Phase 3
N=388
A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT00876447 ↗Enrolled (actual)
388
Serious AEs
13.2%
Results posted
Jun 2014
Primary outcome: Primary: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes — 4.4; 4.5; -3.4; -3.2 Incontinence Episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum Toxin Type A 300U (Biological); Botulinum Toxin Type A 200U (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes |
4.1; 4.6; -3.7; -3.6 | — |
| PRIMARY Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes |
4.1; 4.6; -3.7; -3.6 | — |
| PRIMARY Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes |
4.1; 4.6; -3.7; -3.6 | — |
| PRIMARY Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes |
4.1; 4.6; -3.7; -3.6 | — |
| PRIMARY Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes |
4.1; 4.6; -3.7; -3.6 | — |
| SECONDARY Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score |
32.0; 33.0; 36.6; 27.1 | — |
| SECONDARY Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score |
32.0; 33.0; 36.6; 27.1 | — |
| SECONDARY Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score |
32.0; 33.0; 36.6; 27.1 | — |
| SECONDARY Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score |
32.0; 33.0; 36.6; 27.1 | — |
| SECONDARY Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score |
32.0; 33.0; 36.6; 27.1 | — |
| SECONDARY Change From Study Baseline in Volume Per Void |
182.7; 140.8; 163.5; 160.2 | — |
| SECONDARY Change From Study Baseline in Volume Per Void |
182.7; 140.8; 163.5; 160.2 | — |
| SECONDARY Change From Study Baseline in Volume Per Void |
182.7; 140.8; 163.5; 160.2 | — |
| SECONDARY Change From Study Baseline in Volume Per Void |
182.7; 140.8; 163.5; 160.2 | — |
| SECONDARY Change From Study Baseline in Volume Per Void |
182.7; 140.8; 163.5; 160.2 | — |
Summary
The purpose of this study is to assess the long-term safety and effectiveness of botulinum toxin type A on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292).
Eligibility Criteria
Inclusion Criteria
- Patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled:
- Patient completed at least 52 weeks in the preceding study.
- No longer than 6 months has elapsed since completion of the preceding study
- Patient has not received any prohibited medications during any intervening period between the preceding study and this long-term study.
Exclusion Criteria
- History or evidence of pelvic or urologic abnormality.
- Previous or current diagnosis of bladder or prostate cancer.
Data sourced from ClinicalTrials.gov (NCT00876447). 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.