Using Oxybutynin to Treat Bladder Pain After Surgery
Oxybutynin for Post-surgical Bladder Pain and Urgency
This study is testing if a skin patch of oxybutynin works better than taking it by mouth to help young kids with bladder pain after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 4 Years to 8 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT03952299 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of transdermal oxybutynin compared to oral oxybutynin in managing bladder pain and urgency following bladder surgery in children aged four to eight. The study will involve patients who require an indwelling bladder catheter post-surgery, assessing the pain relief provided by each method of administration. Given the limitations of oral oxybutynin due to poor bioavailability and side effects, the trial seeks to determine if the transdermal patch can offer superior outcomes. The results could provide valuable insights into postoperative care for pediatric patients undergoing bladder surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged four to eight who are scheduled for bladder surgery requiring an indwelling catheter.
Not a fit: Patients with prior bladder surgery or those with neurological diseases affecting bladder sensation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for children recovering from bladder surgery.
How similar studies have performed: Previous studies have shown the efficacy of oxybutynin in adults for similar conditions, but this approach in pediatric populations is less explored, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who will undergo bladder surgery that requires an indwelling bladder catheter after surgery. * Age Range: Four to 8 years of age are eligible for the study. Exclusion Criteria: * Patients who have had prior bladder surgery. * Patients who have neurologic disease that could impair bladder sensation. * Patients who are already taking antimuscarinic or antispasmodic medications. * Patients with glaucoma, any neurologic disease, dementia, impaired mentation or disorder of the central nervous system. * Patients taking any medication that affects the central nervous system such as antidepressant, anxiolytic or antipsychotic medications. * Less than four years of age cannot have the transdermal patch due to fixed dose. Over 8 years of age: less than 5% of our patients, who undergo this surgery, are over 8 years of age and is usually a rare adolescent. Data in an older cohort may confuse the results since they respond differently to bladder surgery due to larger incision and longer hospital stay with a catheter.
Where this trial is running
Sacramento, California
- University of California Davis Medical Center (UCDMC) — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Eric A Kurzrock, MD — UC Davis Health Center
- Study coordinator: Anjali Vij, BS
- Email: avij@ucdavis.edu
- Phone: 9167345173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.