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Oxybutynin and Omega-3 for OAB (Overactive Bladder)

NCT02070042 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-01-31

No results posted yet for this study

Summary

We aim to evaluate whether the addition of Omega-3 fatty acids to oxybutynin, a standard first-line treatment for overactive bladder syndrome, will improve symptoms and quality of life. Secondarily, we will evaluate whether Omega-3 fatty acids help reduce the adverse effects of oxybutynin.

Hypothesis

* Primary: Omega-3 will enhance the beneficial role of oxybutynin in the treatment of overactive bladder (OAB)
* Secondary: Omega-3 will reduce the side effects of dry eyes and constipation associated with oxybutynin

Conditions

Interventions

DRUG

Omega 3 Fatty Acid

Trunature® Triple Strength Omega-3, given twice a day. Each capsule contains 647 mg Eicosapentaenoic Acid (EPA) and 253 mg Docosahexaenoic Acid (DHA).

DRUG

Placebo

Placebo capsules (olive oil) twice a day

Sponsors & Collaborators

  • TriHealth Inc.

    lead OTHER

Principal Investigators

  • Rachel Pauls, MD · TriHealth Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02070042 on ClinicalTrials.gov