Overactive BladderPhase 3NCT00876447

A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis

A Phase 3 study testing Botulinum Toxin Type A 300U and Botulinum Toxin Type A 200U in people with Overactive Bladder, run by Allergan at 22 sites in 22 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 assess the long-term safety and effectiveness of botulinum toxin type A on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder
What is being tested?: Botulinum Toxin Type A 300U and Botulinum Toxin Type A 200U
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 397 participants
Where: 22 sitesin 22 countries
Study dates: 1 Jan 2009to 4 Sep 2013
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

Patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled:
Patient completed at least 52 weeks in the preceding study.
No longer than 6 months has elapsed since completion of the preceding study
Patient has not received any prohibited medications during any intervening period between the preceding study and this long-term study.

Who cannot join

History or evidence of pelvic or urologic abnormality.
Previous or current diagnosis of bladder or prostate cancer.

Trial locations and contacts

22 sites in 22 countries.

Country

City, postcode or hospital

22 sites in 22 countries

United States1 site

Study site
Middlebury, Connecticut

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Australia1 site

Study site
Randwick

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Austria1 site

Study site
Innsbruck

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Belgium1 site

Study site
Ghent

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Brazil1 site

Study site
Rio de Janeiro

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Canada1 site

Study site
Victoria, British Columbia

Other trials in Canada

Czechia1 site

Study site
Ostrava

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France1 site

Study site
Salouël

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Germany1 site

Study site
Kiel

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Italy1 site

Study site
Florence

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Netherlands1 site

Study site
Amsterdam

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New Zealand1 site

Study site
Epsom

Other trials in New Zealand

Poland1 site

Study site
Poznan

Other trials in Poland

Portugal1 site

Study site
Porto

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Russia1 site

Study site
Moscow

Other trials in Russia

Singapore1 site

Study site
Singapore

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Slovakia1 site

Study site
Prešov

Other trials in Slovakia

South Africa1 site

Study site
Pretoria

Other trials in South Africa

Spain1 site

Study site
Santa Cruz de Tenerife

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Taiwan1 site

Study site
Hualien City

Other trials in Taiwan

Ukraine1 site

Study site
Kiev

Other trials in Ukraine

United Kingdom1 site

Study site
London

Other trials in United Kingdom

About this study

Read the detailed description

Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the arm containing botulinum toxin Type A 300U will receive botulinum toxin Type A 200U moving forward. Also, the masking of the study is now open-label.

Conditions: Overactive Bladder
Being tested: Botulinum Toxin Type A 300U, 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.

Botulinum Toxin Type A 300UBiological
Also called BOTOX®
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
Botulinum Toxin Type A 200UBiological
Also called BOTOX®
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Study groups in NCT00876447
Study group	Role	What they receive
Botulinum Toxin Type A 300U	Experimental	Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years. Receives: Biological: Botulinum Toxin Type A 300U
Botulinum Toxin Type A 200U	Experimental	Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years. Receives: Biological: Botulinum Toxin Type A 200U

What is being measured

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

Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Measured: Study Baseline, Week 6 Treatment Cycle 1
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Measured: Study Baseline, Week 6 Treatment Cycle 2
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Measured: Study Baseline, Week 6 Treatment Cycle 3
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Measured: Study Baseline, Week 6 Treatment Cycle 4
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Measured: Study Baseline, Week 6 Treatment Cycle 5

Secondary outcomes (10)

Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
Measured: Study Baseline, Week 6 Treatment Cycle 1
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
Measured: Study Baseline, Week 6 Treatment Cycle 2
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
Measured: Study Baseline, Week 6 Treatment Cycle 3
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
Measured: Study Baseline, Week 6 Treatment Cycle 4
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
Measured: Study Baseline, Week 6 Treatment Cycle 5
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
Measured: Study Baseline, Week 6 Treatment Cycle 1
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
Measured: Study Baseline, Week 6 Treatment Cycle 2
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
Measured: Study Baseline, Week 6 Treatment Cycle 3
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
Measured: Study Baseline, Week 6 Treatment Cycle 4
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
Measured: Study Baseline, Week 6 Treatment Cycle 5

