Oxybutynin for Bladder Pain and Urgency After Surgery in Children

This study is looking at ways to reduce bladder pain and urgency after bladder surgery in children aged 4 to 8 years old. Researchers want to see if a transdermal patch of oxybutynin (a medicine to relax the bladder) works better than taking oxybutynin by mouth. Bladder pain and urgency are common after this type of surgery. The study will measure how much pain and urgency children experience, as well as how much pain medication they need. You may be able to join if your child is having bladder surgery that requires a catheter afterwards and has not had previous bladder surgery or certain nerve conditions affecting the bladder. The study aims to enroll 100 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It will involve about 100 children.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Urgency and pain scores will be measured from before surgery up to six weeks after surgery. Narcotic use will be measured for six weeks after surgery.

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NCT03952299

Oxybutynin for Post-surgical Bladder Pain and Urgency

Recruiting
PHASE3Ages 4–8InterventionalTreatment
University of California, Davis
~100 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:Oxybutynin Transdermal PatchOral Oxybutynin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Urgency Scores
Measured over Preoperative (one week to two months) to postoperative period (six weeks).
+2 more outcomes measured
Overactive Bladder Syndrome
Neuropathic Bladder
1 sites across 1 states
California1
  • Eric A Kurzrock, MD · PRINCIPAL_INVESTIGATOR · UC Davis Health Center

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Eligibility criteria

Inclusion

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

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.
  • Urgency ScoresPreoperative (one week to two months) to postoperative period (six weeks).

    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.

  • Pain ScoresPreoperative (one week to two months) to postoperative period (six weeks).

    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.

  • Narcotic UsagePostoperative (six weeks)

    Narcotic usage will be assessed. Morphine and hydrocodone in mg/kg will be recorded and evaluated over the hospitalization period.