Vanderbilt Clinical Trials

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

Purpose

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).

Conditions

Urinary Incontinence
Overactive Bladder

Eligibility

Eligible Ages: Between 18 Years and 80 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental 600 U Dysport® Group		Biological: Botulinum toxin type A 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points Other names: AbobotulinumtoxinA (Dysport®) Clostridium BTX-A-haemagglutinin complex
Placebo Comparator 600 U Dysport® Placebo Group		Drug: Placebo AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Experimental 800 U Dysport® Group		Biological: Botulinum toxin type A 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points Other names: AbobotulinumtoxinA (Dysport®) Clostridium BTX-A-haemagglutinin complex
Placebo Comparator 800 U Dysport® Placebo Group		Drug: Placebo AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

More Details

Status: Terminated
Sponsor: Ipsen

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.