Trial Outcomes & Findings for VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate (NCT NCT01777217)

NCT ID: NCT01777217

Last Updated: 2015-01-16

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 8 participants
• Primary outcome timeframe: baseline and 16 weeks
• Results posted on: 2015-01-16

Participant Flow

Participant milestones

Measure	Solifenacin Succinate Solifenacin succinate, 5mg or 10 mg once daily Solifenacin succinate	Placebo Drug: Placebo oral Placebo
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Solifenacin Succinate n=4 Participants Solifenacin succinate, 5mg or 10 mg once daily Solifenacin succinate	Placebo n=4 Participants Drug: Placebo oral Placebo	Total n=8 Participants Total of all reporting groups
Age, Continuous	64.5 Years STANDARD_DEVIATION 8.74 • n=5 Participants	66 Years STANDARD_DEVIATION 7.57 • n=7 Participants	65.25 Years STANDARD_DEVIATION 7.61 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Solifenacin Succinate n=4 Participants Solifenacin succinate, 5mg or 10 mg once daily Solifenacin succinate	Placebo n=4 Participants Drug: Placebo oral Placebo
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	6.7 Scores on a scale Standard Deviation 4.52

Adverse Events

Solifenacin Succinate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sanjay Mehta

Century Cancer Centers

Phone: 713-631-8181

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place