Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1 (CONTENT1)

Ipsen

Status and phase: Terminated; Phase 3

Conditions: Urinary Incontinence; Overactive Bladder

Treatments: Biological: Botulinum toxin type A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02660138

D-FR-52120-222

2015-003471-30 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).

Enrollment: 227 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Urinary Incontinence for at least 3 months prior to Screening as a result of Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis.
• Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening.
• Subjects with Multiple Sclerosis must be clinically stable in the investigator's opinion, with no exacerbation (relapse) of MS for at least 3 months prior to Screening.
• Subjects must have had an inadequate response after at least 4 weeks of oral medications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists) and/or have intolerable side-effects.
• Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequate bladder emptying.
• An average of at least two episodes per day of Urinary Incontinence recorded on the screening bladder diary.

Key Exclusion Criteria:

• Any current condition (other than NDO) that may impact on bladder function.
• Previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other unstable cause of SCI.
• Any condition that will prevent cystoscopic treatment administration or CIC usage, e.g. urethral strictures.
• Current indwelling bladder catheter, or removal of indwelling bladder catheter less than 4 weeks prior to Screening.
• BTX-A treatment within 9 months prior to Screening for any urological condition (e.g. detrusor or urethral sphincter treatments).
• Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within 4 weeks prior to Screening. Any implanted neuromodulation device must be switched off at least 4 weeks prior to Screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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227 participants in 4 patient groups, including a placebo group

600 U Dysport® Group

Experimental group

Treatment:

Biological: Botulinum toxin type A

600 U Dysport® Placebo Group

Placebo Comparator group

Treatment:

Drug: Placebo

800 U Dysport® Group

Experimental group

Treatment:

Biological: Botulinum toxin type A

800 U Dysport® Placebo Group

Placebo Comparator group

Treatment:

Drug: Placebo