Caffeine Reduction and Overactive Bladder Symptoms

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Tola Omotosho, University of New Mexico

ClinicalTrials.gov Identifier:

NCT00754260

First received: September 2, 2008

Last updated: November 4, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 2, 2008
Last Updated Date	November 4, 2011
Start Date ^ICMJE	March 2008
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 15, 2008)	urinary frequency, as measured on a 3-day voiding diary [ Time Frame: baseline and 2 - 4 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00754260 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 15, 2008)	Improved Quality of life scores [ Time Frame: baseline and 2 - 4 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Caffeine Reduction and Overactive Bladder Symptoms
Official Title ^ICMJE	Caffeine Reduction Education And Overactive Bladder Symptoms
Brief Summary	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-
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Overactive Bladder
Intervention ^ICMJE	Behavioral: Reduction in caffeine intake patients are randomized to receive caffeine reduction counseling versus no caffeine reduction counseling
Study Arm (s)	Experimental: 1 Caffeine reduction group versus no caffeine reduction Intervention: Behavioral: Reduction in caffeine intake No Intervention: 2 No Caffeine reduction group
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	110
Estimated Completion Date	June 2012
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: only women 18 years and older with Overactive Bladder syndrome and who report that they consume an average of two cups of caffeinated beverages (approximately 200mg caffeine) daily will be included. Exclusion Criteria: Women presenting with stress predominate bladder symptoms as evaluated by the QUID, urinary tract infection or hematuria as evaluated on urine dip analysis, currently pregnant or pregnant within the past six months or history of radiation to the pelvic floor will be excluded from participation
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00754260
Other Study ID Numbers ^ICMJE	07-277
Has Data Monitoring Committee	Yes
Responsible Party	Tola Omotosho, University of New Mexico
Study Sponsor ^ICMJE	University of New Mexico
Collaborators ^ICMJE	Pfizer
Investigators ^ICMJE	Not Provided
Information Provided By	University of New Mexico
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top