VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate
Condition: Over-Active Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Solifenacin succinate; Placebo
Intervention description: IGRT with VESIcare; IGRT with placebo
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 8.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Urination Disorder; Overactive Bladder; Prostate Cancer Radiation; Vesicare

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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)

          2. Subject must be an ambulatory male at least 18 years of age.

          3. Subject has been diagnosed with prostate carcinoma and has elected to undergo external
             beam radiation therapy.

          4. Subject is willing to complete the American Urology Association Symptom Score (AUASS)
             Questionnaire.

        Exclusion Criteria:

          1. Subject has undergone a prostatectomy

          2. Subject exhibits symptoms of urinary tract infection.

          3. Subject exhibits severe neurologic damage or has undergone prostatectomy.

          4. Subject diagnosed with OAB and is being treated with medication for alleviation of OAB
             symptoms within 12 months prior to the Screening Visit.

          5. Subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric
             retention, neurogenic bladder; prostatitis, or persistent UTI.

          6. Subject exhibits hypersensitivity to Solifenacin succinate, any ingredients, or other
             anticholinergic agents.

          7. Subject has undergone treatment with any investigational drug within 30 days prior to
             screening procedure.

          8. Subject has exhibited history of diagnosed gastrointestinal obstructive disease.

          9. Subjects with co-morbid lower urinary tract symptoms (LUTS).

         10. Subjects exhibiting clinically significant bladder outflow obstruction (BOO).

         11. 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.

         12. Subjects who have received prior pelvic radiation.

         13. Subjects with history of severe hepatic impairment.

         14. Subjects with history of Congenital or Acquired QT prolongation.