Caffeine Reduction and Overactive Bladder Symptoms

NCT00754260 | Terminated DMC

• 1 other identifier: 07-277
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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:

1. 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).
2. 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).

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

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

  baseline and 2 - 4 weeks

Secondary Outcomes (1)

• Improved Quality of life scores

  baseline and 2 - 4 weeks

Study Arms (2)

Caffiene reduction group

EXPERIMENTAL

Caffeine reduction group Intervention is to counseling to reduce caffeine intake

Behavioral: Caffeine reduction

No caffeine reduction group

NO INTERVENTION

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

Interventions

Caffeine reduction BEHAVIORAL

patients are randomized to receive caffeine reduction counseling versus no caffeine reduction counseling

Caffiene reduction group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead
• Pfizer: collaborator

Study Sites (2)

Dr. Kammerer- Doak

Albuquerque, New Mexico, 87111, United States

Location

Tola Omotosho , MD

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rebecca Rogers

  University of New Mexico

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 17, 2008
• Study Start: March 1, 2008
• Primary Completion: June 30, 2009
• Study Completion: June 30, 2009
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

US (2)