Phase 4
Completed N=33
Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
Overactive Detrusor · Neurogenic Bladder
Source: ClinicalTrials.gov NCT01192568 ↗
Enrolled (actual)
33
Serious AEs
7.1%
Results posted
Sep 2024
Primary outcomePrimary: Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6 — -0.45; 16.91; 13.82; 15.32 percentage of point — p=0.0928
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6 |
-0.45; 16.91; 13.82; 15.32 | 0.0928 |
| SECONDARY Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6 |
-24.59; 14.33 | 0.0054 sig |
| SECONDARY Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6 |
-12.03; 14.18; 29.78; 22.20 | 0.1739 |
| SECONDARY Change From Baseline in Average Number of Catheterizations Per Day at Week 6 |
0.19; -0.03; -0.67; -0.36 | 0.2660 |
Eligibility Criteria
Inclusion Criteria
- 3 years to < 17 years
- Neurogenic bladder
- Neurological condition
- CIC
Exclusion Criteria
- Have anatomical bladder abnormalities
- Sensitivity to anticholinergics
- Bladder augmentation
Data sourced from ClinicalTrials.gov (NCT01192568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.