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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

Phase 4
18 Years
Open (Enrolling)
Over-Active Bladder

Thank you

Trial Information

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

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.

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

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)

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Change from baseline to end of study measured by the American Urology Association Symptom Score Questionnaire (AUASS).

Outcome Time Frame:

baseline and 12 weeks

Safety Issue:


Principal Investigator

Sanjay Mehta, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Century Cancer Centers


United States: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

March 2014

Related Keywords:

  • Over-Active Bladder
  • Urination Disorder
  • Overactive Bladder
  • Prostate Cancer Radiation
  • Vesicare
  • Urinary Bladder, Overactive



Century Cancer Center Greenwood Village, Colorado  80111
Century Cancer Center Houston, Texas  77025