Phase 3
N=356
A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
Overactive Bladder · Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT01767519 ↗Enrolled (actual)
356
Serious AEs
4.0%
Results posted
Jan 2016
Primary outcome: Primary: Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 — 4.86; 5.23; 4.38; -3.10 Incontinence Episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BOTOX® (Biological); solifenacin (Drug); Botox placebo (normal saline) (Drug); solifenacin placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 |
4.86; 5.23; 4.38; -3.10; -2.66; -0.98 | — |
| PRIMARY Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 |
33.8; 24.5; 11.7 | — |
| SECONDARY Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1 |
71.3; 74.0; 44.8 | — |
| SECONDARY Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1 |
10.74; 10.40; 10.18; -2.40; -2.03; -0.87 | — |
| SECONDARY Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1 |
2.03; 2.04; 1.98; -0.54; -0.49; -0.23 | — |
| SECONDARY Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 |
76.09; 72.11; 81.36; -30.0; -23.79; -17.25 | — |
| SECONDARY Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 |
59.66; 56.22; 62.57; -13.46; -12.70; -7.60 | — |
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
Data sourced from ClinicalTrials.gov (NCT01767519). 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.