RecruitingPhase 3NCT03952299
Oxybutynin for Post-surgical Bladder Pain and Urgency
Sponsor
University of California, Davis
Enrollment
100 participants
Start Date
Sep 1, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
Bladder pain and urgency are common after bladder surgery. The objective is to determine if transdermal administration is superior to oral administration in alleviating pain and urgency.
Eligibility
Min Age: 4 YearsMax Age: 8 Years
Inclusion Criteria2
- 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 Criteria6
- 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.
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Interventions
DRUGOxybutynin Transdermal Patch
Transdermal patch of oxybutynin will be used instead of oral oxybutynin.
DRUGOral Oxybutynin
Oral administration of oxybutynin (5mg) every 8 hours in the hospital.
Locations(1)
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NCT03952299
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