A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371994
• Other study ID #: 905-UC-050
• Status: Completed
• Phase: Phase 4
• Start date: August 2, 2011
• Est. completion date: October 21, 2013

Study information

• Verified date: July 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: October 21, 2013
• Est. primary completion date: October 21, 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Drug:
• solifenacin succinate
oral
• Placebo
oral

Locations

Country	Name	City	State
Canada	University Health Network/ Princess Margaret Hospital	Toronto	Ontario
Canada	The Prostate Centre, Diamond Health Care Centre	Vancouver	British Columbia
United States	Community Care Physicians PC	Albany	New York
United States	Alaska Clinical Research Center	Anchorage	Alaska
United States	Urologic Consultants of Southeastern Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	Brooklyn Urology Research Group	Brooklyn	New York
United States	Lahey Clinic Medical Center	Burlington	Massachusetts
United States	Cary Urology	Cary	North Carolina
United States	CAMC Institute Clinical Trial Center	Charleston	West Virginia
United States	Academic Urologists	Chattanooga	Tennessee
United States	Northwestern University	Chicago	Illinois
United States	The Urology Group	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Urology Clinics of North Texas	Dallas	Texas
United States	Urology Center of Colorado	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Pharma Resources	East Providence	Rhode Island
United States	Urology Associates	Englewood	Colorado
United States	Northeast Indiana Research	Fort Wayne	Indiana
United States	University of Florida	Gainesville	Florida
United States	Spectrum Health Medical Group	Grand Rapids	Michigan
United States	Urology of Indiana	Greenwood	Indiana
United States	Urology Research Network	Hialeah	Florida
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Methodist Hospital Research Institute	Houston	Texas
United States	Methodist Urology Associates	Houston	Texas
United States	The University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	East Coast Institute for Research	Jacksonville	Florida
United States	Volunteer Research Group	Knoxville	Tennessee
United States	University of California, San Diego Moores Cancer Center	La Jolla	California
United States	South Nevada Aids Research	Las Vegas	Nevada
United States	AdvanceMed Research	Lawrenceville	New Jersey
United States	Tower Urology	Los Angeles	California
United States	University of Wisconsin Hospital	Madison	Wisconsin
United States	Southeast Urology Network	Memphis	Tennessee
United States	Connecticut Clinical Research Center	Middlebury	Connecticut
United States	Five Valley Urology	Missoula	Montana
United States	Delaware Valley Urology	Mount Laurel	New Jersey
United States	Grove Hill Medical Center	New Britain	Connecticut
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Tulane University School of Medicine, Department of Urology	New Orleans	Louisiana
United States	University Urology Associates	New York	New York
United States	Winter Park Urology Associates	Orlando	Florida
United States	Advanced Urology	Parker	Colorado
United States	Oregon Health and Science University	Portland	Oregon
United States	Hudson Valley Urology, PC	Poughkeepsie	New York
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	University of Rochester Medical Center	Rochester	New York
United States	Radiological Associates of Sacramento Medical Group, Inc.	Sacramento	California
United States	Urology San Antonio Research	San Antonio	Texas
United States	Adult and Pediatric Urology Group	Sartell	Minnesota
United States	Swedish Urology Group	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Springfield Clinic	Springfield	Illinois
United States	AMP Urology	Syracuse	New York
United States	Southeastern Research Group	Tallahassee	Florida
United States	Romius Institute of Northwest Ohio	Toledo	Ohio
United States	Urological Associates of Southern Arizona	Tucson	Arizona
United States	Urologic Surgeons of Washington	Washington	District of Columbia
United States	The Iowa Clinic	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time From First Dose to Urinary Continence	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.	12 weeks
Secondary	Percentage of Participants Who Gain Continence During 12-week Treatment Period	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.	Weeks 4, 8, and 12
Secondary	Average Daily Pad Usage at Baseline	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.	Baseline (7 days prior to Day 1)
Secondary	Change From Baseline in Average Daily Pad Usage	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.	Baseline and Weeks 4, 8 and 12
Secondary	American Urology Association Symptom Score (AUASS) at 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).	Baseline
Secondary	Change From Baseline in American Urology Association Symptom Score (AUASS)	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.	Baseline and Week 12
Secondary	American Urology Association Quality of Life (QOL) Score at 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).	Baseline
Secondary	Change From Baseline in American Urology Association Quality of Life (QOL) Score	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.	Baseline and Week 12
Secondary	International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at 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).	Baseline
Secondary	Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score	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 and Week 12
Secondary	Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed	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.	Baseline
Secondary	Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed	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 and Week 12
Secondary	Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working	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.	Baseline
Secondary	Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working	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 and Week 12
Secondary	Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment	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.	Baseline
Secondary	Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment	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 and Week 12
Secondary	Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment	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.	Baseline
Secondary	Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment	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.	Baseline and Week 12
Secondary	Time From Baseline to First Day of Returning to Work	The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method.	From Baseline to Week 12

External Links

•   Link to results on the Astellas Clinical Study Results website.