NCT07046156

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Sep 2022Jun 2026

Study Start

First participant enrolled

September 1, 2022

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2025

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

2.8 years

First QC Date

June 23, 2025

Last Update Submit

June 23, 2025

Conditions

Keywords

overactive bladderchildrenoxybutyninpropiverinetolterodine

Outcome Measures

Primary Outcomes (2)

  • Number of patients treated with anticholinergic

    6 months

  • Number of patients with drug related adverse effects

    1 month

Study Arms (3)

Oxybutynin

Patients treated with oxybutynin

Drug: Oxybutynin Cl

Propiverine

Patients treated with propiverine

Drug: propiverine

Tolterodine

Patients treated with tolterodine

Drug: Tolterodine

Interventions

Oxybutynin in a dose of 0.5 mg/kg will be used in the treatment of overactive bladder

Oxybutynin

Propiverine in a dose of 0.8 mg/kg will be used in the treatment of overactive bladder

Propiverine

Tolterodine in a dose of 0.1 mg/kg will be used in the treatment of overactive bladder

Tolterodine

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients who were treated for overactive bladder in pediatric urology clinic of Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital

You may qualify if:

  • Patients diagnosed with overactive bladder
  • Patients treated with an anticholinergic

You may not qualify if:

  • Presence of anatomical or neurological problems
  • Patients with missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sancaktepe Sehit Prof dr Ilhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 28265325BACKGROUND
  • Park 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.

    PMID: 25408588BACKGROUND
  • Canbaz 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.

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

propiverineTolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenols

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 1, 2025

Study Start

September 1, 2022

Primary Completion

June 30, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

July 1, 2025

Record last verified: 2025-06

Locations