Trial Outcomes & Findings for Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy (Part II) (NCT NCT01215721)

Last Updated: 2014-01-23

Results Overview

Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

12 months

Results posted on

2014-01-23

Participants are limited to men undergoing a robot assistered radical prostatectomy at the University of California, Irvine.

Only men who at the 6th or 7th day post-catheter removal are multiple pad users (3 pads or more) will be invited to participate in this trial.

Participant milestones
Measure	Vesicare Vesicare™ (Solifenacin) : 5 mg daily
Overall Study STARTED	40
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	Vesicare Vesicare™ (Solifenacin) : 5 mg daily
Overall Study Adverse Event	2

Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy (Part II)

Baseline characteristics by cohort
Measure	Vesicare n=40 Participants Vesicare™ (Solifenacin) : 5 mg daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Age, Continuous	64.5 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants
Severely Incontinent Men Post RARP	40 Participants n=5 Participants

Timeframe: 12 months

Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card.

Outcome measures
Measure	Vesicare, 5mg Treatment Group n=40 Participants Vesicare™ (Solifenacin) : 5 mg daily
Time to Continence	95 Days to Continence Standard Deviation 128.8

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Vesicare, 5mg Treatment Group n=40 participants at risk Vesicare™ (Solifenacin) : 5 mg daily
Gastrointestinal disorders Stomach Cramps	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the duration of 3 months from the time of medication administration.
General disorders Faintness, Flushing	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the duration of 3 months from the time of medication administration.

UC Irvine

Phone: 714-456-6068