Transdermal Versus Oral Oxybutynin in Pediatric OAB

Not Applicable

Completed

• Conditions: Drug Delivery Systems; Overactive Bladder (OAB); Anticholinergic Side Effects; Children and Adolescents, Boys and Girls
• Interventions: Drug: Oral Oxybutynin; Drug: transdermal oxybutinin

• Registration Number: NCT07081906
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

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

Not available

Study Timeline

• Study Start: 2019-02-15
• Primary Completion: 2019-07-15
• Study Completion: 2020-05-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Persistent symptoms of overactive bladder (OAB) despite at least 3 months of conservative treatment (e.g., behavioral therapy, planned fluid intake, and voiding schedules)
• No prior medical or surgical treatment for OAB
• Ability to attend follow-up visits with family/guardian
• Written informed consent obtained from a legal guardian

Exclusion Criteria

• History of febrile or recurrent urinary tract infections
• Presence of urethral stricture
• Known or suspected neurogenic bladder dysfunction
• Previous bladder surgery
• History of urolithiasis (kidney stones)
• Contraindications to oxybutynin therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Oxybutynin	Oral Oxybutynin	Participants received oral oxybutynin suspension (5 mg, 2-3 times daily depending on body weight) for 3 months.
Transdermal oxybutynin	transdermal oxybutinin	Participants received transdermal oxybutynin patch (3.9 mg/day) applied twice weekly for 3 months.

Primary Outcome Measures

Name	Time	Method
Dysfunctional Voiding and Incontinence Symptom Score (DVISS)	From enrollment to the end of treatment at three months	The primary outcome was the change in DVISS score, a validated questionnaire assessing lower urinary tract symptoms in children. Scores range from 0 to 35, with higher scores indicating more severe symptoms.

Trial Locations

Locations (1)

Kartal Dr. Lütfi Kırdar Training and Research Hospital; 🇹🇷 Istanbul, Kartal, Turkey