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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Oxybutynin | Active Comparator | Participants received oral oxybutynin suspension (5 mg, 2-3 times daily depending on body weight) for 3 months. |
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| Transdermal oxybutynin | Active Comparator | Participants received transdermal oxybutynin patch (3.9 mg/day) applied twice weekly for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet H Sevinc, MD, Urology Specialist | Kartal Dr. Lütfi Kırdar Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kartal Dr. Lütfi Kırdar Training and Research Hospital | Istanbul | Kartal | 34890 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C005419 | oxybutynin |
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| 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. |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |