Premarin Versus Toviaz for Treatment of Overactive Bladder

NCT01613170

Last updated date
Study Location
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Contact
954-659-6342

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-100 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Premarin Versus Toviaz for Treatment of Overactive Bladder
Official Title  ICMJE A Combined Treatment Program for the Symptoms of Urinary Urgency and Frequency With Toviaz and Premarin Vaginal Cream
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • Drug: Toviaz
    Toviaz 4mg daily
    Other Name: fesoteridine
  • Drug: Premarin
    Premarin cream 1 g per vagina twice weekly
    Other Name: estrogen, conjugated vaginal
  • Drug: Placebo cream
    Placebo cream 1 g per vagina twice weekly, to mimic Premarin cream
    Other Name: Verba base cream
Study Arms  ICMJE
  • Experimental: Toviaz and Premarin Vaginal Cream
    Toviaz 4 mg PO q day and premarin cream 1 g per vagina 2 times a week.
    Interventions:
    • Drug: Toviaz
    • Drug: Premarin
  • Placebo Comparator: Toviaz , Placebo Premarin Vaginal Cream
    Toviaz 4 mg PO q day and placebo cream 1 g per vagina 2 times a week.
    Interventions:
    • Drug: Toviaz
    • Drug: Placebo cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 4, 2012)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 30 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01613170
Other Study ID Numbers  ICMJE 11074
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party G. Willy Davila, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Eric Hurtado, MDCleveland Clinic Florida
Study Director:Alexandriah Alas, MDCleveland Clinic Florida
PRS Account The Cleveland Clinic
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP