Oxybutynin and Omega-3 for OAB (Overactive Bladder)
Information source: TriHealth Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder
Intervention: Omega 3 Fatty Acid (Drug)
Phase: N/A
Status: Terminated
Sponsored by: TriHealth Inc. Official(s) and/or principal investigator(s):
Rachel Pauls, MD, Study Chair, Affiliation: TriHealth Inc.
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
Clinical Details
Official title: Randomized Controlled Trial of Oxybutynin and Omega-3 Fatty Acid Supplementation Versus Oxybutynin and Placebo for Treatment of Overactive Bladder in Women
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline in urinary voids per day
Detailed description:
Overactive bladder (OAB) is a troubling condition affecting over 17 million people in the
U. S. with an estimated prevalence of 16. 9% among women. The cost of this burden nationally
was estimated at $66 billion in 2007. The morbidity of the disease impacts quality of life
scores and increases risks of falls and fractures.
First-line therapeutic modalities for OAB focus on anticholinergic medications and
behavioral modification. However, the indirect impact of these medications on the gut and
salivary glands, have been troubling. Resultant side effect profiles with anticholinergic
medications have caused a high rate of cessation, with some studies showing as low as 14% of
patients still taking their medication at a one-year follow up. Given the burden and
morbidity associated with this highly prevalent condition among women, our aim is to improve
our therapeutic options, while possibly reducing subsequent side effects. As such, there is
potential to revolutionize treatment for this condition.
Omega-3 fatty acids have been evaluated with success in treating many medical conditions.
Specifically, diseases with an inflammatory component, such as Crohn's disease, ulcerative
colitis, and rheumatoid arthritis have seen promising improvements with the addition of
Omega-3 fatty acids. Other studies have shown a beneficial role in the treatment of dry
eyes, depression, burn injuries, and even cancer. Although not previously explored in the
setting of irritative bladder conditions, we believe that Omega-3 fatty acids may be helpful
in interventions for OAB via several purported mechanisms.
Prostaglandin E2 (PGE2) and inflammation have both been implicated in the biochemistry of
overactive bladder. Reduction in PGE2 may be paramount in reducing the symptoms of
overactive bladder. In fact, a proposed mechanism of action of the success of
anticholinergic medications, commonly first line treatment for OAB, is reduction of PGE2.
Animal models have demonstrated that non-steroidal anti-inflammatory drugs (NSAIDs) can be
used to decrease micturition frequency, which is thought to be a result of the
anti-inflammatory process. In humans, anti-inflammatory medications have been shown to
decrease nocturia and even cause urinary retention in high doses. Omega-3 fatty acids have
been shown to have anti-inflammatory actions and the ability to reduce PGE2. We therefore,
have reason to believe it may be an effective adjunct to current therapy to improve
overactive bladder symptoms.
Additionally, Omega-3 fatty acids have been implemented in the treatment of dry eyes and
animal studies have shown their role in increasing intestinal motility. Hence, we propose
that Omega-3 fatty acids may help alleviate the common side effects of dry eyes and
constipation associated with common anticholinergic therapies.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
Women between the ages of 18-85; Desiring treatment for symptoms of urinary frequency,
defined as >8 voids/day and/or nocturia > 1 void/night or urge incontinence episodes of
>1/day
Exclusion Criteria:
Bleeding disorder; Uncontrolled diabetes; Hypotension; Liver disease, such as hepatitis
A/B/C, cirrhosis, acute fatty liver, liver tumors; Post voiding residual (PVR) > 150 on
more than one occasion; Uncontrolled narrow-angle glaucoma; Hematuria of unknown cause;
Obstructive uropathy; Known hypersensitivity to study medications; Recent use of
study/omega 3 or anticholinergic medication in the prior 3 weeks with an inability to
discontinue this medication; Planning any surgery in the 6 weeks of study duration
Locations and Contacts
Good Samaritan Hospital, Cincinnati, Ohio 45220, United States
Additional Information
Starting date: February 2014
Last updated: April 7, 2015
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