Premarin Versus Toviaz for Treatment of Overactive Bladder
|Overactive Bladder||Drug: Toviaz Drug: Premarin Drug: Placebo cream||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Combined Treatment Program for the Symptoms of Urinary Urgency and Frequency With Toviaz and Premarin Vaginal Cream|
- Urinary frequency as measured by a 3 day voiding diary [ Time Frame: 1 year ]number of voids per day
- Lifestyle Impact of Overactive Bladder as measured using 3 validated questionnaires: OAB-Q, PPBC, and Urgency Severity and Impact Questionnaire [ Time Frame: 1 year ]quality of life assessment via questionnaire
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
Experimental: Toviaz and Premarin Vaginal Cream
Toviaz 4 mg PO q day and premarin cream 1 g per vagina 2 times a week.
Toviaz 4mg daily
Other Name: fesoteridineDrug: Premarin
Premarin cream 1 g per vagina twice weekly
Other Name: estrogen, conjugated vaginal
Placebo Comparator: Toviaz , Placebo Premarin Vaginal Cream
Toviaz 4 mg PO q day and placebo cream 1 g per vagina 2 times a week.
Toviaz 4mg daily
Other Name: fesoteridineDrug: Placebo cream
Placebo cream 1 g per vagina twice weekly, to mimic Premarin cream
Other Name: Verba base cream
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613170
|Contact: Alexandriah Alas, MDfirstname.lastname@example.org|
|Contact: Eric Hurtado, MDemail@example.com|
|United States, Florida|
|Cleveland Clinic Florida||Recruiting|
|Weston, Florida, United States, 33331|
|Contact: Alexandriah Alas, MD 954-659-6342 firstname.lastname@example.org|
|Sub-Investigator: GW Davila, MD|
|Sub-Investigator: Leon Plowright, MD|
|Sub-Investigator: Vivian Aguilar, MD|
|Sub-Investigator: Alexandriah Alas, MD|
|Sub-Investigator: Luis Espaillat, MD|
|Principal Investigator: Eric Hurtado, MD|
|Principal Investigator:||Eric Hurtado, MD||Cleveland Clinic Florida|
|Study Director:||Alexandriah Alas, MD||Cleveland Clinic Florida|