What side effects are associated with this type of intervention?

Common treatments for Overactive Bladder (OAB) include anticholinergic medications and beta3-adrenoceptor agonists. Anticholinergics, such as oxybutynin and tolterodine, can cause side effects like dry mouth, constipation, blurred vision, and cognitive dysfunction. Transdermal administration of oxybutynin, which is absorbed through the skin, may reduce some of these side effects, particularly dry mouth, but can still cause local skin reactions such as itching and redness. Beta3-adrenoceptor agonists like mirabegron are generally well-tolerated but can cause hypertension, urinary tract infections, and headaches.

What prior FDA approvals exist?

The FDA has approved several treatments for Overactive Bladder (OAB), including transdermal options. One notable transdermal treatment is oxybutynin, which is available in a transdermal patch form. This method allows for the medication to be absorbed through the skin, providing a steady release of the drug to help manage symptoms of OAB such as urgency, frequency, and incontinence. Other commonly approved oral medications for OAB include anticholinergics like tolterodine and solifenacin, which work by blocking muscarinic receptors to reduce bladder contractions.

What other types of research exist?

Promising novel alternatives to transdermal administration for Overactive Bladder (OAB) patients include: 1) Oral anticholinergics such as solifenacin and darifenacin, which are selective M3 receptor antagonists and may have fewer side effects. 2) Beta3-adrenoceptor agonists like mirabegron, which are effective for treating OAB symptoms. These options provide effective symptom management and may be better tolerated by some patients compared to transdermal methods.

← Back to Search

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.

Must not have

Patients who are already taking antimuscarinic or antispasmodic medications.

Patients who have neurologic disease that could impair bladder sensation.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if using a skin patch to deliver oxybutynin is better than taking it by mouth for children after bladder surgery. The goal is to reduce pain and urgency with fewer side effects. The skin patch method is expected to be more effective because it avoids processing by the liver. Oxybutynin has been used to treat bladder dysfunction in both adults and children, with various formulations showing effectiveness but also significant side effects.

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.

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.

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

Select...

I am between 4 and 8 years old.

Select...

I will need a catheter after my bladder surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking medication for muscle spasms or bladder control.

Select...

I have a neurological condition that affects my bladder sensation.

Select...

I do not have glaucoma, dementia, or any central nervous system disorders.

Select...

I have had surgery on my bladder before.

Select...

I am currently taking medication for my mental health.

Select...

I am older than four years, so I can use the transdermal patch.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Narcotic Usage

Pain Scores

Urgency Scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Overactive Bladder (OAB) include anticholinergic medications and beta3-adrenoceptor agonists. Anticholinergics block muscarinic receptors in the bladder, reducing involuntary contractions and increasing bladder capacity. Beta3-adrenoceptor agonists, such as mirabegron, relax bladder muscles by activating beta3 receptors, enhancing storage capacity. Transdermal administration, like oxybutynin patches, delivers medication through the skin, potentially minimizing systemic side effects such as dry mouth and constipation. This method is beneficial for OAB patients who are sensitive to these side effects, improving treatment adherence and quality of life.