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

Completed · Phase 4 · Has a placebo group

Conditions studied: Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT01371994

Run by

Astellas Pharma Inc

People needed

640

Starts

2011-08-02

Expected to finish

2013-10-21

Last updated by the study team

2024-11-21

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Grove Hill Medical Center — New Britain, Connecticut, United States
• Urologic Surgeons of Washington — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Urology Research Network — Hialeah, Florida, United States
• East Coast Institute for Research — Jacksonville, Florida, United States
• Winter Park Urology Associates — Orlando, Florida, United States
• Southeastern Research Group — Tallahassee, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• Northeast Indiana Research — Fort Wayne, Indiana, United States
• Urology of Indiana — Greenwood, Indiana, United States
• The University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• The Iowa Clinic — West Des Moines, Iowa, United States
• Tulane University School of Medicine, Department of Urology — New Orleans, Louisiana, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• Urology Centers of Alabama — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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