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Premarin Versus Toviaz for Treatment of Overactive Bladder

This study is currently recruiting participants.
Verified June 2012 by Cleveland Clinic Florida
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
G. Willy Davila, Cleveland Clinic Florida
ClinicalTrials.gov Identifier:
NCT01613170
First received: May 24, 2012
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613170

Contacts
Contact: Carey Gross, DO 954-659-5559 carey.gross@gmail.com
Contact: GW Davila, MD 954-659-5559 davilag@ccf.org

Locations
United States, Florida
Cleveland Clinic Florida Not yet recruiting
Weston, Florida, United States, 33331
Contact: Carey Gross, DO     954-659-5559     carey.gross@gmail.com    
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Carey` Gross, DO     954-659-5559     grossc2@ccf.org    
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
Pfizer
Investigators
Principal Investigator: G.W. Davila, MD Cleveland Clinic Florida
Study Director: Carey Gross, DO Cleveland Clinic Florida
  More Information

No publications provided

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

Keywords provided by Cleveland Clinic Florida:
Overactive Bladder
Vaginal Estrogen
Anticholinergics
Antimuscarinics

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Estrogens, Conjugated (USP)
 Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013