Solifenacin Succinate Versus Fesoterodine A Comparison Trial for Urgency Symptoms (no)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Lior Lowenstein, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01595152
First received: May 8, 2012
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Urinary Bladder, Overactive
Drug: solifenacin succinate
Drug: fesoterodine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Solifenacin Succinate vs. Fesoterodine A Comparison Trial for the Treatment of Bothersome Urgency Symptoms

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Changes in urgency sensation [ Time Frame: two months following treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adverse events [ Time Frame: two months ] [ Designated as safety issue: Yes ]
    Tolerability of both drugs will be monitored throughout the study based on reported AEs and discontinuations.


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: solifenacin succinate (10 mg OD) Drug: solifenacin succinate
8 mg once daily for 60 days
Other Name: vesicare
Active Comparator: fesoterodine (8mg OD) Drug: fesoterodine
8 mg, once daily for 60 dyas
Other Name: Toviaz

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595152

Contacts
Contact: Lior Lowenstein, MD, MS 97248542653 l_lior@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel
Contact: Lior Lowenstein, MD    048542382    lowensteinmd@gmailc.om   
Hadassah Not yet recruiting
Jerusalem, Israel
Contact: David Shveiky, MD    97248542653    dshveiky@gmail.com   
Principal Investigator: David Shveiky, MD         
Belinson Not yet recruiting
Petach Tikva, Israel
Contact: Haim Krissi, MD    97248542653    haimkrissi@hotmail.com   
Principal Investigator: Haim Krissi, MD         
Asaf harofeh Not yet recruiting
Tel Aviv, Israel
Contact: Anna Padoa, MD    97248542653    annapadoa@gmail.com   
Principal Investigator: Anna Padoa, MD         
Rebecca Ziv Not yet recruiting
Zefat, Israel
Contact: Naama Marcus, MD    97248542653    naama.m@ziv.health.gov.il   
Principal Investigator: Naama Marcus, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Lior Lowenstein, Head Of Urgoyncology Service, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01595152     History of Changes
Other Study ID Numbers: RMB-0096-12, RMB-0096-12
Study First Received: May 8, 2012
Last Updated: May 14, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
Urgency, urgency incontinence,USIQ

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Solifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014