Overactive BladderPhase 2NCT00575016

Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

A Phase 2 study testing botulinum toxin Type A (50U); botulinum toxin Type A (200U), botulinum toxin Type A (100U); botulinum toxin Type A (200U) and botulinum toxin Type A (200U) in people with Overactive Bladder, run by Allergan at 6 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Overactive Bladder
What is being tested?: botulinum toxin Type A (50U); botulinum toxin Type A (200U), botulinum toxin Type A (100U); botulinum toxin Type A (200U) and botulinum toxin Type A (200U)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 6 sitesin 6 countries
Study dates: Dec 2007to Jul 2010
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury
Inadequate response to anticholinergic medication used to treat overactive bladder

Who cannot join

History or evidence of pelvic or urologic abnormality
Previous or current diagnosis of bladder or prostate cancer
Urinary tract infection at time of enrollment

Trial locations and contacts

6 sites in 6 countries.

Country

City, postcode or hospital

6 sites in 6 countries

Egypt1 site

Study site
Cairo

Other trials in Egypt

Greece1 site

Study site
Thessaloniki

Other trials in Greece

India1 site

Study site
Ahmadābād

Other trials in India

Lebanon1 site

Study site
Beirut

Other trials in Lebanon

Serbia1 site

Study site
Belgrade

Other trials in Serbia

Turkey (Türkiye)1 site

Study site
Ankara

Other trials in Turkey (Türkiye)

About this study

The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.

Conditions: Overactive Bladder
Being tested: Normal saline (Placebo); botulinum toxin Type A (200U), botulinum toxin Type A (50U); botulinum toxin Type A (200U), botulinum toxin Type A (100U); botulinum toxin Type A (200U), botulinum toxin Type A (200U)
Medical subject headings: Urinary Bladder, Overactive

What participants receive

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

Normal saline (Placebo); botulinum toxin Type A (200U)Biological
Also called BOTOX®
Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor
botulinum toxin Type A (50U); botulinum toxin Type A (200U)Biological
Also called BOTOX®
botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
botulinum toxin Type A (100U); botulinum toxin Type A (200U)Biological
Also called BOTOX®
botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
botulinum toxin Type A (200U)Biological
Also called BOTOX®
botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor

Study groups in NCT00575016
Study group	Role	What they receive
1	Experimental	botulinum toxin Type A (50U); botulinum toxin Type A (200U) Receives: Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U)
2	Experimental	botulinum toxin Type A (100U); botulinum toxin Type A (200U) Receives: Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)
3	Experimental	botulinum toxin Type A (200U) Receives: Biological: botulinum toxin Type A (200U)
4	Other	placebo; botulinum toxin Type A (200U) Receives: Biological: Normal saline (Placebo); botulinum toxin Type A (200U)

What is being measured

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

Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Measured: Baseline, Week 6

Secondary outcomes (2)

Change From Baseline in Maximum Cystometric Capacity (MCC)
Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.
Measured: Baseline, Week 6
Change From Baseline in Maximum Detrusor Pressure (MDP)
Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.
Measured: Baseline, Week 6

Timeline

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

Dec 2007Jul 2010

First posted17 Dec 2007 (estimated)
Study startDec 2007
Primary completionFeb 2010
Study completionJul 2010

Why it stopped: The study was terminated early due to enrollment challenges.

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.
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: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00575016
Sponsor's protocol ID: 191622-518
Status last verified: Sep 2015
First submitted: 13 Dec 2007
Last updated: 2 Oct 2015
Results posted: Yes, on ClinicalTrials.gov

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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UCon Treatment of Overactive Bladder (OAB) in Males
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All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
ClinicalTrials.gov ID: NCT00575016
Acronym / sponsor ID: 191622-518
Conditions: Overactive Bladder
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated early due to enrollment challenges.
Enrolment: 74 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Feb 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 17 Dec 2007 (estimated)
Results: Posted 17 Oct 2011

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 explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U)botulinum toxin Type A (50U); botulinum toxin Type A (200U)
2	Experimental	Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)botulinum toxin Type A (100U); botulinum toxin Type A (200U)
3	Experimental	Biological: botulinum toxin Type A (200U)botulinum toxin Type A (200U)
4	Other	Biological: Normal saline (Placebo); botulinum toxin Type A (200U)placebo; botulinum toxin Type A (200U)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury
Inadequate response to anticholinergic medication used to treat overactive bladder

Key exclusion criteria (3 listed)

History or evidence of pelvic or urologic abnormality
Previous or current diagnosis of bladder or prostate cancer
Urinary tract infection at time of enrollment

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
Normal saline (Placebo); botulinum toxin Type A (200U)Also: BOTOX®Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor	Biological	4
botulinum toxin Type A (50U); botulinum toxin Type A (200U)Also: BOTOX®botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor	Biological	1
botulinum toxin Type A (100U); botulinum toxin Type A (200U)Also: BOTOX®botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor	Biological	2
botulinum toxin Type A (200U)Also: BOTOX®botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor	Biological	3

Primary outcome

Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
Time frame: Baseline, Week 6
Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

2 secondary outcomes

Change From Baseline in Maximum Cystometric Capacity (MCC)
Time frame: Baseline, Week 6
Change From Baseline in Maximum Detrusor Pressure (MDP)
Time frame: Baseline, Week 6

Results and safety

Results posted to the registry on 17 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Botulinum Toxin Type A (200U)	17	8
Botulinum Toxin Type A (100U)	21	16
Botulinum Toxin Type A (50U)	19	15
Placebo	17	12

Primary outcome: Change From Baseline in Number of Weekly Episodes of Urinary Incontinence

Time frame: Baseline, Week 6. Mean (Standard Deviation). Unit: Number of Weekly Episodes

Measure	Botulinum Toxin Type A (200U) n = 17	Botulinum Toxin Type A (100U) n = 21	Botulinum Toxin Type A (50U) n = 19	Placebo n = 16
Baseline	28.8 (20.26)	37.8 (27.63)	26.3 (19.29)	24.6 (9.08)
Week 6	-15.8 (18.01)	-14.1 (23.90)	-7.7 (11.52)	-8.6 (8.12)

Population analysed: Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment

2 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
Botulinum Toxin Type A (200U)	2 of 17 (11.8%)	11 of 17 (64.7%)	Not reported
Botulinum Toxin Type A (100U)	2 of 21 (9.5%)	17 of 21 (81%)	Not reported
Botulinum Toxin Type A (50U)	2 of 19 (10.5%)	11 of 19 (57.9%)	Not reported
Placebo	6 of 16 (37.5%)	13 of 16 (81.3%)	Not reported

Limitations and caveats (from the sponsor): Due to recruitment difficulties, study enrollment was stopped early.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Overactive Bladder

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
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Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
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RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)

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?

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 3 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: stopped early, as of the sponsor's last update on 2 Oct 2015. 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 Egypt, Greece, India, Lebanon, Serbia 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. 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 17 Oct 2011). 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 Baseline in Number of Weekly Episodes of Urinary Incontinence (time frame: Baseline, Week 6). 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 NCT00575016.

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 2 Oct 2015.