Oxybutynin for Post-surgical Bladder Pain and Urgency (NCT03952299) | Clinical Trial Compass
RecruitingPhase 3
Oxybutynin for Post-surgical Bladder Pain and Urgency
United States100 participantsStarted 2021-09-01
Plain-language summary
Bladder pain and urgency are common after bladder surgery. The objective is to determine if transdermal administration is superior to oral administration in alleviating pain and urgency.
Who can participate
Age range
4 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Urgency Scores
Timeframe: Preoperative (one week to two months) to postoperative period (six weeks).
2
Pain Scores
Timeframe: Preoperative (one week to two months) to postoperative period (six weeks).