Oxybutynin for Post-surgical Bladder Pain and Urgency

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT03952299
Phase
PHASE3
Status
Recruiting
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Conditions

  • Neuropathic Bladder
  • Overactive Bladder Syndrome

Eligibility Criteria

Sex
ALL
Age
4 Years - 8 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxybutynin Transdermal Patch — DRUG
    Transdermal patch of oxybutynin will be used instead of oral oxybutynin.
  • Oral Oxybutynin — DRUG
    Oral administration of oxybutynin (5mg) every 8 hours in the hospital.

Study Details

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.

Key Dates

Start date
Sep 1, 2021
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Urgency Scores [ Time Frame: Preoperative (one week to two months) to postoperative period (six weeks). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Medical Center (UCDMC)SacramentoCalifornia95817
Eric A Kurzrock, MD
[email protected]
916-734-6490
Anjali Vij, BS
[email protected]
9167345173

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By research site
University of California Davis Medical Center (UCDMC)· Sacramento, CA

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