Oxybutynin for Post-surgical Bladder Pain and Urgency
Who is this study for? Patients with post-surgical bladder pain and urgency
What treatments are being studied? Oxybutynin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 8
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
University of California Davis Medical Center (UCDMC)
RECRUITING
Sacramento
Contact Information
Primary
Anjali Vij, BS
avij@ucdavis.edu
9167345173
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Active_comparator: Oral administration
Oral oxybutynin (5mg) is administered in the preoperative area prior to surgery. The current regimen is to mix the oxybutynin with the standard preoperative Versed so children do not have to take two dosages.~Post-operatively oral oxybutynin (5mg) is administered every 8 hours in the hospital.
Experimental: Transdermal administration
Guardian will be given the transdermal patch (3.9mg oxybutynin) at the preoperative appointment with instructions to apply the day prior to surgery. While in the hospital no oral oxybutynin will be prescribed.
Related Therapeutic Areas
Sponsors
Leads: University of California, Davis