Overactive Bladder
Conditions
Keywords
Experimental Medicine
Brief summary
The purpose of this study is to determine if standardizing fluid intake in a clinic setting will reduce variability of individual voiding parameters and potentially serve as a way to limit patient exposure in the initial assessment of efficacy of compounds being developed for Overactive Bladder.
Interventions
DRUGDETROL LA (drug)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible participants will be females who are 18 years of age or older, with Overactive Bladder as evidenced by daily episodes of urgency without incontinence, which may be associated with frequency or nocturia but without bladder pain. At screening, eligible patients must report frequency, defined as at least 8 micturitions per 24 hour period. * Eligible patients must have signed the informed consent and must meet all inclusion and
Exclusion criteria
as determined during the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variability of change from baseline in mean volume per void measured on 3 consecutive days. | 3 consecutive days |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in volume voided per void. Percent and actual change from baseline in maximum volume voided, number of micturitions, number of incontinence episodes, number of urgency episodes, and time to first void on 3 consecutive days. | 3 consecutive days |
Countries
Australia
Outcome results
None listed