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| Sponsored by: |
IWK Health Centre |
|---|---|
| Information provided by: | IWK Health Centre |
| ClinicalTrials.gov Identifier: | NCT00780832 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Overactive Bladder |
Behavioral: Dietary Caffeine reduction Drug: Anticholinergic medication |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Caffeine reduction
|
Behavioral: Dietary Caffeine reduction
Participants are counseled about reduction of dietary caffeine, given written information and a bladder control log.
|
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2: Active Comparator
Anticholinergic medication
|
Drug: Anticholinergic medication
Ditropan XL 10mg. orally, once daily for 30 days
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cora A Fanning, BN, RN | (902)470-7158 | cora.fanning@iwk.nshealth.ca |
| Contact: Scott A Farrell, MD, FRCSC | (902)470-6799 | scott.farrell@iwk.nshealth.ca |
| Canada, Nova Scotia | |
| IWK Health Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Contact: Scott A Farrell, MD, FRCSC (902)470-6799 scott.farrell@iwk.nshealth.ca | |
| Contact: Cora A Fanning, BN (902)470-7158 cora.fanning@iwk.nshealth.ca | |
| Principal Investigator: Kimberly Trites, MD, FRCSC | |
| Principal Investigator: | Kimberly Trites, MD, FRCSC | IWK Health Centre |
More Information
| Responsible Party: | IWK Health Centre ( Dr. Kimberly Trites ) |
| Study ID Numbers: | REB #4121 |
| Study First Received: | October 27, 2008 |
| Last Updated: | October 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00780832 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
overactive bladder dietary caffeine anticholinergic medication |
lifestyle modification incontinence urinary frequency |
|
Caffeine citrate Oxybutynin Urinary Bladder, Overactive Neurotransmitter Agents Cystocele Cholinergic Antagonists Urinary Bladder Diseases Citric Acid |
Central Nervous System Stimulants Cholinergic Agents Signs and Symptoms Phosphodiesterase Inhibitors Urologic Diseases Urinary Incontinence Caffeine |
|
Caffeine citrate Urinary Bladder, Overactive Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urinary Bladder Diseases Enzyme Inhibitors Central Nervous System Stimulants |
Cholinergic Agents Pharmacologic Actions Urological Manifestations Signs and Symptoms Phosphodiesterase Inhibitors Urologic Diseases Therapeutic Uses Caffeine Central Nervous System Agents |
