Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT07081906
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2025-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transdermal Versus Oral Oxybutynin in Pediatric OAB
Sponsor:
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Organization:
Study Overview
Official Title:
A Prospective and Randomized Study of Efficacy and Safety of Transdermal Oxybutynin Versus Oral Oxybutynin in The Management of Children With Overactive Bladder
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective, randomized controlled clinical trial designed to compare the efficacy and safety of transdermal versus oral oxybutynin in children diagnosed with overactive bladder (OAB) who remain symptomatic despite conservative management. A total of 90 children were planned to be enrolled and randomized to receive either oral oxybutynin suspension or a transdermal oxybutynin patch. The primary outcome was defined as the change in Dysfunctional Voiding and Incontinence Symptom Score (DVISS) from baseline to the end of the treatment period. Secondary outcomes included changes in urinary frequency, voided volume, maximum flow rate (Qmax), and the incidence of adverse events. The study aimed to assess whether the transdermal route of administration provides an alternative therapeutic option with favorable tolerability in pediatric OAB patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: