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

NCT06465576 | Recruiting Phase 4

• 1 other identifier: StayDry
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Urinary incontinence; Withdrawal; Children; Solifenacin; Mirabegron

Outcome Measures

Primary Outcomes (1)

• Recurrence of incontinence after withdrawal

  Assessed by a 14-day calendar of incontinence episodes

  Baseline and up to 12 months follow-up

Secondary Outcomes (1)

• Development of any symptoms related to abrupt or gradual withdrawal symptoms

  Baseline up to 44 days after initiation of withdrawal

Study Arms (6)

Abrupt withdrawal of solifenacin

EXPERIMENTAL

Drug: Solifenacin

Gradual withdrawal of solifenacin

EXPERIMENTAL

Drug: Solifenacin

Abrupt withdrawal of mirabegron

EXPERIMENTAL

Drug: Mirabegron

Gradual withdrawal of mirabegron

EXPERIMENTAL

Drug: Mirabegron

Abrupt withdrawal of solifenacin + mirabegron

EXPERIMENTAL

Drug: Solifenacin + Mirabegron

Gradual withdrawal of solifenacin + mirabegron

EXPERIMENTAL

Drug: Solifenacin + Mirabegron

Interventions

Solifenacin DRUG

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.

Abrupt withdrawal of solifenacin; Gradual withdrawal of solifenacin

Mirabegron DRUG

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.

Abrupt withdrawal of mirabegron; Gradual withdrawal of mirabegron

Solifenacin + Mirabegron DRUG

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.

Abrupt withdrawal of solifenacin + mirabegron; Gradual withdrawal of solifenacin + mirabegron

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.
• Diagnose with urinary incontinence as per ICCS criteria.
• Pharmacological treatment with solifenacin and/or mirabegron.
• Continence has been achieved on pharmacological therapy with solifenacin and/or mirabegron.
• Previously withdrawal attempts are accepted.
• Continence remained on the same dosage of medication for a minimum of three months.

You may not qualify if:

• Inability of the patent(s) or parental custody holder(s) to understand the Danish written and oral information.
• Neurogenic detrusor overactivity (neurogenic bladder)

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (5)

Department of Pediatric and Adolescent Medicine, Aalborg University Hospital

Aalborg, Aalborg, 9000, Denmark

RECRUITING

Department of Pediatric and Adolescent Medicine, Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

RECRUITING

Department of Pediatric and Adolescent medicine, Esbjerg Hospital

Esbjerg, Esbjerg, 6700, Denmark

NOT YET RECRUITING

Department of Pediatric and Adolescent Medicine, Gødstrup Hospital

Herning, Herning, 7400, Denmark

RECRUITING

Department of Pediatric and Adolescent Medicine, Kolding Hospital

Kolding, Kolding, 6000, Denmark

NOT YET RECRUITING

Related Publications (1)

• Svendsen AM, Hagstrom S, Kamperis K, Andersen AE, Henneberg NC, Van Batavia J, Olesen AE, Borch L. Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry): Protocol for an Open-Label Prospective Randomized Trial. JMIR Res Protoc. 2025 Jul 9;14:e63226. doi: 10.2196/63226.

  PMID: 40633093 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Solifenacin Succinate; mirabegron

Condition Hierarchy (Ancestors)

Urination Disorders; 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

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Luise Borch, MD, PhD

  Department of Pediatric and Adolescent Medicine, Gødstrup Hospital

  STUDY DIRECTOR

Central Study Contacts

Ann-Kristine Mandøe Svendsen, MD

CONTACT

+45 78430408; ankrso@rm.dk

Luise Borch, MD, PhD

CONTACT

+45 78433654; luise.borch@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within each pharmaceutical group, the participant will be randomized 1:1 to the intervention being compared; either abrupt withdrawal or gradual withdrawal.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: May 27, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)