Overactive BladderNCT07046156
Treatment of Overactive Bladder With Anticholinergic Agents
An observational study of Overactive Bladder, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the efficacy and adverse effect incidence of three different anticholinergics (oxybutinin, propiverine, and tolterodine) that are used in children with overactive bladder. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Oxybutynin Cl, propiverine and Tolterodine
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients who were treated for overactive bladder in pediatric urology clinic of Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital
Who may be able to join
- Patients diagnosed with overactive bladder
- Patients treated with an anticholinergic
Who cannot join
- Presence of anatomical or neurological problems
- Patients with missing data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sancaktepe Sehit Prof dr Ilhan Varank Training and Research Hospital
Istanbul
About this study
Official title: Evaluation of Anticholinergic Treatment Response and Predictive Factors in Pediatric Overactive Bladder
This study aims to evaluate the efficacy and adverse effect incidence of three different anticholinergics (oxybutinin, propiverine, and tolterodine) that are used in children with overactive bladder.
Read the detailed description
A total of approximately 150 patients with overactive bladder will be evaluated retrospectively. Clinical and demographic data and voiding diaries of these patients will be evaluated. For this purpose, patients will be divided into mainly three groups according to the anticholinergic agent used.
- Conditions
- Overactive Bladder
- Being tested
- Oxybutynin Cl, propiverine, Tolterodine
- Keywords
- overactive bladder, children, oxybutynin, propiverine, tolterodine
- 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.
Oxybutynin ClDrug
Oxybutynin in a dose of 0.5 mg/kg will be used in the treatment of overactive bladder
propiverineDrug
Propiverine in a dose of 0.8 mg/kg will be used in the treatment of overactive bladder
TolterodineDrug
Tolterodine in a dose of 0.1 mg/kg will be used in the treatment of overactive bladder
| Study group | Role | What they receive |
|---|---|---|
| Oxybutynin | Patients treated with oxybutynin Receives: Drug: Oxybutynin Cl | |
| Propiverine | Patients treated with propiverine Receives: Drug: propiverine | |
| Tolterodine | Patients treated with tolterodine Receives: Drug: Tolterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated with anticholinergic
Measured: 6 months
Number of patients with drug related adverse effects
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Sep 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Adem Canbaz, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046156
- Sponsor's protocol ID
- Ivstrh - OAB
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ramsay S, Bolduc S. Overactive bladder in children. Can Urol Assoc J. 2017 Jan-Feb;11(1-2Suppl1):S74-S79. doi: 10.5489/cuaj.4337.
PubMed 28265325Park SJ, Pai KS, Kim JM, Park K, Kim KS, Song SH, Park S, Kim SO, Ryu DS, Baek M, Lee SD, Lee JW, Im YJ, Han SW, Chung JM, Cho MH, Ha TS, Cho WY, Suh HJ; Korean Children's Continence and Enuresis Society. Efficacy and tolerability of anticholinergics in Korean children with overactive bladder: a multicenter retrospective study. J Korean Med Sci. 2014 Nov;29(11):1550-4. doi: 10.3346/jkms.2014.29.11.1550. Epub 2014 Nov 4.
PubMed 25408588Canbaz FA. Response to anticholinergic therapy and its predictors in pediatric overactive bladder. Eur J Pediatr. 2025 Nov 3;184(11):727. doi: 10.1007/s00431-025-06545-3.
PubMed 41182445
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anticholinergic Treatment Response and Predictive Factors in Pediatric Overactive Bladder
- ClinicalTrials.gov ID
- NCT07046156
- Acronym / sponsor ID
- Ivstrh - OAB
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, children, oxybutynin, propiverine, tolterodine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 1 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 study aims to evaluate the efficacy and adverse effect incidence of three different anticholinergics (oxybutinin, propiverine, and tolterodine) that are used in children with overactive bladder.
Detailed description
A total of approximately 150 patients with overactive bladder will be evaluated retrospectively. Clinical and demographic data and voiding diaries of these patients will be evaluated. For this purpose, patients will be divided into mainly three groups according to the anticholinergic agent used.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxybutynin | – | Drug: Oxybutynin ClPatients treated with oxybutynin |
| Propiverine | – | Drug: propiverinePatients treated with propiverine |
| Tolterodine | – | Drug: TolterodinePatients treated with tolterodine |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients who were treated for overactive bladder in pediatric urology clinic of Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital
Key inclusion criteria (2 listed)
- Patients diagnosed with overactive bladder
- Patients treated with an anticholinergic
Key exclusion criteria (2 listed)
- Presence of anatomical or neurological problems
- Patients with missing data
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 |
|---|---|---|
| Oxybutynin ClOxybutynin in a dose of 0.5 mg/kg will be used in the treatment of overactive bladder | Drug | Oxybutynin |
| propiverinePropiverine in a dose of 0.8 mg/kg will be used in the treatment of overactive bladder | Drug | Propiverine |
| TolterodineTolterodine in a dose of 0.1 mg/kg will be used in the treatment of overactive bladder | Drug | Tolterodine |
Primary outcome
Number of patients treated with anticholinergic
Time frame: 6 months
Number of patients with drug related adverse effects
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Background: PubMed 28265325Ramsay S, Bolduc S. Overactive bladder in children. Can Urol Assoc J. 2017 Jan-Feb;11(1-2Suppl1):S74-S79. doi: 10.5489/cuaj.4337.
- Background: PubMed 25408588Park SJ, Pai KS, Kim JM, Park K, Kim KS, Song SH, Park S, Kim SO, Ryu DS, Baek M, Lee SD, Lee JW, Im YJ, Han SW, Chung JM, Cho MH, Ha TS, Cho WY, Suh HJ; Korean Children's Continence and Enuresis Society. Efficacy and tolerability of anticholinergics in Korean children with overactive bladder: a multicenter retrospective study. J Korean Med Sci. 2014 Nov;29(11):1550-4. doi: 10.3346/jkms.2014.29.11.1550. Epub 2014 Nov 4.
- Derived from this study: PubMed 41182445Canbaz FA. Response to anticholinergic therapy and its predictors in pediatric overactive bladder. Eur J Pediatr. 2025 Nov 3;184(11):727. doi: 10.1007/s00431-025-06545-3.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 1 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of patients treated with anticholinergic (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07046156, which also lists 3 linked publications.
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 1 Jul 2025.