A Study to Evaluate the Safety and Efficacy of OROS® Oxybutynin Chloride for the Treatment of Urge Urinary Incontinence
Information source: Alza Corporation, DE, USA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Incontinence
Intervention: OROS® oxybutynin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alza Corporation, DE, USA Official(s) and/or principal investigator(s): Alza Corporation Clinical Trial, Study Director, Affiliation: Alza Corporation, DE, USA
Summary
The purpose of this study is to is to evaluate the safety and efficacy of OROS® oxybutynin
chloride in patients being treated for urge urinary incontinence. Oxybutynin is an
antispasmodic, anticholinergic medication for the treatment of the symptoms of overactive
bladder.
Clinical Details
Official title: Open-Label Safety And Dose Conversion/Determination Study of OROS® Oxybutynin Chloride for Urge Urinary Incontinence
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of adverse events; Results from Physician's Anticholinergic Effects Assessment (P-ACEA)
Secondary outcome: Change from Week 1 to Week 12 of Maintenance Period in: Urge urinary incontinence episodes per week; Urinary incontinence episodes per week; Void frequency per week
Detailed description:
Urinary incontinence refers to the involuntary loss of urine in sufficient amounts to be
considered a social or health problem. It is under-reported and under-treated as patients
are often ashamed and embarrassed to discuss their condition and clinicians may also fail to
ask patients about incontinence. This is a multi-center, open-label study including dose
conversion and dose determination to evaluate the safety of OROS® oxybutynin chloride at a
clinically acceptable dose. There are three study periods: Run-in, Dose
Conversion/Determination, and Maintenance. During the 1-week Run-in Period, baseline
incontinence, urinary frequency, and health related quality-of-life data are collected.
During the Dose Conversion/Determination Period, any previous urge urinary incontinence
medications are discontinued and each patient is started on OROS® oxybutynin chloride. The
dose is titrated to a clinically acceptable dose in 5-mg increments at 7 ± 3 day intervals
to a possible maximum dose of 30 mg/day. The clinically acceptable dose is defined as
either the minimum effective dose (i. e., the dose at which the patient has no incontinent
episodes for the last 2 days of the dosing interval) or the dose providing the best balance
between symptomatic improvement and side effects. Patients taking immediate-release
oxybutynin at enrollment started dose titration on OROS® oxybutynin chloride at a dose equal
to their immediate-release oxybutynin dose; all others started at 5 mg per day OROS®
(oxybutynin chloride). After the clinically acceptable dose is established, the patient
continues for an additional week at that dose to confirm that it is appropriate. Then the
patient enters the 12-week Maintenance Period that evaluates whether the urge urinary
incontinence reduction that is achieved by the beginning of maintenance has persisted. The
primary outcome of the study is an evaluation of the safety of OROS® oxybutynin chloride.
Safety assessments include the incidence of adverse events, physical examination and medical
history, clinical laboratory tests, urinalysis, electrocardiograms (ECGs), vital signs, and
the Physician's Anticholinergic Effects Assessment (P-ACEA), an assessment completed by the
physician if severe or intolerable anticholinergic effects occur.
OROS® oxybutynin chloride (5 mg and 10 mg systems): One to five systems taken orally per day
(5 mg per day to a maximum of 30 mg per day) as a single morning dose. The duration of the
Maintenance Period of the study is 12 weeks.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with non-neurogenic urge urinary incontinence, neurogenic urge urinary
incontinence, or mixed urge urinary incontinence with a clinically significant urge
component
- Patients currently taking medications for urge urinary incontinence (that are listed
in the protocol) including immediate-release oxybutynin chloride, or patients not
currently taking medication for urge urinary incontinence who have had at least 6
urge urinary incontinence episodes during the 1-week Run-in Period
- Patients who are able to differentiate incontinent episodes associated with urgency
from incontinent episodes not associated with urgency when recording incontinent
episodes in the diary
- Patients who are in good general health prior to study participation, without
significant bacteria or fewer than 10 WBC/hpf on urinalysis, or a negative urine
culture
- Patients agreeing that a medically acceptable and effective birth control method will
be used by the patient and partner throughout the study and for one week following
the end of the study-drug treatment
Exclusion Criteria:
- Patients with known treatable genitourinary conditions that may cause incontinence
(e. g., urinary tract infection, prostatitis, urinary tract obstruction, bladder
tumor, bladder stone, prostate cancer)
- Patients with narrow-angle glaucoma or untreated narrow anterior chamber angles
obstructive uropathy, partial or complete obstruction or narrowing of the
gastrointestinal tract, paralytic ileus, intestinal atony, colitis or myasthenia
gravis
- Patients with known allergy or hypersensitivity to oxybutynin chloride, or with
clinically significant medical problems or other organ abnormality or pathology for
whom, administration of oxybutynin chloride would present undue risk
- Male patients who have had prostate surgery less than six months before study
enrollment or any history of prostate cancer
- Patients who have been treated with anticholinergic medications for urge urinary
incontinence and have been found to be not responsive to these treatments, and
patients who are at significant risk of developing complete urinary retention if
placed on an anticholinergic medication
Locations and Contacts
Additional Information
Open-label safety and dose conversion/determination study of OROS® (oxybutynin chloride) for urge urinary incontinence
Starting date: March 1997
Last updated: May 18, 2011
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