Caffeine Reduction and Overactive Bladder Symptoms
A. Statement of Objective: To conduct a randomized trial to evaluate the impact of caffeine restriction on Overactive Bladder(OAB) symptoms including urinary frequency, nocturia, incontinence episodes, symptom severity and bother and quality of life.
B. Specific Aims/Hypothesis:
To determine if reduction in caffeine intake decreases urinary frequency, nocturia and incontinence episodes as measured on a 3-day voiding diary in women with Overactive Bladder (OAB).
We hypothesize that women with overactive bladder will report less frequent urination and decreased nocturia and incontinence episodes with caffeine reduction.
- To determine whether caffeine reduction results in decreased symptom severity and bother and improved quality of life scores as measured by the Questionnaire for Incontinence Severity Index (ISI), Questionnaire for Urinary Incontinence Diagnosis (QUID), Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7).
We hypothesize that women with OAB who reduce their intake of caffeine will report decreased symptom bother and improved quality of life as measured by the ISI, UDI-6 and the IIQ-
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Caffeine Reduction Education And Overactive Bladder Symptoms|
- urinary frequency, as measured on a 3-day voiding diary [ Time Frame: baseline and 2 - 4 weeks ] [ Designated as safety issue: No ]
- Improved Quality of life scores [ Time Frame: baseline and 2 - 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Caffiene reduction group
Caffeine reduction group Intervention is to counseling to reduce caffeine intake
Behavioral: Caffeine reduction
patients are randomized to receive caffeine reduction counseling versus no caffeine reduction counseling
No Intervention: No caffeine reduction group
No Caffeine reduction group Intervention is to not counsel regarding caffeine intake
Objective: To evaluate the impact of caffeine reduction education on urinary frequency.
Methods: Women with overactive bladder (OAB) symptoms who scored a 6 on the Questionnaire for Urinary Incontinence Diagnosis and who consumed at least 200 mg of caffeine daily were recruited. After completing baseline 3-day bladder diaries including amount and type of caffeine consumption, as well as validated urinary symptom severity, bother and quality of life questionnaires, women were randomized to receive caffeine reduction education vs. a control group who reviewed their voiding diary with no counseling to reduce caffeine; both groups were asked to maintain total fluid intake. Participants repeated the 3-day bladder diary and validated questionnaires following randomization. A total of 80 women were required to achieve 80% power with an alpha error of 0.05 to detect a difference of 1.3 in mean number of daily voids averaged over a 3-day voiding diary.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754260
|United States, New Mexico|
|Dr. Kammerer- Doak|
|Albuquerque, New Mexico, United States, 87111|
|Tola Omotosho , MD|
|Albuquerque, New Mexico, United States, 87131|
|Study Chair:||Rebecca Rogers||University of New Mexico|