Clinical trial NCT00915525: Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Urinary Incontinence
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-06-08
Enrollment: 829
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_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 in treating patients with idiopathic overactive bladder with urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Participation in preceding study 191622-095 (NCT00910845) or 191622-520 (NCT00910520)

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy
* Patient has any condition or situation which, in the Investigators opinion, would put the patient at risk from continuing treatment with botulinum toxin Type A

Primary outcomes:
measure: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 1
measure: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 2
measure: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 3
measure: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 4
measure: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 5
measure: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 6
measure: Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)
timeFrame: Week 12 Treatment Cycle 1
measure: Percentage of Patients With a Positive Response on the 4-Point TBS
timeFrame: Week 12 Treatment Cycle 2
measure: Percentage of Patients With a Positive Response on the 4-Point TBS
timeFrame: Week 12 Treatment Cycle 3
measure: Percentage of Patients With a Positive Response on the 4-Point TBS
timeFrame: Week 12 Treatment Cycle 4
measure: Percentage of Patients With a Positive Response on the 4-Point TBS
timeFrame: Week 12 Treatment Cycle 5
measure: Percentage of Patients With a Positive Response on the 4-Point TBS
timeFrame: Week 12 Treatment Cycle 6
Secondary outcomes:
measure: Change From Study Baseline in the Daily Average Number of Micturition Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 1
measure: Change From Study Baseline in the Daily Average Number of Micturition Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 2
measure: Change From Study Baseline in the Daily Average Number of Micturition Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 3
measure: Change From Study Baseline in the Daily Average Number of Micturition Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 4
measure: Change From Study Baseline in the Daily Average Number of Micturition Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 5
measure: Change From Study Baseline in the Daily Average Number of Micturition Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 6
measure: Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score
timeFrame: Study Baseline, Week 12 Treatment Cycle 1
measure: Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
timeFrame: Study Baseline, Week 12 Treatment Cycle 2
measure: Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
timeFrame: Study Baseline, Week 12 Treatment Cycle 3
measure: Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
timeFrame: Study Baseline, Week 12 Treatment Cycle 4
measure: Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
timeFrame: Study Baseline, Week 12 Treatment Cycle 5
measure: Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
timeFrame: Study Baseline, Week 12 Treatment Cycle 6
measure: Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain
timeFrame: Study Baseline, Week 12 Treatment Cycle 1
measure: Change From Study Baseline in the KHQ Role Limitations Domain
timeFrame: Study Baseline, Week 12 Treatment Cycle 2
measure: Change From Study Baseline in the KHQ Role Limitations Domain
timeFrame: Study Baseline, Week 12 Treatment Cycle 3
measure: Change From Study Baseline in the KHQ Role Limitations Domain
timeFrame: Study Baseline, Week 12 Treatment Cycle 4
measure: Change From Study Baseline in the KHQ Role Limitations Domain
timeFrame: Study Baseline, Week 12 Treatment Cycle 5
measure: Change From Study Baseline in the KHQ Role Limitations Domain
timeFrame: Study Baseline, Week 12 Treatment Cycle 6
measure: Change From Study Baseline in the KHQ Social Limitations Domain
timeFrame: Study Baseline, Week 12 Treatment Cycle 1
measure: Change From Study Baseline in the KHQ Social Limitations Domain
timeFrame: Study Baseline, Week 12 Treatment Cycle 2
measure: Change From Study Baseline in the KHQ Social Limitations Domain
timeFrame: Study Baseline, Week 12 Treatment Cycle 3
measure: Change From Study Baseline in the KHQ Social Limitations Domain
timeFrame: Study Baseline, Week 12 Treatment Cycle 4
measure: Change From Study Baseline in the KHQ Social Limitations Domain
timeFrame: Study Baseline, Week 12 Treatment Cycle 5
measure: Change From Study Baseline in the KHQ Social Limitations Domain
timeFrame: Study Baseline, Week 12 Treatment Cycle 6
measure: Change From Study Baseline in Daily Frequency of Urgency Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 1
measure: Change From Study Baseline in Daily Frequency of Urgency Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 2
measure: Change From Study Baseline in Daily Frequency of Urgency Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 3
measure: Change From Study Baseline in Daily Frequency of Urgency Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 4
measure: Change From Study Baseline in Daily Frequency of Urgency Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 5
measure: Change From Study Baseline in Daily Frequency of Urgency Episodes
timeFrame: Study Baseline, Week 12 Treatment Cycle 6
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
city: Gent
country: Belgium
city: Victoria
country: Canada
state: British Columbia
city: Prague
country: Czechia
city: Tubingen
country: Germany
city: Warsaw
country: Poland
city: Moscow
country: Russian Federation
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Nitti VW, Ginsberg D, Sievert KD, Sussman D, Radomski S, Sand P, De Ridder D, Jenkins B, Magyar A, Chapple C; 191622-096 Investigators. Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study. J Urol. 2016 Sep;196(3):791-800. doi: 10.1016/j.juro.2016.03.146. Epub 2016 Mar 30.