Solifenacin Succinate Versus Fesoterodine A Comparison Trial for Urgency Symptoms

• Status: Unknown status
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

Hypothesis:

Objective 1: To advance the investigators understanding on the effect of solifenacin succinate (10 mg OD) vs. fesoterodine (8mg OD) on urinary urgency using a validated Urgency Severity and Impact Questionnaire (USIQ).

Hypothesis 1.1: The severity of urgency symptoms as measured by USIQ will change differently in women with OAB following a 3 month treatment with solifenacin succinate (10 mg OD) vs. fesoterodine (8mg OD).

Hypothesis 2.1: Condition-specific quality of life (QOL) as measured by USIQ will change differently in women with OAB following a 3 month treatment with solifenacin succinate (10 mg OD) vs. fesoterodine (8mg OD).

Objective 2: To advance the investigators understanding on the adverse events (AE's) of solifenacin succinate (10 mg OD) vs. fesoterodine (8mg OD).

Hypothesis 1.1: The severity and rate of AE's in women with OAB following a 3 month of treatment with solifenacin succinate (10 mg OD) vs. fesoterodine (8mg OD) will be different.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Treatments: Fesoterodine; Solifenacin Succinate

Criteria

Inclusion Criteria:

• Are > 18 years old

• Have a clinical diagnosis of OAB (wet or dry) with urinary urgency

• Are seeking treatment for OAB

• No contraindication to solifenacin succinate (10 mg OD) or fesoterodine (8mg OD)

• Have a negative urine dipstick analysis

• Are able to consent and fill out study documents and complete all study visits

• Have not been treated with an anticholinergic medication in the past 1-month

Exclusion Criteria:

• Have known neurologic disorder, e.g.: multiple sclerosis, Parkinson's Disease, spinal cord injury, stroke

• Are currently receiving treatment for OAB, including medications, physical and/or formal behavioral therapy, or electrical stimulation

• Have an elevated post -void residual volume by ultrasound or straight catheterization (PVR>150 ml)

• Were treated for a urinary tract infection in the last month

• Have untreated narrow angle glaucoma

• Are unable to comprehend and complete study tasks

• Have an allergy to or had previously failed treatment with solifenacin succinate or fesoterodine