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Premarin Versus Toviaz for Treatment of Overactive Bladder

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by The Cleveland Clinic
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
G. Willy Davila, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01613170
First received: May 24, 2012
Last updated: April 18, 2017
Last verified: April 2017
  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
Drug: Premarin
Drug: Placebo cream
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

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


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 ]
    quality of life assessment via questionnaire


Estimated Enrollment: 90
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)
Arms Assigned Interventions
Experimental: Toviaz and Premarin Vaginal Cream
Toviaz 4 mg PO q day and premarin cream 1 g per vagina 2 times a week.
Drug: Toviaz
Toviaz 4mg daily
Other Name: fesoteridine
Drug: 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.
Drug: Toviaz
Toviaz 4mg daily
Other Name: fesoteridine
Drug: Placebo cream
Placebo cream 1 g per vagina twice weekly, to mimic Premarin cream
Other Name: Verba base cream

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 to 100 Years   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier: NCT01613170

Contacts
Contact: Alexandriah Alas, MD 954-659-6342 alasa@ccf.org
Contact: Eric Hurtado, MD 954-659-5559 hurtade@ccf.org

Locations
United States, Florida
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Alexandriah Alas, MD    954-659-6342    alasa@ccf.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         
Sponsors and Collaborators
The Cleveland Clinic
Pfizer
Investigators
Principal Investigator: Eric Hurtado, MD Cleveland Clinic Florida
Study Director: Alexandriah Alas, MD Cleveland Clinic Florida
  More Information

Responsible Party: G. Willy Davila, Chairmain of Department of Gynecology and Head of Section of Urogynecology, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01613170     History of Changes
Other Study ID Numbers: 11074
Study First Received: May 24, 2012
Last Updated: April 18, 2017
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on April 24, 2017