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

NCT01767519 | Completed Phase 3 Results

• 1 other identifier: 191622-125
• Study Type: interventional
• Target: 356
• Locations: 7 countries
• Sites: 8

Brief Summary

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

Conditions

Overactive Bladder; Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1

  Week 12

• Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1

  Study Baseline, Week 12

• Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1

  Study Baseline, Week 12

• Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1

  Study Baseline, Week 12

• Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1

  Study Baseline, Week 12

Study Arms (3)

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.

Biological: BOTOX®; Drug: solifenacin placebo

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.

Biological: BOTOX®; Drug: solifenacin; Drug: Botox placebo (normal saline)

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.

Biological: BOTOX®; Drug: Botox placebo (normal saline); Drug: solifenacin placebo

Interventions

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.

Also known as: onabotulinumtoxinA, botulinum toxin Type A

BOTOX®; placebo; solifenacin

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.

Also known as: Vesicare

solifenacin

Botox placebo (normal saline) DRUG

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

placebo; solifenacin

solifenacin placebo DRUG

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

BOTOX®; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (8)

Unknown Facility

Newport Beach, California, United States

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 28161352 BACKGROUND

• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

  PMID: 37160401 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

Botulinum Toxins, Type A; Solifenacin Succinate; Saline Solution

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 14, 2013
• Study Start: March 1, 2013
• Primary Completion: September 30, 2014
• Study Completion: March 18, 2015
• Last Updated: April 23, 2019
• Results First Posted: January 12, 2016

Record last verified: 2019-04

Locations

CA (2); US (1); DE (1); PL (1); CZ (1); GB (1); BE (1)