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

CompletedPhase 3MS (type not specified)NCT00876447 2009-009216-53

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Onabotulinumtoxina
Synaptosomal nerve-associated protein 25 (SNAP-25) inhibitor
Botulinum toxin type a
Synaptosomal nerve-associated protein 25 (SNAP-25) hydrolytic enzyme

Results by group

Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Study Baseline, Week 6 Treatment Cycle 1

Group	Value	Interval	Number analysed
Botulinum Toxin Type A 300U	4.4 Incontinence Episodes	2.54 (Standard Deviation)	183
Botulinum Toxin Type A 200U	4.5 Incontinence Episodes	2.64 (Standard Deviation)	201
Botulinum Toxin Type A 300U	-3.4 Incontinence Episodes	3.16 (Standard Deviation)	183
Botulinum Toxin Type A 200U	-3.2 Incontinence Episodes	2.69 (Standard Deviation)	201

Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U

Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U

Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Study Baseline, Week 6 Treatment Cycle 2

Group	Value	Interval	Number analysed
Botulinum Toxin Type A 300U	4.5 Incontinence Episodes	2.62 (Standard Deviation)	161
Botulinum Toxin Type A 200U	4.6 Incontinence Episodes	2.71 (Standard Deviation)	186
Botulinum Toxin Type A 300U	-3.5 Incontinence Episodes	3.13 (Standard Deviation)	161
Botulinum Toxin Type A 200U	-3.3 Incontinence Episodes	2.85 (Standard Deviation)	186

Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U

Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U

Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Study Baseline, Week 6 Treatment Cycle 3

Group	Value	Interval	Number analysed
Botulinum Toxin Type A 300U	4.4 Incontinence Episodes	2.33 (Standard Deviation)	118
Botulinum Toxin Type A 200U	4.6 Incontinence Episodes	2.65 (Standard Deviation)	173
Botulinum Toxin Type A 300U	-3.3 Incontinence Episodes	2.39 (Standard Deviation)	118
Botulinum Toxin Type A 200U	-3.5 Incontinence Episodes	2.96 (Standard Deviation)	173

Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U

Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U

Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Study Baseline, Week 6 Treatment Cycle 4

Group	Value	Interval	Number analysed
Botulinum Toxin Type A 300U	4.4 Incontinence Episodes	2.13 (Standard Deviation)	67
Botulinum Toxin Type A 200U	4.4 Incontinence Episodes	2.57 (Standard Deviation)	149
Botulinum Toxin Type A 300U	-3.4 Incontinence Episodes	2.57 (Standard Deviation)	67
Botulinum Toxin Type A 200U	-3.5 Incontinence Episodes	2.61 (Standard Deviation)	149

Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U

Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U

Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Study Baseline, Week 6 Treatment Cycle 5

Group	Value	Interval	Number analysed
Botulinum Toxin Type A 300U	4.1 Incontinence Episodes	2.34 (Standard Deviation)	33
Botulinum Toxin Type A 200U	4.6 Incontinence Episodes	2.57 (Standard Deviation)	108
Botulinum Toxin Type A 300U	-3.7 Incontinence Episodes	2.82 (Standard Deviation)	33
Botulinum Toxin Type A 200U	-3.6 Incontinence Episodes	2.27 (Standard Deviation)	108

Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U

Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

Group	Participants at risk	Serious adverse events
Botulinum Toxin Type A 300U Treatment Cycle 1	185	28 (15.1%)
Botulinum Toxin Type A 200U Treatment Cycle 1	203	35 (17.2%)
Botulinum Toxin Type A 300U Treatment Cycle 2	163	26 (16.0%)
Botulinum Toxin Type A 200U Treatment Cycle 2	187	21 (11.2%)
Botulinum Toxin Type A 300U Treatment Cycle 3	119	20 (16.8%)
Botulinum Toxin Type A 200U Treatment Cycle 3	175	19 (10.9%)
Botulinum Toxin Type A 300U Treatment Cycle 4	69	11 (15.9%)
Botulinum Toxin Type A 200U Treatment Cycle 4	153	20 (13.1%)
Botulinum Toxin Type A 300U Treatment Cycle 5	34	5 (14.7%)
Botulinum Toxin Type A 200U Treatment Cycle 5	110	11 (10.0%)
Botulinum Toxin Type A 300U Treatment Cycle 6	16	0 (0.0%)
Botulinum Toxin Type A 200U Treatment Cycle 6	70	9 (12.9%)
Botulinum Toxin Type A 300U Treatment Cycle 7	8	0 (0.0%)
Botulinum Toxin Type A 200U Treatment Cycle 7	48	6 (12.5%)
Botulinum Toxin Type A 300U Treatment Cycle 8	0	0
Botulinum Toxin Type A 200U Treatment Cycle 8	36	0 (0.0%)
Botulinum Toxin Type A 300U Treatment Cycle 9	0	0
Botulinum Toxin Type A 200U Treatment Cycle 9	22	2 (9.1%)
Botulinum Toxin Type A 300U Treatment Cycle 10	0	0
Botulinum Toxin Type A 200U Treatment Cycle 10	11	1 (9.1%)
Botulinum Toxin Type A 300U Treatment Cycle 11	0	0
Botulinum Toxin Type A 200U Treatment Cycle 11	5	0 (0.0%)
Botulinum Toxin Type A 300U Treatment Cycle 12	0	0
Botulinum Toxin Type A 200U Treatment Cycle 12	2	0 (0.0%)
Botulinum Toxin Type A 300U Treatment Cycle 13	0	0
Botulinum Toxin Type A 200U Treatment Cycle 13	1	0 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Study Baseline, Week 6 Treatment Cycle 1
Bladder, bowel and sexual function
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Study Baseline, Week 6 Treatment Cycle 2
Bladder, bowel and sexual function
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Study Baseline, Week 6 Treatment Cycle 3
Bladder, bowel and sexual function
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Study Baseline, Week 6 Treatment Cycle 4
Bladder, bowel and sexual function
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Study Baseline, Week 6 Treatment Cycle 5
Bladder, bowel and sexual function
Number of episodes of urinary incontinence as recorded by patient bladder diary during the 3 consecutive days prior to each study visit. The change from baseline in the daily average frequency of episodes of urinary incontinence. The timepoint of primary interest is week 6 after each treatment in this study.
Bladder, bowel and sexual function

Other measures (10)

Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Study Baseline, Week 6 Treatment Cycle 1
Bladder, bowel and sexual functionQuality of life (reported by participants)
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Study Baseline, Week 6 Treatment Cycle 2
Bladder, bowel and sexual functionQuality of life (reported by participants)
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Study Baseline, Week 6 Treatment Cycle 3
Bladder, bowel and sexual functionQuality of life (reported by participants)
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Study Baseline, Week 6 Treatment Cycle 4
Bladder, bowel and sexual functionQuality of life (reported by participants)
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Study Baseline, Week 6 Treatment Cycle 5
Bladder, bowel and sexual functionQuality of life (reported by participants)
Change From Study Baseline in Volume Per Void
Study Baseline, Week 6 Treatment Cycle 1
Bladder, bowel and sexual function
Change From Study Baseline in Volume Per Void
Study Baseline, Week 6 Treatment Cycle 2
Bladder, bowel and sexual function
Change From Study Baseline in Volume Per Void
Study Baseline, Week 6 Treatment Cycle 3
Bladder, bowel and sexual function
Change From Study Baseline in Volume Per Void
Study Baseline, Week 6 Treatment Cycle 4
Bladder, bowel and sexual function
Change From Study Baseline in Volume Per Void
Study Baseline, Week 6 Treatment Cycle 5
Bladder, bowel and sexual function

Who could take part

MS (type not specified) · 18 and over

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

Background
Kennelly M, Dmochowski R, Schulte-Baukloh H, Ethans K, Del Popolo G, Moore C, Jenkins B, Guard S, Zheng Y, Karsenty G; 191622-094 Investigators. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: Final results of a long-term extension study. Neurourol Urodyn. 2017 Feb;36(2):368-375. doi: 10.1002/nau.22934. Ep

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History

Started
Jan 2009
Main results due
Jun 2013
Finished
Sept 2013
Results posted
Jun 2014

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