Clinical trial NCT01767519: A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Urinary Incontinence
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-01-14
Enrollment: 356
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: A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Symptoms of Overactive Bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
* Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

* Overactive Bladder caused by neurological condition
* Patient has predominance of stress incontinence
* Use of anticholinergics or other medications to treat OAB symptoms in the 7 days prior to screening
* Previous use of solifenacin
* History or evidence of pelvic or urological abnormality
* Previous use of any botulinum toxin of any serotype for any urological condition
* Previous use of any botulinum toxin of any serotype for any non-urological condition within 12 weeks of randomization
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

Primary outcomes:
measure: Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1
timeFrame: Study Baseline, Week 12
measure: Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1
timeFrame: Study Baseline, Week 12
Secondary outcomes:
measure: Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1
timeFrame: Week 12
measure: Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1
timeFrame: Study Baseline, Week 12
measure: Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1
timeFrame: Study Baseline, Week 12
measure: Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
timeFrame: Study Baseline, Week 12
measure: Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
timeFrame: Study Baseline, Week 12
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
city: Leuven
country: Belgium
city: Vancouver
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Prague 6
country: Czechia
city: Berlin
country: Germany
city: Warsaw
country: Poland
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Herschorn S, Kohan A, Aliotta P, McCammon K, Sriram R, Abrams S, Lam W, Everaert K. The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naive Patients with Refractory Overactive Bladder: Results from a Multicenter, Randomized, Double-Blind Phase 3b Trial. J Urol. 2017 Jul;198(1):167-175. doi: 10.1016/j.juro.2017.01.069. Epub 2017 Feb 1.