Timeline

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

1 Jan 20094 Sep 2013

First posted6 Apr 2009 (estimated)
Study start1 Jan 2009
Primary completion12 Jun 2013
Study completion4 Sep 2013

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 397 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00876447
Sponsor's protocol ID: 191622-094
Status last verified: Apr 2019
First submitted: 1 Apr 2009
Last updated: 1 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kennelly M, Dmochowski R, Schulte-Baukloh H, Ethans K, Del Popolo G, Moore C, Jenkins B, Guard S, Zheng Y, Karsenty G; 191622-094 Investigators. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: Final results of a long-term extension study. Neurourol Urodyn. 2017 Feb;36(2):368-375. doi: 10.1002/nau.22934. Epub 2015 Nov 24.
PubMed 26607743

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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Overactive Bladder (OAB)

All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis
ClinicalTrials.gov ID: NCT00876447
Acronym / sponsor ID: 191622-094
Conditions: Overactive Bladder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 397 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 1 Jan 2009 (actual)
Primary completion: 12 Jun 2013 (actual)
Study completion: 4 Sep 2013 (actual)
First posted: 6 Apr 2009 (estimated)
Results: Posted 13 Jun 2014

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Botulinum Toxin Type A 300U	Experimental	Biological: Botulinum Toxin Type A 300UBotulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
Botulinum Toxin Type A 200U	Experimental	Biological: Botulinum Toxin Type A 200UBotulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Who may qualify

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

Key inclusion criteria (4 listed)

Patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled:

Key exclusion criteria (2 listed)

History or evidence of pelvic or urologic abnormality.
Previous or current diagnosis of bladder or prostate cancer.

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 A 300UAlso: BOTOX®Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.	Biological	Botulinum Toxin Type A 300U
Botulinum Toxin Type A 200UAlso: BOTOX®Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.	Biological	Botulinum Toxin Type A 200U

Primary outcome

Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time frame: Study Baseline, Week 6 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 each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time frame: Study Baseline, Week 6 Treatment Cycle 2
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time frame: Study Baseline, Week 6 Treatment Cycle 3
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time frame: Study Baseline, Week 6 Treatment Cycle 4
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time frame: Study Baseline, Week 6 Treatment Cycle 5
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

10 secondary outcomes

Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Time frame: Study Baseline, Week 6 Treatment Cycle 1
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Time frame: Study Baseline, Week 6 Treatment Cycle 2
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Time frame: Study Baseline, Week 6 Treatment Cycle 3
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Time frame: Study Baseline, Week 6 Treatment Cycle 4
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Time frame: Study Baseline, Week 6 Treatment Cycle 5
Change From Study Baseline in Volume Per Void
Time frame: Study Baseline, Week 6 Treatment Cycle 1
Change From Study Baseline in Volume Per Void
Time frame: Study Baseline, Week 6 Treatment Cycle 2
Change From Study Baseline in Volume Per Void
Time frame: Study Baseline, Week 6 Treatment Cycle 3
Change From Study Baseline in Volume Per Void
Time frame: Study Baseline, Week 6 Treatment Cycle 4
Change From Study Baseline in Volume Per Void
Time frame: Study Baseline, Week 6 Treatment Cycle 5

Results and safety

Results posted to the registry on 13 Jun 2014, 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 300U	185	105
Botulinum Toxin Type A 200U	203	122

Primary outcome: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Time frame: Study Baseline, Week 6 Treatment Cycle 1. Mean (Standard Deviation). Unit: Incontinence Episodes

Measure	Botulinum Toxin Type A 300U n = 183	Botulinum Toxin Type A 200U n = 201
Study Baseline (BL)	4.4 (2.54)	4.5 (2.64)
Chg from Study BL at Wk 6 Tmt Cycle1 (N=176, 195)	-3.4 (3.16)	-3.2 (2.69)

Population analysed: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received

Primary outcome: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Time frame: Study Baseline, Week 6 Treatment Cycle 2. Mean (Standard Deviation). Unit: Incontinence Episodes

Measure	Botulinum Toxin Type A 300U n = 161	Botulinum Toxin Type A 200U n = 186
Study Baseline	4.5 (2.62)	4.6 (2.71)
Chg from Study BL at Wk 6 Tmt Cycle2 (N=153, 175)	-3.5 (3.13)	-3.3 (2.85)

