Overactive Bladder Syndrome Clinical Trial
Official title:
Oxybutynin for Post-surgical Bladder Pain and Urgency
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 8 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California Davis Medical Center (UCDMC) | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. doi: 10.1016/j.juro.2009.06.058. Epub 2009 Aug 15. Er — View Citation
Chamie K, Chi A, Hu B, Keegan KA, Kurzrock EA. Contemporary open ureteral reimplantation without morphine: assessment of pain and outcomes. J Urol. 2009 Sep;182(3):1147-51. doi: 10.1016/j.juro.2009.05.054. Epub 2009 Jul 22. — View Citation
Gleason JM, Daniels C, Williams K, Varghese A, Koyle MA, Bagli DJ, Pippi Salle JL, Lorenzo AJ. Single center experience with oxybutynin transdermal system (patch) for management of symptoms related to non-neuropathic overactive bladder in children: an att — View Citation
Kurzrock EA, Chan YY, Durbin-Johnson BP, DeCristoforo L. Pictorial Urgency Scale: A New Tool for Evaluating Bladder Urgency in Children. J Urol. 2019 Mar;201(3):620-625. doi: 10.1016/j.juro.2018.09.047. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urgency Scores | Mean and peak urgency scores measured using the Pictorial Scale of Bladder Urgency. Children will choose one of four illustrations depicting bladder urgency. These illustrations have been assigned a number 1 through 4. The score of 1 indicates less urgency and a score of 4 indicating greatest urgency. | Preoperative (one week to two months) to postoperative period (six weeks). | |
Primary | Pain Scores | Mean and peak pain scores assessed using current standard University of California, Davis Medical Center protocols in the preoperative and postoperative period. Depending upon the age of the child and development, the Wong-Baker-Facies scale or numerical scale will be utilized in the hospital, both scored on a scale from 0 to 10, with higher scores indicating greater pain. | Preoperative (one week to two months) to postoperative period (six weeks). | |
Primary | Narcotic Usage | Narcotic usage will be assessed. Morphine and hydrocodone in mg/kg will be recorded and evaluated over the hospitalization period. | Postoperative (six weeks) |
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