Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01767519 | A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence | PHASE3 | COMPLETED | 356 | — | — | Mar 1, 2013 | Mar 18, 2015 | Apr 23, 2019 | 8 | United States, Belgium +5 |
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes.
| Arm | Type | Description |
|---|---|---|
| BOTOX® | EXPERIMENTAL | Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection. |
| solifenacin | ACTIVE_COMPARATOR | Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection. |
| placebo | PLACEBO_COMPARATOR | Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection. |
| Name | Type | Description |
|---|---|---|
| BOTOX® | BIOLOGICAL | BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection. |
| solifenacin | DRUG | Beginning on Day 1, one 5 mg solifenicin capsule, with optional dose increase to 10 mg at Week 6, (both overencapsulated for blinding purposes) taken orally once daily for up to 24 weeks. |
| Botox placebo (normal saline) | DRUG | Botox placebo (normal saline) intradetrusor injection at Day 1. |
| solifenacin placebo | DRUG | Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks. |
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 * ...