The Role of Urinary ATP in the Diagnosis, Treatment, and Follow-up of Children with Overactive Bladder

NCT06785558 | Completed

• 1 other identifier: MAR.UAD.0012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder (OAB)

Keywords

Overactive bladder, urinary ATP, pediatric urology

Outcome Measures

Primary Outcomes (1)

• Urinary ATP levels

  Baseline

Secondary Outcomes (1)

• Urinary ATP levels

  1 month

Study Arms (2)

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

Drug: Anticholinergic therapy

Interventions

Anticholinergic therapy DRUG

Overactive bladder group use anticholinergic drug and 1 month later their urinary atp levels calculated again

Overactive Bladder Group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The patient is under 18 years of age
• OAB symptoms may be accompanied by frequent urination, urgency, and urinary incontinence

You may not qualify if:

• Neurological disease
• malignancy
• active urinary tract infection
• bladder anomaly (uroterocele, diverticulum),
• LUS obstruction, ectopic ureter
• history of previous urological surgery

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Urology Department

Istanbul, Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 34906515 BACKGROUND

• Altuntas 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.

  PMID: 41097836 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• CAGRI AKIN SEKERCİ

  MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 21, 2025
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: November 15, 2024
• Last Updated: January 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)