Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
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First Received Date ICMJE | October 27, 2008 | ||||||||
Last Updated Date | July 22, 2011 | ||||||||
Start Date ICMJE | May 2008 | ||||||||
Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Change in Bladder Function Questionnaire score [ Time Frame: 30 days ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00780832 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
Does the amount of caffeine consumed relate to symptom severity? [ Time Frame: 30 days ] [ Designated as safety issue: No ] | ||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder | ||||||||
Official Title ICMJE | Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder | ||||||||
Brief Summary | The purpose of this study is to assess the effects of caffeine reduction/elimination on urinary symptoms in women with overactive bladders and compare this therapeutic approach to anticholinergic therapy. We hope to show a reduction in symptoms with caffeine reduction and determine how effective caffeine reduction is compared to medication. If caffeine reduction is shown to be beneficial, women may be encouraged to use this strategy before resorting to medications. |
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Detailed Description | 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. Research Questions
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | |||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Overactive Bladder | ||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 60 | ||||||||
Estimated Completion Date | July 2013 | ||||||||
Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||||||
Ages | |||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Canada | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00780832 | ||||||||
Other Study ID Numbers ICMJE | REB #4121 | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Dr. Scott Farrell, IWK Health Centre | ||||||||
Study Sponsor ICMJE | IWK Health Centre | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | IWK Health Centre | ||||||||
Verification Date | July 2011 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |