Anticholinergic Side Effects, Children and Adolescents, Boys and Girls, Drug Delivery Systems, Overactive Bladder (OAB)
Conditions
Keywords
overactive bladder, oxybutynin, transdermal, children, anticholinergic side effects
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.
Interventions
DRUGOral 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.
DRUGtransdermal 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.
Sponsors
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed