Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

Antares Pharma

Status and phase: Completed; Phase 3

Conditions: Urinary Frequency; Urge Urinary Incontinence

Treatments: Drug: Placebo; Drug: Oxybutynin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909181

20070060

Details and patient eligibility

About

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.

Enrollment: 626 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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626 participants in 3 patient groups, including a placebo group

Oxybutynin Gel 56 mg/day

Experimental group

Treatment:

Drug: Oxybutynin

Drug: Placebo

Oxybutynin Gel 84 mg/day

Experimental group

Treatment:

Drug: Oxybutynin

Drug: Placebo

Placebo Gel

Placebo Comparator group

Treatment:

Drug: Oxybutynin

Drug: Placebo