Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Frequency; Urge Urinary Incontinence
• Intervention / Treatment: Drug: Oxybutynin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 626
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
  • California
    • Laguna Hills, California, United States, 92653
    • Los Angeles, California, United States, 90048
    • San Diego, California, United States, 92103
    • San Diego, California, United States, 92120
  • Connecticut
    • Farmington, Connecticut, United States, 06032
    • New Britain, Connecticut, United States, 06052
  • Florida
    • N. Miami, Florida, United States, 33161
    • New Port Richey, Florida, United States, 34625
    • Pembroke Pines, Florida, United States, 33024
    • Sarasota, Florida, United States, 34232
    • St. Petersburg, Florida, United States, 33710
    • Tampa, Florida, United States, 33607
    • Wellington, Florida, United States, 33414
  • Georgia
    • Columbus, Georgia, United States, 31904
    • Sandy Springs, Georgia, United States, 30328
    • Stockbridge, Georgia, United States, 30281
  • Illinois
    • Evanston, Illinois, United States, 60201
  • Iowa
    • West Des Moines, Iowa, United States, 50266
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
  • Maryland
    • Annapolis, Maryland, United States, 21401
    • Towson, Maryland, United States, 21204
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
    • Saginaw, Michigan, United States, 48604
  • Missouri
    • Chesterfield, Missouri, United States, 63017
  • Nevada
    • Las Vegas, Nevada, United States, 89130
  • New York
    • Brooklyn, New York, United States, 11211
    • Endwell, New York, United States, 13760
    • Kingston, New York, United States, 12401
    • Poughkeepsie, New York, United States, 12601
    • Williamsville, New York, United States, 14221
  • North Carolina
    • Cary, North Carolina, United States, 27518
    • Charlotte, North Carolina, United States, 28209
    • Harrisburg, North Carolina, United States, 28075
    • Raleigh, North Carolina, United States, 27607
    • Raleigh, North Carolina, United States, 27609
    • Salisbury, North Carolina, United States, 28144
    • Wilmington, North Carolina, United States, 28401
    • Winston-Salem, North Carolina, United States, 27103
  • Ohio
    • Wadsworth, Ohio, United States, 44218
  • Oklahoma
    • Bethany, Oklahoma, United States, 73008
  • Oregon
    • Corvallis, Oregon, United States, 97330
  • Pennsylvania
    • Bala Cynwyd, Pennsylvania, United States, 19004
    • Landsdale, Pennsylvania, United States, 19446
  • South Carolina
    • Greenville, South Carolina, United States, 29615
    • Mount Pleasant, South Carolina, United States, 29464
    • Myrtle Beach, South Carolina, United States, 29572
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
  • Tennessee
    • Fayetteville, Tennessee, United States, 37334
  • Utah
    • Provo, Utah, United States, 84604
  • Virginia
    • Richmond, Virginia, United States, 23294
  • Washington
    • Seattle, Washington, United States, 98104
    • Spokane, Washington, United States, 99207

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxybutynin Gel 56 mg/day	Drug: Oxybutynin; 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; Other Names: Anturol; Oxybutynin Gel 3%; Drug: Placebo; 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; Other Names: Anturol; Oxybutynin Gel 3%
Experimental: Oxybutynin Gel 84 mg/day	Drug: Oxybutynin; 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; Other Names: Anturol; Oxybutynin Gel 3%; Drug: Placebo; 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; Other Names: Anturol; Oxybutynin Gel 3%
Placebo Comparator: Placebo Gel	Drug: Oxybutynin; 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; Other Names: Anturol; Oxybutynin Gel 3%; Drug: Placebo; 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; Other Names: Anturol; Oxybutynin Gel 3%

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Antares Pharma Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: May 25, 2009
• First Submitted That Met QC Criteria: May 26, 2009
• First Posted (Estimate): May 27, 2009

Study Record Updates

• Last Update Posted (Estimate): July 2, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Urge; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Anti-Infective Agents, Urinary; Renal Agents; Oxybutynin; Mandelic Acids
• Other Study ID Numbers: 20070060