Caffeine Reduction and Overactive Bladder Symptoms
Recruitment status was Active, not recruiting
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:||June 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Caffeine reduction group versus no caffeine reduction
Behavioral: Reduction in caffeine intake
patients are randomized to receive caffeine reduction counseling versus no caffeine reduction counseling
No Intervention: 2
No Caffeine reduction group
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754260
|United States, New Mexico|
|Tola Omotosho , MD|
|Albuquerque, New Mexico, United States, 87131|
|Dr. Kammerer- Doak|
|Albuquerque, New Mexico, United States, 87111|