Over-Active Bladder
Conditions
Keywords
Urination Disorder, Overactive Bladder, Prostate Cancer Radiation, Vesicare
Brief 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.
Detailed description
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.
Interventions
DRUGSolifenacin succinate
IGRT with VESIcare
DRUGPlacebo
IGRT with placebo
Sponsors
Astellas Pharma US, Inc.
Advanced Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS). | baseline and 16 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Solifenacin Succinate Solifenacin succinate, 5mg or 10 mg once daily
Solifenacin succinate | 4 |
| Placebo Drug: Placebo oral
Placebo | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | Solifenacin Succinate | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Continuous | 64.5 Years STANDARD_DEVIATION 8.74 | 66 Years STANDARD_DEVIATION 7.57 | 65.25 Years STANDARD_DEVIATION 7.61 |
| Region of Enrollment United States | 4 participants | 4 participants | 8 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
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.
Time frame: baseline and 16 weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS). | 9.4 Scores on a scale | Standard Deviation 4.24 |
| Placebo | Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS). | 6.7 Scores on a scale | Standard Deviation 4.52 |