Overactive Bladder (OAB)NCT06785558
The Role of Urinary ATP in the Diagnosis, Treatment, and Follow-up of Children With Overactive Bladder
A study testing Anticholinergic therapy in people with Overactive Bladder (OAB), run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aim to evaluate the role of urinary ATP as a biomarker for the diagnosis, treatment, and follow-up of OAB in children for the first time in a clinical investigation, as previous research has been limited to adults. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Anticholinergic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 15 Nov 2024
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The patient is under 18 years of age
- OAB symptoms may be accompanied by frequent urination, urgency, and urinary incontinence
Who cannot join
- Neurological disease
- malignancy
- active urinary tract infection
- bladder anomaly (uroterocele, diverticulum),
- LUS obstruction, ectopic ureter
- history of previous urological surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Urology Department
Istanbul, Istanbul, 34854
About this study
In this study, the investigators aim to evaluate the role of urinary ATP as a biomarker for the diagnosis, treatment, and follow-up of OAB in children for the first time in a clinical investigation, as previous research has been limited to adults.
Read the detailed description
The diagnosis of OAB primarily relies on medical history and physical examination. Diagnosis is supported by appropriate laboratory findings and imaging methods. The role of various urinary biomarkers has been investigated as a non-invasive and simple diagnostic method. In recent years, research has focused on several biomarkers, particularly low-grade inflammatory mediators such as cytokines, Prostaglandin E2 (PGE2), Nerve Growth Factor (NGF), and Brain-Derived Neurotrophic Factor (BDNF). However, although these biomarkers are correlated with the severity of OAB symptoms, no studies have demonstrated their independent prognostic value.
For example, some studies report significant variability in urinary NGF levels, with not all patients showing increased urinary NGF. Other studies have noted that NGF correlates with OAB symptoms and decreases significantly after treatment. Consequently, no biomarker has yet been defined for routine clinical use. Moreover, biomarker studies specifically targeting pediatric OAB are limited, with most research focusing on adult populations and extrapolating findings to children.
Today, there is growing recognition of the role of purinergic transmission in urinary dysfunction. Purinergic transmission involves both afferent and efferent pathways in bladder emptying and has been implicated in the pathogenesis of detrusor overactivity (DO). In vitro studies have demonstrated that bladders with DO release higher amounts of Adenosine Triphosphate (ATP) from urothelium and cholinergic nerve terminals compared to normal bladders. Clinical studies suggest that urinary ATP levels could serve as a potential biomarker for OAB in adults. However, our literature review revealed that this biomarker has not yet been evaluated in children with OAB.
In this study, the investigators aim to evaluate the role of urinary ATP as a biomarker for the diagnosis, treatment, and follow-up of OAB in children for the first time in a clinical investigation, as previous research has been limited to adults.
Two midstream urine samples will collected from the OAB group: one pre-treatment and one at the first month of anticholinergic treatment. Urine samples will centrifuged, stored at -80°C, and ATP levels will measure via ELISA. Comparisons will make between the groups and pre-/post-treatment ATP levels in the OAB group. Correlation analysis will conduct between ATP levels and lower urinary system (LUS) parameters.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- Anticholinergic therapy
- Keywords
- Overactive bladder, urinary ATP, pediatric urology
- 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.
Anticholinergic therapyDrug
Overactive bladder group use anticholinergic drug and 1 month later their urinary atp levels calculated again
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Group | No intervention | The study include healthy control group with 10 child who haven't overactive bladder symptoms |
| Overactive Bladder Group | Active comparator | 30 child wit overactive bladder symptoms Receives: Drug: Anticholinergic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary ATP levels
Measured: Baseline
Secondary outcomes (1)
Urinary ATP levels
Measured only overactive bladder group
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 posted21 Jan 2025
- Study start1 Jan 2024
- Primary completion1 Sep 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CAGRI AKIN SEKERCİ, Study director, MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785558
- Sponsor's protocol ID
- MAR.UAD.0012
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seltzsam S, Wang C, Zheng B, Mann N, Connaughton DM, Wu CW, Schneider S, Schierbaum L, Kause F, Kolvenbach CM, Nakayama M, Dai R, Ottlewski I, Schneider R, Deutsch K, Buerger F, Klambt V, Mao Y, Onuchic-Whitford AC, Nicolas-Frank C, Yousef K, Pantel D, Lai EW, Salmanullah D, Majmundar AJ, Bauer SB, Rodig NM, Somers MJG, Traum AZ, Stein DR, Daga A, Baum MA, Daouk GH, Tasic V, Awad HS, Eid LA, El Desoky S, Shalaby M, Kari JA, Fathy HM, Soliman NA, Mane SM, Shril S, Ferguson MA, Hildebrandt F. Reverse phenotyping facilitates disease allele calling in exome sequencing of patients with CAKUT. Genet Med. 2022 Feb;24(2):307-318. doi: 10.1016/j.gim.2021.09.010. Epub 2021 Nov 30.
PubMed 34906515Altuntas T, Sekerci CA, Basok BI, Fidan M, Ozkan OC, Yucel S, Cam K, Tarcan T. The Role of Urinary ATP in the Diagnosis, Treatment, and Follow-up of Children With Overactive Bladder. Neurourol Urodyn. 2026 Jan;45(1):218-224. doi: 10.1002/nau.70168. Epub 2025 Oct 15.
