Trial · NCT00909181

Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

NCT00909181, Phase 3, Completed, Antares Pharma Inc.; results first posted 2011-01-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence. Trials, record NCT00909181. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00909181

On this page

Trial

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

Title: Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
NCT number: NCT00909181
Status: Completed
Phases: Phase 3
Enrollment: 626 participants, actual
Lead sponsor: Antares Pharma Inc.
Conditions: Urge Urinary Incontinence, Urinary Frequency
Interventions: Oxybutynin, Placebo
First posted: 2009-05-27
Last updated: 2014-07-02
Results first posted: 2011-01-19

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12	12 weeks	Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12	12 weeks	mITT (modified intended to treatment) per protocol Difference between Baseline and after 12 weeks treatment	Episodes	MEAN

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12	Oxybutynin Gel 56 mg/Day	-24.8	Standard Deviation 28.7	Episodes
Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12	Oxybutynin Gel 84 mg/Day	-21.9	Standard Deviation 25.1	Episodes
Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12	Placebo Gel	-20.0	Standard Deviation 27.0	Episodes

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Oxybutynin Gel 56 mg/Day	210
Overall Study	STARTED	Oxybutynin Gel 84 mg/Day	214
Overall Study	STARTED	Placebo Gel	202
Overall Study	COMPLETED	Oxybutynin Gel 56 mg/Day	171
Overall Study	COMPLETED	Oxybutynin Gel 84 mg/Day	196
Overall Study	COMPLETED	Placebo Gel	169
Overall Study	NOT COMPLETED	Oxybutynin Gel 56 mg/Day	39
Overall Study	NOT COMPLETED	Oxybutynin Gel 84 mg/Day	18
Overall Study	NOT COMPLETED	Placebo Gel	33

Source ClinicalTrials.gov

Adverse events69

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	Dry mouth	Gastrointestinal disorders	Oxybutynin Gel 56 mg/Day	23	210
other	Dry mouth	Gastrointestinal disorders	Oxybutynin Gel 84 mg/Day	26	214
other	Dry mouth	Gastrointestinal disorders	Placebo Gel	10	202
other	Constipation	Gastrointestinal disorders	Oxybutynin Gel 56 mg/Day	3	210
other	Constipation	Gastrointestinal disorders	Oxybutynin Gel 84 mg/Day	8	214
other	Constipation	Gastrointestinal disorders	Placebo Gel	5	202
other	Diarrhoe	Gastrointestinal disorders	Oxybutynin Gel 56 mg/Day	5	210
other	Diarrhoe	Gastrointestinal disorders	Oxybutynin Gel 84 mg/Day	2	214
other	Diarrhoe	Gastrointestinal disorders	Placebo Gel	1	202
other	Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	Oxybutynin Gel 56 mg/Day	6	210

1 to 10 of 69Source ClinicalTrials.gov

See all 69 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oxybutynin Gel 56 mg/Day
Total, all-cause mortality	Oxybutynin Gel 84 mg/Day
Total, all-cause mortality	Placebo Gel
Total, other adverse events	Oxybutynin Gel 56 mg/Day	98	210
Total, other adverse events	Oxybutynin Gel 84 mg/Day	90	214
Total, other adverse events	Placebo Gel	53	202
Total, serious adverse events	Oxybutynin Gel 56 mg/Day	3	210
Total, serious adverse events	Oxybutynin Gel 84 mg/Day	4	214
Total, serious adverse events	Placebo Gel	2	202

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

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/NCT00909181

GET https://conductscience.org/api/trials/v1/NCT00909181/events?page=2

API reference For AI assistants