Solifenacin Succinate Versus Fesoterodine A Comparison Trial for Urgency Symptoms

NCT01595152 | Unknown

• 1 other identifier: RMB-0096-12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Urinary Bladder, Overactive

Keywords

Urgency, urgency incontinence,USIQ

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Adverse events

  two months

Study Arms (2)

solifenacin succinate (10 mg OD)

ACTIVE COMPARATOR

Drug: solifenacin succinate

fesoterodine (8mg OD)

ACTIVE COMPARATOR

Drug: fesoterodine

Interventions

solifenacin succinate DRUG

8 mg once daily for 60 days

Also known as: vesicare

solifenacin succinate (10 mg OD)

fesoterodine DRUG

8 mg, once daily for 60 dyas

Also known as: Toviaz

fesoterodine (8mg OD)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (5)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Hadassah

Jerusalem, Israel

NOT YET RECRUITING

Belinson

Petah Tikva, Israel

NOT YET RECRUITING

Rebecca Ziv

Safed, Israel

NOT YET RECRUITING

Asaf harofeh

Tel Aviv, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate; fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lior Lowenstein, MD, MS

CONTACT

97248542653; l_lior@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Of Urgoyncology Service

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 9, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

IL (5)