Use of Biotene Moisturizing Mouth Spray for Xerostomia Associated With Oral Oxybutynin Use
Information source: University of Southern California
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder; Xerostomia; Compliance
Intervention: Biotene oral spray (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: University of Southern California Official(s) and/or principal investigator(s): Christina Dancz, Study Chair, Affiliation: University of Southern California
Summary
This is a randomized placebo controlled trial of the use of Biotene versus no treatment in
women receiving oral oxybutynin for overactive bladder. The primary outcome will be rate of
discontinuation of oxybutynin at 6 month.
Clinical Details
Official title: Use of Biotene Moisturizing Mouth Spray for Xerostomia Associated With Oral Oxybutynin Use
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Discontinuation rate of oxybutynin at 6 month by patient report
Secondary outcome: Discontinuation rate of oxybutynin at 6 months based on pill countDiscontinuation rate of oxybutynin at 3 months as measured by patient report Discontinuation rate of oxybutynin at 3 months as measured by pill count Symptoms of dry mouth as measured by global xerostomia question Number of daily voids as measured by voiding diary
Detailed description:
Overactive bladder (OAB) is a common condition affecting roughly 20% of women.
Anticholinergic medications are the main treatment modality for women with OAB; however,
treatment is hampered by high rates of dry mouth which limit tolerability. Discontinuation
rates for anticholinergic medications for dry mouth have been reported to be as high as 71%
at 6 months. Biotène(TM) Moisturizing Mouth Spray is used for xerostomia due to various
etiologies in adults.
The purpose of our study is to determine the rate of discontinuation of oral oxybutynin
therapy for overactive bladder in women using Biotène(TM) Moisturizing Mouth Spray versus no
additional treatment. This is a randomized open label trial. Participants will be randomized
to moisturizing mouth spray versus no additional treatment. Urinary symptoms, xerostomia
symptoms, and compliance with oral oxybutynin will be compared between groups. Our primary
outcome is rate of discontinuation of oral oxybutynin at 6 months.
Assuming a baseline discontinuation rate of 70% at 6 months, and assuming 80% power and α =
0. 05 for a two-sided test, we will require 42 subjects in each group to detect a difference
of 30% in cure rate between the two groups. Assuming followup of 75%, 60 subjects in each
group will be recruited.
Participants within groups will be compared with respect to differences in baseline
demographics, questionnaire scores and compliance with oxybutynin using a Chi Square test
for categorical variable, a T test for normally distributed continuous variables or a Mann
Whitney U test for non-normally distributed or ordinal variables.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Age >18
- Able to give informed consent
- Women diagnosed with overactive bladder or urgency incontinence who are being started
on oral oxybutynin.
Exclusion Criteria:
- Any allergy to Biotène® Moisturizing Mouth Spray or its components
- Any contraindication to oxybutynin, including urinary retention (PVR > 100ml),
gastric retention and other severe decreased gastrointestinal motility conditions,
uncontrolled narrow-angle glaucoma and in patients who are at risk for these
conditions, and patients who have demonstrated hypersensitivity to the drug substance
or other components of the product.
- Using ocular anti-cholinergic agents, treatment for dry mouth or oral
anti-muscarinics in the preceding 3 months.
- Prior history of head/neck surgery or radiation (excluding thyroid surgery).
Locations and Contacts
Additional Information
Starting date: August 2015
Last updated: August 12, 2015
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