Trial Outcomes & Findings for Study to Determine Effects of Vesicare on Return to Continence Post- Radical Prostatectomy (NCT NCT00581061)

NCT ID: NCT00581061

Last Updated: 2010-10-07

Results Overview

Time in days to achieve pad free urinary continence

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2010-10-07

Participant Flow

Participant milestones

Measure	Vesicare Number of subjects that were in compliance with the study protocol and took medication for at least one month.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Determine Effects of Vesicare on Return to Continence Post- Radical Prostatectomy

Baseline characteristics by cohort

Measure	Vesicare n=13 Participants Number of subjects that were in compliance with the study protocol and took medication for at least one month.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age Continuous	62.9 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Time in days to achieve pad free urinary continence

Outcome measures

Measure	Vesicare n=10 Participants Number of days it takes for subjects to achieve pad free urinary continence
Time to Continence	50 days Standard Deviation 2.5

SECONDARY outcome

Timeframe: 3 months

Population: per protocol

Number of subjects that were in compliance with the study protocol and took medication for at least one month.

Outcome measures

Measure	Vesicare n=13 Participants Number of days it takes for subjects to achieve pad free urinary continence
Compliance	10 participants

SECONDARY outcome

Timeframe: 3 months

Number of people who experienced side effects while taking Vesicare, per study protocol.

Outcome measures

Measure	Vesicare n=10 Participants Number of days it takes for subjects to achieve pad free urinary continence
Side Effects Constipation	2 participants
Side Effects Fatigue	1 participants
Side Effects Heartburn	1 participants
Side Effects Dry Hands	1 participants
Side Effects Dry Mouth	2 participants

Adverse Events

Vesicare

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vesicare n=13 participants at risk Number of subjects that were in compliance with the study protocol and took medication for at least one month.
Gastrointestinal disorders Constipation	15.4% 2/13
General disorders Fatigue	7.7% 1/13
Gastrointestinal disorders Heartburn	7.7% 1/13
Skin and subcutaneous tissue disorders Dry Hands	7.7% 1/13
General disorders Dry Mouth	15.4% 2/13

Additional Information

Doug Skarecky

University of California, Irvine

Phone: 714-456-6744

Email: dwskarec@uci.edu

Results disclosure agreements

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

Restriction type: LTE60