Trial Outcomes & Findings for A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition (NCT NCT00224029)

Results Overview

Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

8 weeks

Results posted on

2010-04-30

Participant Flow

washout of previous anticholinergic therapy during the screening period

Participant milestones

Participant milestones
Measure	Oxybutynin Transdermal System
Overall Study STARTED	24
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxybutynin Transdermal System
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	4
Overall Study Other	1

Baseline Characteristics

A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxybutynin Transdermal System n=24 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	41.9 years STANDARD_DEVIATION 10.35 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF.

Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.

Outcome measures

Outcome measures
Measure	Oxybutynin Transdermal System n=22 Participants
Average Number of Catheterizations Without Leaking Per Day Baseline at Week 0	2.4 Number of Dry Catheterizations per Day Standard Deviation 1.8
Average Number of Catheterizations Without Leaking Per Day Change from baseline at Week 8	1.5 Number of Dry Catheterizations per Day Standard Deviation 2.2

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

Adverse Events

Oxybutynin Transdermal System

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oxybutynin Transdermal System n=24 participants at risk
Gastrointestinal disorders Dry mouth	8.3% 2/24 • Number of events 5 • 8 weeks
General disorders Headache	8.3% 2/24 • Number of events 2 • 8 weeks
Renal and urinary disorders Infection urinary tract	12.5% 3/24 • Number of events 3 • 8 weeks
Skin and subcutaneous tissue disorders Sweat	8.3% 2/24 • Number of events 3 • 8 weeks
Eye disorders Vision abnormal	8.3% 2/24 • Number of events 2 • 8 weeks

Additional Information

Gary Hoel, RPh, PhD, Executive Director of Clinical Research

Watson Laboratories, Inc.

Phone: 801-588-6641

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60