A Phase 4 interventional study of Oxybutynin and Oxybutynin in Detrusor Hyperreflexia, sponsored by Watson Pharmaceuticals. Completed at 23 sites in United States. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2012-02-09.
Sponsored by Watson Pharmaceuticals (part of AbbVie) · Phase 4, Interventional, and Treatment
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.
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.
18 studies on the registry are indexed under Reflex, Abnormal; 1 is open to participants now.
This study's enrollment of 57 is above the median of 16 across 13 interventional studies indexed under Reflex, Abnormal.
Browse Reflex, Abnormal studies →Watson Pharmaceuticals is the lead sponsor of 30 studies on the registry; none are open to participants now.
First submitted before Watson Pharmaceuticals became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day
Drug: Oxybutynin
5 to 15 mg/day immediate release or extended release tablets, or syrup
Drug: Oxybutynin
1.3, 2.6, 3.9 mg/day transdermal
Also known as: Oxytrol
5 to 15 mg/day immediate release or extended release tablets, or syrup
Also known as: Ditropan, Ditropan XL, Oxybutynin
Average Catheterization Urine Volume
Change from baseline in average volume of urine collected by catheterization
Time frame: 14 weeks
Catheterizations Without Leakage
Percentage of catherizations without leakage
Time frame: 14 weeks
Urine Volume After First Awakening
Change from baseline in average volume of urine collected after first morning awakening
Time frame: 14 weeks
| Milestone | Oxybutynin TDS | Oral Oxybutynin |
|---|---|---|
| Started | 39 | 16 |
| Completed | 38 | 15 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Milestone | Oxybutynin TDS | Oral Oxybutynin |
|---|---|---|
| Started | 38 | 15 |
| Completed | 36 | 14 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Milestone | Oxybutynin TDS | Oral Oxybutynin |
|---|---|---|
| Started | 35 | 0 |
| Completed | 35 | 0 |
| Not completed | 0 | 0 |
Change from baseline in average volume of urine collected by catheterization
| mL | Oxybutynin TDS | Oral Oxybutynin |
|---|---|---|
| Baseline Catheterization Volume | 95.3 ± 63.88 | 114.0 ± 74.67 |
| Change from Baseline in Cath Volume | 30.0 ± 46.20 | 52.4 ± 50.45 |
Percentage of catherizations without leakage
| % of participants | Oxybutynin TDS | Oral Oxybutynin |
|---|---|---|
| Baseline % Catheterizations without leakage | 28.7 ± 34.85 | 38.1 ± 41.86 |
| Endpoint % Catheterizations without leakage | 53.8 ± 36.05 | 72.6 ± 26.44 |
Change from baseline in average volume of urine collected after first morning awakening
Results for this outcome have not been posted.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxybutynin TDS | — | 6/39 (15.4%) | 33/39 (84.6%) |
| Oral Oxybutynin | — | 3/16 (18.8%) | 12/16 (75%) |
| Event | Oxybutynin TDS | Oral Oxybutynin |
|---|---|---|
| Allergic reactionGeneral disorders | 0/39 | 1/16 |
| Worsening abdominal painGeneral disorders | 0/39 | 1/16 |
| ThrombophlebitisCardiac disorders | 0/39 | 1/16 |
| VP shunt malfunctionNervous system disorders | 2/39 | 1/16 |
| Knee wound dehiscenceSkin and subcutaneous tissue disorders | 1/39 | 0/16 |
| Worsening dehydrationMetabolism and nutrition disorders | 1/39 | 0/16 |
| FeverGeneral disorders | 1/39 | 0/16 |
| GastritisGastrointestinal disorders | 1/39 | 0/16 |
| Tethered cordMusculoskeletal and connective tissue disorders | 1/39 | 0/16 |
| Event | Oxybutynin TDS | Oral Oxybutynin |
|---|---|---|
| FeverGeneral disorders | 6/39 | 3/16 |
| HeadacheGeneral disorders | 7/39 | 2/16 |
| InfectionInfections and infestations | 7/39 | 0/16 |
| Urinary tract infectionInfections and infestations | 6/39 | 2/16 |
| PharyngitisRespiratory, thoracic and mediastinal disorders | 5/39 | 1/16 |
| RashSkin and subcutaneous tissue disorders | 5/39 | 1/16 |
| VomitingGastrointestinal disorders | 5/39 | 1/16 |
| Pain abdominalGeneral disorders | 3/39 | 2/16 |
| PainGeneral disorders | 4/39 | 2/16 |
| ConstipationGastrointestinal disorders | 4/39 | 1/16 |
| Age, Categorical(Participants) | Oxybutynin TDS | Oral Oxybutynin | Total |
|---|---|---|---|
| <=18 years | 39 | 16 | 55 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Oxybutynin TDS | Oral Oxybutynin | Total |
|---|---|---|---|
| Mean | 10.2 ± 2.64 | 11.8 ± 2.82 | 10.6 ± 2.76 |
| Sex: Female, Male(Participants) | Oxybutynin TDS | Oral Oxybutynin | Total |
|---|---|---|---|
| Female | 17 | 11 | 28 |
| Male | 22 | 5 | 27 |
| Region of Enrollment(participants) | Oxybutynin TDS | Oral Oxybutynin | Total |
|---|---|---|---|
| United States | 39 | 16 | 55 |
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxybutynin