Oxybutynin and Omega-3 for OAB (Overactive Bladder)

NCT02070042 | Terminated

• 1 other identifier: 13105-13-057
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Overactive Bladder

Keywords

Overactive Bladder; Oxybutynin; Omega -3 Fatty Acid

Outcome Measures

Primary Outcomes (1)

• Change from baseline in urinary voids per day

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

  Baseline, 3 weeks and 6 weeks after enrollment

Study Arms (2)

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.

Drug: Omega 3 Fatty Acid

Placebo

PLACEBO COMPARATOR

Seagate® Extra Virgin Olive oil capsules

Drug: Placebo

Interventions

Omega 3 Fatty Acid DRUG

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

Omega- 3 Fatty Acid

Placebo DRUG

Placebo capsules (olive oil) twice a day

Also known as: Olive Oil

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Fatty Acids, Omega-3; Olive Oil

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Rachel Pauls, MD

  TriHealth Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 24, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 31, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)