Primary outcome: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Time frame: Study Baseline, Week 6 Treatment Cycle 3. Mean (Standard Deviation). Unit: Incontinence Episodes

Measure	Botulinum Toxin Type A 300U n = 118	Botulinum Toxin Type A 200U n = 173
Study Baseline	4.4 (2.33)	4.6 (2.65)
Chg from Study BL at Wk 6 Tmt Cycle3 (N=109, 164)	-3.3 (2.39)	-3.5 (2.96)

Primary outcome: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Time frame: Study Baseline, Week 6 Treatment Cycle 4. Mean (Standard Deviation). Unit: Incontinence Episodes

Measure	Botulinum Toxin Type A 300U n = 67	Botulinum Toxin Type A 200U n = 149
Study Baseline	4.4 (2.13)	4.4 (2.57)
Chg from Study BL at Wk 6 Tmt Cycle4 (N=62, 141)	-3.4 (2.57)	-3.5 (2.61)

10 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 300U Treatment Cycle 1	28 of 185 (15.1%)	154 of 185 (83.2%)	Not reported
Botulinum Toxin Type A 200U Treatment Cycle 1	35 of 203 (17.2%)	170 of 203 (83.7%)	Not reported
Botulinum Toxin Type A 300U Treatment Cycle 2	26 of 163 (16%)	126 of 163 (77.3%)	Not reported
Botulinum Toxin Type A 200U Treatment Cycle 2	21 of 187 (11.2%)	147 of 187 (78.6%)	Not reported
Botulinum Toxin Type A 300U Treatment Cycle 3	20 of 119 (16.8%)	89 of 119 (74.8%)	Not reported
Botulinum Toxin Type A 200U Treatment Cycle 3	19 of 175 (10.9%)	123 of 175 (70.3%)	Not reported
Botulinum Toxin Type A 300U Treatment Cycle 4	11 of 69 (15.9%)	51 of 69 (73.9%)	Not reported
Botulinum Toxin Type A 200U Treatment Cycle 4	20 of 153 (13.1%)	109 of 153 (71.2%)	Not reported
Botulinum Toxin Type A 300U Treatment Cycle 5	5 of 34 (14.7%)	19 of 34 (55.9%)	Not reported
Botulinum Toxin Type A 200U Treatment Cycle 5	11 of 110 (10%)	72 of 110 (65.5%)	Not reported
Botulinum Toxin Type A 300U Treatment Cycle 6	0 of 16 (0%)	8 of 16 (50%)	Not reported
Botulinum Toxin Type A 200U Treatment Cycle 6	9 of 70 (12.9%)	46 of 70 (65.7%)	Not reported
Botulinum Toxin Type A 300U Treatment Cycle 7	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
Botulinum Toxin Type A 200U Treatment Cycle 7	6 of 48 (12.5%)	28 of 48 (58.3%)	Not reported
Botulinum Toxin Type A 300U Treatment Cycle 8	0 of 0	0 of 0	Not reported
Botulinum Toxin Type A 200U Treatment Cycle 8	0 of 36 (0%)	23 of 36 (63.9%)	Not reported
Botulinum Toxin Type A 300U Treatment Cycle 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26607743Kennelly M, Dmochowski R, Schulte-Baukloh H, Ethans K, Del Popolo G, Moore C, Jenkins B, Guard S, Zheng Y, Karsenty G; 191622-094 Investigators. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: Final results of a long-term extension study. Neurourol Urodyn. 2017 Feb;36(2):368-375. doi: 10.1002/nau.22934. Epub 2015 Nov 24.

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Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
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

22 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Botulinum Toxin Type A 300U and Botulinum Toxin Type A 200U in people with Overactive Bladder, run by Allergan at 22 sites in 22 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 4 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 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Australia, Austria, Belgium, Brazil and 17 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. 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 13 Jun 2014). 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 the Daily Average Number of Urinary Incontinence Episodes (time frame: Study Baseline, Week 6 Treatment Cycle 1). The study lists 5 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 NCT00876447, 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 1 May 2019.