Solifenacin Succinate Versus Fesoterodine A Comparison Trial for Urgency Symptoms

May 14, 2012 updated by: Lior Lowenstein, Rambam Health Care Campus

Solifenacin Succinate vs. Fesoterodine A Comparison Trial for the Treatment of Bothersome Urgency Symptoms

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Recruiting
        • Rambam Health Care Campus
        • Contact:
      • Jerusalem, Israel
        • Not yet recruiting
        • Hadassah
        • Contact:
        • Principal Investigator:
          • David Shveiky, MD
      • Petach Tikva, Israel
        • Not yet recruiting
        • Belinson
        • Contact:
        • Principal Investigator:
          • Haim Krissi, MD
      • Tel Aviv, Israel
        • Not yet recruiting
        • Asaf Harofeh
        • Contact:
        • Principal Investigator:
          • Anna Padoa, MD
      • Zefat, Israel
        • Not yet recruiting
        • Rebecca Ziv
        • Contact:
        • Principal Investigator:
          • Naama Marcus, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: solifenacin succinate (10 mg OD)
Drug: solifenacin succinate
8 mg once daily for 60 days
Other Names:
  • vesicare
Active Comparator: fesoterodine (8mg OD)
Drug: fesoterodine
8 mg, once daily for 60 dyas
Other Names:
  • Toviaz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in urgency sensation
Time Frame: two months following treatment
The effect of two different antochloinergic treatment on urgency symptoms will be measured by comparing USIQ scores changes in the two study arms, before and after treatment. Changes in urgency sensation will be analysed by subsiding the USIQ scopre at 2 months (second visit) from the USIQ score at baseline. Independent student t- test will be used for Comparison between the changes in USIQ score of the two groups.
two months following treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: two months
Tolerability of both drugs will be monitored throughout the study based on reported AEs and discontinuations.
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Anna Padoa, MD, Assaf-Harofeh Medical Center
  • Principal Investigator: Haim Krissi, MD, Belinson Medical Center
  • Principal Investigator: David Shveiky, MD, Hadassa
  • Principal Investigator: Naama Marcus, MD, Rebecca Ziv
  • Principal Investigator: Lior Lowenstein, MD, MS, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 8, 2012

First Posted (Estimate)

May 9, 2012

Study Record Updates

Last Update Posted (Estimate)

May 16, 2012

Last Update Submitted That Met QC Criteria

May 14, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMB-0096-12 (Other Identifier: Helsinki Rambam)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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