Overactive Bladder Clinical Trial
Official title:
A Combined Treatment Program for the Symptoms of Urinary Urgency and Frequency With Toviaz and Premarin Vaginal Cream
The use of vaginal estrogen cream in conjunction with Toviaz will be more effective than the use of Toviaz alone for the treatment of overactive bladder.
Participants will be randomized to two treatment arms with 45 patients enrolled in each
study arm: Toviaz and Premarin Vaginal Cream and Toviaz and Placebo Premarin Vaginal Cream.
The Toviaz will be dosed at 4mg tablet given as a once daily dose. Premarin vaginal cream
will be dosed at 1 gram per vagina twice weekly. Compliance will be assessed at the 4-week
mark and again at completion of the study, 8 weeks after the commencement of treatment.
The questionnaires chosen for this study have been designed and validated as effective tools
to assess and evaluate OAB. Patients will be asked to complete three symptoms questionnaires
and a 3-day voiding dairy. The questionnaires include Overactive Bladder Questionnaire
(OAB-q), The Patient Perception of Bladder Condition, and Urgency Severity and Impact
Questionnaire. The voiding diary and questionnaires will be filled out and collected at the
initial visit and again at the end of the study which is defined as 8 weeks after the
commencement of treatment.
Additionally, patients will be asked to rate their symptoms associated with urogenital
atrophy at the start of the study and then again at 8 weeks. The severity of each symptom
will be graded based on a four-point scale (0=none, 1=mild, 2= moderate, 3=severe) and a
composite score will then be generated. Examiners will also rate the severity of signs of
urogenital atrophy at the first visit and at the conclusion of the study.
An objective evaluation of the effectiveness of the estrogen cream treatment will be
accomplished by a pathological evaluation of the vaginal cell samples at the beginning of
treatment and then again at the 8 week point. These cells will be collected and analyzed by
an independent pathologist to determine the percentage of parabasal, intermediate, and
superficial cells and to document the change in these three categories of cells as a result
of the vaginal estrogen treatment. A 3-Day voiding diary will be used to document changes
from baseline for urinary urgency, frequency, and incontinence episodes. Based on previous
studies we predict there will be a 45% improvement on urinary frequency from baseline when
using both Toviaz and vaginal Premarin cream. Secondary outcomes will be measured using the
following validated questionnaires given at the start of the study and again at completion:
OAB-q, Patient Perception of Bladder Condition, Urgency Severity and Impact Questionnaire.
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