Transdermal Versus Oral Oxybutynin in Pediatric OAB

NCT07081906 | Completed

• 1 other identifier: kartalcity_ahs_01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

overactive bladder; oxybutynin; transdermal; children; anticholinergic side effects

Outcome Measures

Primary Outcomes (1)

• Dysfunctional Voiding and Incontinence Symptom Score (DVISS)

  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.

  From enrollment to the end of treatment at three months

Study Arms (2)

Oral Oxybutynin

ACTIVE COMPARATOR

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

Drug: Oral Oxybutynin

Transdermal oxybutynin

ACTIVE COMPARATOR

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

Drug: transdermal oxybutinin

Interventions

Oral Oxybutynin 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.

Oral Oxybutynin

transdermal oxybutinin 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

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr. Lütfi Kırdar Training and Research Hospital

Istanbul, Kartal, 34890, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmet H Sevinc, MD, Urology Specialist

  Kartal Dr. Lütfi Kırdar Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD - Urology Specialist

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 23, 2025
• Study Start: February 15, 2019
• Primary Completion: July 15, 2019
• Study Completion: May 1, 2020
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)