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

• Status: Withdrawn
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Treatments: Muramidase; Oxybutynin

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).