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Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)

NCT06465576 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2025-12-15

No results posted yet for this study

Summary

The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy (solifenacin and/or mirabegron) influences the risk of recurrence of incontinence.

Children aged 5-14 years diagnosed with urinary incontinence, treated with pharmacotherapy of solifenacin and/or mirabegron and ready for withdrawal will be randomized 1:1 to either abrupt or gradual withdrawal, according to the medical treatment that the child is receiving.

Conditions

  • Urinary Incontinence in Children

Interventions

DRUG

Solifenacin

Abrupt withdrawal indicates stopping the medication on the date of withdrawal initiation. Gradual withdrawal involves taking the applied dosage of the medication every other day over a period of 14 days, with the complete cessation of the medication occurring 14 days after the gradual withdrawal process begins.

DRUG

Mirabegron

Abrupt withdrawal indicates stopping the medication on the date of withdrawal initiation. Gradual withdrawal involves taking the applied dosage of the medication every other day over a period of 14 days, with the complete cessation of the medication occurring 14 days after the gradual withdrawal process begins.

DRUG

Solifenacin + Mirabegron

Abrupt withdrawal indicates stopping the medication on the date of withdrawal initiation. Gradual withdrawal involves taking the applied dosage of the medication every other day over a period of 14 days, with the complete cessation of the medication occurring 14 days after the gradual withdrawal process begins.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Luise Borch, MD, PhD · Department of Pediatric and Adolescent Medicine, Gødstrup Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-27
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06465576 on ClinicalTrials.gov