Oxybutynin for Post-surgical Bladder Pain and Urgency
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-8
SponsorUniversity of California, Davis
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Oxybutynin Transdermal Patch
DrugTransdermal patch of oxybutynin will be used instead of oral oxybutynin.
Oral Oxybutynin
DrugOral administration of oxybutynin (5mg) every 8 hours in the hospital.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Oral administrationActive comparator 1 intervention
Group B: Transdermal administrationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Urgency Scores
Mean and peak urgency scores measured using the Pictorial Scale of Bladder Urgency. Children will choose one of four illustrations depicting bladder urgency. These illustrations have been assigned a number 1 through 4. The score of 1 indicates less urgency and a score of 4 indicating greatest urgency.
Time frame
Preoperative (one week to two months) to postoperative period (six weeks).2
Pain Scores
Mean and peak pain scores assessed using current standard University of California, Davis Medical Center protocols in the preoperative and postoperative period. Depending upon the age of the child and development, the Wong-Baker-Facies scale or numerical scale will be utilized in the hospital, both scored on a scale from 0 to 10, with higher scores indicating greater pain.
Time frame
Preoperative (one week to two months) to postoperative period (six weeks).3
Narcotic Usage
Narcotic usage will be assessed. Morphine and hydrocodone in mg/kg will be recorded and evaluated over the hospitalization period.
Time frame
Postoperative (six weeks)Sponsors and contacts
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Source ClinicalTrials.gov