VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate

Study Overview
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Brief Summary
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The purpose of this study is to determine if Vesicare (Solifenacin succinate) is effective in treating over-active bladder symptoms during radiation therapy of the prostate.

Detailed Description
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This is a randomized double blind placebo controlled flexible dose 12 week study. Following screening, subjects will receive their first dose of study medication following completion of AUASS questionnaire on the first day of radiation treatment (baseline) and will continue for twelve weeks. Subjects will be started on 5 mg of study medication. The AUASS will be completed at baseline, weeks 4, 8 and 12. A 16 week visit conducted over a phone interview.

Official Title
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A Pilot Study to Assess the Safety and Efficacy of Solifenacin (VESIcare) for Improving Urinary and Bladder Functions in Patients Undergoing Radiation Therapy of the Prostate

Conditions
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Over-Active Bladder

Intervention / Treatment
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* Drug: Solifenacin succinate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per HIPAA Authorization for the USA test sites is obtained from subject or legally authorized representative prior to the initiation of this study (including withdrawal of prohibited medication, if applicable) Subject must be an ambulatory male at least 18 years of age. Subject has been diagnosed with prostate carcinoma and has elected to undergo external beam radiation therapy. Subject is willing to complete the American Urology Association Symptom Score (AUASS) Questionnaire. Exclusion Criteria: Subject has undergone a prostatectomy Subject exhibits symptoms of urinary tract infection. Subject exhibits severe neurologic damage or has undergone prostatectomy. Subject diagnosed with OAB and is being treated with medication for alleviation of OAB symptoms within 12 months prior to the Screening Visit. Subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric retention, neurogenic bladder; prostatitis, or persistent UTI. Subject exhibits hypersensitivity to Solifenacin succinate, any ingredients, or other anticholinergic agents. Subject has undergone treatment with any investigational drug within 30 days prior to screening procedure. Subject has exhibited history of diagnosed gastrointestinal obstructive disease. Subjects with co-morbid lower urinary tract symptoms (LUTS). Subjects exhibiting clinically significant bladder outflow obstruction (BOO). In the opinion of the Study Investigator, the patient has exhibited prior to the screening or Baseline visit, a clinically significant disease or medical condition that would exclude the subject from participating in the study. Subjects who have received prior pelvic radiation. Subjects with history of severe hepatic impairment. Subjects with history of Congenital or Acquired QT prolongation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: solifenacin succinate<br>Solifenacin succinate, 5mg or 10 mg once daily | Drug: Solifenacin succinate<br>* IGRT with VESIcare<br>* Other names: VESIcare;|
| Placebo Comparator: Placebo<br>Drug: Placebo oral | Drug: Placebo<br>* IGRT with placebo<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS). | The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score. | baseline and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urination Disorder, Overactive Bladder, Prostate Cancer Radiation, Vesicare