Overactive BladderPhase 2NCT00168454

A Research Study for Patients With Overactive Bladder

A Phase 2 study testing botulinum toxin Type A in people with Overactive Bladder and Urinary Incontinence, run by Allergan at 6 sites in 6 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

The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Overactive Bladder, Urinary Incontinence
What is being tested?: botulinum toxin Type A
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 313 participants
Where: 6 sitesin 6 countries
Study dates: Jul 2005to Jun 2008
Phase: Phase 2
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must be between 18-85 years old
Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
Must weigh at least 50 kg (110 lbs)
Must be willing and able to record information regarding bladder function into a diary (provided)
Must be willing and able to complete the entire course of the study

Who cannot join

Cannot currently be catheterizing as a way to control incontinence
Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition

Trial locations and contacts

6 sites in 6 countries.

Country

City, postcode or hospital

6 sites in 6 countries

United States1 site

Study site
Pittsburgh, Pennsylvania

Other trials in United States

Belgium1 site

Study site
Ghent

Other trials in Belgium

Canada1 site

Study site
Victoria, British Columbia

Other trials in Canada

Germany1 site

Study site
Berlin

Other trials in Germany

Poland1 site

Study site
Warsaw

Other trials in Poland

United Kingdom1 site

Study site
Sheffield

Other trials in United Kingdom

About this study

The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.

Conditions: Overactive Bladder, Urinary Incontinence
Being tested: botulinum toxin Type A, 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.

botulinum toxin Type ABiological
Also called BOTOX®
botulinum toxin Type A injected into detrusor on Day 1
PlaceboDrug
Placebo (normal saline) injected into detrusor on Day 1

Study groups in NCT00168454
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo (normal saline) injected into detrusor on Day 1 Receives: Drug: Placebo
BOTOX 50 U	Experimental	botulinum toxin Type A 50 U injected into detrusor on Day 1 Receives: Biological: botulinum toxin Type A
BOTOX 100 U	Experimental	botulinum toxin Type A 100 U injected into detrusor on Day 1 Receives: Biological: botulinum toxin Type A
BOTOX 150 U	Experimental	botulinum toxin Type A 150 U injected into detrusor on Day 1 Receives: Biological: botulinum toxin Type A
BOTOX 200 U	Experimental	botulinum toxin Type A 200 U injected into detrusor on Day 1 Receives: Biological: botulinum toxin Type A
BOTOX 300 U	Experimental	botulinum toxin Type A 300 U injected into detrusor on Day 1 Receives: Biological: botulinum toxin Type A

What is being measured

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

Change in Number of Urinary Urge Incontinence Episodes
Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.
Measured: Baseline, Week 2, Week 6, Week 12

Secondary outcomes (4)

Change in Number of Micturitions
Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.
Measured: Baseline, Week 2, Week 6, Week 12
Change in Number of Nocturia Episodes
Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.
Measured: Baseline, Week 12
Maximum Cystometric Capacity (MCC) by Urodynamic Measurements
Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters
Measured: Baseline, Week 12
Incontinence Quality of Life Instrument (I-QOL)
Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.
Measured: Baseline, Week 2, Week 6, Week 12

Timeline

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

Jul 2005Jun 2008

First posted15 Sep 2005 (estimated)
Study startJul 2005
Primary completionJan 2008
Study completionJun 2008

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 (1)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 313 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00168454
Sponsor's protocol ID: 191622-077
Status last verified: Oct 2013
First submitted: 12 Sep 2005
Last updated: 6 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fowler CJ, Auerbach S, Ginsberg D, Hale D, Radziszewski P, Rechberger T, Patel VD, Zhou J, Thompson C, Kowalski JW. OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder: a 36-week, double-blind, placebo-controlled, randomized, dose-ranging trial. Eur Urol. 2012 Jul;62(1):148-57. doi: 10.1016/j.eururo.2012.03.005. Epub 2012 Mar 14.
PubMed 22464310

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

Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder

All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Research Study for Patients With Overactive Bladder
ClinicalTrials.gov ID: NCT00168454
Acronym / sponsor ID: 191622-077
Conditions: Overactive Bladder, Urinary Incontinence
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 313 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Jan 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 15 Sep 2005 (estimated)
Results: Posted 11 Feb 2010

