A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01767519

Enrollment

356

Registered

2013-01-14

Start date

2013-03-01

Completion date

2015-03-18

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder, Urinary Incontinence

Brief summary

A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.

Interventions

BIOLOGICALBOTOX®

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.

DRUGsolifenacin

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.

DRUGBotox placebo (normal saline)

Botox placebo (normal saline) intradetrusor injection at Day 1.

DRUGsolifenacin placebo

Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1	Study Baseline, Week 12	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.
Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1	Study Baseline, Week 12	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.

Secondary

Measure	Time frame	Description
Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1	Study Baseline, Week 12	Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1	Week 12	A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.'
Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1	Study Baseline, Week 12	The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1	Study Baseline, Week 12	The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1	Study Baseline, Week 12	The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Countries

Belgium, Canada, Czechia, Germany, Poland, United Kingdom, United States

Participant flow

Recruitment details

Participant Flow is for Treatment cycle 1, which is the double-blind portion of the study and includes the primary timepoint.

Participants by arm

Arm	Count
BOTOX® 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.	145
Solifenacin 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.	151
Placebo 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.	60
Total	356

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	5	5	1
Overall Study	Lack of Efficacy	1	0	0
Overall Study	Lost to Follow-up	3	1	2
Overall Study	Other Reasons	4	4	2
Overall Study	Personal Reasons	1	0	0
Overall Study	Protocol Violation	0	3	0

Baseline characteristics

Characteristic	BOTOX®	Solifenacin	Placebo	Total
Age, Customized <65 years	77 Participants	79 Participants	34 Participants	190 Participants
Age, Customized ≥65 years	68 Participants	72 Participants	26 Participants	166 Participants
Sex: Female, Male Female	123 Participants	134 Participants	51 Participants	308 Participants
Sex: Female, Male Male	22 Participants	17 Participants	9 Participants	48 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	57 / 145	40 / 147	13 / 60
serious Total, serious adverse events	6 / 145	6 / 147	2 / 60

Outcome results

Primary

Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1

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.

Time frame: Study Baseline, Week 12