A Study of Oral vs Transdermal (through skin patch) Oxybutynin for Post-surgical Bladder Pain and Urgency in Children

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Age: 4 to 8 years old
Gender:
Any
Healthy Volunteers: No
Keywords: bladder surgery, pediatric bladder surgery
Type: Drug study, Phase 3
Target:
200 Participants
Investigator:
Description
After bladder surgery, most patients have urinary urgency (the feeling of having to urinate). Doctors may give a medication to help treat or prevent this feeling. The medication Ditropan (oxybutynin) relaxes the bladder muscle and is currently given.

This research study will test if oxybutynin works better in the oral form (liquid) or given through a skin patch (transdermal). Ultimately, we want to find the best form of the medicine for our patients to feel better after surgery.
This study requires

If you decide to allow your child to take part in the study, the treatment your child receives will be chosen by chance, like flipping a coin.

Your child will have an equal chance of receiving either: - the current standard treatment of oral oxybutynin right before surgery while in the hospital or - the transdermal (skin) patch one to two days prior to surgery.

During the stay in the hospital, which is usually one to two days, we will monitor your child to see if s/he has pain or a feeling of urgency to urinate. These procedures would be done whether or you’re your child participates in the study. .

Both groups will receive a new prescription for oral oxybutynin. This is to be given to your child if he/she is having urinary urgency or frequency.

If you take part in this research, you will be responsible to read, understand and sign this informed consent form. If your child is in the group that uses the patch, you will be required to apply this to his/her back or leg one to two days prior to surgery.

Who can participate

Inclusion criteria:

  • Patients who will undergo bladder surgery that requires an indwelling bladder catheter after surgery.
  • Age Range: Four to 8 years of age are eligible for the study.

Exclusion criteria:

  • Patients who have had prior bladder surgery.
  • Patients who have neurologic disease that could impair bladder sensation.
  • Patients who are already taking antimuscarinic or antispasmodic medications.
  • Patients with glaucoma, any neurologic disease, dementia, impaired mentation or disorder of the central nervous system.
  • Patients taking any medication that affects the central nervous system such as antidepressant, anxiolytic or antipsychotic medications.
  • Less than four years of age cannot have the transdermal patch due to fixed dose. Over 8 years of age: less than 5% of our patients, who undergo this surgery, are over 8 years of age and is usually a rare adolescent. Data in an older cohort may confuse the results since they respond differently to bladder surgery due to larger incision and longer hospital stay with a catheter.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
The study duration is 6 weeks.
Recruitment period
From March 8, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Clinical Trials Office
Research Topic
Conditions:
  • Overactive Bladder Syndrome
  • Neuropathic Bladder

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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