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Premarin Versus Toviaz for Treatment of Overactive Bladder

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Cleveland Clinic Florida.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
G. Willy Davila, Cleveland Clinic Florida Identifier:
First received: May 24, 2012
Last updated: June 4, 2012
Last verified: June 2012
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.

Condition Intervention Phase
Overactive Bladder
Drug: Toviaz, Premarin Vaginal Cream
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Combined Treatment Program for the Symptoms of Urinary Urgency and Frequency With Toviaz and Premarin Vaginal Cream

Resource links provided by NLM:

Further study details as provided by Cleveland Clinic Florida:

Primary Outcome Measures:
  • Urinary frequency as measured by a 3 day voiding diary [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Lifestyle Impact of Overactive Bladder as measured using 3 validated questionnaires: OAB-Q, PPBC, and Urgency Severity and Impact Questionnaire [ Time Frame: 1 year ]

Estimated Enrollment: 90
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Toviaz and Premarin Vaginal Cream Drug: Toviaz, Premarin Vaginal Cream
Toviaz 4mg daily Premarin estrogen cream 1 g per vagina twice weekly
Sham Comparator: Toviaz , Placebo Premarin Vaginal Cream
Toviaz, Placebo vaginal estrogen cream
Drug: Toviaz, Premarin Vaginal Cream
Toviaz 4mg daily Premarin estrogen cream 1 g per vagina twice weekly

Detailed Description:

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.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Postmenopausal Women defined as at least 12 months since last menstrual period
  • OAB symptoms for 6 months or longer with complaints of frequency (8 or more voids in a 24 hour period), and either 6 or more urgency episodes in 24 hours, and either 3 or more urge urinary incontinence episodes per 24 hours.

Exclusion Criteria:

  • Current or recent treatment (within the last 6 months) with estrogens
  • Past or present history of estrogen dependent neoplasm
  • Undiagnosed genital tract bleeding
  • Current urinary or vaginal infection
  • History of thromboembolic disorders associated with estrogen use
  • Commencement or alteration of diuretic therapy within three months of study enrollment
  • No contraindications for anticholinergic medical therapy
  • No contraindications to estrogen therapy
  • Symptoms must not have commenced more than three years prior to menopause
  • Post Void Residual must be under or equal to 150 ml
  • Recurrent Urinary Tract Infections (3 culture proven UTI's within the past 12 months)
  • Not on any other anticholinergic medications for the last 4 weeks
  • Painful Bladder Syndrome
  • Chronic Pelvic Pain
  • Vaginal Prolapse POPQ > stage 2/ maximal prolapse point greater than +1 cm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01613170

Contact: Carey Gross, DO 954-659-5559
Contact: GW Davila, MD 954-659-5559

United States, Florida
Cleveland Clinic Florida Not yet recruiting
Weston, Florida, United States, 33331
Contact: Carey Gross, DO    954-659-5559   
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Carey` Gross, DO    954-659-5559   
Principal Investigator: GW Davila, MD         
Principal Investigator: Carey Gross, DO         
Sub-Investigator: Leon Plowright, MD         
Sub-Investigator: Vivian Aguilar, MD         
Sub-Investigator: Aimee Smith, MD         
Sponsors and Collaborators
Cleveland Clinic Florida
Principal Investigator: G.W. Davila, MD Cleveland Clinic Florida
Study Director: Carey Gross, DO Cleveland Clinic Florida
  More Information

Responsible Party: G. Willy Davila, Chairmain of Department of Gynecology and Head of Section of Urogynecology, Cleveland Clinic Florida Identifier: NCT01613170     History of Changes
Other Study ID Numbers: 11074
Study First Received: May 24, 2012
Last Updated: June 4, 2012

Keywords provided by Cleveland Clinic Florida:
Overactive Bladder
Vaginal Estrogen

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Estrogens, Conjugated (USP)
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on March 23, 2017