Caffeine Reduction and Overactive Bladder Symptoms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of New Mexico.
Recruitment status was  Active, not recruiting
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
  Purpose

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: Reduction in caffeine intake

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 University of New Mexico:

Primary Outcome Measures:
  • urinary frequency, as measured on a 3-day voiding diary [ Time Frame: baseline and 2 - 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved Quality of life scores [ Time Frame: baseline and 2 - 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
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)
Arms Assigned Interventions
Experimental: 1
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  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 ClinicalTrials.gov identifier: NCT00754260

Locations
United States, New Mexico
Tola Omotosho , MD
Albuquerque, New Mexico, United States, 87131
Dr. Kammerer- Doak
Albuquerque, New Mexico, United States, 87111
Sponsors and Collaborators
University of New Mexico
Pfizer
  More Information

No publications provided

Responsible Party: Tola Omotosho, Principal Investigator, University of New Mexico
ClinicalTrials.gov Identifier: NCT00754260     History of Changes
Other Study ID Numbers: 07-277
Study First Received: September 2, 2008
Last Updated: November 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 22, 2014