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

Ipsen82 sites in 11 countries258 target enrollmentJuly 8, 2016

ConditionsUrinary Incontinence Overactive Bladder

InterventionsBotulinum toxin type A Placebo

DrugsPlacebo

Overview

Phase: Phase 3
Intervention: Botulinum toxin type A
Conditions: Urinary Incontinence
Sponsor: Ipsen
Enrollment: 258
Locations: 82
Primary Endpoint: Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

July 8, 2016

End Date

July 4, 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

600 U Dysport® Group

Intervention: Botulinum toxin type A

600 U Dysport® Placebo Group

Intervention: Placebo

800 U Dysport® Group

Intervention: Botulinum toxin type A

800 U Dysport® Placebo Group

Intervention: Placebo

Outcomes

Primary Outcomes

Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle

Time Frame: Baseline and Week 6 of DBPC Cycle

The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The least square (LS) mean of the change in weekly number of UI episodes at 6 weeks after the first study treatment was calculated using a mixed model repeated measures (MMRM) analysis.

Secondary Outcomes

Mean Change From Baseline in Maximum Detrusor Pressure (MDP) During Storage at Week 6 of DBPC Cycle(Baseline and Week 6 of DBPC Cycle)
Percentage of Subjects With No Episodes of UI at Week 6 of DBPC Cycle(Baseline and Week 6 of DBPC Cycle)
Percentage of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle(Baseline and Week 6 of DBPC Cycle)
Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle(Baseline and Week 6 of DBPC Cycle)
Mean Change From Baseline in Volume at First Involuntary Detrusor Contraction (Vol@1stIDC) at Week 6 of DBPC Cycle(Baseline and Week 6 of DBPC Cycle)
Median Time Between Treatments(Day of first treatment (baseline) to day of retreatment, up to 2 years)
Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle(Baseline and Week 6 of DBPC Cycle)
Percentage of Subjects With No Involuntary Detrusor Contraction (IDCs) During Storage at Week 6 of DBPC Cycle(Baseline and Week 6 of DBPC Cycle)