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Antimuscarinic

Oxybutynin for Post-surgical Bladder Pain and Urgency

Phase 3

Recruiting

Led By Eric A Kurzrock, MD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age Range: Four to 8 years of age are eligible for the study.

Patients who will undergo bladder surgery that requires an indwelling bladder catheter after surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperative (one week to two months) to postoperative period (six weeks).

Awards & highlights

Study Summary

This trial is testing if a medication given through a patch is better than a pill for people who have pain and urgency after bladder surgery.

Who is the study for?

This trial is for children aged 4 to 8 who are about to have bladder surgery and will need a catheter afterwards. It's not for kids under 4, those with previous bladder surgeries, neurologic diseases affecting the bladder, or on certain meds like antispasmodics or CNS-affecting drugs.Check my eligibility

What is being tested?

The study is testing if an Oxybutynin patch (applied to the skin) is better than oral Oxybutynin pills at reducing post-surgery bladder pain and urgency in young patients following their procedure.See study design

What are the potential side effects?

Oxybutynin may cause dry mouth, constipation, dizziness, blurred vision, and difficulty urinating. The patch might also irritate the skin where it's applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 4 and 8 years old.

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I will need a catheter after my bladder surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperative (one week to two months) to postoperative period (six weeks).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperative (one week to two months) to postoperative period (six weeks).

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative (one week to two months) to postoperative period (six weeks). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Narcotic Usage

Pain Scores

Urgency Scores

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Transdermal administrationExperimental Treatment1 Intervention

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.

Group II: Oral administrationActive Control1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,483 Total Patients Enrolled

Eric A Kurzrock, MDPrincipal InvestigatorUC Davis Health Center

Media Library

Oxybutynin (Antimuscarinic) Clinical Trial Eligibility Overview. Trial Name: NCT03952299 — Phase 3

Overactive Bladder Research Study Groups: Transdermal administration, Oral administration

Overactive Bladder Clinical Trial 2023: Oxybutynin Highlights & Side Effects. Trial Name: NCT03952299 — Phase 3

Oxybutynin (Antimuscarinic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03952299 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies has Oxybutynin Transdermal Patch shown to be effective in treating?

"Oxybutynin Transdermal Patch can help patients who experience urinary urge incontinence, neurological disorders, and urinary urgency."

Answered by AI

Are there serious dangers associated with the use of Oxybutynin Transdermal Patch?

"There is some evidence from past trials to support the efficacy of Oxybutynin Transdermal Patch, and it has received multiple rounds of testing for safety, so our team at Power gave it a score of 3."

Answered by AI

Are patients being actively sought for this research project?

"That is correct. Based on the information available on clinicaltrials.gov, this trial is still in need of 100 patients from a single location. The listing was created on September 1st, 2021 and updated January 25th, 2022."

Answered by AI

Would it be possible for me to join this clinical trial?

"Up to 100 children, aged 4-8 years old, who have neurogenic urinary bladder and are scheduled to have surgery that requires an indwelling bladder catheter may be enrolled in this study."

Answered by AI

If a patient is over 35 years, can they still participate in this trial?

"This particular clinical trial is recruiting patients aged 4 to 8 years old. In contrast, there are 22 other medical studies underway for minors and 90 research projects investigating treatments for elderly patients."

Answered by AI

Is the Oxybutynin Transdermal Patch a common medication?

"Currently, there are 5 different clinical trials underway for the use of Oxybutynin Transdermal Patch. 1 of these is in Phase 3. Although many of the studies are based in West Hollywood, California, 136 medical centres across America are running similar trials."

Answered by AI

To your knowledge, is this the initial study of its kind?

"Oxybutynin Transdermal Patch has been researched since 2011 by AbbVie. After the first Phase 4 study in 2011 with 58 participants, it received drug approval and there are now 5 active trials across 102 cities and 2 countries."

Answered by AI

Recent research and studies

Journal of UrologyJournal

Efficacy and Safety of Transdermal and Oral Oxybutynin in Children with Neurogenic Detrusor Overactivity

Cartwright, Patrick C., Douglas E. Coplen, Barry A. Kogan, Weining Volinn, Eileen Finan, and Gary Hoel. 2009. “Efficacy and Safety of Transdermal and Oral Oxybutynin in Children with Neurogenic Detrusor Overactivity”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2009.06.058.

Journal of UrologyJournal

Pictorial Urgency Scale: A New Tool for Evaluating Bladder Urgency in Children

Kurzrock, Eric A., Yvonne Y. Chan, Blythe P. Durbin-Johnson, and Lora DeCristoforo. 2019. “Pictorial Urgency Scale: A New Tool for Evaluating Bladder Urgency in Children”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2018.09.047.

Journal of UrologyJournal

Contemporary Open Ureteral Reimplantation Without Morphine: Assessment of Pain and Outcomes

Chamie, Karim, Andrew Chi, Brian Hu, Kirk A. Keegan, and Eric A. Kurzrock. 2009. “Contemporary Open Ureteral Reimplantation Without Morphine: Assessment of Pain and Outcomes”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2009.05.054.

Journal of Pediatric UrologyJournal