Oxybutynin for Post-surgical Bladder Pain and Urgency

NCT03952299 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 1336293
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Neuropathic Bladder; Overactive Bladder Syndrome

Keywords

Transdermal Oxybutynin

Outcome Measures

Primary Outcomes (3)

• 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.

  Preoperative (one week to two months) to postoperative period (six weeks).

• 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.

  Preoperative (one week to two months) to postoperative period (six weeks).

• Narcotic Usage

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

  Postoperative (six weeks)

Study Arms (2)

Oral administration

ACTIVE COMPARATOR

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.

Drug: Oral Oxybutynin

Transdermal administration

EXPERIMENTAL

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.

Drug: Oxybutynin Transdermal Patch

Interventions

Oxybutynin Transdermal Patch DRUG

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

Also known as: Ditropan XL

Transdermal administration

Oral Oxybutynin DRUG

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

Also known as: Ditropan XL

Oral administration

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Medical Center (UCDMC)

Sacramento, California, 95817, United States

RECRUITING

Related Publications (4)

• Chamie K, Chi A, Hu B, Keegan KA, Kurzrock EA. Contemporary open ureteral reimplantation without morphine: assessment of pain and outcomes. J Urol. 2009 Sep;182(3):1147-51. doi: 10.1016/j.juro.2009.05.054. Epub 2009 Jul 22.

  PMID: 19625056 RESULT

• Kurzrock EA, Chan YY, Durbin-Johnson BP, DeCristoforo L. Pictorial Urgency Scale: A New Tool for Evaluating Bladder Urgency in Children. J Urol. 2019 Mar;201(3):620-625. doi: 10.1016/j.juro.2018.09.047.

  PMID: 30266334 RESULT

• Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. doi: 10.1016/j.juro.2009.06.058. Epub 2009 Aug 15.

  PMID: 19683731 RESULT

• Gleason JM, Daniels C, Williams K, Varghese A, Koyle MA, Bagli DJ, Pippi Salle JL, Lorenzo AJ. Single center experience with oxybutynin transdermal system (patch) for management of symptoms related to non-neuropathic overactive bladder in children: an attractive, well tolerated alternative form of administration. J Pediatr Urol. 2014 Aug;10(4):753-7. doi: 10.1016/j.jpurol.2013.12.017. Epub 2014 Jan 17.

  PMID: 24477421 RESULT

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Interventions

Tolterodine Tartrate; oxybutynin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Eric A Kurzrock, MD

  UC Davis Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anjali Vij, BS

CONTACT

9167345173; avij@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A: Oral Administration Current standard treatment at U.C. Davis Children's Hospital Oral oxybutynin (5mg) is administered in the preoperative area prior to surgery. Our 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. Group B: 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.

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 16, 2019
• Study Start: September 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)