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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-01-31

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.

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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.

Conditions

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Over-Active Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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solifenacin succinate

Solifenacin succinate, 5mg or 10 mg once daily

Group Type ACTIVE_COMPARATOR

Solifenacin succinate

Intervention Type DRUG

IGRT with VESIcare

Placebo

Drug: Placebo oral

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IGRT with placebo

Interventions

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Solifenacin succinate

IGRT with VESIcare

Intervention Type DRUG

Placebo

IGRT with placebo

Intervention Type DRUG

Other Intervention Names

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VESIcare Control

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes