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

Must not be taking: Antimuscarinics, Antispasmodics, Antidepressants, others

Disqualifiers: Prior bladder surgery, Neurologic disease, others

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

Research Team

Eric A Kurzrock, MD

Principal Investigator

UC Davis Health Center

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 am over 8 years old and understand my case is rare for this surgery.

I have a neurological condition that affects my bladder sensation.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative

Transdermal or oral oxybutynin is administered prior to surgery

1 week

1 visit (in-person)

Postoperative Treatment

Participants receive either transdermal or oral oxybutynin post-surgery

6 weeks

Regular hospital visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Oxybutynin (Antimuscarinic)

Trial Overview 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.

Participant Groups

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 Canada for the following indications:

Approved in Canada as Ditropan for:

• Overactive bladder
• Urinary incontinence
• Urinary frequency

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Rakesh Dixit

University of California, Davis

Chief Executive Officer since 2024

PhD in Biochemistry and Molecular Biology from the University of California, Davis

Suresh Mahabhashyam

University of California, Davis

Chief Medical Officer since 2020

MD from Bangalore Medical College

Findings from Research

In a study of 27 children with persistent daytime urinary incontinence, switching from regular oxybutynin to the extended-release form (Ditropan XL) resulted in significant improvements, with 13 patients becoming dry or showing significant improvement shortly after the switch.

The change to Ditropan XL also led to increased voided volume and bladder capacity, indicating enhanced bladder function, while the overall dosage remained similar and side effects varied among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved efficacy of extended release oxybutynin in children with persistent daytime urinary incontinence converted from regular oxybutynin. Van Arendonk, KJ., Knudson, MJ., Austin, JC., et al.[2013]

In a study involving 25 patients with idiopathic hyperactive bladder function, Ditropan (oxybutynin chloride) significantly reduced voiding frequency and eliminated urgency, indicating its efficacy in managing bladder overactivity.

Control cystometry showed a significant increase in bladder capacity after treatment, while oral dryness was reported as a tolerable side effect, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Idiopathic bladder hyperactivity treated with Ditropan (oxybutynin chloride). Nagy, F., Hamvas, A., Frang, D.[2019]

Oxybutynin chloride is effective in managing conditions like neurovesical dysfunction, enuresis, and bladder spasms due to its anticholinergic and muscle relaxant properties, as shown in controlled clinical studies.

The drug's synergistic effects on both the nervous system and muscle relaxation make it a valuable treatment option for patients with uninhibited bladders and primary muscle spasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxybutynin in bladder spasm, neurogenic bladder, and enuresis. Thompson, IM., Lauvetz, R.[2019]

In a double-blind trial, oxybutynin chloride (Ditropan) was effective in controlling post-transurethral pain and spasm, indicating its potential as a treatment option for patients experiencing these symptoms.

The study reported no significant side effects associated with oxybutynin chloride, suggesting it is a safe option for managing post-procedural discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxybutynin chloride in control of post-trasurethral vesical pain and spasm. Paulson, DF.[2019]

In a study of 46 men undergoing radical prostatectomy, sublingual oxybutynin significantly reduced bladder catheter pain, with only 17% of patients experiencing pain compared to 65% in the placebo group (P < 0.01).

Oxybutynin also led to a notable decrease in overall pain scores and reduced the need for tramadol, with patients in the oxybutynin group consuming an average of 146 mg compared to 322.9 mg in the placebo group (P < 0.01), and no side effects were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sublingual oxybutynin reduces postoperative pain related to indwelling bladder catheter after radical retropubic prostatectomy. Tauzin-Fin, P., Sesay, M., Svartz, L., et al.[2022]

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]

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

Idiopathic bladder hyperactivity treated with Ditropan (oxybutynin chloride). [2019]

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

Oxybutynin in bladder spasm, neurogenic bladder, and enuresis. [2019]

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

Oxybutynin chloride in control of post-trasurethral vesical pain and spasm. [2019]

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]

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

Sublingual oxybutynin reduces postoperative pain related to indwelling bladder catheter after radical retropubic prostatectomy. [2022]