Overactive BladderPhase 3NCT01767519

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

A Phase 3 study testing BOTOX® and solifenacin in people with Overactive Bladder and Urinary Incontinence, run by Allergan at 8 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder, Urinary Incontinence
What is being tested?: BOTOX® and solifenacin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 356 participants
Where: 8 sitesin 7 countries
Study dates: 1 Mar 2013to 18 Mar 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

8 sites in 7 countries.

Country

City, postcode or hospital

8 sites in 7 countries

Canada2 sites

Study site
Toronto, Ontario
Study site
Vancouver, British Columbia

Other trials in Canada

United States1 site

Study site
Newport Beach, California

Other trials in United States

Belgium1 site

Study site
Leuven

Other trials in Belgium

Czechia1 site

Study site
Prague

Other trials in Czechia

Germany1 site

Study site
Berlin

Other trials in Germany

Poland1 site

Study site
Warsaw

Other trials in Poland

United Kingdom1 site

Study site
London

Other trials in United Kingdom

About this study

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
Being tested: BOTOX®, solifenacin, Botox placebo (normal saline), solifenacin placebo
Medical subject headings: Urinary Bladder, Overactive, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BOTOX®Biological
Also called onabotulinumtoxinA, botulinum toxin Type A
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.
solifenacinDrug
Also called Vesicare
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 placeboDrug
Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.

Study groups in NCT01767519
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Biological: BOTOX®; Drug: Botox placebo (normal saline); Drug: solifenacin placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.'
Measured: Week 12
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.
Measured: Study Baseline, Week 12
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.
Measured: Study Baseline, Week 12
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.
Measured: Study Baseline, Week 12
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.
Measured: Study Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201318 Mar 2015

First posted14 Jan 2013 (estimated)
Study start1 Mar 2013
Primary completion30 Sep 2014
Study completion18 Mar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Overactive BladderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 356 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01767519
Sponsor's protocol ID: 191622-125
Status last verified: Apr 2019
First submitted: 11 Jan 2013
Last updated: 23 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 28161352
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.
PubMed 37160401

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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Recruiting
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Active, not recruitingObservational study
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RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)

All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
ClinicalTrials.gov ID: NCT01767519
Acronym / sponsor ID: 191622-125
Conditions: Overactive Bladder, Urinary Incontinence
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 356 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 1 Mar 2013 (actual)
Primary completion: 30 Sep 2014 (actual)
Study completion: 18 Mar 2015 (actual)
First posted: 14 Jan 2013 (estimated)
Results: Posted 12 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
BOTOX®	Experimental	Biological: BOTOX®, Drug: solifenacin placeboTreatment 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	Biological: BOTOX®, Drug: solifenacin, Drug: Botox placebo (normal saline)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	Biological: BOTOX®, Drug: Botox placebo (normal saline), Drug: solifenacin placeboTreatment 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BOTOX®Also: onabotulinumtoxinA, botulinum toxin Type ABOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.	Biological	BOTOX®, placebo, solifenacin
solifenacinAlso: VesicareBeginning 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.	Drug	solifenacin
Botox placebo (normal saline)Botox placebo (normal saline) intradetrusor injection at Day 1.	Drug	placebo, solifenacin
solifenacin placeboBeginning on Day 1, one capsule taken orally once daily for up to 24 weeks.	Drug	BOTOX®, placebo

Primary outcome

Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1
Time frame: 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
Time frame: 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.

5 secondary outcomes

Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1
Time frame: Week 12
Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1
Time frame: Study Baseline, Week 12
Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1
Time frame: Study Baseline, Week 12
Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
Time frame: Study Baseline, Week 12
Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
Time frame: Study Baseline, Week 12

Results and safety

Results posted to the registry on 12 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BOTOX®	145	131
Solifenacin	151	138
Placebo	60	55

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

Time frame: Study Baseline, Week 12. Mean (Standard Deviation). Unit: Incontinence Episodes

Measure	BOTOX® n = 145	Solifenacin n = 151	Placebo n = 60
Study Baseline	4.86 (3.206)	5.23 (3.333)	4.38 (2.485)
Change from Study Baseline at Week 12	-3.10 (2.799)	-2.66 (3.059)	-0.98 (2.417)

Population analysed: Intent-to-Treat: includes all patients according to the group to which they are randomized

Primary outcome: Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1

Time frame: Study Baseline, Week 12. Number. Unit: Percentage of Patients

Measure	BOTOX® n = 145	Solifenacin n = 151	Placebo n = 60
Value	33.8	24.5	11.7

Population analysed: Intent-to-Treat: includes all patients according to the group to which they are randomized

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BOTOX®	6 of 145 (4.1%)	57 of 145 (39.3%)	Not reported
Solifenacin	6 of 147 (4.1%)	40 of 147 (27.2%)	Not reported
Placebo	2 of 60 (3.3%)	13 of 60 (21.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28161352Herschorn 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.
Derived from this study: PubMed 37160401Stoniute 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.

Related trials for Overactive Bladder

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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

8 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BOTOX® and solifenacin in people with Overactive Bladder and Urinary Incontinence, run by Allergan at 8 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada, United States, Belgium, Czechia, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 (time frame: Study Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01767519, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.