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.
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.
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.
- Conditions
- Overactive Bladder
- 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 group | Role | What they receive |
|---|---|---|
| Omega- 3 Fatty Acid | Experimental | 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. Receives: Drug: Omega 3 Fatty Acid |
| Placebo | Placebo comparator | Seagate® 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.
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.
- First posted24 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Lack of participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Pauls, MD, Study chair, TriHealth Inc.
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Oxybutynin and Omega-3 Fatty Acid Supplementation Versus Oxybutynin and Placebo for Treatment of Overactive Bladder in Women
- ClinicalTrials.gov ID
- NCT02070042
- Acronym / sponsor ID
- 13105-13-057
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder, Oxybutynin, Omega -3 Fatty Acid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participation
- Enrolment
- 31 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega- 3 Fatty Acid | Experimental | Drug: Omega 3 Fatty AcidThe 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. |
| Placebo | Placebo comparator | Drug: PlaceboSeagate® Extra Virgin Olive oil capsules |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 Fatty AcidTrunature® Triple Strength Omega-3, given twice a day. Each capsule contains 647 mg Eicosapentaenoic Acid (EPA) and 253 mg Docosahexaenoic Acid (DHA). | Drug | Omega- 3 Fatty Acid |
| PlaceboAlso: Olive OilPlacebo capsules (olive oil) twice a day | Drug | Placebo |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Lack of participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Pauls, MD study chair
TriHealth Inc.
1 site in 1 country: see every site and its status.
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.