Clinical trial NCT00876447: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-04-06
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the arm containing botulinum toxin Type A 300U will receive botulinum toxin Type A 200U moving forward. Also, the masking of the study is now open-label.

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.

Primary outcomes:
measure: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
timeFrame: Study Baseline, Week 6 Treatment Cycle 1
measure: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
timeFrame: Study Baseline, Week 6 Treatment Cycle 2
measure: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
timeFrame: Study Baseline, Week 6 Treatment Cycle 3
measure: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
timeFrame: Study Baseline, Week 6 Treatment Cycle 4
measure: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
timeFrame: Study Baseline, Week 6 Treatment Cycle 5
Secondary outcomes:
measure: Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
timeFrame: Study Baseline, Week 6 Treatment Cycle 1
measure: Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
timeFrame: Study Baseline, Week 6 Treatment Cycle 2
measure: Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
timeFrame: Study Baseline, Week 6 Treatment Cycle 3
measure: Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
timeFrame: Study Baseline, Week 6 Treatment Cycle 4
measure: Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
timeFrame: Study Baseline, Week 6 Treatment Cycle 5
measure: Change From Study Baseline in Volume Per Void
timeFrame: Study Baseline, Week 6 Treatment Cycle 1
measure: Change From Study Baseline in Volume Per Void
timeFrame: Study Baseline, Week 6 Treatment Cycle 2
measure: Change From Study Baseline in Volume Per Void
timeFrame: Study Baseline, Week 6 Treatment Cycle 3
measure: Change From Study Baseline in Volume Per Void
timeFrame: Study Baseline, Week 6 Treatment Cycle 4
measure: Change From Study Baseline in Volume Per Void
timeFrame: Study Baseline, Week 6 Treatment Cycle 5
Other outcomes:
Locations:
city: Middlebury
country: United States
state: Connecticut
city: Randwick
country: Australia
city: Innsbruck
country: Austria
city: Ghent
country: Belgium
city: Rio de Janeiro
country: Brazil
city: Victoria
country: Canada
state: British Columbia
city: Ostrava
country: Czechia
city: Salouel
country: France
city: Kiel
country: Germany
city: Florence
country: Italy
city: Amsterdam
country: Netherlands
city: Epsom
country: New Zealand
city: Poznan
country: Poland
city: Porto
country: Portugal
city: Moscow
country: Russian Federation
city: Singapore
country: Singapore
city: Presov
country: Slovakia
city: Pretoria
country: South Africa
city: Tenerife
country: Spain
city: Hualien
country: Taiwan
city: Kiev
country: Ukraine
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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. Epub 2015 Nov 24.