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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 count

Discontinuation 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. Biotčne(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

Page last updated: August 23, 2015

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