Clinical Trials Directory

Trials / Terminated

TerminatedNCT00780832

Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
8 (actual)
Sponsor
IWK Health Centre · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDietary Caffeine reductionParticipants are counseled about reduction of dietary caffeine, given written information and a bladder control log.
DRUGAnticholinergic medicationDetrol LA 4mg. orally, once daily for 30 days

Timeline

Start date
2008-05-01
Primary completion
2012-12-01
Completion
2013-04-01
First posted
2008-10-28
Last updated
2016-02-24

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00780832. Inclusion in this directory is not an endorsement.