Caffeine Reduction and Overactive Bladder Symptoms
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2008 |
| End Date: | August 2016 |
Caffeine Reduction Education And Overactive Bladder Symptoms
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-
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-
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.
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.
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
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