Clinical trial NCT00780832: Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
Official title: Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overactive Bladder
Keywords: overactive bladder
dietary caffeine
anticholinergic medication
lifestyle modification
incontinence
urinary frequency
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2008-10-28
Enrollment: 8
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Women with OAB symptoms including urgency, frequency (voids ≥8/day), and urge incontinence
2. Women who consume \> one cup (250ml) caffeinated beverage per day
3. Women who score $ 6 on the QUID Questionnaire for urgency symptoms

Exclusion Criteria:

1. Women currently receiving treatment for OAB symptoms
2. Women with narrow angle Glaucoma
3. Women taking anticholinergics or loop diuretics
4. 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.
5. Women with a diagnosis of painful bladder syndrome or other abnormal urinary tract lesions
6. Women scoring \>4 on the QUID Questionnaire for stress symptoms
7. Women with de novo symptoms following surgery
8. Women with major pelvic prolapse

Primary outcomes:
measure: Change in Bladder Function Questionnaire score
timeFrame: 30 days
Secondary outcomes:
measure: Does the amount of caffeine consumed relate to symptom severity?
timeFrame: 30 days
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Scott A Farrell, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: