Clinical trial NCT01371994: A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
Official title: A Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase 4, Multicenter Study to Assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects After Robotic Assisted Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Keywords: Radical Robotic Arm
Vesicare
Post Prostatectomy Incontinence
YM905
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-06-13
Enrollment: 640
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of solifenacin succinate versus placebo in participants who are incontinent after Robotic Assisted Radical Prostatectomy.

This study will also assess the effect of 12 weeks of treatment with solifenacin succinate versus placebo on quality of life (QOL) as measured by questionnaires.

Detailed description: The study duration includes a 14-day treatment free wash-out period. The maximum total study duration is 15 weeks (2-3 week screening/washout period and a 12 week treatment period). The Baseline, Week 4, and Week 8 visits will be telephone contact visits.

Participants will complete an electronic daily pad use diary during the study

duration. Participants will also be asked to complete several questionnaires during the study.

Eligibility criteria: Inclusion Criteria:

* Ambulatory
* Willing and able to complete the daily pad use diary,

American Urology Association Symptom Score (AUASS) with Bother Score, the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), and the Work Productivity and Activity Impairment Questionnaire (WPAI)

* Has not used any medication for over-active bladder symptoms for at least 14 days prior to enrollment
* Diagnosed with prostate cancer, treated by Robotic Assisted Radical Prostatectomy, is voiding spontaneously and has urinary incontinence one week after removal of the indwelling catheter which requires management with 2 to 10 pads inclusive per day (24 hour days) for 7 consecutive days

Exclusion Criteria:

* Evidence of severe neurologic damage post-prostatectomy
* Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stone; uncontrolled narrow angle glaucoma; urinary or gastric retention or neurogenic bladder
* Symptomatic for urinary tract infection or has a urine culture result which requires treatment as determined by the investigator.
* Clinically significant history of hepatic or renal impairment (2 X Upper Limit of Normal (ULN) values in alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine clearance \< 30 ml/min)
* History of diagnosed gastrointestinal obstruction disease
* Any prior history of local radiation therapy to the prostate or rectum or any prior hormonal therapy or has planned such therapy during study conduct
* Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics
* Treated with any investigational drug within last 30 days
* History of a clinically significant illness or medical condition that would preclude participation in the study
* Diagnosed with New York Heart Association Class III and IV heart failure
* Any of the following peri-operative laboratory results: ALT \> 2.0 ULN, AST \> 2.0 ULN, serum creatinine \> 1.5 mg/L, blood glucose \> 130 mg/dL, blood urea nitrogen (BUN) \> 23 mg/dL.
* Severe hypertension on peri-operative evaluation which is defined as a sitting systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg, and which is not corrected
* Electrolytes (sodium, potassium, chloride or bicarbonate) that are not in normal range and clinically significant as determined by the investigator in the perioperative period. Can be eligible if electrolytes are corrected to within normal range prior to randomization
* Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives, whichever is longer, prior to the initiation of Screening.

Primary outcomes:
measure: Time From First Dose to Urinary Continence
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of Participants Who Gain Continence During 12-week Treatment Period
timeFrame: Weeks 4, 8, and 12
measure: Average Daily Pad Usage at Baseline
timeFrame: Baseline (7 days prior to Day 1)
measure: Change From Baseline in Average Daily Pad Usage
timeFrame: Baseline and Weeks 4, 8 and 12
measure: American Urology Association Symptom Score (AUASS) at Baseline
timeFrame: Baseline
measure: Change From Baseline in American Urology Association Symptom Score (AUASS)
timeFrame: Baseline and Week 12
measure: American Urology Association Quality of Life (QOL) Score at Baseline
timeFrame: Baseline
measure: Change From Baseline in American Urology Association Quality of Life (QOL) Score
timeFrame: Baseline and Week 12
measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline
timeFrame: Baseline
measure: Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score
timeFrame: Baseline and Week 12
measure: Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
timeFrame: Baseline
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
timeFrame: Baseline and Week 12
measure: Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
timeFrame: Baseline
measure: Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working
timeFrame: Baseline and Week 12
measure: Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
timeFrame: Baseline
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
timeFrame: Baseline and Week 12
measure: Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
timeFrame: Baseline
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
timeFrame: Baseline and Week 12
measure: Time From Baseline to First Day of Returning to Work
timeFrame: From Baseline to Week 12
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center
state: Alaska
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Sacramento
country: United States
facility: Radiological Associates of Sacramento Medical Group, Inc.
state: California
city: Denver
country: United States
facility: Urology Center of Colorado
state: Colorado
city: Englewood
country: United States
facility: Urology Associates
state: Colorado
city: Parker
country: United States
facility: Advanced Urology
state: Colorado
city: Middlebury
country: United States
facility: Connecticut Clinical Research Center
state: Connecticut
city: New Britain
country: United States
facility: Grove Hill Medical Center
state: Connecticut
city: Washington
country: United States
facility: Urologic Surgeons of Washington
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hialeah
country: United States
facility: Urology Research Network
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research
state: Florida
city: Orlando
country: United States
facility: Winter Park Urology Associates
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Research Group
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Fort Wayne
country: United States
facility: Northeast Indiana Research
state: Indiana
city: Greenwood
country: United States
facility: Urology of Indiana
state: Indiana
city: Iowa City
country: United States
facility: The University of Iowa Hospitals and Clinics
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: New Orleans
country: United States
facility: Tulane University School of Medicine, Department of Urology
state: Louisiana
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group
state: Michigan
city: Sartell
country: United States
facility: Adult and Pediatric Urology Group
state: Minnesota
city: Missoula
country: United States
facility: Five Valley Urology
state: Montana
city: Las Vegas
country: United States
facility: South Nevada Aids Research
state: Nevada
city: Lawrenceville
country: United States
facility: AdvanceMed Research
state: New Jersey
city: Mount Laurel
country: United States
facility: Delaware Valley Urology
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Albany
country: United States
facility: Community Care Physicians PC
state: New York
city: Brooklyn
country: United States
facility: Brooklyn Urology Research Group
state: New York
city: New York
country: United States
facility: University Urology Associates
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology, PC
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: AMP Urology
state: New York
city: Cary
country: United States
facility: Cary Urology
state: North Carolina
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: Romius Institute of Northwest Ohio
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeastern Pennsylvania
state: Pennsylvania
city: East Providence
country: United States
facility: Pharma Resources
state: Rhode Island
city: Chattanooga
country: United States
facility: Academic Urologists
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Memphis
country: United States
facility: Southeast Urology Network
state: Tennessee
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Houston
country: United States
facility: Methodist Hospital Research Institute
state: Texas
city: Houston
country: United States
facility: Methodist Urology Associates
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Urology Group
state: Washington
city: Charleston
country: United States
facility: CAMC Institute Clinical Trial Center
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
city: Vancouver
country: Canada
facility: The Prostate Centre, Diamond Health Care Centre
state: British Columbia
city: Toronto
country: Canada
facility: University Health Network/ Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
References: