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Overactive BladderNCT02070042

Oxybutynin and Omega-3 for OAB (Overactive Bladder)

A study testing Omega 3 Fatty Acid in people with Overactive Bladder, run by TriHealth Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years, women onlyHealthy volunteers can take part
Conditions the study is for
Overactive Bladder
What is being tested?
Omega 3 Fatty Acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteUnited States
Study dates
Feb 2014to Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

Other trials in United States

About this study

Official title: Randomized Controlled Trial of Oxybutynin and Omega-3 Fatty Acid Supplementation Versus Oxybutynin and Placebo for Treatment of Overactive Bladder in Women

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
Read the 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.

Being tested
Omega 3 Fatty Acid, Placebo
Keywords
Overactive Bladder, Oxybutynin, Omega -3 Fatty Acid
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega 3 Fatty AcidDrug

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

  • PlaceboDrug

    Also called Olive Oil

    Placebo capsules (olive oil) twice a day

Study groups in NCT02070042
Study groupRoleWhat they receive
Omega- 3 Fatty AcidExperimentalThe 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.
Receives: Drug: Omega 3 Fatty Acid
PlaceboPlacebo comparatorSeagate® Extra Virgin Olive oil capsules
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in urinary voids per day

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

    Measured: Baseline, 3 weeks and 6 weeks after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Why it stopped: Lack of participation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02070042
Sponsor's protocol ID
13105-13-057
Status last verified
Jan 2018
First submitted
13 Feb 2014
Last updated
31 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Omega 3 Fatty Acid in people with Overactive Bladder, run by TriHealth Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Lack of participation). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in urinary voids per day (time frame: Baseline, 3 weeks and 6 weeks after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018; AzTrials last refreshed its copy on 1 Nov 2026.

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