Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Caffeine Reduction and Overactive Bladder Symptoms

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Tola Omotosho, University of New Mexico Identifier:
First received: September 2, 2008
Last updated: December 10, 2015
Last verified: December 2015

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:

  1. 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.

  2. 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-

Condition Intervention
Overactive Bladder
Behavioral: Caffeine reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Caffeine Reduction Education And Overactive Bladder Symptoms

Resource links provided by NLM:

Further study details as provided by Tola Omotosho, University of New Mexico:

Primary Outcome Measures:
  • urinary frequency, as measured on a 3-day voiding diary [ Time Frame: baseline and 2 - 4 weeks ]

Secondary Outcome Measures:
  • Improved Quality of life scores [ Time Frame: baseline and 2 - 4 weeks ]

Estimated Enrollment: 110
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)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00754260

United States, New Mexico
Dr. Kammerer- Doak
Albuquerque, New Mexico, United States, 87111
Tola Omotosho , MD
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Study Chair: Rebecca Rogers University of New Mexico
  More Information

Responsible Party: Tola Omotosho, Principal Investigator, University of New Mexico Identifier: NCT00754260     History of Changes
Other Study ID Numbers: 07-277
Study First Received: September 2, 2008
Last Updated: December 10, 2015

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents processed this record on May 25, 2017