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Recruitment Status : Withdrawn (Due to lack of funding and necessary personnel we determined that the study could not be done.)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
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Xerostomia Compliance||Drug: Biotene oral spray||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
No Intervention: Routine care
Participants will be given routine care.
- Discontinuation rate of oxybutynin at 6 month by patient report [ Time Frame: 6 months ]
- Discontinuation rate of oxybutynin at 6 months based on pill count [ Time Frame: 6 months ]
- Discontinuation rate of oxybutynin at 3 months as measured by patient report [ Time Frame: 3 months ]
- Discontinuation rate of oxybutynin at 3 months as measured by pill count [ Time Frame: 3 months ]
- Symptoms of dry mouth as measured by global xerostomia question [ Time Frame: 3 months ]
- Number of daily voids as measured by voiding diary [ Time Frame: 3 months ]
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
|Study Chair:||Christina Dancz||University of Southern California|