NCT03952299 Oxybutynin for Post-surgical Bladder Pain and Urgency
| NCT ID | NCT03952299 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of California, Davis |
| Condition | Overactive Bladder Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2021-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Eric A Kurzrock, MD
PRINCIPAL INVESTIGATOR
UC Davis Health Center
Frequently Asked Questions
Who can join the NCT03952299 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 8 Years, studying Overactive Bladder Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03952299 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT03952299 currently recruiting?
Yes, NCT03952299 is actively recruiting participants. Contact the research team at avij@ucdavis.edu for enrollment information.
Where is the NCT03952299 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT03952299 clinical trial?
NCT03952299 is sponsored by University of California, Davis. The principal investigator is Eric A Kurzrock, MD at UC Davis Health Center. The trial plans to enroll 100 participants.