Phase 2
N=47
Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis
Detrusor Muscle Hyperactivity
Bottom Line
View on ClinicalTrials.gov: NCT01357980 ↗Enrolled (actual)
47
Serious AEs
12.8%
Results posted
Sep 2014
Primary outcome: Primary: Daily Incontinence Episode Frequency (IEF) — 4.21; 3.33; 3.23; 4.40 episodes per day — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Botulinum toxin type A (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Incontinence Episode Frequency (IEF) |
4.21; 3.33; 3.23; 4.40; -3.51; -1.05 | 0.11 |
| SECONDARY Urodynamics: Maximum Cystometric Capacity |
281; 287; 288; 220; 186; -36 | <0.01 sig |
| SECONDARY Urodynamics:Maximum Detrusor Pressure |
59; 53; 46; 70; -24; -4 | 0.25 |
| SECONDARY Physician's Global Assessment Score of Treatment Response |
0; 0; 0; 0; 0; 0 | 0.05 |
| SECONDARY Physician's Global Assessment Score of Treatment Response |
0; 0; 0; 0; 0; 0 | 0.05 |
| SECONDARY Physician's Global Assessment Score of Treatment Response |
0; 0; 0; 0; 0; 0 | 0.05 |
| SECONDARY Quality of Life (QoL) Total Summary Score |
2.4; 2.7; 2.4; 2.3; -1.1; -0.2 | <0.01 sig |
| SECONDARY Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection |
2.7; 12.2; 1.3; 6.7 | — |
| SECONDARY Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure |
13.7; 11.0; 15.8; 10.0 | — |
Summary
The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.
Eligibility Criteria
Inclusion Criteria
- Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study
- Inadequate response or refractory to anticholinergic medication
- Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition
- Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit
Exclusion Criteria
- Significant Baseline renal and/or urinary tract pathology
- Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection
Data sourced from ClinicalTrials.gov (NCT01357980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.