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Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition

A Multi-Center, Open-Label (OL), Active-Controlled, Dose-Titration Study Evaluating the Safety, Efficacy and PK of Oxybutynin Transdermal Systems in the Treatment of Detrusor Overactivity in Pediatric Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00224016
Enrollment
57
Registered
2005-09-22
Start date
2004-12-31
Completion date
2008-09-30
Last updated
2012-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Detrusor Hyperreflexia

Brief summary

This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.

Detailed description

This study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.

Interventions

DRUGOxybutynin

1.3, 2.6, 3.9 mg/day transdermal

Sponsors

Watson Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

* Pediatric patient with a diagnosis of detrusor overactivity associated with a neurological condition; * Use clean intermittent catheterization * On stable dose of oral oxybutynin before participation

Exclusion criteria

* Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency * Have any medical condition that precludes their participation in the study or may confound the outcome of the study

Design outcomes

Primary

MeasureTime frameDescription
Average Catheterization Urine Volume14 weeksChange from baseline in average volume of urine collected by catheterization

Secondary

MeasureTime frameDescription
Catheterizations Without Leakage14 weeksPercentage of catherizations without leakage
Urine Volume After First Awakening14 weeksChange from baseline in average volume of urine collected after first morning awakening

Countries

United States

Participant flow

Participants by arm

ArmCount
Oxybutynin TDS
Oxybutynin Transdermal System
39
Oral Oxybutynin
Oxybutynin tablets
16
Total55

Withdrawals & dropouts

PeriodReasonFG000FG001
Maintenance PeriodLost to Follow-up01
Maintenance PeriodWithdrawal by Subject20
Titration PeriodLost to Follow-up10
Titration PeriodWithdrawal by Subject01

Baseline characteristics

CharacteristicOral OxybutyninOxybutynin TDSTotal
Age, Categorical
<=18 years
16 Participants39 Participants55 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age Continuous11.8 years
STANDARD_DEVIATION 2.82
10.2 years
STANDARD_DEVIATION 2.64
10.6 years
STANDARD_DEVIATION 2.76
Region of Enrollment
United States
16 participants39 participants55 participants
Sex: Female, Male
Female
11 Participants17 Participants28 Participants
Sex: Female, Male
Male
5 Participants22 Participants27 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
33 / 3912 / 16
serious
Total, serious adverse events
6 / 393 / 16

Outcome results

Primary

Average Catheterization Urine Volume

Change from baseline in average volume of urine collected by catheterization

Time frame: 14 weeks

Population: Modified intent-to-treat (mITT) population, Last Observation Carried Forward (LOCF) imputation

ArmMeasureGroupValue (MEAN)Dispersion
Oxybutynin TDSAverage Catheterization Urine VolumeBaseline Catheterization Volume95.3 mLStandard Deviation 63.88
Oxybutynin TDSAverage Catheterization Urine VolumeChange from Baseline in Cath Volume30.0 mLStandard Deviation 46.2
Oral OxybutyninAverage Catheterization Urine VolumeBaseline Catheterization Volume114.0 mLStandard Deviation 74.67
Oral OxybutyninAverage Catheterization Urine VolumeChange from Baseline in Cath Volume52.4 mLStandard Deviation 50.45
Secondary

Catheterizations Without Leakage

Percentage of catherizations without leakage

Time frame: 14 weeks

Population: mITT, LOCF

ArmMeasureGroupValue (MEAN)Dispersion
Oxybutynin TDSCatheterizations Without LeakageBaseline % Catheterizations without leakage28.7 % of participantsStandard Deviation 34.85
Oxybutynin TDSCatheterizations Without LeakageEndpoint % Catheterizations without leakage53.8 % of participantsStandard Deviation 36.05
Oral OxybutyninCatheterizations Without LeakageBaseline % Catheterizations without leakage38.1 % of participantsStandard Deviation 41.86
Oral OxybutyninCatheterizations Without LeakageEndpoint % Catheterizations without leakage72.6 % of participantsStandard Deviation 26.44
Secondary

Urine Volume After First Awakening

Change from baseline in average volume of urine collected after first morning awakening

Time frame: 14 weeks

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026