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

February 23, 2016 updated by: IWK Health Centre
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Lifestyle modification
Active Comparator: 2
Anticholinergic medication
Drug: Anticholinergic medication
Detrol LA 4mg. orally, once daily for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Bladder Function Questionnaire score
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Does the amount of caffeine consumed relate to symptom severity?
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Investigators

  • Principal Investigator: Scott A Farrell, MD, FRCSC, IWK Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 27, 2008

First Submitted That Met QC Criteria

October 27, 2008

First Posted (Estimate)

October 28, 2008

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB #4121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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