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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 640
- Locations
- 60
- Primary Endpoint
- Time From First Dose to Urinary Continence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: solifenacin succinate (Drug)
Placebo
Participants received matching placebo tablets once a day for 12 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Time From First Dose to Urinary Continence
Time Frame: 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 Outcomes
- Percentage of Participants Who Gain Continence During 12-week Treatment Period(Weeks 4, 8, and 12)
- Average Daily Pad Usage at Baseline(Baseline (7 days prior to Day 1))
- Change From Baseline in Average Daily Pad Usage(Baseline and Weeks 4, 8 and 12)
- American Urology Association Symptom Score (AUASS) at Baseline(Baseline)
- Change From Baseline in American Urology Association Symptom Score (AUASS)(Baseline and Week 12)
- American Urology Association Quality of Life (QOL) Score at Baseline(Baseline)
- Change From Baseline in American Urology Association Quality of Life (QOL) Score(Baseline and Week 12)
- International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline(Baseline)
- Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score(Baseline and Week 12)
- Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed(Baseline)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed(Baseline and Week 12)
- Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working(Baseline)
- Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working(Baseline and Week 12)
- Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment(Baseline)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment(Baseline and Week 12)
- Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment(Baseline)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment(Baseline and Week 12)
- Time From Baseline to First Day of Returning to Work(From Baseline to Week 12)