Solifenacin Succinate Versus Fesoterodine A Comparison Trial for Urgency Symptoms
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| ClinicalTrials.gov Identifier: NCT01595152 |
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Recruitment Status : Unknown
Verified May 2012 by Lior Lowenstein, Rambam Health Care Campus.
Recruitment status was: Recruiting
First Posted : May 9, 2012
Last Update Posted : May 16, 2012
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Sponsor:
Rambam Health Care Campus
Information provided by (Responsible Party):
Lior Lowenstein, Rambam Health Care Campus
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Urinary Bladder, Overactive | Drug: solifenacin succinate Drug: fesoterodine | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Solifenacin Succinate vs. Fesoterodine A Comparison Trial for the Treatment of Bothersome Urgency Symptoms |
| Study Start Date : | May 2012 |
| Estimated Primary Completion Date : | May 2013 |
| Estimated Study Completion Date : | May 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Overactive Bladder
| Arm | Intervention/treatment |
|---|---|
| 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 |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Adverse events [ Time Frame: two months ]Tolerability of both drugs will be monitored throughout the study based on reported AEs and discontinuations.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Lior Lowenstein, Head Of Urgoyncology Service, Rambam Health Care Campus |
| ClinicalTrials.gov Identifier: | NCT01595152 |
| Other Study ID Numbers: |
RMB-0096-12 RMB-0096-12 ( Other Identifier: Helsinki Rambam ) |
| First Posted: | May 9, 2012 Key Record Dates |
| Last Update Posted: | May 16, 2012 |
| Last Verified: | May 2012 |
Keywords provided by Lior Lowenstein, Rambam Health Care Campus:
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Urgency, urgency incontinence,USIQ |
Additional relevant MeSH terms:
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Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Solifenacin Succinate Fesoterodine |
Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |