Premarin Versus Toviaz for Treatment of Overactive Bladder

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cleveland Clinic Florida; The Cleveland Clinic
• Collaborator: Pfizer
• Treatments: Estrogens; Estrogens, Conjugated (USP); Fesoterodine

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