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"The Effects of Caffeine on Overactive Bladder Symptoms and Mental Health in Postmenopausal Women"

NCT02180048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2018-10-25

No results posted yet for this study

Summary

The purpose of this study is to observe effects of caffeine on overactive bladder symptoms and wellbeing. This study looks at whether caffeine has bad effects on urinary symptoms or if lower doses of caffeine decrease the effects.

The study will propose the following hypothesis:

1. The voiding and mental health symptoms will be greatest in the high dose treatment and lowest in the placebo treatment.
2. The low dose treatment will produce more voiding and mental health symptoms than the placebo treatment.
3. Voiding and mental health symptoms will be mediated by hydration status of the patient which will be assessed using a Tanita Scale.

Conditions

Interventions

DIETARY_SUPPLEMENT

400 mg of caffeine/day (Two 200mg pills/day)

One phase of treatment will have participants consume two 200 mg-caffeine pills day (total of 400 mg of caffeine/ d) for 7 days.

DIETARY_SUPPLEMENT

200 mg of caffeine/day (One 200mg pill and one placebo pill)

This arm will receive one 200 mg caffeine pill and one sugar pill (placebo pill)

DIETARY_SUPPLEMENT

Two placebo pills/day

This arm will have participants consume two placebo pills each day.

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Andrea Staack, MD · Loma Linda University, Urology Medical Group, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
58 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2018-09-20
Completion
2018-09-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02180048 on ClinicalTrials.gov