NCT02522936

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2018

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
3 years until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

August 12, 2015

Last Update Submit

July 10, 2018

Conditions

Overactive BladderXerostomiaCompliance

Outcome Measures

Primary Outcomes (1)

  • Discontinuation rate of oxybutynin at 6 month by patient report

    6 months

Secondary Outcomes (5)

  • Discontinuation rate of oxybutynin at 6 months based on pill count

    6 months

  • Discontinuation rate of oxybutynin at 3 months as measured by patient report

    3 months

  • Discontinuation rate of oxybutynin at 3 months as measured by pill count

    3 months

  • Symptoms of dry mouth as measured by global xerostomia question

    3 months

  • Number of daily voids as measured by voiding diary

    3 months

Study Arms (2)

Biotene

EXPERIMENTAL

Participants will be given Biotene oral spray to use as needed when taking oxybutynin.

Drug: Biotene oral spray

Routine care

NO INTERVENTION

Participants will be given routine care.

Interventions

Biotene oral sprayDRUG

Biotene oral spray will be provided to participants.

Also known as: Biotene, Mouth spray
Biotene

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18
  • Able to give informed consent
  • Women diagnosed with overactive bladder or urgency incontinence who are being started on oral oxybutynin.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 10775736RESULT

  • 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.

    PMID: 10435146RESULT

  • 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.

    PMID: 21532512RESULT

  • 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.

    PMID: 15712851RESULT

  • 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.

    PMID: 21684773RESULT

MeSH Terms

Conditions

Urinary Bladder, OveractiveXerostomiaPatient Compliance

Interventions

Biotene

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Christina Dancz

    University of Southern California

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 12, 2015

First Posted

August 13, 2015

Study Start

August 1, 2018

Primary Completion

July 31, 2019

Study Completion

December 30, 2019

Last Updated

July 12, 2018

Record last verified: 2018-07