Transdermal Versus Oral Oxybutynin in Pediatric OAB

NCT ID: NCT07081906

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2020-05-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Oxybutynin

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

Group Type: ACTIVE_COMPARATOR

Oral Oxybutynin

Intervention Type: DRUG

The oral form of oxybutinin was preferred for patients who had no difficulty swallowing and whose families preferred a conventional administration route. Medication was given under parental supervision to ensure adherence. Patients were monitored monthly for potential anticholinergic side effects. The patch form of oxybutinin was chosen for patients who experienced difficulties with oral intake or had previous intolerance to oral anticholinergics. Application sites were rotated to reduce the risk of local skin reactions. Families received instructions on proper patch application technique.

Transdermal oxybutynin

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

Group Type: ACTIVE_COMPARATOR

transdermal oxybutinin

Intervention Type: DRUG

The oral form of oxybutinin was preferred for patients who had no difficulty swallowing and whose families preferred a conventional administration route. Medication was given under parental supervision to ensure adherence. Patients were monitored monthly for potential anticholinergic side effects. The patch form of oxybutinin was chosen for patients who experienced difficulties with oral intake or had previous intolerance to oral anticholinergics. Application sites were rotated to reduce the risk of local skin reactions. Families received instructions on proper patch application technique.

Interventions

Oral Oxybutynin

The oral form of oxybutinin was preferred for patients who had no difficulty swallowing and whose families preferred a conventional administration route. Medication was given under parental supervision to ensure adherence. Patients were monitored monthly for potential anticholinergic side effects. The patch form of oxybutinin was chosen for patients who experienced difficulties with oral intake or had previous intolerance to oral anticholinergics. Application sites were rotated to reduce the risk of local skin reactions. Families received instructions on proper patch application technique.

Intervention Type: DRUG

transdermal oxybutinin

The oral form of oxybutinin was preferred for patients who had no difficulty swallowing and whose families preferred a conventional administration route. Medication was given under parental supervision to ensure adherence. Patients were monitored monthly for potential anticholinergic side effects. The patch form of oxybutinin was chosen for patients who experienced difficulties with oral intake or had previous intolerance to oral anticholinergics. Application sites were rotated to reduce the risk of local skin reactions. Families received instructions on proper patch application technique.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ahmet Halil Sevinc

MD - Urology Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmet H Sevinc, MD, Urology Specialist

Role: PRINCIPAL_INVESTIGATOR

Kartal Dr. Lütfi Kırdar Training and Research Hospital

Locations

Kartal Dr. Lütfi Kırdar Training and Research Hospital

Istanbul, Kartal, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

kartalcity_ahs_01

Identifier Type: -

Identifier Source: org_study_id