What side effects are associated with this type of intervention?

Common side effects of anticholinergic agents like oxybutynin, which are used to treat overactive bladder by relaxing the bladder muscle, include dry mouth, constipation, blurred vision, dizziness, and urinary retention. Some patients may also experience cognitive side effects such as confusion or memory impairment, particularly in older adults. Topical formulations like oxybutynin gel may reduce the incidence of systemic side effects compared to oral forms, but local skin reactions such as itching or redness can occur.

What prior FDA approvals exist?

The FDA has approved several anticholinergic agents for the treatment of Overactive Bladder (OAB). These include oral oxybutynin, which is available in immediate-release and extended-release formulations, as well as transdermal patches and topical gels. Other anticholinergic drugs approved for OAB include tolterodine, solifenacin, darifenacin, fesoterodine, and trospium. These medications work by inhibiting the muscarinic receptors in the bladder, thereby reducing bladder muscle contractions and alleviating symptoms of urgency, frequency, and incontinence.

What other types of research exist?

Promising novel alternatives to Oxybutynin Chloride 10% Topical Gel for Overactive Bladder patients include: 1) Beta-3 adrenergic agonists like Mirabegron, which relax the bladder muscle by a different mechanism than anticholinergics. 2) Vibegron, another beta-3 adrenergic agonist, which has shown efficacy in recent studies. 3) Intravesical botulinum toxin injections, which can reduce bladder muscle overactivity. 4) Emerging neuromodulation techniques such as percutaneous tibial nerve stimulation (PTNS) and sacral neuromodulation (SNM), which modulate nerve signals to the bladder. These alternatives provide different mechanisms of action and may offer benefits in terms of efficacy and side effect profiles.

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Antimuscarinic Agent

Oxybutynin Gel for Pediatric Overactive Bladder

Phase 4

Waitlist Available

Research Sponsored by Allergan

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0) up to week 6

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests a skin-applied gel medicine for children with bladder issues caused by nerve problems. The gel helps relax the bladder muscles to reduce overactivity. Children will use the gel for a few months, with doses adjusted based on their response.

Who is the study for?

This trial is for children aged 3 to less than 17 with an overactive bladder due to a neurogenic condition. They must be able to perform clean intermittent catheterization (CIC). Children cannot participate if they have sensitivity to anticholinergics, bladder augmentation, or anatomical bladder abnormalities.

What is being tested?

The study tests Oxybutynin Chloride 10% Topical Gel's safety and effectiveness in managing overactive bladders in children with neurogenic conditions. Treatment starts at 0.75 g of gel per day for two weeks, with possible dose adjustments after that based on response and tolerability for a total of 14 weeks.

What are the potential side effects?

Potential side effects may include dry mouth, constipation, headache, dizziness, blurred vision, and difficulty urinating. These are common side effects associated with anticholinergic medications like Oxybutynin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0) up to week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0) up to week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0) up to week 6 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6

Secondary study objectives

Change From Baseline in Average Number of Catheterizations Per Day at Week 6

Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6

Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6

Side effects data

From 2008 Phase 4 trial • 57 Patients • NCT00224016

18%

Infection

18%

Headache

15%

Urinary tract infection

15%

Fever

13%

Pharyngitis

13%

Rash

13%

Vomiting

10%

Pain

10%

Constipation

Pain abdominal

Pruritis

Rhinitis

Diarrhea

Pain back

VP shunt malfunction

Skin ulcer

Gastritis

Knee wound dehiscence

Worsening dehydration

Tethered cord

100%

80%

60%

40%

20%

Study treatment Arm

Oxybutynin TDS

Oral Oxybutynin

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: OL: OTG (Post-Amend 3)Experimental Treatment1 Intervention

Open-Label Oxybutynin Chloride topical gel (OTG) (Pre \& Post-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose for Pre- and Post-Amendment 3), or 1 g sachets, applied transdermally once daily for 14 weeks.

Group II: DB: OTG (Pre-Amend 3)Experimental Treatment1 Intervention

Double-Blind Oxybutynin Chloride topical gel (OTG) (Pre-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose), or 1 g sachets, applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.

Group III: DB: Placebo (Pre-Amend 3)Placebo Group1 Intervention

Double-Blind Placebo (Pre-Amendment 3) Placebo Gel sachets applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxybutynin

2015

Completed Phase 4

~2750

Do I qualify?Apply below to find out

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 agents like Oxybutynin Chloride. These medications work by blocking acetylcholine from binding to muscarinic receptors in the bladder muscle, which helps to relax the bladder and reduce involuntary contractions. This mechanism is important for OAB patients as it helps to manage symptoms such as frequent urination, urgency, and incontinence, ultimately improving their daily functioning and quality of life.

Trospium chloride: an update on a quaternary anticholinergic for treatment of urge urinary incontinence.