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Caffeine Reduction and Overactive Bladder Symptoms

Primary Purpose

Overactive Bladder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caffeine reduction
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Dr. Kammerer- Doak
  • Tola Omotosho , MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Caffiene reduction group

No caffeine reduction group

Arm Description

Caffeine reduction group Intervention is to counseling to reduce caffeine intake

No Caffeine reduction group Intervention is to not counsel regarding caffeine intake

Outcomes

Primary Outcome Measures

urinary frequency, as measured on a 3-day voiding diary

Secondary Outcome Measures

Improved Quality of life scores

Full Information

First Posted
September 2, 2008
Last Updated
May 26, 2022
Sponsor
University of New Mexico
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00754260
Brief Title
Caffeine Reduction and Overactive Bladder Symptoms
Official Title
Caffeine Reduction Education And Overactive Bladder Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Primary Investigator left recruiting center
Study Start Date
March 2008 (Actual)
Primary Completion Date
June 30, 2009 (Actual)
Study Completion Date
June 30, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caffiene reduction group
Arm Type
Experimental
Arm Description
Caffeine reduction group Intervention is to counseling to reduce caffeine intake
Arm Title
No caffeine reduction group
Arm Type
No Intervention
Arm Description
No Caffeine reduction group Intervention is to not counsel regarding caffeine intake
Intervention Type
Behavioral
Intervention Name(s)
Caffeine reduction
Intervention Description
patients are randomized to receive caffeine reduction counseling versus no caffeine reduction counseling
Primary Outcome Measure Information:
Title
urinary frequency, as measured on a 3-day voiding diary
Time Frame
baseline and 2 - 4 weeks
Secondary Outcome Measure Information:
Title
Improved Quality of life scores
Time Frame
baseline and 2 - 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Rogers
Organizational Affiliation
University of New Mexico
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Kammerer- Doak
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87111
Country
United States
Facility Name
Tola Omotosho , MD
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

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Caffeine Reduction and Overactive Bladder Symptoms

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