Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder |
- Change in Bladder Function Questionnaire score [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Does the amount of caffeine consumed relate to symptom severity? [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Enrollment: | 8 |
| Study Start Date: | May 2008 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Anticholinergic medication
|
Drug: Anticholinergic medication
Detrol LA 4mg. orally, once daily for 30 days
|
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
- 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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women with OAB symptoms including urgency, frequency (voids ≥8/day), and urge incontinence
- Women who consume > one cup (250ml) caffeinated beverage per day
- Women who score $ 6 on the QUID Questionnaire for urgency symptoms
Exclusion Criteria:
- Women currently receiving treatment for OAB symptoms
- Women with narrow angle Glaucoma
- Women taking anticholinergics or loop diuretics
- Women with an untreated urinary tract infection. After resolution of the UTI, and if all other eligibility criteria are met, the woman can be a candidate for inclusion in the study.
- Women with a diagnosis of painful bladder syndrome or other abnormal urinary tract lesions
- Women scoring >4 on the QUID Questionnaire for stress symptoms
- Women with de novo symptoms following surgery
- Women with major pelvic prolapse
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cora fanning, Dr. Scott Farrell, Urogynecologist, IWK Health Centre |
| ClinicalTrials.gov Identifier: | NCT00780832 History of Changes |
| Other Study ID Numbers: | REB #4121 |
| Study First Received: | October 27, 2008 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by IWK Health Centre:
|
overactive bladder dietary caffeine anticholinergic medication |
lifestyle modification incontinence urinary frequency |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms Caffeine Cholinergic Antagonists Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Cholinergic Agents |
ClinicalTrials.gov processed this record on May 21, 2013