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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02522936
• Other study ID #: HS-14-00800
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: July 2018
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Compliance
• Overactive Bladder
• Urinary Bladder, Overactive
• Xerostomia

Intervention

Drug:
• Biotene oral spray
Biotene oral spray will be provided to participants.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

References & Publications (5)

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. — View 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. — View 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. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discontinuation rate of oxybutynin at 6 month by patient report		6 months
Secondary	Discontinuation rate of oxybutynin at 6 months based on pill count		6 months
Secondary	Discontinuation rate of oxybutynin at 3 months as measured by patient report		3 months
Secondary	Discontinuation rate of oxybutynin at 3 months as measured by pill count		3 months
Secondary	Symptoms of dry mouth as measured by global xerostomia question		3 months
Secondary	Number of daily voids as measured by voiding diary		3 months