Transdermal Versus Oral Oxybutynin in Pediatric OAB

Republic of Turkey Ministry of Health

Status: Completed

Conditions: Anticholinergic Side Effects; Overactive Bladder (OAB); Drug Delivery Systems; Children and Adolescents, Boys and Girls

Treatments: Drug: transdermal oxybutinin; Drug: Oral Oxybutynin

Study type: Interventional

Funder types: Other

Identifiers

NCT07081906

kartalcity_ahs_01

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Oral Oxybutynin

Active Comparator group

Description:

Participants received oral oxybutynin suspension (5 mg, 2-3 times daily depending on body weight) for 3 months.

Treatment:

Drug: Oral Oxybutynin

Transdermal oxybutynin

Active Comparator group

Description:

Participants received transdermal oxybutynin patch (3.9 mg/day) applied twice weekly for 3 months.

Treatment:

Drug: transdermal oxybutinin