Recruitment

Recruitment Status
Completed

Inclusion Criterias

58 years of age or older
Able to communicate and read in English
Post-menopausal
...
58 years of age or older
Able to communicate and read in English
Post-menopausal
Low to moderate coffee drinkers (between 1-3 cups/day, or 50-450mg caffeine/d)

Exclusion Criterias

Vaginal pain
Uncontrolled hypertension
Pre- or perimenopausal
...
Vaginal pain
Uncontrolled hypertension
Pre- or perimenopausal
Individual who do not regularly consume caffeine
Excessive coffee drinkers (>450 mg/d)
Chronic pelvic pain/ Interstitial cystitis

Summary

Conditions
  • Caffeine
  • Menopause
  • Overactive Bladder
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double (Participant, Care Provider)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 58 years and 125 years
Gender
Only females

Description

Subjects will be exposed to 200 mg and 400 mg caffeine pills and placebo pills (free of caffeine). During each treatment period, participants will be required to avoid caffeine (except for the caffeine within the given treatment). The study is staged into 3 phases, which will last for 7 days each. A...

Subjects will be exposed to 200 mg and 400 mg caffeine pills and placebo pills (free of caffeine). During each treatment period, participants will be required to avoid caffeine (except for the caffeine within the given treatment). The study is staged into 3 phases, which will last for 7 days each. After enrollment, participants will be asked to refrain from consuming any substances containing caffeine during the 21 days of treatment. Instead of coffee or other caffeine items, they will be exposed to caffeine in pill form. Participants will complete each treatment in a random, cross over blinded fashion. One phase of treatment will have participants consume two 200 mg-caffeine pills a day (total of 400 mg of caffeine/day), a second treatment will have participants consume one 200 mg-caffeine pill and one placebo pill a day. And the final treatment will have participants consume two placebo pills each day. Treatment phases will be assigned randomly to each participant. The participant will not know which phase they are receiving. Prior to the treatment, the participant will be asked to fill out a detailed diet log of her eating and drinking habits. Participants will also be asked a series of questions on a survey related to bladder symptoms and mental health periodically throughout the study. It will take about 30 minutes of their time to answer the questionnaires at individual time points. During the 21 days of the study period participants will be asked to self-monitor fluid intake and note any major changes of fluid intake compared to the initial intake log. They will be asked to conduct a 24-hour voiding and defecation log at two different time points within each treatment phase as well as prior to the study. 24-hour urine will be collected during each treatment phase at two different time points as well as prior to the study. Participants weight and lean body mass will be assessed in clinic using a Tanita scale at two times within each treatment phase and one time prior to the study

Inclusion Criterias

58 years of age or older
Able to communicate and read in English
Post-menopausal
...
58 years of age or older
Able to communicate and read in English
Post-menopausal
Low to moderate coffee drinkers (between 1-3 cups/day, or 50-450mg caffeine/d)

Exclusion Criterias

Vaginal pain
Uncontrolled hypertension
Pre- or perimenopausal
...
Vaginal pain
Uncontrolled hypertension
Pre- or perimenopausal
Individual who do not regularly consume caffeine
Excessive coffee drinkers (>450 mg/d)
Chronic pelvic pain/ Interstitial cystitis

Locations

Loma Linda, California, 92354
Loma Linda, California, 92354

Tracking Information

NCT #
NCT02180048
Collaborators
Not Provided
Investigators
  • Principal Investigator: Andrea Staack, MD Loma Linda University, Urology Medical Group, Inc.
  • Andrea Staack, MD Loma Linda University, Urology Medical Group, Inc.