Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-30 @ 6:29 AM
Study NCT ID:
NCT00780832
Status:
TERMINATED
Last Update Posted:
2016-02-24
First Post:
2008-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
Sponsor:
IWK Health Centre
Organization:
Study Overview
Official Title:
Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
Status:
TERMINATED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient elligible patients available in a reasonable time frame.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
1. Does caffeine reduction decrease OAB symptoms?
2. Does the amount of caffeine consumed relate to symptom severity?
3. If symptoms do improve with caffeine reduction, are women compliant with this treatment?
4. 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.
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
1. Does caffeine reduction decrease OAB symptoms?
2. Does the amount of caffeine consumed relate to symptom severity?
3. If symptoms do improve with caffeine reduction, are women compliant with this treatment?
4. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: