Recruiting
Phase 3

Oxybutynin

Sponsor:

UCLA

Code:

NCT03952299

Conditions

Overactive Bladder Syndrome

Neuropathic Bladder

Eligibility Criteria

Sex: All

Age: 4 - 8

Healthy Volunteers: Not accepted

Interventions

Oxybutynin Transdermal Patch

Oral Oxybutynin

Study Details

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.

Conditions

Overactive Bladder Syndrome

Neuropathic Bladder

Study ID

NCT03952299

Start date

Sep 1, 2021

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 8

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Oxybutynin Transdermal Patch

Transdermal patch of oxybutynin will be used instead of oral oxybutynin.

Oral Oxybutynin

Oral administration of oxybutynin (5mg) every 8 hours in the hospital.

Primary outcome measure

  • Urgency Scores [ Time Frame: Preoperative (one week to two months) to postoperative period (six weeks). ]
  • Pain Scores [ Time Frame: Preoperative (one week to two months) to postoperative period (six weeks). ]
  • Narcotic Usage [ Time Frame: Postoperative (six weeks) ]

Central Contacts and Locations

Central contacts

Anjali Vij, BS

9167345173avij@ucdavis.edu

Locations

University of California Davis Medical Center (UCDMC)

Recruiting

Sacramento, California, United States, 95817

Contacts

Eric A Kurzrock, MD

916-734-6490eakurzrock@ucdavis.edu

Anjali Vij, BS

9167345173avij@ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Keywords

  • Transdermal Oxybutynin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-01-29.