Trial · NCT00350636

A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

NCT00350636, Phase 3, Completed, Watson Pharmaceuticals; results first posted 2010-05-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo. Trials, record NCT00350636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00350636

On this page

Trial

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

Title: A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
NCT number: NCT00350636
Status: Completed
Phases: Phase 3
Enrollment: 789 participants, actual
Lead sponsor: Watson Pharmaceuticals
Conditions: Overactive Bladder
Interventions: Oxybutynin topical gel, Placebo topical gel
First posted: 2006-07-11
Last updated: 2010-05-10
Results first posted: 2010-05-10

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Baseline Average Number of Daily Incontinence Episodes	Baseline	Average number of daily incontinence episodes at baseline
Primary	Change From Baseline in Average Daily Number of Incontinence Episodes	Baseline to Week 12	Change from Baseline to Week 12 in average daily number of incontinence episodes
Secondary	Baseline Average Daily Urinary Frequency	Baseline	Number of daily urinary voids
Secondary	Change From Baseline in Average Daily Urinary Frequency	Baseline to 12 weeks	Change from baseline in average daily urinary frequency
Secondary	Baseline Average Urine Void Volume	Baseline	Baseline average urine void volume
Secondary	Change From Baseline in Average Urine Void Volume	Change from Baseline to Week 12	Change from baseline to Week 12 in average urine void volume

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Baseline Average Number of Daily Incontinence Episodes	Baseline	Number of episodes	MEAN
SECONDARY	Baseline Average Daily Urinary Frequency	Baseline	Number of urinary episodes	MEAN
SECONDARY	Change From Baseline in Average Daily Urinary Frequency	Baseline to 12 weeks	Number of urinary episodes	MEAN
PRIMARY	Change From Baseline in Average Daily Number of Incontinence Episodes	Baseline to Week 12	Number of episodes	MEAN
SECONDARY	Baseline Average Urine Void Volume	Baseline	mL	MEAN
SECONDARY	Change From Baseline in Average Urine Void Volume	Change from Baseline to Week 12	mL	MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Baseline Average Number of Daily Incontinence Episodes	Oxybutynin Topical Gel	5.4	Standard Deviation 3.26	Number of episodes
Baseline Average Number of Daily Incontinence Episodes	Placebo Topical Gel	5.4	Standard Deviation 3.28	Number of episodes
Baseline Average Daily Urinary Frequency	Oxybutynin Topical Gel	12.4	Standard Deviation 3.34	Number of urinary episodes
Baseline Average Daily Urinary Frequency	Placebo Topical Gel	12.2	Standard Deviation 3.32	Number of urinary episodes
Change From Baseline in Average Daily Urinary Frequency	Oxybutynin Topical Gel	-2.7	Standard Deviation 3.21	Number of urinary episodes
Change From Baseline in Average Daily Urinary Frequency	Placebo Topical Gel	-2.0	Standard Deviation 2.82	Number of urinary episodes
Change From Baseline in Average Daily Number of Incontinence Episodes	Oxybutynin Topical Gel	-3.0	Standard Deviation 2.73	Number of episodes
Change From Baseline in Average Daily Number of Incontinence Episodes	Placebo Topical Gel	-2.5	Standard Deviation 3.06	Number of episodes
Baseline Average Urine Void Volume	Oxybutynin Topical Gel	163.4	Standard Deviation 65.85	mL
Baseline Average Urine Void Volume	Placebo Topical Gel	167.9	Standard Deviation 68.40	mL

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Oxybutynin Topical Gel	389
Overall Study	STARTED	Placebo Topical Gel	400
Overall Study	COMPLETED	Oxybutynin Topical Gel	346
Overall Study	COMPLETED	Placebo Topical Gel	355
Overall Study	NOT COMPLETED	Oxybutynin Topical Gel	43
Overall Study	NOT COMPLETED	Placebo Topical Gel	45

Source ClinicalTrials.gov

Adverse events60

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	Events
other	Application site pruritis	General disorders	Oxybutynin Topical Gel	8	389	10
other	Application site pruritis	General disorders	Placebo Topical Gel	3	400	3
other	Bronchitis	Infections and infestations	Oxybutynin Topical Gel	9	389	9
other	Bronchitis	Infections and infestations	Placebo Topical Gel	9	400	11
other	Constipation	Gastrointestinal disorders	Oxybutynin Topical Gel	7	389	7
other	Constipation	Gastrointestinal disorders	Placebo Topical Gel	8	400	9
other	Diarrhea	Gastrointestinal disorders	Oxybutynin Topical Gel	9	389	11
other	Diarrhea	Gastrointestinal disorders	Placebo Topical Gel	13	400	13
other	Dizziness	Nervous system disorders	Oxybutynin Topical Gel	11	389	12
other	Dizziness	Nervous system disorders	Placebo Topical Gel	4	400	4

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oxybutynin Topical Gel
Total, all-cause mortality	Placebo Topical Gel
Total, other adverse events	Oxybutynin Topical Gel	176	389
Total, other adverse events	Placebo Topical Gel	145	400
Total, serious adverse events	Oxybutynin Topical Gel	7	389
Total, serious adverse events	Placebo Topical Gel	10	400

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19233423	RESULT	PubMed
37160401	DERIVED	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 comparisons1

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

Comparison
Oxybutynin Topical Gel vs Placebo Topical Gel: serious adverse events

Source Trial comparisons

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00350636

GET https://conductscience.org/api/trials/v1/NCT00350636/events?page=2

API reference For AI assistants