Trial Outcomes & Findings for Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition (NCT NCT00224016)
NCT ID: NCT00224016
Last Updated: 2012-02-09
Results Overview
Change from baseline in average volume of urine collected by catheterization
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
57 participants
Primary outcome timeframe
14 weeks
Results posted on
2012-02-09
Participant Flow
Participant milestones
| Measure |
Oxybutynin TDS
Oxybutynin Transdermal System
|
Oral Oxybutynin
Oxybutynin tablets
|
|---|---|---|
|
Titration Period
STARTED
|
39
|
16
|
|
Titration Period
COMPLETED
|
38
|
15
|
|
Titration Period
NOT COMPLETED
|
1
|
1
|
|
Maintenance Period
STARTED
|
38
|
15
|
|
Maintenance Period
COMPLETED
|
36
|
14
|
|
Maintenance Period
NOT COMPLETED
|
2
|
1
|
|
Follow-Up Period
STARTED
|
35
|
0
|
|
Follow-Up Period
COMPLETED
|
35
|
0
|
|
Follow-Up Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Oxybutynin TDS
Oxybutynin Transdermal System
|
Oral Oxybutynin
Oxybutynin tablets
|
|---|---|---|
|
Titration Period
Withdrawal by Subject
|
0
|
1
|
|
Titration Period
Lost to Follow-up
|
1
|
0
|
|
Maintenance Period
Withdrawal by Subject
|
2
|
0
|
|
Maintenance Period
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
Baseline characteristics by cohort
| Measure |
Oxybutynin TDS
n=39 Participants
Oxybutynin Transdermal System
|
Oral Oxybutynin
n=16 Participants
Oxybutynin tablets
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
39 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age Continuous
|
10.2 years
STANDARD_DEVIATION 2.64 • n=93 Participants
|
11.8 years
STANDARD_DEVIATION 2.82 • n=4 Participants
|
10.6 years
STANDARD_DEVIATION 2.76 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=93 Participants
|
16 participants
n=4 Participants
|
55 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 14 weeksPopulation: Modified intent-to-treat (mITT) population, Last Observation Carried Forward (LOCF) imputation
Change from baseline in average volume of urine collected by catheterization
Outcome measures
| Measure |
Oxybutynin TDS
n=38 Participants
Oxybutynin Transdermal System
|
Oral Oxybutynin
n=14 Participants
Oxybutynin tablets
|
|---|---|---|
|
Average Catheterization Urine Volume
Baseline Catheterization Volume
|
95.3 mL
Standard Deviation 63.88
|
114.0 mL
Standard Deviation 74.67
|
|
Average Catheterization Urine Volume
Change from Baseline in Cath Volume
|
30.0 mL
Standard Deviation 46.20
|
52.4 mL
Standard Deviation 50.45
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: mITT, LOCF
Percentage of catherizations without leakage
Outcome measures
| Measure |
Oxybutynin TDS
n=38 Participants
Oxybutynin Transdermal System
|
Oral Oxybutynin
n=14 Participants
Oxybutynin tablets
|
|---|---|---|
|
Catheterizations Without Leakage
Baseline % Catheterizations without leakage
|
28.7 % of participants
Standard Deviation 34.85
|
38.1 % of participants
Standard Deviation 41.86
|
|
Catheterizations Without Leakage
Endpoint % Catheterizations without leakage
|
53.8 % of participants
Standard Deviation 36.05
|
72.6 % of participants
Standard Deviation 26.44
|
SECONDARY outcome
Timeframe: 14 weeksChange from baseline in average volume of urine collected after first morning awakening
Outcome measures
Outcome data not reported
Adverse Events
Oxybutynin TDS
Serious events: 6 serious events
Other events: 33 other events
Deaths: 0 deaths
Oral Oxybutynin
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxybutynin TDS
n=39 participants at risk
Oxybutynin Transdermal System
|
Oral Oxybutynin
n=16 participants at risk
Oxybutynin tablets
|
|---|---|---|
|
General disorders
Allergic reaction
|
0.00%
0/39
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Knee wound dehiscence
|
2.6%
1/39 • Number of events 2
|
0.00%
0/16
|
|
General disorders
Worsening abdominal pain
|
0.00%
0/39
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Thrombophlebitis
|
0.00%
0/39
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
VP shunt malfunction
|
5.1%
2/39 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Worsening dehydration
|
2.6%
1/39 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Fever
|
2.6%
1/39 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/39 • Number of events 1
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Tethered cord
|
2.6%
1/39 • Number of events 1
|
0.00%
0/16
|
Other adverse events
| Measure |
Oxybutynin TDS
n=39 participants at risk
Oxybutynin Transdermal System
|
Oral Oxybutynin
n=16 participants at risk
Oxybutynin tablets
|
|---|---|---|
|
General disorders
Fever
|
15.4%
6/39 • Number of events 7
|
18.8%
3/16 • Number of events 4
|
|
General disorders
Headache
|
17.9%
7/39 • Number of events 12
|
12.5%
2/16 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
15.4%
6/39 • Number of events 6
|
12.5%
2/16 • Number of events 2
|
|
Infections and infestations
Infection
|
17.9%
7/39 • Number of events 8
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
12.8%
5/39 • Number of events 5
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.8%
5/39 • Number of events 5
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
5/39 • Number of events 5
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
10.3%
4/39 • Number of events 4
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Pain abdominal
|
7.7%
3/39 • Number of events 3
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Pain back
|
7.7%
3/39 • Number of events 6
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
3/39 • Number of events 4
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.7%
3/39 • Number of events 3
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
7.7%
3/39 • Number of events 4
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.1%
2/39 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Pain
|
10.3%
4/39 • Number of events 7
|
12.5%
2/16 • Number of events 3
|
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