Overactive Bladder (OAB)NCT07081906
Transdermal Versus Oral Oxybutynin in Pediatric OAB
A study testing Oral Oxybutynin and transdermal oxybutinin in people with Overactive Bladder (OAB) and Drug Delivery Systems, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Overactive Bladder (OAB), Drug Delivery Systems, Anticholinergic Side Effects
- What is being tested?
- Oral Oxybutynin and transdermal oxybutinin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kırdar Training and Research Hospital
Istanbul, Kartal, 34890
About this study
Official title: A Prospective and Randomized Study of Efficacy and Safety of Transdermal Oxybutynin Versus Oral Oxybutynin in The Management of Children With Overactive Bladder
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
- Being tested
- Oral Oxybutynin, transdermal oxybutinin
- Keywords
- overactive bladder, oxybutynin, transdermal, children, anticholinergic side effects
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral OxybutyninDrug
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 oxybutininDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Oxybutynin | Active comparator | Participants received oral oxybutynin suspension (5 mg, 2-3 times daily depending on body weight) for 3 months. Receives: Drug: Oral Oxybutynin |
| Transdermal oxybutynin | Active comparator | Participants received transdermal oxybutynin patch (3.9 mg/day) applied twice weekly for 3 months. Receives: Drug: transdermal oxybutinin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start15 Feb 2019
- Primary completion15 Jul 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Halil Sevinc, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Ahmet H Sevinc, MD, Urology Specialist, Principal investigator, Kartal Dr. Lütfi Kırdar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081906
- Sponsor's protocol ID
- kartalcity_ahs_01
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Randomized Study of Efficacy and Safety of Transdermal Oxybutynin Versus Oral Oxybutynin in The Management of Children With Overactive Bladder
- ClinicalTrials.gov ID
- NCT07081906
- Acronym / sponsor ID
- kartalcity_ahs_01
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Oxybutynin | Active comparator | Drug: Oral OxybutyninParticipants received oral oxybutynin suspension (5 mg, 2-3 times daily depending on body weight) for 3 months. |
| Transdermal oxybutynin | Active comparator | Drug: transdermal oxybutininParticipants received transdermal oxybutynin patch (3.9 mg/day) applied twice weekly for 3 months. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral OxybutyninThe 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. | Drug | Oral Oxybutynin |
| transdermal oxybutininThe 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. | Drug | Transdermal oxybutynin |
Primary outcome
Dysfunctional Voiding and Incontinence Symptom Score (DVISS)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet H Sevinc, MD, Urology Specialist principal investigator
Kartal Dr. Lütfi Kırdar Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Oxybutynin and transdermal oxybutinin in people with Overactive Bladder (OAB) and Drug Delivery Systems, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysfunctional Voiding and Incontinence Symptom Score (DVISS) (time frame: From enrollment to the end of treatment at three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.