Recruiting

Premarin vs. Toviaz

Sponsor:

The Cleveland Clinic

Code:

NCT01613170

Conditions

Overactive Bladder

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

Toviaz

Premarin

Placebo cream

Study Details

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.

Conditions

Overactive Bladder

Study ID

NCT01613170

Start date

Apr, 2012

Status verified date

Apr, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Apr, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Toviaz and Premarin Vaginal Cream

Toviaz 4 mg PO q day and premarin cream 1 g per vagina 2 times a week.

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

Toviaz

Toviaz 4mg daily

Premarin

Premarin cream 1 g per vagina twice weekly

Placebo cream

Placebo cream 1 g per vagina twice weekly, to mimic Premarin cream

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Alexandriah Alas, MD

954-659-6342alasa@ccf.org

Eric Hurtado, MD

954-659-5559hurtade@ccf.org

Locations

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Contacts

Alexandriah Alas, MD

954-659-6342alasa@ccf.org

Principal Investigator:

Eric Hurtado, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Apr 20, 2017

Last verified

Apr, 2017

Keywords

  • Overactive Bladder
  • Vaginal Estrogen
  • Anticholinergics
  • Antimuscarinics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2017-04-20.