Premarin Versus Toviaz for Treatment of Overactive Bladder

NCT01613170 | Unknown Phase 4 DMC

• 1 other identifier: 11074
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Overactive Bladder; Vaginal Estrogen; Anticholinergics; Antimuscarinics

Outcome Measures

Primary Outcomes (1)

• Urinary frequency as measured by a 3 day voiding diary

  number of voids per day

  1 year

Secondary Outcomes (1)

• Lifestyle Impact of Overactive Bladder as measured using 3 validated questionnaires: OAB-Q, PPBC, and Urgency Severity and Impact Questionnaire

  1 year

Study Arms (2)

Toviaz and Premarin Vaginal Cream

EXPERIMENTAL

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

Drug: Toviaz; Drug: Premarin

Toviaz , Placebo Premarin Vaginal Cream

PLACEBO COMPARATOR

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

Drug: Toviaz; Drug: Placebo cream

Interventions

Toviaz DRUG

Toviaz 4mg daily

Also known as: fesoteridine

Toviaz , Placebo Premarin Vaginal Cream; Toviaz and Premarin Vaginal Cream

Premarin DRUG

Premarin cream 1 g per vagina twice weekly

Also known as: estrogen, conjugated vaginal

Toviaz and Premarin Vaginal Cream

Placebo cream DRUG

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

Also known as: Verba base cream

Toviaz , Placebo Premarin Vaginal Cream

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Pfizer: collaborator

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine; Estrogens, Conjugated (USP); Estrogens

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Eric Hurtado, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

• Alexandriah Alas, MD

  Cleveland Clinic Florida

  STUDY DIRECTOR

Central Study Contacts

Alexandriah Alas, MD

CONTACT

954-659-6342; alasa@ccf.org

Eric Hurtado, MD

CONTACT

954-659-5559; hurtade@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairmain of Department of Gynecology and Head of Section of Urogynecology

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: June 7, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)