PubMed 41097836
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Urinary ATP in the Diagnosis, Treatment, and Follow-up of Children With Overactive Bladder
- ClinicalTrials.gov ID
- NCT06785558
- Acronym / sponsor ID
- MAR.UAD.0012
- Conditions
- Overactive Bladder (OAB)
- Keywords
- Overactive bladder, urinary ATP, pediatric urology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 21 Jan 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.
In this study, the investigators aim to evaluate the role of urinary ATP as a biomarker for the diagnosis, treatment, and follow-up of OAB in children for the first time in a clinical investigation, as previous research has been limited to adults.
Detailed description
The diagnosis of OAB primarily relies on medical history and physical examination. Diagnosis is supported by appropriate laboratory findings and imaging methods. The role of various urinary biomarkers has been investigated as a non-invasive and simple diagnostic method. In recent years, research has focused on several biomarkers, particularly low-grade inflammatory mediators such as cytokines, Prostaglandin E2 (PGE2), Nerve Growth Factor (NGF), and Brain-Derived Neurotrophic Factor (BDNF). However, although these biomarkers are correlated with the severity of OAB symptoms, no studies have demonstrated their independent prognostic value.
For example, some studies report significant variability in urinary NGF levels, with not all patients showing increased urinary NGF. Other studies have noted that NGF correlates with OAB symptoms and decreases significantly after treatment. Consequently, no biomarker has yet been defined for routine clinical use. Moreover, biomarker studies specifically targeting pediatric OAB are limited, with most research focusing on adult populations and extrapolating findings to children.
Today, there is growing recognition of the role of purinergic transmission in urinary dysfunction. Purinergic transmission involves both afferent and efferent pathways in bladder emptying and has been implicated in the pathogenesis of detrusor overactivity (DO). In vitro studies have demonstrated that bladders with DO release higher amounts of Adenosine Triphosphate (ATP) from urothelium and cholinergic nerve terminals compared to normal bladders. Clinical studies suggest that urinary ATP levels could serve as a potential biomarker for OAB in adults. However, our literature review revealed that this biomarker has not yet been evaluated in children with OAB.
In this study, the investigators aim to evaluate the role of urinary ATP as a biomarker for the diagnosis, treatment, and follow-up of OAB in children for the first time in a clinical investigation, as previous research has been limited to adults.
Two midstream urine samples will collected from the OAB group: one pre-treatment and one at the first month of anticholinergic treatment. Urine samples will centrifuged, stored at -80°C, and ATP levels will measure via ELISA. Comparisons will make between the groups and pre-/post-treatment ATP levels in the OAB group. Correlation analysis will conduct between ATP levels and lower urinary system (LUS) parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | No intervention | –The study include healthy control group with 10 child who haven't overactive bladder symptoms |
| Overactive Bladder Group | Active comparator | Drug: Anticholinergic therapy30 child wit overactive bladder symptoms |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- The patient is under 18 years of age
- OAB symptoms may be accompanied by frequent urination, urgency, and urinary incontinence
Key exclusion criteria (6 listed)
- Neurological disease
- malignancy
- active urinary tract infection
- bladder anomaly (uroterocele, diverticulum),
- LUS obstruction, ectopic ureter
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 |
|---|---|---|
| Anticholinergic therapyOveractive bladder group use anticholinergic drug and 1 month later their urinary atp levels calculated again | Drug | Overactive Bladder Group |
Primary outcome
Urinary ATP levels
Time frame: Baseline
1 secondary outcome
Urinary ATP levels
Time frame: 1 month
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 21 Jan 2025.
- Results publication: PubMed 34906515Seltzsam S, Wang C, Zheng B, Mann N, Connaughton DM, Wu CW, Schneider S, Schierbaum L, Kause F, Kolvenbach CM, Nakayama M, Dai R, Ottlewski I, Schneider R, Deutsch K, Buerger F, Klambt V, Mao Y, Onuchic-Whitford AC, Nicolas-Frank C, Yousef K, Pantel D, Lai EW, Salmanullah D, Majmundar AJ, Bauer SB, Rodig NM, Somers MJG, Traum AZ, Stein DR, Daga A, Baum MA, Daouk GH, Tasic V, Awad HS, Eid LA, El Desoky S, Shalaby M, Kari JA, Fathy HM, Soliman NA, Mane SM, Shril S, Ferguson MA, Hildebrandt F. Reverse phenotyping facilitates disease allele calling in exome sequencing of patients with CAKUT. Genet Med. 2022 Feb;24(2):307-318. doi: 10.1016/j.gim.2021.09.010. Epub 2021 Nov 30.
- Derived from this study: PubMed 41097836Altuntas T, Sekerci CA, Basok BI, Fidan M, Ozkan OC, Yucel S, Cam K, Tarcan T. The Role of Urinary ATP in the Diagnosis, Treatment, and Follow-up of Children With Overactive Bladder. Neurourol Urodyn. 2026 Jan;45(1):218-224. doi: 10.1002/nau.70168. Epub 2025 Oct 15.
- 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.
CAGRI AKIN SEKERCİ study director
MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticholinergic therapy in people with Overactive Bladder (OAB), run by Marmara University 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 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 21 Jan 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?
Urinary ATP levels (time frame: Baseline). 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 NCT06785558, which also lists 2 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 21 Jan 2025.