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

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ClinicalTrials.gov Identifier: NCT02522936
Recruitment Status : Withdrawn (Due to lack of funding and necessary personnel we determined that the study could not be done.)
First Posted : August 13, 2015
Last Update Posted : July 12, 2018
Information provided by (Responsible Party):
Begum Ozel, 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Xerostomia Compliance Drug: Biotene oral spray Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Biotene Moisturizing Mouth Spray for Xerostomia Associated With Oral Oxybutynin Use
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth
Drug Information available for: Oxybutynin

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.

Primary Outcome Measures :
  1. Discontinuation rate of oxybutynin at 6 month by patient report [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Discontinuation rate of oxybutynin at 6 months based on pill count [ Time Frame: 6 months ]
  2. Discontinuation rate of oxybutynin at 3 months as measured by patient report [ Time Frame: 3 months ]
  3. Discontinuation rate of oxybutynin at 3 months as measured by pill count [ Time Frame: 3 months ]
  4. Symptoms of dry mouth as measured by global xerostomia question [ Time Frame: 3 months ]
  5. Number of daily voids as measured by voiding diary [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522936

Sponsors and Collaborators
University of Southern California
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Study Chair: Christina Dancz University of Southern California
Publications of Results:
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Responsible Party: Begum Ozel, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02522936    
Other Study ID Numbers: HS-14-00800
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents