Solifenacin Succinate Versus Fesoterodine A Comparison Trial for Urgency Symptoms

Urinary Bladder, Overactive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01595152
• Other study ID #: RMB-0096-12
• Secondary ID: RMB-0096-12
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2012
• Last updated: May 14, 2012
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2012
• Source: Rambam Health Care Campus
• Contact: Lior Lowenstein, MD, MS
• Phone: 97248542653
• Email: l_lior[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• solifenacin succinate
8 mg once daily for 60 days
• fesoterodine
8 mg, once daily for 60 dyas

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah	Jerusalem
Israel	Belinson	Petach Tikva
Israel	Asaf harofeh	Tel Aviv
Israel	Rebecca Ziv	Zefat

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in urgency sensation	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	No
Secondary	Adverse events	Tolerability of both drugs will be monitored throughout the study based on reported AEs and discontinuations.	two months	Yes