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Oxybutynin for Post-surgical Bladder Pain and Urgency

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ClinicalTrials.gov Identifier: NCT03952299
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date May 24, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Urgency Scores [ Time Frame: Preoperative (one week to two months) to postoperative period (six weeks). ]
    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.
  • Pain Scores [ Time Frame: Preoperative (one week to two months) to postoperative period (six weeks). ]
    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.
  • Narcotic Usage [ Time Frame: Postoperative (six weeks) ]
    Narcotic usage will be assessed. Morphine and hydrocodone in mg/kg will be recorded and evaluated over the hospitalization period.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Urgency Scores [ Time Frame: Preoperative (one week to two months) to postoperative period (six weeks). ]
    Mean and peak urgency scores measured using the Pictorial Scale of Bladder Urgency. Children will choose one of four illustrations depicting bladder urgency.
  • Pain Scores [ Time Frame: Preoperative (one week to two months) to postoperative period (six weeks). ]
    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.
  • Narcotic Usage [ Time Frame: Postoperative (six weeks) ]
    Narcotic usage will be assessed. Morphine and hydrocodone in mg/kg will be recorded and evaluated over the hospitalization period.
Change History Complete list of historical versions of study NCT03952299 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxybutynin for Post-surgical Bladder Pain and Urgency
Official Title  ICMJE Oxybutynin for Post-surgical Bladder Pain and Urgency
Brief 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.
Detailed Description

Pain after bladder surgery is typically controlled with narcotics, non-steroidal anti-inflammatory medications, acetaminophen, regional anesthesia (caudal or epidural) and/or bladder muscle (detrusor) antispasmodic medication. It is often difficult to distinguish bladder pain from a sensation of urinary urgency and most likely patients are experiencing both sensations despite the bladder being empty from the indwelling catheter.

Prior studies on adults have demonstrated the efficacy of preoperative oxybutynin and other antimuscarinics on decreasing catheter-related bladder discomfort in the postoperative period. For pediatric bladder surgery very few studies have been published. Intravenous ketorolac, epidural and caudal analgesia and intravesical ropivacaine have been shown to decrease postoperative bladder spasms. Intravesical oxybutynin has been used in the operating room in adults to decrease post-operative ureteral stent pain.

For open bladder surgery the current pain management standard is intra- and postoperative ketorolac (Q6hrs) and acetaminophen and narcotic as needed. Oral oxybutynin is started pre-operatively and then continued post-operatively every 8 hours. Unfortunately, the bioavailability of oral oxybutynin is poor due to first pass (liver) metabolism of the absorbed medication and a subsequent high level of desethyloxybutynin (DEO) produced by the liver. DEO, responsible for most of the side effects such as dry mouth, dizziness, over-heating, drowsiness and constipation. This metabolite and side effects are less with the transdermal route.

A prior retrospective analysis of children by the investigators did not show a difference in pain between starting oral oxybutynin pre-operatively or initiating medication post-operatively. Whether this was due to no difference, insufficient patient numbers or inability to distinguish bladder spasms from pain is unknown. That study employed the Wong-Baker-Facies scale for pain measurement in children. At the time of that study there was no valid scale for objective measurement of bladder urgency in adults or children. Over the last five years the investigators have developed a validated scale (IRB 647657, 638967) that will allow for a better measure and distinguish bladder and incisional pain from bladder spasms/urgency.

The objective is to determine if transdermal administration is superior to oral administration in alleviating pain and urgency after bladder surgery in children. Oral oxybutynin is a commonly used treatment in children with neuropathic bladder dysfunction and for adults with overactive bladder (OAB) and incontinence. As mentioned, transdermal administration has higher bioavailability and a lower adverse event profile. Transdermal administration has been shown to be safe and efficacious in children with neuropathic bladder disease. The hypothesis is that the transdermal route will decrease bladder pain and urgency if applied prior to surgery with a lower side effect profile.

Based upon the power analysis by Blythe Durbin-Johnson, Ph. D. The investigators plan to evaluate up to 100 patients with early termination if endpoints are reached before 100 subjects.

Outcomes will be compared between groups using two-sample t-tests if the outcome is sufficiently normally distributed, and Wilcoxon-rank sum tests otherwise. With 60 subjects divided among two groups, the two-sample t-test will have 80% power to detect a 0.74 standard deviation difference in outcomes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Group A: Oral Administration Current standard treatment at U.C. Davis Children's Hospital Oral oxybutynin (5mg) is administered in the preoperative area prior to surgery. Our 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.

Group B: Transdermal Administration 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.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Overactive Bladder Syndrome
  • Neuropathic Bladder
Intervention  ICMJE
  • Drug: Oxybutynin Transdermal Patch
    Transdermal patch of oxybutynin will be used instead of oral oxybutynin.
  • Drug: Oral Oxybutynin
    Oral administration of oxybutynin (5mg) every 8 hours in the hospital.
Study Arms  ICMJE
  • Active Comparator: Oral administration

    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.

    Intervention: Drug: Oral Oxybutynin
  • Experimental: Transdermal administration
    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.
    Intervention: Drug: Oxybutynin Transdermal Patch
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anjali Vij, BS 9167345173 avij@ucdavis.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952299
Other Study ID Numbers  ICMJE 1336293
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric A Kurzrock, MD UC Davis Health Center
PRS Account University of California, Davis
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP