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

Urinary Incontinence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767519
• Other study ID #: 191622-125
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2013
• Est. completion date: March 18, 2015

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: March 18, 2015
• Est. primary completion date: September 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Biological:
• BOTOX®
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.

Drug:
• solifenacin
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)
Botox placebo (normal saline) intradetrusor injection at Day 1.
• solifenacin placebo
Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

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

References & Publications (1)

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 Naïve 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Study Baseline, Week 12
Primary	Percentage of Patients With 100% Reduction in Incontinence Episodes 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 and compared to baseline to determine 100% reduction in episodes.	Study Baseline, Week 12
Secondary	Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1	A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.'	Week 12
Secondary	Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1	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.	Study Baseline, Week 12
Secondary	Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1	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.	Study Baseline, Week 12
Secondary	Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1	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.	Study Baseline, Week 12
Secondary	Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1	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.	Study Baseline, Week 12