CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Oxybutynin transdermal systemdrug
Likely dose
Oxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day, or 11.7 mg/day, titratedAI-extracted
Key inclusion· 6
  • ✓Age ≥18 years
  • ✓History of urinary incontinence from neurogenic bladder due to spinal cord injury
  • ✓Spinal cord impairment documented by American Spinal Injury Association (ASIA) classification
  • ✓Currently using clean intermittent catheterization
Key exclusion· 6
  • ✕Other treatable conditions causing urinary incontinence or urgency (aside from neurogenic bladder)
  • ✕Any medical condition that precludes study participation or may confound outcomes
  • ✕History of major lower urinary tract surgery or procedures
  • ✕Active skin disorder affecting transdermal patch application sites

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00224029
NCT00224029Phase 4Completed
CompareCT.gov

A Multi-center, Open-label, Dose-titration Pilot Study Evaluating the Efficacy and Safety of Oxybutynin Transdermal Systems in Patients With Neurogenic Bladder Resulting From Spinal Cord Injury

Watson Pharmaceuticals·interventional·Posted Sep 22, 2005·Updated Apr 30, 2010

In Brief

A Phase 4 clinical trial evaluating Oxybutynin transdermal system for Detrusor Hyperreflexia. Completed, enrolled 24 participants across 6 sites.

Detailed Summary

This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDetrusor Hyperreflexia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartDec 1, 2004
Primary CompletionDec 1, 2005
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 20.8 years ago

Interventions

Oxybutynin transdermal systemdrug

3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration