Phase 3 N=626 Randomized Double-blind Treatment

Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

Urge Urinary Incontinence · Urinary Frequency

Bottom Line

View on ClinicalTrials.gov: NCT00909181 ↗

Enrolled (actual)

626

Serious AEs

1.4%

Results posted

Jan 2011

Primary outcome: Primary: Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12 — -24.8; -21.9; -20.0 Episodes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Oxybutynin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Antares Pharma Inc.
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12	-24.8; -21.9; -20.0	—

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00909181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.