A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence Af… (NCT01371994) | Clinical Trial Compass
CompletedPhase 4
A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
United States640 participantsStarted 2011-08-02
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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 therap…