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

Phase 4CompletedNCT01371994

Astellas Pharma Inc640 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

640

Conditions

Urinary Incontinence

Interventions

solifenacin succinateDRUG

oral

PlaceboDRUG

oral

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (60)

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: Weeks 4, 8, and 12

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.

Time frame: Baseline (7 days prior to Day 1)

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.

Time frame: Baseline and Weeks 4, 8 and 12

American Urology Association Symptom Score (AUASS) at Baseline

Data from ClinicalTrials.gov

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Urology Centers of Alabama

Homewood, Alabama, United States

Alaska Clinical Research Center

Anchorage, Alaska, United States

Urological Associates of Southern Arizona

Tucson, Arizona, United States

University of California, San Diego Moores Cancer Center

La Jolla, California, United States

Tower Urology

Los Angeles, California, United States

Radiological Associates of Sacramento Medical Group, Inc.

Sacramento, California, United States

Urology Center of Colorado

Denver, Colorado, United States

Urology Associates

Englewood, Colorado, United States

Advanced Urology

Parker, Colorado, United States

Connecticut Clinical Research Center

Middlebury, Connecticut, United States

...and 50 more locations

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).

Time frame: Baseline

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.

Time frame: Baseline and Week 12

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).

Time frame: Baseline

Change From Baseline in American Urology Association Quality of Life (QOL) Score

Time frame: Baseline and Week 12

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).

Time frame: Baseline

Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score

Time frame: Baseline and Week 12

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.

Time frame: Baseline

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed

Time frame: Baseline and Week 12

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.

Time frame: Baseline

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.

Time frame: Baseline and Week 12

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.

Time frame: Baseline

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.

Time frame: Baseline and Week 12

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.

Time frame: Baseline

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.

Time frame: Baseline and Week 12

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.

Time frame: From Baseline to Week 12