Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
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|ClinicalTrials.gov Identifier: NCT00780832|
Recruitment Status : Terminated (Insufficient elligible patients available in a reasonable time frame.)
First Posted : October 28, 2008
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Behavioral: Dietary Caffeine reduction Drug: Anticholinergic medication||Not Applicable|
Urinary symptoms such as frequency, urgency, nocturia, and incontinence occur in many women. Overactive bladder (OAB) accounts for forty to seventy percent of urinary incontinence. These symptoms can be mildly annoying to life altering. Many women wear pads or adult diapers daily and avoid social situations for fear of embarrassment. It is felt that up to sixteen percent of the adult population may suffer from these symptoms and many of these women seek medical help.
Currently, the standard of care for OAB includes some combination of lifestyle modification counseling, bladder retraining, or anticholinergic medications. It is anticipated that stimulants such as caffeine irritate the bladder and exacerbate OAB symptoms. There have been a few studies looking at the effect of caffeine but interventions have varied, and the results have been mixed.
Perhaps the most common treatment for significant OAB symptoms is the prescription of anticholinergic medications. We know that these are efficacious in many women but they can be expensive and have significant side effects4. In fact, many women discontinue their anticholinergics due to dry mouth, dry eyes, gastrointestinal, and genitourinary effects.
To date there have been no studies comparing caffeine reduction to anticholinergic medications.
- Does caffeine reduction decrease OAB symptoms?
- Does the amount of caffeine consumed relate to symptom severity?
- If symptoms do improve with caffeine reduction, are women compliant with this treatment?
- How does caffeine reduction compare to anticholinergic medication in treating OAB?
Study Goal:Compare caffeine reduction to anticholinergic medication as a treatment for overactive bladder.
Study Design:Randomized prospective study. Eligible participants will be randomized to either the anticholinergic arm or the caffeine reduction arm.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||April 2013|
Active Comparator: 1
Caffeine reduction through diet and beverage counselling
Behavioral: Dietary Caffeine reduction
Participants are counseled about reduction of dietary caffeine, given written information and a bladder control log.
Other Name: Lifestyle modification
Active Comparator: 2
Drug: Anticholinergic medication
Detrol LA 4mg. orally, once daily for 30 days
- Change in Bladder Function Questionnaire score [ Time Frame: 30 days ]
- Does the amount of caffeine consumed relate to symptom severity? [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780832
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Principal Investigator:||Scott A Farrell, MD, FRCSC||IWK Health Centre|