Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- IWK Health Centre
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Change in Bladder Function Questionnaire score
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- 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
Arms & Interventions
1
Caffeine reduction through diet and beverage counselling
Intervention: Dietary Caffeine reduction (Behavioral)
2
Anticholinergic medication
Intervention: Anticholinergic medication (Drug)
Outcomes
Primary Outcomes
Change in Bladder Function Questionnaire score
Time Frame: 30 days
Secondary Outcomes
- Does the amount of caffeine consumed relate to symptom severity?(30 days)