Oxybutynin for Post-surgical Bladder Pain and Urgency

Overseen By Anjali Vij, BS

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, Davis

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

Disqualifiers: Prior bladder surgery, Neurologic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to use oxybutynin, a medication, to ease bladder pain and urgency after bladder surgery. Researchers aim to determine if a skin patch (transdermal) is more effective than oral administration for these symptoms. Children undergoing bladder surgery who will need a catheter afterward might be suitable candidates, particularly if they haven't had previous bladder surgery and aren't taking certain medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both skin patches and pills of oxybutynin are generally safe for treating bladder issues. Studies have found that oxybutynin patches, applied to the skin, are safe for children with bladder problems and tend to cause fewer side effects, such as dry mouth, compared to the pill form.

The FDA has approved the pill form of oxybutynin for treating overactive bladder in adults, and it is often used for children with bladder issues. While effective, the pill can sometimes lead to more side effects due to higher drug levels in the body.

Both the patch and the pill relax bladder muscles to reduce pain and urgency. Although both are generally well-tolerated, the patch might offer a smoother experience with potentially fewer side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for post-surgical bladder pain and urgency, which typically involve oral medications, this trial explores a transdermal patch method for delivering oxybutynin. Researchers are excited about the transdermal patch because it provides a steady release of medication directly through the skin, potentially reducing the need for frequent oral doses and minimizing gastrointestinal side effects. Additionally, the patch is applied before surgery, aiming to manage symptoms right from the start, which could be more convenient and effective for patients.

What evidence suggests that this trial's treatments could be effective for post-surgical bladder pain and urgency?

Research has shown that a skin patch with oxybutynin can effectively reduce the frequency of urination. One study demonstrated that participants significantly decreased their daily bathroom visits. Another study found that switching from oxybutynin pills to the patch was safe and improved symptoms for people with an overactive bladder. In this trial, participants will receive either the transdermal patch or oral administration of oxybutynin. This suggests that the patch might also help with bladder pain and urgency after surgery. Using the patch could be a better option than taking pills for managing these symptoms post-surgery. ^{1 4 6 7 8}

Who Is on the Research Team?

Eric A Kurzrock, MD

Principal Investigator

UC Davis Health Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Oxybutynin

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

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 involving 256 participants, once-daily controlled-release oxybutynin (Ditropan XL) significantly reduced urge incontinence episodes, with the mean episodes dropping from 18.8 at baseline to 2.8 by the end of the 12-week treatment period.

The treatment was effective across various doses (5 to 30 mg/day), with 70.8% of participants maintaining doses of 5 to 15 mg/day, and while dry mouth was a common side effect, only 1.6% discontinued due to this issue.

NCBI (Pubmed)

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. Gleason, DM., Susset, J., White, C., et al.[2022]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03952299

Oxybutynin for Post-surgical Bladder Pain and Urgency Transdermal administration has been shown to be safe and efficacious in children with neuropathic bladder disease. The hypothesis is that the transdermal route ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6087608/

Efficacy of Transdermal Oxybutynin in the Treatment ... Significant improvements from baseline were observed in urinary frequency (−2.6 voids/24 hours (95% CI: −3.5; −1.8), p < 0.001); daily number of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772973722009948

First reported study of daily, high dose transdermal ... Conclusion: The transdermal oxybutynin patch was effective and safe in the treatment of patients with OAB after switching from oral OAB medications.

4. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT03952299

Oxybutynin for Post-surgical Bladder Pain and Urgency The objective is to determine if transdermal administration is superior to oral administration in alleviating pain and urgency after bladder ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2695169/

Transdermal oxybutynin in the treatment of overactive bladder Compared with placebo, there was a significant reduction in the median number of incontinence episodes with TDOXY (−3, p=0.0137) and tolterodine (−3, p=0.0011), ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/oxybutynin-oral-route/description/drg-20065229

Oxybutynin (oral route) - Side effects & dosage Oxybutynin is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control) or a frequent need to urinate.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2228367/

Effects of oxybutynin transdermal system on health-related ... Oxybutynin transdermal system treatment of men with OAB was effective and well tolerated, regardless of history of prostate condition.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4772360/

An update on the use of transdermal oxybutynin ... Transdermal administration appears to translate into a decreased risk of dry mouth and possibly other untoward anticholinergic side effects; however, ...