Clinical summary

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

The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo (normal saline) injected into detrusor on Day 1
BOTOX 50 U	Experimental	Biological: botulinum toxin Type Abotulinum toxin Type A 50 U injected into detrusor on Day 1
BOTOX 100 U	Experimental	Biological: botulinum toxin Type Abotulinum toxin Type A 100 U injected into detrusor on Day 1
BOTOX 150 U	Experimental	Biological: botulinum toxin Type Abotulinum toxin Type A 150 U injected into detrusor on Day 1
BOTOX 200 U	Experimental	Biological: botulinum toxin Type Abotulinum toxin Type A 200 U injected into detrusor on Day 1
BOTOX 300 U	Experimental	Biological: botulinum toxin Type Abotulinum toxin Type A 300 U injected into detrusor on Day 1

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Must be between 18-85 years old
Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
Must weigh at least 50 kg (110 lbs)
Must be willing and able to record information regarding bladder function into a diary (provided)
Must be willing and able to complete the entire course of the study

Key exclusion criteria (2 listed)

Cannot currently be catheterizing as a way to control incontinence
Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition

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
botulinum toxin Type AAlso: BOTOX®botulinum toxin Type A injected into detrusor on Day 1	Biological	BOTOX 100 U, BOTOX 150 U, BOTOX 200 U, BOTOX 300 U, BOTOX 50 U
PlaceboPlacebo (normal saline) injected into detrusor on Day 1	Drug	Placebo

Primary outcome

Change in Number of Urinary Urge Incontinence Episodes
Time frame: Baseline, Week 2, Week 6, Week 12
Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.

4 secondary outcomes

Change in Number of Micturitions
Time frame: Baseline, Week 2, Week 6, Week 12
Change in Number of Nocturia Episodes
Time frame: Baseline, Week 12
Maximum Cystometric Capacity (MCC) by Urodynamic Measurements
Time frame: Baseline, Week 12
Incontinence Quality of Life Instrument (I-QOL)
Time frame: Baseline, Week 2, Week 6, Week 12

Results and safety

Results posted to the registry on 11 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	44	37
BOTOX 50 U	57	50
BOTOX 100 U	54	48
BOTOX 150 U	49	40
BOTOX 200 U	53	47
BOTOX 300 U	56	50

Primary outcome: Change in Number of Urinary Urge Incontinence Episodes

Time frame: Baseline, Week 2, Week 6, Week 12. Number. Unit: episodes

Measure	Placebo n = 44	BOTOX 50 U n = 57	BOTOX 100 U n = 54	BOTOX 150 U n = 49	BOTOX 200 U n = 53	BOTOX 300 U n = 56
Baseline	32.5	30.3	27.8	28.3	24.1	26.8
Week 2	-17.3	-20.0	-18.6	-20.8	-16.8	-18.6
Week 6	-18.2	-21.2	-19.9	-23.4	-20.0	-18.8
Week 12	-17.4	-20.7	-18.4	-23.0	-19.6	-19.4

Population analysed: Intent to Treat

4 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
Placebo	5 of ?	33 of ?	Not reported
BOTOX 50 U	9 of ?	44 of ?	Not reported
BOTOX 100 U	5 of ?	44 of ?	Not reported
BOTOX 150 U	7 of ?	39 of ?	Not reported
BOTOX 200 U	4 of ?	44 of ?	Not reported
BOTOX 300 U	4 of ?	46 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22464310Fowler CJ, Auerbach S, Ginsberg D, Hale D, Radziszewski P, Rechberger T, Patel VD, Zhou J, Thompson C, Kowalski JW. OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder: a 36-week, double-blind, placebo-controlled, randomized, dose-ranging trial. Eur Urol. 2012 Jul;62(1):148-57. doi: 10.1016/j.eururo.2012.03.005. Epub 2012 Mar 14.

Related trials for Overactive Bladder

Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder

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

6 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing botulinum toxin Type A in people with Overactive Bladder and Urinary Incontinence, run by Allergan at 6 sites in 6 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 5 inclusion and 2 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 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Belgium, Canada, Germany, Poland and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Feb 2010). 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 in Number of Urinary Urge Incontinence Episodes (time frame: Baseline, Week 2, Week 6, Week 12). 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 NCT00168454, which also lists 1 linked publication.

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 6 Nov 2013; AzTrials last refreshed its copy on 31 Oct 2026.