Oxybutynin and Omega-3 for OAB (Overactive Bladder)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by TriHealth Inc.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT02070042
First received: February 13, 2014
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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

Condition Intervention
Overactive Bladder
Drug: Omega 3 Fatty Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Oxybutynin and Omega-3 Fatty Acid Supplementation Versus Oxybutynin and Placebo for Treatment of Overactive Bladder in Women

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • Change from baseline in urinary voids per day [ Time Frame: Baseline, 3 weeks and 6 weeks after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 226
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omega- 3 Fatty Acid
The patient will receive oxybutynin 5 mg twice daily (BID). The patients in the study group will receive a 0.9 gm capsule of Omega-3 BID. The amount of medication was chosen based on dosage used in prior studies and the current FDA recommendations to not exceed 2gm/day of omega-3 in dietary supplementation.
Drug: Omega 3 Fatty Acid
Trunature® Triple Strength Omega-3. Each capsule contains 647 mg Eicosapentaenoic Acid (EPA) and 253 mg Docosahexaenoic Acid (DHA).
Other Name: Fish Oil
Placebo Comparator: Placebo
Seagate® Extra Virgin Olive oil capsules

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070042

Contacts
Contact: Donna Mazloomdoost, MD 513-862-4171 donna_mazloomdoost@trihealth.com
Contact: Vivian Ghodsi, RN 513-853-4213 vivian_ghodsi@trihealth.com

Locations
United States, Ohio
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Vivian Ghodsi, RN CCRC    513-853-4213    vivian_ghodsi@trihealth.com   
Principal Investigator: Donna Mazloomdoost, MD         
Sponsors and Collaborators
TriHealth Inc.
Investigators
Study Chair: Rachel Pauls, MD TriHealth Inc.
  More Information

No publications provided

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02070042     History of Changes
Other Study ID Numbers: 13105-13-057
Study First Received: February 13, 2014
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:
Overactive Bladder
Oxybutynin
Omega -3 Fatty Acid

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014