Use of Biotene Moisturizing Mouth Spray for Xerostomia Associated With Oral Oxybutynin Use

Phase 4

Withdrawn

• Conditions: Compliance; Overactive Bladder; Xerostomia
• Interventions: Drug: Biotene oral spray

• Registration Number: NCT02522936
• Lead Sponsor: University of Southern California

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-13
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-12
• Study Start: 2018-08-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Age >18
• Able to give informed consent
• Women diagnosed with overactive bladder or urgency incontinence who are being started on oral oxybutynin.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biotene	Biotene oral spray	Participants will be given Biotene oral spray to use as needed when taking oxybutynin.

Primary Outcome Measures

Name	Time	Method
Discontinuation rate of oxybutynin at 6 month by patient report	6 months

Secondary Outcome Measures

Name	Time	Method
Symptoms of dry mouth as measured by global xerostomia question	3 months
Discontinuation rate of oxybutynin at 6 months based on pill count	6 months
Discontinuation rate of oxybutynin at 3 months as measured by pill count	3 months
Number of daily voids as measured by voiding diary	3 months
Discontinuation rate of oxybutynin at 3 months as measured by patient report	3 months