Trial · NCT00168454

A Research Study for Patients With Overactive Bladder

NCT00168454, Phase 2, Completed, Allergan; results first posted 2010-02-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Research Study for Patients With Overactive Bladder. Trials, record NCT00168454. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00168454

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Research Study for Patients With Overactive Bladder
NCT number: NCT00168454
Status: Completed
Phases: Phase 2
Enrollment: 313 participants, actual
Lead sponsor: Allergan
Conditions: Overactive Bladder, Urinary Incontinence
Interventions: botulinum toxin Type A, Placebo
First posted: 2005-09-15
Last updated: 2013-11-06
Results first posted: 2010-02-11

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Number of Urinary Urge Incontinence Episodes	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.
Secondary	Change in Number of Micturitions	Baseline, Week 2, Week 6, Week 12	Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.
Secondary	Change in Number of Nocturia Episodes	Baseline, Week 12	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.
Secondary	Maximum Cystometric Capacity (MCC) by Urodynamic Measurements	Baseline, Week 12	Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters
Secondary	Incontinence Quality of Life Instrument (I-QOL)	Baseline, Week 2, Week 6, Week 12	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Number of Urinary Urge Incontinence Episodes	Baseline, Week 2, Week 6, Week 12	Intent to Treat	episodes	NUMBER
SECONDARY	Change in Number of Micturitions	Baseline, Week 2, Week 6, Week 12	Intent to Treat	micturitions	NUMBER
SECONDARY	Change in Number of Nocturia Episodes	Baseline, Week 12	Intent to Treat	episodes	NUMBER
SECONDARY	Maximum Cystometric Capacity (MCC) by Urodynamic Measurements	Baseline, Week 12	Intent to Treat	milliliters	NUMBER
SECONDARY	Incontinence Quality of Life Instrument (I-QOL)	Baseline, Week 2, Week 6, Week 12	Intent to Treat	Units on a scale	NUMBER
POST_HOC	Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes	Baseline, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36	Intent to Treat	Percentage of patients	NUMBER

Source ClinicalTrials.gov

Results by group138

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Change in Number of Urinary Urge Incontinence Episodes	Placebo	Baseline	32.5	episodes
Change in Number of Urinary Urge Incontinence Episodes	BOTOX 50 U	Baseline	30.3	episodes
Change in Number of Urinary Urge Incontinence Episodes	BOTOX 100 U	Baseline	27.8	episodes
Change in Number of Urinary Urge Incontinence Episodes	BOTOX 150 U	Baseline	28.3	episodes
Change in Number of Urinary Urge Incontinence Episodes	BOTOX 200 U	Baseline	24.1	episodes
Change in Number of Urinary Urge Incontinence Episodes	BOTOX 300 U	Baseline	26.8	episodes
Change in Number of Urinary Urge Incontinence Episodes	Placebo	Week 2	-17.3	episodes
Change in Number of Urinary Urge Incontinence Episodes	BOTOX 50 U	Week 2	-20.0	episodes
Change in Number of Urinary Urge Incontinence Episodes	BOTOX 100 U	Week 2	-18.6	episodes
Change in Number of Urinary Urge Incontinence Episodes	BOTOX 150 U	Week 2	-20.8	episodes

1 to 10 of 138Source ClinicalTrials.gov

See all 138 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	44
Overall Study	STARTED	BOTOX 50 U	57
Overall Study	STARTED	BOTOX 100 U	54
Overall Study	STARTED	BOTOX 150 U	49
Overall Study	STARTED	BOTOX 200 U	53
Overall Study	STARTED	BOTOX 300 U	56
Overall Study	COMPLETED	Placebo	37
Overall Study	COMPLETED	BOTOX 50 U	50
Overall Study	COMPLETED	BOTOX 100 U	48
Overall Study	COMPLETED	BOTOX 150 U	40

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events402

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Urinary tract infection	Infections and infestations	Placebo	7	43
other	Urinary tract infection	Infections and infestations	BOTOX 50 U	19	56
other	Urinary tract infection	Infections and infestations	BOTOX 100 U	20	55
other	Urinary tract infection	Infections and infestations	BOTOX 150 U	22	50
other	Urinary tract infection	Infections and infestations	BOTOX 200 U	25	52
other	Urinary tract infection	Infections and infestations	BOTOX 300 U	19	55
other	Upper respiratory tract infection	Infections and infestations	Placebo	2	43
other	Upper respiratory tract infection	Infections and infestations	BOTOX 50 U	3	56
other	Upper respiratory tract infection	Infections and infestations	BOTOX 100 U	3	55
other	Upper respiratory tract infection	Infections and infestations	BOTOX 150 U	4	50

1 to 10 of 402Source ClinicalTrials.gov

See all 402 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Placebo
Total, all-cause mortality	BOTOX 50 U
Total, all-cause mortality	BOTOX 100 U
Total, all-cause mortality	BOTOX 150 U
Total, all-cause mortality	BOTOX 200 U
Total, all-cause mortality	BOTOX 300 U
Total, other adverse events	Placebo	33
Total, other adverse events	BOTOX 50 U	44
Total, other adverse events	BOTOX 100 U	44
Total, other adverse events	BOTOX 150 U	39

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22464310	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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