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

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.

Study Overview

• Status: Withdrawn
• Conditions: Overactive Bladder; Xerostomia; Compliance
• Intervention / Treatment: Drug: Biotene oral spray

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.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biotene; Participants will be given Biotene oral spray to use as needed when taking oxybutynin.	Drug: Biotene oral spray; Biotene oral spray will be provided to participants.; Other Names: Biotene; Mouth spray
No Intervention: Routine care; Participants will be given routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Discontinuation rate of oxybutynin at 6 month by patient report	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Study Chair: Christina Dancz, University of Southern California

Publications and helpful links

General Publications

• Versi E, Appell R, Mobley D, Patton W, Saltzstein D. Dry mouth with conventional and controlled-release oxybutynin in urinary incontinence. The Ditropan XL Study Group. Obstet Gynecol. 2000 May;95(5):718-21. doi: 10.1016/s0029-7844(99)00661-4.
• Epstein JB, Emerton S, Le ND, Stevenson-Moore P. A double-blind crossover trial of Oral Balance gel and Biotene toothpaste versus placebo in patients with xerostomia following radiation therapy. Oral Oncol. 1999 Mar;35(2):132-7. doi: 10.1016/s1368-8375(98)00109-2.
• Nelken RS, Ozel BZ, Leegant AR, Felix JC, Mishell DR Jr. Randomized trial of estradiol vaginal ring versus oral oxybutynin for the treatment of overactive bladder. Menopause. 2011 Sep;18(9):962-6. doi: 10.1097/gme.0b013e3182104977.
• Matear DW, Barbaro J. Effectiveness of saliva substitute products in the treatment of dry mouth in the elderly: a pilot study. J R Soc Promot Health. 2005 Jan;125(1):35-41. doi: 10.1177/146642400512500113.
• Thomson WM, van der Putten GJ, de Baat C, Ikebe K, Matsuda K, Enoki K, Hopcraft MS, Ling GY. Shortening the xerostomia inventory. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Sep;112(3):322-7. doi: 10.1016/j.tripleo.2011.03.024. Epub 2011 Jul 16.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): July 31, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: August 12, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Urinary Bladder, Overactive; Xerostomia; Anti-Infective Agents; Muramidase
• Other Study ID Numbers: HS-14-00800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No