Overview

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