A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
- Registration Number
- NCT01371994
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 640
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received matching placebo tablets once a day for 12 weeks. Solifenacin succinate solifenacin succinate Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
- Primary Outcome Measures
Name Time Method Time From First Dose to Urinary Continence 12 weeks Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period were considered as censored at the End of Treatment (EOT) visit or Week 12, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Gain Continence During 12-week Treatment Period Weeks 4, 8, and 12 Urinary continence is defined as three consecutive 24-hour days in which a participant uses no pads or a pad for security which remains completely dry. Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. End of treatment is the last on-treatment assessment during the treatment period.
Average Daily Pad Usage at Baseline Baseline (7 days prior to Day 1) Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.
Change From Baseline in Average Daily Pad Usage Baseline and Weeks 4, 8 and 12 Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage. End of treatment is the last on-treatment assessment during the treatment period.
American Urology Association Symptom Score (AUASS) at Baseline Baseline Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always). The AUASS is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst).
Change From Baseline in American Urology Association Symptom Score (AUASS) Baseline and Week 12 Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always). The AUASS Symptom Score is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst). End of treatment is the last on-treatment assessment during the treatment period.
American Urology Association Quality of Life (QOL) Score at Baseline Baseline The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).
Change From Baseline in American Urology Association Quality of Life (QOL) Score Baseline and Week 12 The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible). End of treatment is the last on-treatment assessment during the treatment period.
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline Baseline The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score Baseline and Week 12 The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).
Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Baseline Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed.
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Baseline and Week 12 Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from Baseline indicates improvement.
Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working Baseline Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.
Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working Baseline and Week 12 Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.
Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Baseline Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Baseline and Week 12 Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.
Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment Baseline Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity.
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment Baseline and Week 12 Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.
Time From Baseline to First Day of Returning to Work From Baseline to Week 12 The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method.
Trial Locations
- Locations (60)
Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Swedish Urology Group
🇺🇸Seattle, Washington, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
University of California, San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Tower Urology
🇺🇸Los Angeles, California, United States
Urologic Surgeons of Washington
🇺🇸Washington, District of Columbia, United States
Urology Research Network
🇺🇸Hialeah, Florida, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Urology of Indiana
🇺🇸Greenwood, Indiana, United States
Northeast Indiana Research
🇺🇸Fort Wayne, Indiana, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
The University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
The Iowa Clinic
🇺🇸West Des Moines, Iowa, United States
Spectrum Health Medical Group
🇺🇸Grand Rapids, Michigan, United States
Adult and Pediatric Urology Group
🇺🇸Sartell, Minnesota, United States
AdvanceMed Research
🇺🇸Lawrenceville, New Jersey, United States
Brooklyn Urology Research Group
🇺🇸Brooklyn, New York, United States
Community Care Physicians PC
🇺🇸Albany, New York, United States
Hudson Valley Urology, PC
🇺🇸Poughkeepsie, New York, United States
University Urology Associates
🇺🇸New York, New York, United States
AMP Urology
🇺🇸Syracuse, New York, United States
Cary Urology
🇺🇸Cary, North Carolina, United States
Associated Urologists of North Carolina
🇺🇸Raleigh, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States
Romius Institute of Northwest Ohio
🇺🇸Toledo, Ohio, United States
Pharma Resources
🇺🇸East Providence, Rhode Island, United States
Urologic Consultants of Southeastern Pennsylvania
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
The Prostate Centre, Diamond Health Care Centre
🇨🇦Vancouver, British Columbia, Canada
South Nevada Aids Research
🇺🇸Las Vegas, Nevada, United States
Urology San Antonio Research
🇺🇸San Antonio, Texas, United States
Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Advanced Urology
🇺🇸Parker, Colorado, United States
Urology Associates
🇺🇸Englewood, Colorado, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Methodist Urology Associates
🇺🇸Houston, Texas, United States
Urological Associates of Southern Arizona
🇺🇸Tucson, Arizona, United States
Lahey Clinic Medical Center
🇺🇸Burlington, Massachusetts, United States
Grove Hill Medical Center
🇺🇸New Britain, Connecticut, United States
East Coast Institute for Research
🇺🇸Jacksonville, Florida, United States
Southeast Urology Network
🇺🇸Memphis, Tennessee, United States
Southeastern Research Group
🇺🇸Tallahassee, Florida, United States
Academic Urologists
🇺🇸Chattanooga, Tennessee, United States
Connecticut Clinical Research Center
🇺🇸Middlebury, Connecticut, United States
University Health Network/ Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Five Valley Urology
🇺🇸Missoula, Montana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
CAMC Institute Clinical Trial Center
🇺🇸Charleston, West Virginia, United States
Delaware Valley Urology
🇺🇸Mount Laurel, New Jersey, United States
Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Radiological Associates of Sacramento Medical Group, Inc.
🇺🇸Sacramento, California, United States
Winter Park Urology Associates
🇺🇸Orlando, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Tulane University School of Medicine, Department of Urology
🇺🇸New Orleans, Louisiana, United States
University of Wisconsin Hospital
🇺🇸Madison, Wisconsin, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States