Oxybutynin and Omega-3 for OAB (Overactive Bladder)

• ClinicalTrials.gov Identifier: NCT02070042
• Recruitment Status: Terminated
• First Posted: February 24, 2014
• Last Update Posted: January 31, 2018
• Sponsor: TriHealth Inc.
• Information provided by (Responsible Party): TriHealth Inc.

Tracking Information

• First Submitted Date: February 13, 2014
• First Posted Date: February 24, 2014
• Last Update Posted Date: January 31, 2018
• Study Start Date: February 2014
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 29, 2018)

Change from baseline in urinary voids per day [ Time Frame: Baseline, 3 weeks and 6 weeks after enrollment ]

The number of times the subjects urinates per day will be decreased

• Original Primary Outcome Measures (submitted: February 20, 2014): Change from baseline in urinary voids per day [ Time Frame: Baseline, 3 weeks and 6 weeks after enrollment ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oxybutynin and Omega-3 for OAB (Overactive Bladder)
• Official Title: Randomized Controlled Trial of Oxybutynin and Omega-3 Fatty Acid Supplementation Versus Oxybutynin and Placebo for Treatment of Overactive Bladder in Women

Brief 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Overactive Bladder

Intervention

• 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
  Other Name: Olive Oil

Study Arms

• 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.
  Intervention: Drug: Omega 3 Fatty Acid
• Placebo Comparator: Placebo
  Seagate® Extra Virgin Olive oil capsules
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 20, 2015): 31
• Original Estimated Enrollment (submitted: February 20, 2014): 226
• Actual Study Completion Date: September 2015
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02070042
• Other Study ID Numbers: 13105-13-057
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: TriHealth Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: TriHealth Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Rachel Pauls, MD; TriHealth Inc.

• PRS Account: TriHealth Inc.
• Verification Date: January 2018