A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units Of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis

TerminadoFase 3ClinicalTrials.gov

ID: NCT02660359Tipo: INTERVENTIONALInicio: 8 de jul de 2016Fin estimado: 4 de jul de 2019

Neurología Gastroenterología Urología Traumatología y Ortopedia

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® 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).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

biological

Botulinum toxin type A

600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points.

biological

Botulinum toxin type A

800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

drug

Placebo

AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

drug

Placebo

AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

Ubicaciones

Instituto Urológico Buenos Aires

Buenos Aires, Argentina

Centro de Urologia

Buenos Aires, Argentina

Centro Urológico Profesor Bengió

Córdoba, Argentina

Hospital Privado - Centro Médico de Córdoba

Córdoba, Argentina

Instituto Médico Rodriguez Alfici

Godoy Cruz, Argentina

Patrocinadores

PrincipalIpsen

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