Clinical trial NCT02522936: Use of Biotene Moisturizing Mouth Spray for Xerostomia Associated With Oral Oxybutynin Use
Official title: Use of Biotene Moisturizing Mouth Spray for Xerostomia Associated With Oral Oxybutynin Use
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Overactive Bladder
Xerostomia
Compliance
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Discontinuation rate of oxybutynin at 6 month by patient report
timeFrame: 6 months
Secondary outcomes:
measure: Discontinuation rate of oxybutynin at 6 months based on pill count
timeFrame: 6 months
measure: Discontinuation rate of oxybutynin at 3 months as measured by patient report
timeFrame: 3 months
measure: Discontinuation rate of oxybutynin at 3 months as measured by pill count
timeFrame: 3 months
measure: Symptoms of dry mouth as measured by global xerostomia question
timeFrame: 3 months
measure: Number of daily voids as measured by voiding diary
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern California
name: Christina Dancz
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.