--- title: Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence nct_id: NCT00909181 overall_status: COMPLETED phase: PHASE3 sponsor: Antares Pharma Inc. study_type: INTERVENTIONAL primary_condition: Urge Urinary Incontinence countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00909181.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00909181" ct_last_update_post_date: 2014-07-02 last_seen_at: "2026-05-12T06:30:02.085Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence **Official Title:** A Double-Blind, Randomized, Parallel, Placebo-Controlled, Multicenter Study Evaluating the Effect of Treatment With Topically Administered Oxybutynin Gel in Patients With Urinary Frequency, and Urge and Mixed Urinary Incontinence With a Predominance of Urge Incontinence Episodes With an Open-Label Extension **NCT ID:** [NCT00909181](https://clinicaltrials.gov/study/NCT00909181) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 626 - **Lead Sponsor:** Antares Pharma Inc. - **Conditions:** Urge Urinary Incontinence, Urinary Frequency - **Start Date:** 2009-03 - **Completion Date:** 2010-11 - **CT.gov Last Update:** 2014-07-02 ## Brief Summary The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel. The hypothesis is that topically administered oxybutynin gel will decrease (compared to placebo) the number of incontinence episodes per week, average daily urinary frequency, and urinary urgency; increase average urinary void volume; and improve patient quality of life. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Overactive bladder (OAB) symptoms of urge and/or mixed UI with a predominance of urge incontinence for at least 3 months * Have a history of at least 1 - 2 urge episodes and 8 or more voids per day Exclusion Criteria: * Incontinence that is predominantly stress, insensate, or overflow in nature, or incontinence related to chronic illness, anatomical weakness/abnormalities or concomitant medications * PVR volume \> 200 mL or relative PVR \> 50% of pre-void volume as determined by bladder ultrasound * History of urinary retention, gastric retention, or uncontrollable narrow-angle glaucoma, or patients who are at risk for these conditions ``` ## Arms - **Oxybutynin Gel 56 mg/day** (EXPERIMENTAL) - **Oxybutynin Gel 84 mg/day** (EXPERIMENTAL) - **Placebo Gel** (PLACEBO_COMPARATOR) ## Interventions - **Oxybutynin** (DRUG) — Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo - **Placebo** (DRUG) — Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo ## Primary Outcomes - **Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12** _(time frame: 12 weeks)_ — Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline. ## Locations (55) - Birmingham, Alabama, United States - Little Rock, Arkansas, United States - Laguna Hills, California, United States - Los Angeles, California, United States - San Diego, California, United States - San Diego, California, United States - Farmington, Connecticut, United States - New Britain, Connecticut, United States - New Port Richey, Florida, United States - North Miami, Florida, United States - Pembroke Pines, Florida, United States - Sarasota, Florida, United States - St. Petersburg, Florida, United States - Tampa, Florida, United States - Wellington, Florida, United States - Columbus, Georgia, United States - Sandy Springs, Georgia, United States - Stockbridge, Georgia, United States - Evanston, Illinois, United States - West Des Moines, Iowa, United States - Shreveport, Louisiana, United States - Annapolis, Maryland, United States - Towson, Maryland, United States - Watertown, Massachusetts, United States - Grand Rapids, Michigan, United States - Saginaw, Michigan, United States - Chesterfield, Missouri, United States - Las Vegas, Nevada, United States - Brooklyn, New York, United States - Endwell, New York, United States - Kingston, New York, United States - Poughkeepsie, New York, United States - Williamsville, New York, United States - Cary, North Carolina, United States - Charlotte, North Carolina, United States - Harrisburg, North Carolina, United States - Raleigh, North Carolina, United States - Raleigh, North Carolina, United States - Salisbury, North Carolina, United States - Wilmington, North Carolina, United States - Winston-Salem, North Carolina, United States - Wadsworth, Ohio, United States - Bethany, Oklahoma, United States - Corvallis, Oregon, United States - Bala-Cynwyd, Pennsylvania, United States - Landsdale, Pennsylvania, United States - Greenville, South Carolina, United States - Mt. Pleasant, South Carolina, United States - Myrtle Beach, South Carolina, United States - Sioux Falls, South Dakota, United States - Fayetteville, Tennessee, United States - Provo, Utah, United States - Richmond, Virginia, United States - Seattle, Washington, United States - Spokane, Washington, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.|st. petersburg|florida|united states` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.|little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.|laguna hills|california|united states` — added _(2026-05-12)_ - `locations.|los angeles|california|united states` — added _(2026-05-12)_ - `locations.|san diego|california|united states` — added _(2026-05-12)_ - `locations.|farmington|connecticut|united states` — added _(2026-05-12)_ - `locations.|new britain|connecticut|united states` — added _(2026-05-12)_ - `locations.|new port richey|florida|united states` — added _(2026-05-12)_ - `locations.|north miami|florida|united states` — added _(2026-05-12)_ - `locations.|pembroke pines|florida|united states` — added _(2026-05-12)_ - `locations.|sarasota|florida|united states` — added _(2026-05-12)_ - `locations.|tampa|florida|united states` — added _(2026-05-12)_ - `locations.|wellington|florida|united states` — added _(2026-05-12)_ - `locations.|columbus|georgia|united states` — added _(2026-05-12)_ - `locations.|sandy springs|georgia|united states` — added _(2026-05-12)_ - `locations.|stockbridge|georgia|united states` — added _(2026-05-12)_ - `locations.|evanston|illinois|united states` — added _(2026-05-12)_ - `locations.|west des moines|iowa|united states` — added _(2026-05-12)_ - `locations.|shreveport|louisiana|united states` — added _(2026-05-12)_ - `locations.|annapolis|maryland|united states` — added _(2026-05-12)_ - `locations.|towson|maryland|united states` — added _(2026-05-12)_ - `locations.|watertown|massachusetts|united states` — added _(2026-05-12)_ - `locations.|grand rapids|michigan|united states` — added _(2026-05-12)_ - `locations.|saginaw|michigan|united states` — added _(2026-05-12)_ - `locations.|chesterfield|missouri|united states` — added _(2026-05-12)_ - `locations.|las vegas|nevada|united states` — added _(2026-05-12)_ - `locations.|brooklyn|new york|united states` — added _(2026-05-12)_ - `locations.|endwell|new york|united states` — added _(2026-05-12)_ - `locations.|kingston|new york|united states` — added _(2026-05-12)_ - `locations.|poughkeepsie|new york|united states` — added _(2026-05-12)_ - `locations.|williamsville|new york|united states` — added _(2026-05-12)_ - `locations.|cary|north carolina|united states` — added _(2026-05-12)_ - `locations.|charlotte|north carolina|united states` — added _(2026-05-12)_ - `locations.|harrisburg|north carolina|united states` — added _(2026-05-12)_ - `locations.|raleigh|north carolina|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00909181.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00909181* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*