Overactive Bladder > Oxybutynin

Oxybutynin for Post-surgical Bladder Pain and Urgency

Recruiting in Palo Alto (17 mi)

Overseen By Eric A Kurzrock, MD

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: University of California, Davis

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking antimuscarinic, antispasmodic, or any medication that affects the central nervous system, you will need to stop these before joining the trial.

What data supports the effectiveness of the drug Oxybutynin for post-surgical bladder pain and urgency?

Research shows that Oxybutynin is effective in controlling post-surgical bladder pain and spasms, as well as reducing urgency and increasing bladder capacity in other bladder conditions. It has been used successfully in various forms to manage bladder issues, with minimal side effects.

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Is oxybutynin safe for humans?

Oxybutynin, used under various names like Ditropan and Ditropan XL, has been studied for different bladder conditions and generally found to be safe, with no significant side effects noted in some studies. However, mild side effects like dry mouth have been reported.

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How does the drug oxybutynin differ from other treatments for post-surgical bladder pain and urgency?

Oxybutynin is unique because it combines anticholinergic effects (which reduce bladder muscle contractions) with direct muscle relaxant properties, making it effective for controlling bladder pain and spasms after surgery. It can be administered in various forms, including sublingual (under the tongue), which may offer faster relief compared to traditional oral medications.

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Eligibility Criteria

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.

Inclusion Criteria

I am between 4 and 8 years old.

I will need a catheter after my bladder surgery.

Exclusion Criteria

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

I have a neurological condition that affects my bladder sensation.

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

I have had surgery on my bladder before.

I am currently taking medication for my mental health.

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

Participant Groups

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.

Group I: Transdermal administration Experimental Treatment 1 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 administration Active Control 1 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.

Oxybutynin is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Ditropan for:

• Overactive bladder
• Urinary incontinence
• Urinary frequency

🇨🇦 Approved in Canada as Ditropan for:

• Overactive bladder
• Urinary incontinence
• Urinary frequency

🇪🇺 Approved in European Union as Ditropan for:

• Overactive bladder
• Urinary incontinence
• Urinary frequency

Find A Clinic Near You

Research locations nearby Select from list below to view details:

University of California Davis Medical Center (UCDMC) Sacramento, CA

Who is running the clinical trial?

University of California, Davis Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Improved efficacy of extended release oxybutynin in children with persistent daytime urinary incontinence converted from regular oxybutynin. [2013] To examine the response to conversion from regular oxybutynin (Ditropan) to an extended-release form (Ditropan XL) in children with persistent daytime urinary incontinence.

2. Netherlands pubmed.ncbi.nlm.nih.gov

Idiopathic bladder hyperactivity treated with Ditropan (oxybutynin chloride). [2019] Ditropan (oxybutynin chloride), a tertiary amine with slight anticholinergic and marked "papaverine-like" direct spasmolytic effects has been administered to 25 patients with idiopathic hyperactive bladder function. The drug reduced voiding frequency and abolished urgency. Control cystometry confirmed a significant increase in bladder capacity. Oral dryness was a tolerable side effect.

3. United States pubmed.ncbi.nlm.nih.gov

Oxybutynin in bladder spasm, neurogenic bladder, and enuresis. [2019] Oxybutynin chloride (Ditropan), a tertiary amine possessing anticholinergic and papaverine-like, direct muscular antispasmodic effects, has been used in controlled clinical studies in patients with neurovesical reflex activity, uninhibited bladders, enuresis, and primary muscle spasm. The cystometrically documented, synergistic, anticholinergic, and muscle relaxant activity of oxybutynin observed in these studies indicates that the drug can be highly effective in the management of reflex neurovesical dysfunction, enuresis, and bladder spasm.

4. United States pubmed.ncbi.nlm.nih.gov

Oxybutynin chloride in control of post-trasurethral vesical pain and spasm. [2019] Oxybutynin chloride (Ditropan) and placebo were randomized in a double-blind trial to determine the effectiveness of the test agent in controlling post-transurethral pain and spasm. Oxybutynin chloride was found effective in controlling pain and spasm; no significant side effects were noted.

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a new once-daily formulation of oxbutynin for the treatment of urinary urge incontinence. Ditropan XL Study Group. [2022] To evaluate in a 1 6-center, single-treatment study once-daily controlled-release oxybutynin (Ditropan XL) for urinary urge incontinence.

6. England pubmed.ncbi.nlm.nih.gov

Sublingual oxybutynin reduces postoperative pain related to indwelling bladder catheter after radical retropubic prostatectomy. [2022] Bladder discomfort related to an indwelling catheter can exacerbate postoperative pain. It mimics overactive bladder syndrome that is resistant to conventional opioid therapy. Muscarinic receptor antagonists are effective for treatment of the overactive bladder. The aim of this study was to assess the efficacy of oxybutynin in the management of postoperative pain after radical prostatectomy.