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

This study has been terminated.
(Insufficient elligible patients available in a reasonable time frame.)
Sponsor:
Information provided by (Responsible Party):
Cora fanning, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00780832
First received: October 27, 2008
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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 Intervention
Overactive Bladder
Behavioral: Dietary Caffeine reduction
Drug: Anticholinergic medication

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Change in Bladder Function Questionnaire score [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Does the amount of caffeine consumed relate to symptom severity? [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: May 2008
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780832

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

No publications provided

Responsible Party: Cora fanning, Dr. Scott Farrell, Urogynecologist, IWK Health Centre
ClinicalTrials.gov Identifier: NCT00780832     History of Changes
Other Study ID Numbers: REB #4121
Study First Received: October 27, 2008
Last Updated: May 14, 2013
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on September 22, 2014