Brucker BM, Egerdie B, Mandle M, Nicandro JP, Jenkins B, Denys P. Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS. Neurology. 2018 Aug 14;91(7):e657-e665. doi: 10.1212/WNL.0000000000005991. Epub 2018 Jul 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of Treatment Effect Through Week 52	The duration of treatment effect is the time to patient request for retreatment.	Up to 52 Weeks
Primary	Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes	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, Week 6
Secondary	Change From Baseline in Maximum Cystometric Capacity (MCC)	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, Week 6
Secondary	Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)	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, Week 6
Secondary	Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score	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, Week 6