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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780832
Recruitment Status : Terminated (Insufficient elligible patients available in a reasonable time frame.)
First Posted : October 28, 2008
Last Update Posted : February 24, 2016
Information provided by (Responsible Party):
IWK Health Centre

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Behavioral: Dietary Caffeine reduction Drug: Anticholinergic medication Not Applicable

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  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
Study Start Date : May 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

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 Name: Lifestyle modification

Active Comparator: 2
Anticholinergic medication
Drug: Anticholinergic medication
Detrol LA 4mg. orally, once daily for 30 days

Primary Outcome Measures :
  1. Change in Bladder Function Questionnaire score [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Does the amount of caffeine consumed relate to symptom severity? [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00780832

Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Principal Investigator: Scott A Farrell, MD, FRCSC IWK Health Centre

Responsible Party: IWK Health Centre Identifier: NCT00780832     History of Changes
Other Study ID Numbers: REB #4121
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: May 2013

Keywords provided by IWK Health Centre:
overactive bladder
dietary caffeine
anticholinergic medication
lifestyle modification
urinary frequency

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Cholinergic Antagonists
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Cholinergic Agents