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

Primary Purpose

Overactive Bladder

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dietary Caffeine reduction
Anticholinergic medication
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring overactive bladder, dietary caffeine, anticholinergic medication, lifestyle modification, incontinence, urinary frequency

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • IWK Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Caffeine reduction through diet and beverage counselling

Anticholinergic medication

Outcomes

Primary Outcome Measures

Change in Bladder Function Questionnaire score

Secondary Outcome Measures

Does the amount of caffeine consumed relate to symptom severity?

Full Information

First Posted
October 27, 2008
Last Updated
February 23, 2016
Sponsor
IWK Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00780832
Brief Title
Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
Official Title
Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Why Stopped
Insufficient elligible patients available in a reasonable time frame.
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IWK Health Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 Does caffeine reduction decrease OAB symptoms? Does the amount of caffeine consumed relate to symptom severity? If symptoms do improve with caffeine reduction, are women compliant with this treatment? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
overactive bladder, dietary caffeine, anticholinergic medication, lifestyle modification, incontinence, urinary frequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Caffeine reduction through diet and beverage counselling
Arm Title
2
Arm Type
Active Comparator
Arm Description
Anticholinergic medication
Intervention Type
Behavioral
Intervention Name(s)
Dietary Caffeine reduction
Other Intervention Name(s)
Lifestyle modification
Intervention Description
Participants are counseled about reduction of dietary caffeine, given written information and a bladder control log.
Intervention Type
Drug
Intervention Name(s)
Anticholinergic medication
Intervention Description
Detrol LA 4mg. orally, once daily for 30 days
Primary Outcome Measure Information:
Title
Change in Bladder Function Questionnaire score
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Does the amount of caffeine consumed relate to symptom severity?
Time Frame
30 days

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with OAB symptoms including urgency, frequency (voids ≥8/day), and urge incontinence Women who consume > one cup (250ml) caffeinated beverage per day Women who score $ 6 on the QUID Questionnaire for urgency symptoms Exclusion Criteria: Women currently receiving treatment for OAB symptoms Women with narrow angle Glaucoma Women taking anticholinergics or loop diuretics 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. Women with a diagnosis of painful bladder syndrome or other abnormal urinary tract lesions Women scoring >4 on the QUID Questionnaire for stress symptoms Women with de novo symptoms following surgery Women with major pelvic prolapse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott A Farrell, MD, FRCSC
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada

12. IPD Sharing Statement

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

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