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

This study is currently recruiting participants.
Verified July 2011 by IWK Health Centre
Sponsor:
Information provided by:
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00780832
First received: October 27, 2008
Last updated: July 22, 2011
Last verified: July 2011

October 27, 2008
July 22, 2011
May 2008
December 2012   (final data collection date for primary outcome measure)
Change in Bladder Function Questionnaire score [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00780832 on ClinicalTrials.gov Archive Site
Does the amount of caffeine consumed relate to symptom severity? [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
 
 
 
Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder

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.

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.

Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Overactive Bladder
  • Behavioral: Dietary Caffeine reduction
    Participants are counseled about reduction of dietary caffeine, given written information and a bladder control log.
    Other Name: Lifestyle modification
  • Drug: Anticholinergic medication
    Detrol LA 4mg. orally, once daily for 30 days
  • Active Comparator: 1
    Caffeine reduction through diet and beverage counselling
    Intervention: Behavioral: Dietary Caffeine reduction
  • Active Comparator: 2
    Anticholinergic medication
    Intervention: Drug: Anticholinergic medication
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2013
December 2012   (final data collection date for primary outcome measure)

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
Female
 
No
Contact: Cora A Fanning, BN, RN (902)470-7158 cora.fanning@iwk.nshealth.ca
Contact: Scott A Farrell, MD, FRCSC (902)470-6768 scott.farrell@iwk.nshealth.ca
Canada
 
NCT00780832
REB #4121
No
Dr. Scott Farrell, IWK Health Centre
IWK Health Centre
 
Principal Investigator: Scott A Farrell, MD, FRCSC IWK Health Centre
IWK Health Centre
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP