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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02660138
• Date of registration: 14/01/2016
• Prospective Registration: Yes
• Primary sponsor: Ipsen
• Public title: Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1 CONTENT1
• Scientific title: 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
• Date of first enrolment: March 2016
• Target sample size: 227
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02660138
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Canada, Czech Republic, Czechia, Italy, Korea, Republic of, Malaysia, Netherlands, Poland, Portugal, Romania, Turkey, United States

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Overactive Bladder

Urinary Incontinence

Intervention(s)

Biological: Botulinum toxin type A

Drug: Placebo

Primary Outcome(s)

Change in weekly number of UI episodes [Time Frame: Baseline, 6 weeks]

Secondary Outcome(s)

Change in incontinence quality of life (I-QoL) total summary score [Time Frame: Baseline, 6 weeks]

Change in maximum cystometric capacity (MCC) [Time Frame: Baseline, 6 weeks]

Change in maximum detrusor pressure (MDP) during storage [Time Frame: Baseline, 6 weeks]

Proportion of subjects with no episodes of UI [Time Frame: Baseline, 6 weeks]

Change in volume at first involuntary detrusor contraction (Vol@1stIDC) [Time Frame: Baseline, 6 weeks]

Proportion of subjects with no involuntary detrusor contraction (IDCs) during storage [Time Frame: Baseline, 6 weeks]

Secondary ID(s)

2015-003471-30

D-FR-52120-222

Source(s) of Monetary Support

Please refer to primary and secondary sponsors