Solifenacin Succinate Versus Fesoterodine A Comparison Trial for Urgency Symptoms

NCT ID: NCT01595152

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-05-31

Brief 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.

Detailed Description

The National Overactive Bladder Evaluation (NOBLE) Program estimated the prevalence of OAB in the US is nearly 17% affecting approximately 30 million adults. Sixty-one percent of adults with OAB also have urge urinary incontinence (UUI. Urinary urgency is a key symptom of OAB. Urgency may be more bothersome to patients than urinary frequency, although urinary frequency is often the primary focus of study in the field of OAB. This may be partially due to controversy surrounding how to define the term 'urinary urgency'. As currently defined, urgency is meant to describe an abnormal sensation that is distinguishable from the normal feeling of "urge to void," which occurs during a normal bladder-filling cycle. Attempts to measure urgency are confounded by difficulties in understanding this definition in the context of a normal "urge" to void. This controversy probably arises because of the overlap of the English words 'urge' and 'urgency' during clinical conversation, and apparently does not give rise to confusion in other languages. Recently a new validated questionnaire for the measurement of urgency symptoms was validated[5, 6]. The USIQ consists of two parts with an initial filter question, designated for self-administration. The first 5 items, known as USIQ- severity (USIQ-S), inquires about urgency symptoms and severity, while the second part USIQ- quality of life (USIQ-QOL) consists of 8 questions which inquire about bother and condition specific QOL such as: cooping behaviors, work, commuting and travel, sleep, physical activities, social activities, psychological well-being, relationships and sexual function. Items for each scale are summed and transformed to a score ranging from 0-100. Higher symptom bother scores indicate increasing symptom bother, and higher USIQ-QOL scores indicate worse health related quality of life. The main objective of this current study is to compare the effect of two different anticholinergic medications on symptoms of urinary urgency using a validated, subjective instruments designed specifically for this purpose.

Conditions

Urinary Bladder, Overactive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

solifenacin succinate (10 mg OD)

Group Type: ACTIVE_COMPARATOR

solifenacin succinate

Intervention Type: DRUG

8 mg once daily for 60 days

fesoterodine (8mg OD)

Group Type: ACTIVE_COMPARATOR

fesoterodine

Intervention Type: DRUG

8 mg, once daily for 60 dyas

Interventions

solifenacin succinate

8 mg once daily for 60 days

Intervention Type: DRUG

fesoterodine

8 mg, once daily for 60 dyas

Intervention Type: DRUG

Other Intervention Names

vesicare; Toviaz

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Lior Lowenstein

Head Of Urgoyncology Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Padoa, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Haim Krissi, MD

Role: PRINCIPAL_INVESTIGATOR

Belinson Medical center

David Shveiky, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassa

Naama Marcus, MD

Role: PRINCIPAL_INVESTIGATOR

Rebecca ziv

Lior Lowenstein, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Rambam Health Care Campus

Haifa, , Israel

Site Status: RECRUITING

Hadassah

Jerusalem, , Israel

Site Status: NOT_YET_RECRUITING

Belinson

Petah Tikva, , Israel

Site Status: NOT_YET_RECRUITING

Rebecca Ziv

Safed, , Israel

Site Status: NOT_YET_RECRUITING

Asaf harofeh

Tel Aviv, , Israel

Site Status: NOT_YET_RECRUITING

Countries

Israel

Central Contacts

Lior Lowenstein, MD, MS

Role: CONTACT

l_lior@rambam.health.gov.il

97248542653

Facility Contacts

Lior Lowenstein, MD

Role: primary

lowensteinmd@gmailc.om

048542382

David Shveiky, MD

Role: primary

dshveiky@gmail.com

97248542653

Haim Krissi, MD

Role: primary

haimkrissi@hotmail.com

97248542653

Naama Marcus, MD

Role: primary

naama.m@ziv.health.gov.il

97248542653

Anna Padoa, MD

Role: primary

annapadoa@gmail.com

97248542653

Other Identifiers

RMB-0096-12

Identifier Type: OTHER

Identifier Source: secondary_id

RMB-0096-12

Identifier Type: -

Identifier Source: org_study_id